This single-center randomized controlled trial compared outcomes of STEMI patients treated with bivalirudin (n=907) versus unfractionated heparin (n=905) during primary percutaneous coronary intervention (PPCI). At 28 days, the primary efficacy outcome (composite of death, stroke, reinfarction, unplanned revascularization) occurred more frequently in the bivalirudin group (8.7% vs 5.7%, p=0.01). The increased risk was driven by a higher rate of stent thrombosis with bivalirudin (3.4% vs 0.9%, p=0.001). Major bleeding rates were similar between groups (3.5% vs
This document discusses anticoagulation options for percutaneous coronary intervention (PCI). It summarizes trials comparing unfractionated heparin (UFH) to bivalirudin. The HEAT-PPCI trial found UFH was better than bivalirudin for reducing major adverse cardiac events, with equivalent rates of major bleeding. A meta-analysis of 16 trials found UFH reduced MACE compared to bivalirudin, with equivalent major bleeding when provisional glycoprotein IIb/IIIa inhibitors were used symmetrically. The document concludes that UFH at doses of 50-70 units/kg is the preferred anticoagulant for PCI based on superior efficacy and equivalent safety compared to b
This document summarizes the results of several clinical trials evaluating renal denervation for the treatment of hypertension. The SYMPLICITY HTN-3 trial, the largest study to date, found no significant difference in blood pressure reduction between the renal denervation and sham procedure groups. Subgroup analyses found some predictors of greater blood pressure response, such as use of alpha-1 blockers or baseline blood pressure over 180 mmHg. Overall, the data from clinical trials on renal denervation is mixed, with early studies showing promising results but larger trials like SYMPLICITY HTN-3 finding no clear benefit over sham procedures.
This document summarizes the results of the SAFE-PCI for Women Trial, which compared radial versus femoral approaches for percutaneous coronary intervention (PCI) in women. The trial was terminated early due to lower than expected rates of bleeding and vascular complications. In both the total randomized cohort and PCI cohort, radial access was associated with significantly lower rates of bleeding/vascular complications and procedural failure compared to femoral access. Secondary endpoints showed no significant differences in outcomes between approaches. The results suggest an initial strategy of radial access is reasonable for PCI in women.
- A study of 1352 PCI procedures at a radial center found that while 25.2% used femoral access, these cases had fewer complications (12.5% hematomas vs 6.25% requiring intervention) than expected given reduced femoral experience.
- Analysis of UK PCI data found radial use increased from 12-49% for PPCI, with no increase in femoral complications at radial centers and a possible reduction in 30-day mortality for femoral cases at radial centers.
- While radial access is safer, some patients still require femoral, and data suggests radial operators have good outcomes for these cases as well.
This randomized clinical trial compared transradial catheterization performed with or without prophylactic nitroglycerin to prevent radial artery spasm. 328 patients undergoing transradial cardiac catheterization were randomly assigned to receive either intra-arterial nitroglycerin or a saline placebo after sheath insertion. The trial found no significant differences in patient pain levels, procedure duration, radiation exposure, or need for analgesics between the two groups. However, the operators' subjective impression of artery spasm was lower in the nitroglycerin group. The study concluded that prophylactic nitroglycerin does not provide clear advantages and may not be necessarily required for transradial procedures.
This document discusses anticoagulation options for percutaneous coronary intervention (PCI). It summarizes trials comparing unfractionated heparin (UFH) to bivalirudin. The HEAT-PPCI trial found UFH was better than bivalirudin for reducing major adverse cardiac events, with equivalent rates of major bleeding. A meta-analysis of 16 trials found UFH reduced MACE compared to bivalirudin, with equivalent major bleeding when provisional glycoprotein IIb/IIIa inhibitors were used symmetrically. The document concludes that UFH at doses of 50-70 units/kg is the preferred anticoagulant for PCI based on superior efficacy and equivalent safety compared to b
This document summarizes the results of several clinical trials evaluating renal denervation for the treatment of hypertension. The SYMPLICITY HTN-3 trial, the largest study to date, found no significant difference in blood pressure reduction between the renal denervation and sham procedure groups. Subgroup analyses found some predictors of greater blood pressure response, such as use of alpha-1 blockers or baseline blood pressure over 180 mmHg. Overall, the data from clinical trials on renal denervation is mixed, with early studies showing promising results but larger trials like SYMPLICITY HTN-3 finding no clear benefit over sham procedures.
This document summarizes the results of the SAFE-PCI for Women Trial, which compared radial versus femoral approaches for percutaneous coronary intervention (PCI) in women. The trial was terminated early due to lower than expected rates of bleeding and vascular complications. In both the total randomized cohort and PCI cohort, radial access was associated with significantly lower rates of bleeding/vascular complications and procedural failure compared to femoral access. Secondary endpoints showed no significant differences in outcomes between approaches. The results suggest an initial strategy of radial access is reasonable for PCI in women.
- A study of 1352 PCI procedures at a radial center found that while 25.2% used femoral access, these cases had fewer complications (12.5% hematomas vs 6.25% requiring intervention) than expected given reduced femoral experience.
- Analysis of UK PCI data found radial use increased from 12-49% for PPCI, with no increase in femoral complications at radial centers and a possible reduction in 30-day mortality for femoral cases at radial centers.
- While radial access is safer, some patients still require femoral, and data suggests radial operators have good outcomes for these cases as well.
This randomized clinical trial compared transradial catheterization performed with or without prophylactic nitroglycerin to prevent radial artery spasm. 328 patients undergoing transradial cardiac catheterization were randomly assigned to receive either intra-arterial nitroglycerin or a saline placebo after sheath insertion. The trial found no significant differences in patient pain levels, procedure duration, radiation exposure, or need for analgesics between the two groups. However, the operators' subjective impression of artery spasm was lower in the nitroglycerin group. The study concluded that prophylactic nitroglycerin does not provide clear advantages and may not be necessarily required for transradial procedures.
This document summarizes a study on performing transradial cardiac catheterization in patients with a negative Allen's test. The study found:
1) The radial artery occlusion rate was similar between patients with a negative (6.2%) and positive (4.8%) Allen's test.
2) Factors like sheath size, post-procedure compression time, anticoagulation use were more predictive of preventing radial occlusion than the Allen's test.
3) Transradial procedures can be performed safely and effectively regardless of pre-procedure Allen's test results.
Impact of access site on bleeding and ischemic events in patients with non-ST-segment elevation myocardial infarction treated with prasugrel at the time of percutaneous coronary intervention or as pretreatment at the time of diagnosis: the ACCOAST access substudy
1) The study evaluated 565 patients undergoing cardiac catheterization or percutaneous coronary intervention to compare the diameters of the radial and ulnar arteries using intraprocedural ultrasound.
2) The radial artery was found to be larger in 37.1% of patients, while the ulnar artery was larger in 6.5% of patients. A dual radial artery was present in 4.4% of patients.
3) In some cases where the radial artery diameter was very small (<2mm), the ulnar artery was significantly larger and may be a better access site. Evaluating both arteries ultrasonographically can help determine the best access site.
1) The study surveyed interventional cardiologists in VA hospitals about their perceptions of radial access versus femoral access for percutaneous coronary intervention (PCI).
2) While radial access was seen as superior for patient comfort and safety, many cardiologists viewed it as inferior for procedure time and success, especially at hospitals performing fewer radial procedures.
3) The main barriers to radial access identified were the long learning curve and concerns about equivalent outcomes once proficient, while increased radiation exposure was only a key concern for hospitals performing fewer radial procedures.
This document discusses slender techniques for percutaneous coronary intervention (PCI) that aim to minimize trauma to arterial access sites. It describes techniques used in Europe, including the use of 5F guiding catheters and sheathless guiding catheters. A new slender approach is presented involving direct stenting via 4F diagnostic catheters using stents with integrated delivery systems. Initial experience in 22 patients found this technique was safe and feasible with short procedure and compression times and no complications at 30 days. The document concludes slender TRI techniques can reduce radial injury and complications but potential benefits require further validation.
This document summarizes a study examining the use of transradial access (TRA) for non-coronary interventions in patients with severe hepatic dysfunction (MELD score ≥ 20). The study found TRA to be feasible in this high-risk population with a 100% technical success rate and very low rates of bleeding (0%) and access site (1 minor hematoma) complications. TRA in patients with liver dysfunction was shown to be safe and effective for renal/visceral interventions like embolization and stenting as well as radioembolization procedures, with few coagulation blood products required.
This document discusses same day discharge after elective percutaneous coronary intervention (PCI). It reviews the literature on criteria for selecting low-risk patients suitable for same day discharge. Studies show same day discharge is safe and feasible in properly selected patients and can provide significant cost savings compared to overnight admission. The document outlines one institution's protocol for same day discharge following radial PCI, including clinical, procedural, and socio-demographic criteria for patient selection. It emphasizes focusing on low risk patients, procedures, and clinical scenarios to safely implement a same day discharge program.
This document summarizes a study presented by Lukasz Koltowski on quality of life in patients undergoing percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) via radial or femoral access. The study was a single-center, randomized trial that assessed quality of life measures like the EQ-5D and MacNew scales at various time points after PCI. The results showed that radial access was associated with better short-term quality of life, especially for mobility and anxiety/depression, though differences diminished after a few days. The conclusions were that radial access facilitated quicker recovery and should be preferred when considering patient satisfaction.
1) The document discusses carotid artery stenting (CAS) and carotid endarterectomy (CEA) for treating carotid artery disease. It reviews data from clinical trials comparing the two procedures.
2) Operator experience is an important factor for CAS outcomes, with over 100 cases associated with lower risk. New technologies like mesh-covered stents may further reduce risks of CAS.
3) Future studies like CREST-2 aim to provide more data on CAS and CEA in asymptomatic patients to help guide treatment decisions. Both procedures can effectively treat carotid artery disease when performed by experienced operators.
This document discusses radiation exposure for interventional cardiologists and strategies to reduce it. It notes that radiation is a known carcinogen and some studies have found increased cancer risks for interventionalists. While one study found a modest increase in radiation with radial access, experience level is also important. The document reviews techniques like using lead shields and skirts, lowering frame rates, and newer equipment to reduce radiation by up to 62%. Lead drapes and caps have been shown to reduce operator radiation by 75-81% in randomized trials. The conclusion is that while radiation and orthopedic injuries are major occupational hazards, strategies exist to better protect interventionalists.
Same Wrist Intervention via the Cubital (Ulnar) Artery in Case of Radial Puncture Failure for Percutaneous Cardiac Catheterization or Intervention: The Multicenter Prospective SWITCH Registry
Rotational atherectomy can be performed via the radial or femoral artery approaches with similar success rates. A study compared outcomes of 67 patients who underwent rotational atherectomy via the femoral approach to 52 patients who underwent it via the radial approach and found no significant differences in procedural characteristics, success rates, or in-hospital complications between the two groups except that pacing wires were inserted less often in the radial group. Overall, rotational atherectomy performed via the radial approach was found to be a feasible alternative to the femoral approach.
1) The AURA OF ARTEMIS study was a randomized trial comparing transulnar versus transradial arterial access as the default strategy for coronary procedures.
2) In the interim analysis, the composite primary endpoint was significantly higher in the ulnar arm compared to the radial arm, with a 24.3% difference between arms. The study was terminated early due to the inferiority of the transulnar approach.
3) Complications associated with the transulnar approach included pseudoaneurysms, perforations, occlusions and arteriovenous fistulas. Crossover from ulnar to other access sites was also more common.
This document summarizes various studies comparing right and left radial approaches for cardiac catheterization. It begins by outlining several previous studies that found no differences in outcomes between right and left approaches. It then describes a new study comparing right versus left radial access in high-risk patients (elderly, female, hypertensive, short height) done by fellows under supervision. In this study, the left radial approach was associated with shorter fluoroscopy times and less contrast use, suggesting it may be preferable for difficult cases done by new operators.
The document summarizes the proposed SAFE-PCI for Women study, which aims to determine the efficacy and feasibility of the transradial approach to PCI in women compared to the transfemoral approach. The randomized controlled trial plans to enroll 1,800 female patients undergoing elective or urgent PCI at 30 sites. The primary endpoint is a composite of major bleeding or major vascular complications within 72 hours or discharge. Secondary endpoints include procedure time and radiation/contrast use. Funding support is provided through the American Recovery and Reinvestment Act.
The document discusses the relationship between procedure volume and outcomes for transradial PCI procedures. It summarizes several studies that found higher volume radial operators and centers achieved better efficacy and safety outcomes compared to lower volume ones. In particular, a meta-analysis of trials found reduced mortality, heart attacks, bleeding, and crossover to femoral access at higher volume sites. The document concludes there is strong evidence that higher procedure volumes are associated with better outcomes for transradial PCI, supporting a "radial first" approach where radial access is prioritized.
1) A study of 455 patients undergoing transradial cardiac catheterization found that the rate of radial artery occlusion (RAO) was significantly higher when a 6-French sheath was used (30.5%) compared to a 5-French sheath (13.7%).
2) Multivariate analysis identified female sex, younger age, presence of peripheral artery disease, and use of a 6-French sheath as independent predictors of RAO.
3) For patients who developed symptomatic RAO, treatment with low molecular weight heparin showed a higher rate of recanalization (55.6%) compared to patients who did not receive anticoagulation (13.5%).
The document discusses techniques for stenting coronary artery bifurcation lesions via the transradial approach. It provides details on different bifurcation classification schemes and stent strategies such as provisional stenting and double kissing crush. Catheter sizes needed vary by the complexity of the lesion and technique used, with 6F catheters often sufficient but 7F sometimes needed for more complex cases like left main stenting. The conclusion is that while transradial access is generally feasible for bifurcation stenting, catheter sizes up to 7F are commonly required depending on the procedure.
This document provides information on transradial catheterization procedures. It defines ideal candidates for transradial catheterization and lists contraindications. It describes the pre-procedure assessment including checking for dual circulation in the hand. The patient setup is also outlined, including positioning the arm and wrist, applying pulse oximetry, and preparing equipment like sheaths and catheters. Post-procedure care instructions including use of a TR band, monitoring the access site, and discharge instructions are provided.
This document summarizes a study on performing transradial cardiac catheterization in patients with a negative Allen's test. The study found:
1) The radial artery occlusion rate was similar between patients with a negative (6.2%) and positive (4.8%) Allen's test.
2) Factors like sheath size, post-procedure compression time, anticoagulation use were more predictive of preventing radial occlusion than the Allen's test.
3) Transradial procedures can be performed safely and effectively regardless of pre-procedure Allen's test results.
Impact of access site on bleeding and ischemic events in patients with non-ST-segment elevation myocardial infarction treated with prasugrel at the time of percutaneous coronary intervention or as pretreatment at the time of diagnosis: the ACCOAST access substudy
1) The study evaluated 565 patients undergoing cardiac catheterization or percutaneous coronary intervention to compare the diameters of the radial and ulnar arteries using intraprocedural ultrasound.
2) The radial artery was found to be larger in 37.1% of patients, while the ulnar artery was larger in 6.5% of patients. A dual radial artery was present in 4.4% of patients.
3) In some cases where the radial artery diameter was very small (<2mm), the ulnar artery was significantly larger and may be a better access site. Evaluating both arteries ultrasonographically can help determine the best access site.
1) The study surveyed interventional cardiologists in VA hospitals about their perceptions of radial access versus femoral access for percutaneous coronary intervention (PCI).
2) While radial access was seen as superior for patient comfort and safety, many cardiologists viewed it as inferior for procedure time and success, especially at hospitals performing fewer radial procedures.
3) The main barriers to radial access identified were the long learning curve and concerns about equivalent outcomes once proficient, while increased radiation exposure was only a key concern for hospitals performing fewer radial procedures.
This document discusses slender techniques for percutaneous coronary intervention (PCI) that aim to minimize trauma to arterial access sites. It describes techniques used in Europe, including the use of 5F guiding catheters and sheathless guiding catheters. A new slender approach is presented involving direct stenting via 4F diagnostic catheters using stents with integrated delivery systems. Initial experience in 22 patients found this technique was safe and feasible with short procedure and compression times and no complications at 30 days. The document concludes slender TRI techniques can reduce radial injury and complications but potential benefits require further validation.
This document summarizes a study examining the use of transradial access (TRA) for non-coronary interventions in patients with severe hepatic dysfunction (MELD score ≥ 20). The study found TRA to be feasible in this high-risk population with a 100% technical success rate and very low rates of bleeding (0%) and access site (1 minor hematoma) complications. TRA in patients with liver dysfunction was shown to be safe and effective for renal/visceral interventions like embolization and stenting as well as radioembolization procedures, with few coagulation blood products required.
This document discusses same day discharge after elective percutaneous coronary intervention (PCI). It reviews the literature on criteria for selecting low-risk patients suitable for same day discharge. Studies show same day discharge is safe and feasible in properly selected patients and can provide significant cost savings compared to overnight admission. The document outlines one institution's protocol for same day discharge following radial PCI, including clinical, procedural, and socio-demographic criteria for patient selection. It emphasizes focusing on low risk patients, procedures, and clinical scenarios to safely implement a same day discharge program.
This document summarizes a study presented by Lukasz Koltowski on quality of life in patients undergoing percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) via radial or femoral access. The study was a single-center, randomized trial that assessed quality of life measures like the EQ-5D and MacNew scales at various time points after PCI. The results showed that radial access was associated with better short-term quality of life, especially for mobility and anxiety/depression, though differences diminished after a few days. The conclusions were that radial access facilitated quicker recovery and should be preferred when considering patient satisfaction.
1) The document discusses carotid artery stenting (CAS) and carotid endarterectomy (CEA) for treating carotid artery disease. It reviews data from clinical trials comparing the two procedures.
2) Operator experience is an important factor for CAS outcomes, with over 100 cases associated with lower risk. New technologies like mesh-covered stents may further reduce risks of CAS.
3) Future studies like CREST-2 aim to provide more data on CAS and CEA in asymptomatic patients to help guide treatment decisions. Both procedures can effectively treat carotid artery disease when performed by experienced operators.
This document discusses radiation exposure for interventional cardiologists and strategies to reduce it. It notes that radiation is a known carcinogen and some studies have found increased cancer risks for interventionalists. While one study found a modest increase in radiation with radial access, experience level is also important. The document reviews techniques like using lead shields and skirts, lowering frame rates, and newer equipment to reduce radiation by up to 62%. Lead drapes and caps have been shown to reduce operator radiation by 75-81% in randomized trials. The conclusion is that while radiation and orthopedic injuries are major occupational hazards, strategies exist to better protect interventionalists.
Same Wrist Intervention via the Cubital (Ulnar) Artery in Case of Radial Puncture Failure for Percutaneous Cardiac Catheterization or Intervention: The Multicenter Prospective SWITCH Registry
Rotational atherectomy can be performed via the radial or femoral artery approaches with similar success rates. A study compared outcomes of 67 patients who underwent rotational atherectomy via the femoral approach to 52 patients who underwent it via the radial approach and found no significant differences in procedural characteristics, success rates, or in-hospital complications between the two groups except that pacing wires were inserted less often in the radial group. Overall, rotational atherectomy performed via the radial approach was found to be a feasible alternative to the femoral approach.
1) The AURA OF ARTEMIS study was a randomized trial comparing transulnar versus transradial arterial access as the default strategy for coronary procedures.
2) In the interim analysis, the composite primary endpoint was significantly higher in the ulnar arm compared to the radial arm, with a 24.3% difference between arms. The study was terminated early due to the inferiority of the transulnar approach.
3) Complications associated with the transulnar approach included pseudoaneurysms, perforations, occlusions and arteriovenous fistulas. Crossover from ulnar to other access sites was also more common.
This document summarizes various studies comparing right and left radial approaches for cardiac catheterization. It begins by outlining several previous studies that found no differences in outcomes between right and left approaches. It then describes a new study comparing right versus left radial access in high-risk patients (elderly, female, hypertensive, short height) done by fellows under supervision. In this study, the left radial approach was associated with shorter fluoroscopy times and less contrast use, suggesting it may be preferable for difficult cases done by new operators.
The document summarizes the proposed SAFE-PCI for Women study, which aims to determine the efficacy and feasibility of the transradial approach to PCI in women compared to the transfemoral approach. The randomized controlled trial plans to enroll 1,800 female patients undergoing elective or urgent PCI at 30 sites. The primary endpoint is a composite of major bleeding or major vascular complications within 72 hours or discharge. Secondary endpoints include procedure time and radiation/contrast use. Funding support is provided through the American Recovery and Reinvestment Act.
The document discusses the relationship between procedure volume and outcomes for transradial PCI procedures. It summarizes several studies that found higher volume radial operators and centers achieved better efficacy and safety outcomes compared to lower volume ones. In particular, a meta-analysis of trials found reduced mortality, heart attacks, bleeding, and crossover to femoral access at higher volume sites. The document concludes there is strong evidence that higher procedure volumes are associated with better outcomes for transradial PCI, supporting a "radial first" approach where radial access is prioritized.
1) A study of 455 patients undergoing transradial cardiac catheterization found that the rate of radial artery occlusion (RAO) was significantly higher when a 6-French sheath was used (30.5%) compared to a 5-French sheath (13.7%).
2) Multivariate analysis identified female sex, younger age, presence of peripheral artery disease, and use of a 6-French sheath as independent predictors of RAO.
3) For patients who developed symptomatic RAO, treatment with low molecular weight heparin showed a higher rate of recanalization (55.6%) compared to patients who did not receive anticoagulation (13.5%).
The document discusses techniques for stenting coronary artery bifurcation lesions via the transradial approach. It provides details on different bifurcation classification schemes and stent strategies such as provisional stenting and double kissing crush. Catheter sizes needed vary by the complexity of the lesion and technique used, with 6F catheters often sufficient but 7F sometimes needed for more complex cases like left main stenting. The conclusion is that while transradial access is generally feasible for bifurcation stenting, catheter sizes up to 7F are commonly required depending on the procedure.
This document provides information on transradial catheterization procedures. It defines ideal candidates for transradial catheterization and lists contraindications. It describes the pre-procedure assessment including checking for dual circulation in the hand. The patient setup is also outlined, including positioning the arm and wrist, applying pulse oximetry, and preparing equipment like sheaths and catheters. Post-procedure care instructions including use of a TR band, monitoring the access site, and discharge instructions are provided.
This document summarizes the results of the DRAGON trial which compared the radial versus femoral approach for percutaneous coronary intervention (PCI) in over 1,700 patients. The trial found that the radial approach (TRI) was non-inferior to the femoral approach (TFI) for the primary endpoint of major adverse cardiac events at 12 months. TRI also had significantly less major bleeding complications at 7 days compared to TFI, meeting the secondary endpoint for superiority. Propensity score matching was used to adjust for baseline differences between the groups. The trial demonstrated that an ad-hoc radial approach strategy can provide similar clinical outcomes to femoral approach with less bleeding risks.
This study evaluated the safety and efficacy of the novel Svelte Acrobat Integrated Delivery System (IDS) for percutaneous coronary interventions (PCI) via a radial approach using 5-French catheters. The study enrolled 55 patients and found a primary endpoint success rate of 91%, defined as direct stent implantation without need for post-dilation. Secondary endpoints including procedural success rates were also high. The study concluded the IDS system allows for safe and effective PCI via the radial approach in select patient populations and can reduce costs compared to traditional systems by an estimated $300 per procedure.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise causes chemical changes in the brain that may help boost feelings of calmness, happiness and focus.
This document discusses the use of transradial artery (TRA) access for structural heart interventions. It provides reasons for and against TRA, as well as specific examples where TRA is beneficial. Some key benefits of TRA include avoiding bleeding complications, keeping large venous and arterial sheaths separate, and providing hemodynamic monitoring and support during complex procedures. Specific cases where TRA is useful include left atrial appendage occlusion, MitraClip procedures, coronary arteriovenous fistula closure, coarctation of the aorta repair, and post-myocardial infarction ventricular septal defect closure. TRA can improve visualization, device positioning and manipulation, and allow for pressure monitoring during challenging structural heart interventions.
This document discusses a study evaluating the feasibility and technical outcomes of using the Surefire Infusion System to deliver chemotherapy or radiation via a transradial (wrist) approach. The study found that the Surefire Catheter can be safely deployed through the wrist to treat liver tumors in 15 patients. Using a transradial approach with the Surefire System offers advantages over traditional techniques like fewer vascular complications and immediate patient ambulation. Pre-procedural imaging can help guide whether this approach is suitable.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
The document discusses the transradial approach for treating chronic total occlusions (CTOs). It notes that specific techniques are needed when using the transradial approach due to limitations in support and catheter size. These techniques include anchoring balloon techniques for wire handling, the "mother and child" technique using a 5Fr catheter, homolateral microinjection, and parallel wiring. The transradial approach also enables double radial approaches to overcome limitations. While the transradial approach reduces vascular complications, simply using it does not make one an expert CTO operator - experience remains important. The transradial approach can allow good operators to treat CTOs without reducing chances of success for patients.
This document discusses techniques for transradial access and intervention. It begins by outlining three levels of competency for operators and discusses when radial access may not be appropriate. It then provides a step-by-step guide for radial access procedures, covering patient positioning, arterial puncture, navigating vascular anatomy, catheter selection, and hemostasis. Predictors of procedural failure are presented. The document concludes by providing tips for implementing a successful radial program.
Cardiogenic shock is a leading cause of death in AMI patients, with mortality rates between 30-60%. While radial access has been shown to reduce bleeding complications, patients presenting with cardiogenic shock are often treated via transfemoral access. Recent studies have demonstrated that radial access PCI is feasible in cardiogenic shock patients, with one study showing a reduction in in-hospital mortality for radial versus transfemoral access. However, experienced radial centers only use the radial approach in around 50% of cardiogenic shock cases, indicating radial access is still underutilized despite potential benefits in this high-risk group.
This study compared the use of Sheathless Eaucath guiding catheters to standard guiding catheters for transradial percutaneous coronary interventions (TR PCI) in 233 patients. The Sheathless catheter reduced equipment size in the radial artery and was as safe and effective as standard catheters, with comparable complication rates. Crossing over to the Sheathless catheter after standard catheter failure allowed successful PCI in most cases. Patients reported less pain and operators found it easier to cross the arm with the Sheathless catheter.
This multicenter study evaluated the feasibility and safety of using a transradial approach for iliac angioplasty. The study included 149 patients from 5 centers in Italy undergoing iliac interventions via the radial artery. Procedural success was achieved in 98% of patients. At 1 month, 97.3% of patients were free from symptoms and the target vessel revascularization rate was 2.7%. Technical data showed average fluoroscopy and procedural times comparable to femoral access. The study demonstrated that a transradial approach is a feasible and safe option for treating iliac disease in experienced hands.
This document discusses navigating complex anatomies during transradial procedures. It notes that radial artery loops, tortuosity, and anomalies can cause procedural failures. Predictors of failure include high bifurcation, tortuosity, and subclavian anomalies. Wire choice is important, with baby J wires being ideal for transradial procedures. Operators must be aware of anatomical variations and challenges. Retrograde angiography can help plan strategies to avoid complications. Finesse is more important than force when encountering resistance.
The document summarizes a study examining the use of the Amplatzer Vascular Plug 4 (AVP4) for embolization of visceral arteries via a transradial approach. In the study, AVP4 placement was attempted in 20 patients in 21 vessels and was technically successful in all cases. Complete vessel occlusion was achieved in 15 of 18 vessels at deployment and follow-up. There were no procedural complications. The study concludes that AVP4 placement in visceral arteries from a transradial approach is technically feasible, safe and effective.
This document describes a technique called the "Distal Buddy-in-Jail technique" for treating difficult coronary anatomies requiring multiple stents. The technique involves trapping a wire distally during initial stent placement to provide support, allowing subsequent proximal stenting over the trapped "buddy wire" or the free wire. The technique was used in 29 patients with difficult anatomies. It allowed successful placement of multiple stents using 5 or 6F guiding catheters. Outcomes were good with one minor complication, demonstrating this technique can help treat complex cases using conventional guiding catheters.
1) The ACRA study evaluated the effects of transradial access (TRA) on upper limb function and found that upper limb function, as measured by the QuickDASH score, was unaffected after TRA. A clinical relevant decrease in upper limb function occurred in only 6.3% of patients.
2) Rates of persisting extremity problems were equally reported in patients who received TRA or transfemoral access.
3) Cold intolerance, as measured by the CISS questionnaire, was also unaffected after TRA procedures.
4) While the study found no effects of TRA on upper limb function or cold intolerance, limitations included a potential for response bias and lack of power to detect effects in specific patient groups.
The document discusses the use of a 6.5F sheathless guiding catheter for transradial percutaneous coronary interventions (PCI) in patients with small radial arteries. The sheathless guiding catheter has an external diameter smaller than a 5F sheath but an internal diameter larger than a standard 6F guiding catheter. Several studies found that using the 6.5F sheathless guiding catheter for transradial PCI was feasible, effective, and safe for treating all lesion types and with various interventional techniques. The sheathless guiding catheter was particularly useful in cases where there was friction during intervention with smaller 4F-5F diagnostic catheters and sheaths or when a vessel was very small after use of a 6
This document summarizes the initial therapies for chronic lymphocytic leukemia (CLL) including chemoimmunotherapy regimens like FCR and BR as well as targeted therapies like BTK inhibitors. Key points discussed include trial results establishing FCR as the standard therapy but with risks of myeloid neoplasms and infections in older patients. The document also reviews trials demonstrating the efficacy of ibrutinib for CLL treatment with improved progression-free and overall survival compared to chemoimmunotherapy or chlorambucil, though it can cause atrial fibrillation, bleeding risks, and infections. Complications and management of ibrutinib therapy are also summarized.
This document discusses various protocols for anticoagulation during hemodialysis. It begins by noting that patients on hemodialysis are at risk of both bleeding and thrombosis. It then outlines several protocols for anticoagulation including unfractionated heparin (UFH) administered via constant infusion or intermittent bolus, and low molecular weight heparin (LMWH). LMWH has benefits over UFH like longer half-life and more predictable effects, but is also more expensive. The document also discusses heparin-free dialysis, regional citrate anticoagulation, and other alternatives to standard heparin protocols. Selection of the optimal anticoagulation method requires consideration of individual patient
Venous thromboembolism (VTE) is a disorder that includes deep vein thrombosis and pulmonary embolism. A deep vein thrombosis (DVT) occurs when a blood clot forms in a deep vein, usually in the lower leg, thigh, or pelvis.
Hospital Medicine Update, VA ACP Meeting 2015Jon Sweet
This document summarizes a presentation on papers that have changed the presenter's medical practice. It discusses several clinical cases and the evidence from recent studies on how to best manage them. For a patient with upper GI bleeding admitted after endoscopic treatment, intermittent PPI therapy is shown to be non-inferior to continuous infusion PPI based on multiple randomized trials. For heart failure patients under 75, BNP-guided treatment reduces mortality and hospitalizations compared to clinical guidance alone. Lower steroid doses are associated with better outcomes for COPD patients admitted to the ICU. MRCP or EUS are recommended for evaluating the CBD in patients at intermediate risk of retained stones.
Effect of hydrocortisone on development of shock amongDr fakhir Raza
effects of hydrocortisone on development of shock among patients with severe sepsis the HYPRESS Randomized Clinical Trial American Medical Association caring for the critically ill patients Surviving sepsis campaign, to determine weather hydrocortisone therapy in patients with severe sepsis prevents the development of septic shock
approach to Rh Isoimmunization Maternal and neonatal aspects | Dr Habibur RahimDr. Habibur Rahim
This document summarizes the approach and management of a baby born to a Rh-negative mother. The baby presented with respiratory distress and signs of Rh isoimmunization. Key points include:
1) The mother's anti-D titer was 1:64 and Doppler ultrasound revealed increased blood flow, indicating Rh isoimmunization.
2) The baby received an exchange transfusion due to signs of hemolysis and hyperbilirubinemia.
3) With oxygen support and treatment, the baby's respiratory distress resolved within 6 hours and the baby improved after exchange transfusion.
The document discusses various pitfalls that can occur during hospital discharges, with a focus on cardiology. It notes that common components of discharge instructions include activity restrictions, risk factor modification, dietary restrictions, and medication information. However, studies have shown that on average, physicians spend very little time providing discharge instructions. Some key risks that can lead to hospital readmissions include medication noncompliance, alternative therapy use, and lack of follow-up after discharge. The document emphasizes the importance of thorough discharge education to reduce readmission rates.
Ckd dialysis diet in ckd patient educationNilesh Jadhav
Chronic kidney disease (CKD) is defined as abnormalities of kidney structure or function present for at least three months. CKD is staged from 1-5 based on glomerular filtration rate. Common causes include diabetes, hypertension, glomerulonephritis and polycystic kidney disease. Treatment focuses on slowing progression, managing complications like anemia and bone disease, and preparing for renal replacement therapy with dialysis or transplantation as kidney function declines. Dialysis modalities include hemodialysis and peritoneal dialysis (continuous ambulatory, intermittent, or continuous cycler-assisted). A kidney-friendly diet limits protein, phosphorus, potassium, sodium and may restrict fluids in later stages to slow CKD
This talk discusses GI/liver side effects of commonly used drugs and provides guidance on advising patients and monitoring or preventing adverse effects. It covers factors that may contribute to side effects like drug interactions and underlying diseases. Specific drugs discussed include statins, NSAIDs, aspirin, and ketoconazole. The speaker emphasizes advising patients on medication use and seeking medical help if unwell, considering individual risk factors when prescribing or recommending prophylaxis, and consulting specialists if serious adverse effects occur.
This document provides guidance for acute gastroenterology issues commonly seen in acute medical units. It summarizes guidelines on screening for alcohol use, appropriate blood transfusion levels for GI bleeds, paracetamol overdose treatment, and safely refeeding underweight patients to avoid complications.
This document discusses hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome. It provides details on the epidemiology, clinical presentation, risk factors, pathophysiology, prevention, and treatment of VOD. VOD is a serious complication of hematopoietic stem cell transplantation that results from liver cell necrosis and vascular congestion. It most commonly occurs within the first month after transplantation. Prevention strategies include heparin, ursodeoxycholic acid, defibrotide, and controlling risk factors. Treatment focuses on managing symptoms, with defibrotide showing promise for improving outcomes in severe cases. The prognosis depends on the severity of the VOD, with mild cases having low mortality
Video at https://www.youtube.com/watch?v=2rQKMD_5po0
Part of the "Hypoxemia in the Ward Patient with COVID-19" talks in Frederick Southwick's Coursera MOOC on COVID-19, "COVID-19 - A clinical update".
"Dr. Ben Geisler, Hospitalist at Massachusetts General Hospital and Harvard Medical School faculty member reviews the current treatments for COVID-19. He first discusses the management of fluid replacement and diuretics, as well as the indications for bronchodilators and antibiotics. He emphasizes the importance of DVT anticoagulation prophylaxis. He next reviews the potential role of statins, evidence with regards angiotensin converting enzyme inhibitors, and NSAIDS. He next reviews the current indications for the agents of proven efficacy: Remdesivir and Dexamethasone. Finally he discusses the dilemma of equipoise and the best resources for staying up to date with this ever changing topic."
In this iteration, we have added baricitinib and tocilizumab/IL-6 inhibitors.
DPP4 inhibitors have similarities such as sustained glucose lowering, minimal side effects, and weight neutrality. Differences include binding characteristics, with some binding longer to DPP4. Vildagliptin may provide better fasting glucose control due to maintaining overnight GLP1 levels. Vildagliptin has proven efficacy and safety in Ramadan fasting and has shown cardiovascular safety in clinical trials and real-world evidence, with no increased risk of heart failure unlike some other DPP4 inhibitors.
Perioperative Management of Patients with an Insulin PumpAllina Health
A team at Abbott Northwestern Hospital developed guidelines for managing patients with insulin pumps undergoing surgery. Previously, there was no systematic approach, putting patients at risk for severe hypo- and hyperglycemia. The team included diabetes, hospitalist, anesthesia, surgery, nursing and pharmacy staff. They created processes for identifying insulin pump patients pre-op, documenting pump settings, and developing pre-op plans for alternative insulin therapies when pumps cannot be used. Nurses were trained on the guidelines. Since implementation, most patients' blood sugars have remained within target ranges during surgery, and patient satisfaction with team coordination has increased.
Thromboprophylaxis in pregnancy and puerperiumManju Puri
This presentation is about thromboprophylaxis in pregnancy and puerperium and describes the risk assessment , indications, drugs to be used, when to start, for how long to continue.
Cardiorenal Syndrome (Clinical Implications and Treatment Strategies) - Dr. G...NephroTube - Dr.Gawad
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Rifaximin therapy for 2 weeks provided relief of IBS symptoms for up to 10 weeks in 40.7% of patients compared to 31.7% of placebo patients. Fidaxomicin was found to be non-inferior to vancomycin for treating C. difficile infection and resulted in significantly lower recurrence rates of 15.4% versus 25.3%. Regular use of aspirin or NSAIDs was associated with increased risks of diverticulitis and diverticular bleeding. Linaclotide treatment for 12 weeks resulted in a primary endpoint of 3 or more CSBMs per week in 16.6-21.2% of patients on 145 μg and 19.4-21.3
This document discusses guidelines for preventing venous thromboembolism (VTE) in obstetric patients. It outlines a risk stratification system used to determine which patients should receive thromboprophylaxis based on their VTE risk score. Patients are categorized as very high, high, or intermediate risk based on risk factors like prior VTE history, thrombophilia status, BMI, and medical conditions. Recommended thromboprophylaxis includes low molecular weight heparin antenatally and/or postnatally depending on risk level. Contraindications and safety considerations for regional anesthesia are also reviewed.
This document discusses guidelines for preventing venous thromboembolism (VTE) in the obstetric population. It outlines a VTE risk assessment and prevention program implemented in Sarawak, Malaysia. Patients are stratified into very high, high, and intermediate risk categories based on their VTE risk score. Risk factors like obesity, previous VTE, thrombophilia, and multiple pregnancy-related risks can increase VTE risk. Prevention involves antenatal and postnatal thromboprophylaxis with low molecular weight heparin or other anticoagulants depending on risk level. Certain situations like postpartum hemorrhage may contraindicate thromboprophylaxis.
Similar to Stables R - AIMRADIAL 2015 - Bivalirudin and radial approach (20)
This document summarizes Tim Fischell's presentation on innovation in cardiovascular medicine. It discusses Fischell's history of medical device innovations, including the Arrow-Fischell sheath, brachytherapy devices, stents, and the AngelMed Guardian system. It provides guidance on developing new ideas into real innovations, including evaluating intellectual property, regulatory pathways, prototype testing, and clinical trials. Fischell emphasizes the importance of understanding unmet clinical needs and having a team approach to translating ideas into impactful new technologies.
This document discusses opportunities for developing and manufacturing medical devices in Latin America, including coronary stents with an estimated $500M annual market. It outlines the roadmap needed to design, test, manufacture, and gain regulatory approval for a novel stent concept, including requirements for structure and flow, deployability and patency, and clinical performance. Design considerations are discussed such as structural rigidity, flexural rigidity, surface finish, and hemodynamic simulations. The potential for low-cost manufacturing and animal studies are also mentioned.
This document summarizes the evidence from multiple randomized clinical trials that support a Class IA recommendation for the use of radial artery access (TRA) over femoral artery access (TFA) for cardiac catheterization procedures. The data show that TRA is associated with lower rates of major vascular complications and major bleeding compared to TFA, with numbers needed to treat of 21 and 47 respectively. TRA may also reduce mortality in patients with acute coronary syndrome, with a number needed to treat of 100. Both the 2018 AHA guidelines and ESC/EACTS guidelines were updated to strongly recommend a radial-first approach in light of the overwhelming data demonstrating benefits of TRA over TFA.
This document discusses best practices for same day discharge after cardiac procedures. It provides an overview of the history and evidence supporting same day discharge. Key points include:
- Same day discharge has been shown to be safe and effective in studies dating back to the 1990s.
- Dedicated lounges and infrastructure improve outcomes for same day discharge by allowing for close monitoring and care in the immediate post-procedure period.
- The author's hospital has successfully performed over 7,000 same day discharge procedures over 10 years using a dedicated radial lounge with trained nursing staff who provide care and arrange discharge. Complication rates are low with their protocol.
This document describes a case of critical hand ischemia treated through multiple endovascular interventions over several years. Initially, the patient underwent brachial artery recanalization and stenting from left radial access, but presented two days later with stent thrombosis. A second procedure recanalized the stent and treated a brachial dissection with another stent. However, two years later the patient returned with re-occlusion of arm vessels and iliac arteries. Further interventions were needed to recanalize stenosed iliac and brachial arteries over time. In conclusion, long term patency of arm interventions is unknown, and stent CTO recanalization in the arms poses similar challenges to the legs.
This document discusses expanding the FDA indication for protected PCI procedures using the Impella heart pump. Key points include:
1. A study of 891 patients found that those with mildly/moderately reduced ejection fraction (LVEF >35%) undergoing protected PCI had favorable outcomes similar to those with severely reduced LVEF, despite being older with more comorbidities and complex coronary disease.
2. Protected PCI with Impella led to improved LVEF and quality of life in multiple studies. The Protect II trial showed Impella reduced MACCE by 29% compared to IABP at 30 days.
3. Guidelines recommend protected PCI for patients with severe/moderate/mild reduced LVE
This document summarizes the findings of a study analyzing 19,482 left main stem percutaneous coronary intervention (LMS-PCI) procedures from the British Cardiovascular Intervention Society National Database between 2007-2014:
1) Use of radial artery access for LMS-PCI increased significantly over time and radial access was associated with reduced vascular complications, major bleeding, and shorter hospital stays.
2) Radial access was independently associated with lower in-hospital mortality and major adverse cardiac and cerebrovascular events (MACE) compared to femoral access.
3) Independent predictors of 12-month mortality following LMS-PCI included acute kidney injury, older age, chronic renal failure, acute coronary syndrome presentation, and
This document discusses accessing the right heart and central venous system through the radial vein as a safer alternative to traditional femoral access. It provides tips for establishing venous access through the forearm, including using ultrasound or no-touch technology to locate veins and heparin locks to improve efficiency. Challenges like low venous pressure, valves, and junctions are addressed. Images demonstrate techniques for navigating the radial artery into the right atrium, including using flushes of saline. Potential contraindications like arm trauma or breast cancer are noted. The document argues learning both arterial and venous radial techniques will improve cardiologist skills and safety.
This document discusses techniques for radial artery puncture for cardiovascular procedures. It notes that the radial artery is smaller in diameter than the femoral artery. Successful radial access requires correctly positioning and securing the wrist. Ultrasound guidance can help find and access the radial artery, especially for trainees. The initial puncture approach can be anterior wall only or use a counterpuncture technique. Sheath size, length, and coating impact radial artery spasm and occlusion. Cocktails including nitroglycerine and calcium channel blockers are commonly used but acid in the cocktail may damage the artery if felt by the patient.
This document summarizes a presentation given by Dr. Olivier Bertrand on post-PCI FFR measurement. It discusses studies showing that a post-PCI FFR of 0.90 or higher is associated with lower rates of re-PCI and major adverse cardiac events. It then outlines the proposed PREDICT randomized study to evaluate whether routine post-PCI FFR measurement can guide PCI strategy and completion. The study would measure FFR after successful PCI in all-comers and randomize patients to clinical follow-up alone or with guidance from the post-PCI FFR results. The goal is to establish if physiology-guided PCI optimization can improve outcomes and reduce costs.
This document summarizes lessons learned from the DEFINE-FLAIR and iFR-SWEDEHEART clinical trials. The trials found:
1) Decision-making based on instantaneous wave-free ratio (iFR) was non-inferior to fractional flow reserve (FFR) for guiding revascularization and reducing major adverse cardiac events over 1-2 years.
2) iFR-guided decisions resulted in significantly less revascularization procedures compared to FFR.
3) Subgroup analysis found increased event rates among diabetic patients evaluated with FFR compared to iFR.
4) iFR has been upgraded to a Class IA recommendation in European Society of Cardiology guidelines based on these trials
1. The document discusses the use of physiology in acute coronary syndrome (ACS) patients, including trials evaluating fractional flow reserve (FFR) and index myocardial resistance (IMR) measurements.
2. Several trials showed that FFR-guided revascularization in multivessel disease STEMI patients reduced major cardiac events compared to culprit-only PCI or medical therapy. Ongoing trials are further evaluating FFR in ACS.
3. IMR predicts mortality and heart failure in STEMI patients and adversely remodeling post-STEMI.
4. Incomplete revascularization is common in ACS and associated with worse outcomes; FFR may help guide more complete revascularization. The clinical utility of physiology in ACS
This document discusses the potential use of 4 French (4F) catheters for fractional flow reserve (FFR) measurements as a less invasive alternative to larger catheters. It notes that 4F catheters have a smaller profile but can lack the ability to directly perform percutaneous coronary intervention if needed. The document outlines key considerations for using 4F catheters, including ensuring the catheter lumen is well flushed and the pressure transducer is not damped. It concludes that improvements are still needed, such as reducing friction between the pressure wire and catheter, in order to maximize the benefits of using the smallest catheter size possible.
This document discusses using fractional flow reserve (FFR) to evaluate ambiguous left main coronary artery disease. It presents a case of an 82-year-old woman with chest pain and a recent stent in the circumflex artery. FFR measurements of the left main and left anterior descending artery were 0.64, indicating significance. Intravascular ultrasound also suggested significance. The left main and proximal left anterior descending artery were stented, and post-procedure FFR measurements improved. The document reviews evidence that FFR can safely guide decisions about revascularization of ambiguous left main lesions.
This document summarizes a presentation on CT-derived fractional flow reserve (FFR-CT). It discusses how FFR-CT increases the positive predictive value of coronary CT angiography (CTCA). Several landmark studies are summarized that evaluated the diagnostic accuracy of FFR-CT compared to CTCA. The PACIFIC trial findings showing high diagnostic accuracy of FFR-CT are described. Ongoing and upcoming clinical trials using FFR-CT like PRECISION and DECISION are mentioned. Novel applications of FFR-CT for biomechanics analysis and PCI planning are presented. Finally, new methods like user-generated CT-FFR that may reduce processing time are introduced, though accuracy needs further evaluation.
This document summarizes the results of a study evaluating the diagnostic accuracy of quantitative flow ratio (QFR) compared to fractional flow reserve (FFR) as the reference standard. The study included 317 lesions in 273 patients. Key results included:
- QFR showed superior sensitivity and specificity for detecting functionally significant lesions compared to 2D quantitative coronary angiography.
- QFR values correlated well with invasive FFR measurements.
- QFR could be computed within a similar time frame as FFR measurements.
- A hybrid approach using QFR and FFR may allow pressure wire-free assessment in 68% of lesions while maintaining high diagnostic accuracy.
More from International Chair on Interventional Cardiology and Transradial Approach (20)
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
10 Benefits an EPCR Software should Bring to EMS Organizations Traumasoft LLC
The benefits of an ePCR solution should extend to the whole EMS organization, not just certain groups of people or certain departments. It should provide more than just a form for entering and a database for storing information. It should also include a workflow of how information is communicated, used and stored across the entire organization.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Mercurius is named after the roman god mercurius, the god of trade and science. The planet mercurius is named after the same god. Mercurius is sometimes called hydrargyrum, means ‘watery silver’. Its shine and colour are very similar to silver, but mercury is a fluid at room temperatures. The name quick silver is a translation of hydrargyrum, where the word quick describes its tendency to scatter away in all directions.
The droplets have a tendency to conglomerate to one big mass, but on being shaken they fall apart into countless little droplets again. It is used to ignite explosives, like mercury fulminate, the explosive character is one of its general themes.
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
5-hydroxytryptamine or 5-HT or Serotonin is a neurotransmitter that serves a range of roles in the human body. It is sometimes referred to as the happy chemical since it promotes overall well-being and happiness.
It is mostly found in the brain, intestines, and blood platelets.
5-HT is utilised to transport messages between nerve cells, is known to be involved in smooth muscle contraction, and adds to overall well-being and pleasure, among other benefits. 5-HT regulates the body's sleep-wake cycles and internal clock by acting as a precursor to melatonin.
It is hypothesised to regulate hunger, emotions, motor, cognitive, and autonomic processes.
9. A Bivalirudin View of the World
• Anti-thrombotic agent of choice in STEMI PPCI
• New (?)
• Has proven efficacy - better than heparin (?)
• Obviates the need for routine GPI use (?)
• Reduced bleeding (?)
• Better outcomes (?)
• Expensive but cost effective (?)
10. Heparin Does not Have to be Better to Win !
• Heparin does not need to be better
• Much cheaper to purchase
• € 1 versus € 400 - 1600
• Easier and cheaper to administer (nursing time)
• Does not need reconstitution before use
• No iv infusions to manage (or to fail)
• Reversible with protamine
• Familiar and available (A&E, ambulances etc)
11. A Consistent Message From Clinical Trials
A single position that fits all
the clinical trials
12. The Reality: Messages from the Evidence Base
• Heparin (60 - 70 u/kg) is the drug of choice
• Very similar efficacy to bivalirudin
• Comparable ischaemic outcomes
• Less acute stent thrombosis
• Very similar safety to bivalirudin
• Identical bleeding risks - when …
• Minimal (5-15%) selective GPI use
• No use of high dose heparin (100 - 150 u/kg)
13. Bivalirudin - A More Effective Anti-thrombotic ?
• Bivalirudin v Heparin - a 25 year journey
• Multiple trials
• Bivalirudin has NEVER bettered heparin
• In the prevention of thrombotic adverse events
14. A Slow and Faltering Start
• 1990 Development by Biogen (as Hirulog)
• Initial angioplasty trial
• HAS (aka BAT) N Engl J Med 1995;333:764-9
• Disappointing results
• 1994 - Decision for no further investment
• Product licensed to The Medicines Company
• Re-examination of data
15. A Slow and Faltering Start
• 1998 - new application for FDA approval
• PCI in unstable angina
• Application rejected (5:3 vote)
• Re-analysis of trial
• New outcome measures - ‘new results’
“Bivalirudin was equivalent but not superior to
heparin in preventing angioplasty complications”
16. A Slow and Faltering Start
• Dr Clive Meanwell (CEO The Medicines Company)
• 2000 FDA approval granted
• 2010 Extension of patent
"It now turns out that the NEJM paper was plain wrong."
(Heartwire news 21 Dec 2000)
17. Bivalirudin and Anti-Ischaemic Efficacy
• Cavender, Sabatine Lancet 2014; 384: 599-606
• 16 Trials 33 958 patients
• 2422 patients with MACE 1406 with major bleed
• Is Bivalirudin a more effective anti-thrombotic ?
• Look at MACE rates
18. Increased MACE with Bivaliudin
MACE
Death
MI
I-D Revasc
Stent Thrombosis
Acute
Sub Acute
0.4 0.8 1 1.25 2.5 5
Favours HeparinFavours Bivalirudin
RR = 1.09 (1.01-1.17) p = 0.02
19. Increased MACE with Bivalirudin
• MACE risk ratio 1.09 (1.01-1.17) p = 0.02
• Consistent in all presentations
• STEMI NSTEACS Elective
20. Increased MACE with Bivalirudin
• MACE risk ratio 1.09 (1.01-1.17) p = 0.02
• Consistent in all presentations
• STEMI NSTEACS Elective
• Advantage evident for all patterns of GPI use
• Planned GPI in both arms RR 1.08
• Planned GPI heparin alone RR 1.06
• Provisional GPI in both arms - current practice
21. Bivalirudin - A More Effective Anti-thrombotic ?
• Bivalirudin v Heparin - a 25 year journey
• Multiple trials
• Bivalirudin has NEVER bettered heparin
• In the prevention of thrombotic adverse events
• Bivalirudin does not have extra anti-platelet effect
• No evidence based mandate for recent trial design
• No logic for systematic differential use of GPI
22. • Routine (unselected) (widespread) use of GPI agents
• Does not improve ischaemic outcomes
• Results in increased bleeding
Routine v Selective GPI Use
23. • Tested in HORIZONS and BRIGHT trials
• Universal (unselective, routine) use of GPI
• Now rejected as mainstream treatment option
• Selective (intelligent) use is possible
• Consider background bleeding risk
• Patient Presentation Procedure
• Consider response to initial PCI therapy
Routine v Selective GPI Use
24. Does Bivalirudin Cause less Bleeding than Heparin?
• Bivalirudin will reduce bleeding … IF ….
• Heparin patients have higher rates of GPI use
• Optimum GPI strategy - unanswered questions
• Indications for selective use - not characterised
• Optimum rate for GPI use - not known
• Probably in the range 5 - 15%
• Observed rates in bivalirudin arms of trials
• Limited observational data from HEAT-PPCI
25. HEAT-PPCI: Primary MACE Outcome by Operator
0.00%
5.00%
10.00%
15.00%
20.00%
25.00%
30.00%
35.00%
RHS JLM AK MA RAP SM MF NDP CA WLM JDM PV BK DRR
Primary Outcome MACE Event Rates (95%CI)
26. HEAT-PPCI: GPI use and MACE
0.00%
5.00%
10.00%
15.00%
20.00%
25.00%
30.00%
35.00%
RHS JLM AK MA RAP SM MF NDP CA WLM JDM PV BK DRR
MACE% GP USE %
27. HEAT-PPCI Data: GPI Use and Bleeding
0.00%
5.00%
10.00%
15.00%
20.00%
25.00%
30.00%
35.00%
0.00% 5.00% 10.00% 15.00% 20.00% 25.00% 30.00% 35.00%
BleedRate
GP 2b/3a Rate of Use
Scatter Plot Any Bleed v GP 2b/3a Use
28. Does Bivalirudin Cause less Bleeding than Heparin?
• Bivalirudin will reduce bleeding … IF ….
• Heparin patients have higher rates of GPI use
• Heparin is used at high dose
33. Bivalirudin - The Reality
• Bivalirudin is not cost effective
• Cost is high
• No outcome advantage
• Outcomes may be less favourable
34. Bivalirudin - The Reality
• The drive to improve Bivalirudin outcomes
• Give heparin as well !!!
• Use a prolonged infusion
• Promising but failed when tested formally
• Cost implications (purchase + nursing time)
• Why ? Spend more to gain equivalence
‘Adding in the dangerous drug makes ours better’
35. Escalating Costs
• Final bivalirudin drug cost is a function of:
• Patient body weight
• Duration of PCI
• Duration and dose of any continued infusion
• Potential ‘upstream’ use
• Cost relative to unfractionated heparin (UK)
350 x 700x 1050x 1400x
36. Conclusions
• Heparin (50 - 70 u/Kg) is the drug of choice
• Bivalirudin bubble has burst
• Potential for annual global savings
• US $ 700 million
• The ‘bivalirudin story’ is interesting
• As ever - lessons to be learned for EBM ?
• ESC Revascularisation Guidelines 2014
37. ESC Guidelines 2014 STEMI Revascularisation
In summary, recent trials comparing bivalirudin with
UFH without systematic use of GPIIb/IIIa
antagonists uphold concerns over an excess risk
for acute stent thrombosis with bivalirudin, while
differences in major bleeding are small.
UFH I C Bivalirudin IIa B
EHJ doi:10.1093/eurheartj/ehu278
38. • Single centre RCT
• Trial recruitment: Feb 2012 - Nov 2013 22 months
• Bivalirudin v Unfractionated Heparin
• STEMI patients
• Randomised at presentation
• Acute phase management with Primary PCI
39. Inclusion Criterion
• All STEMI patients activating PPCI pathway
Exclusion Criteria
•Active bleeding at presentation
•Factors precluding administration of oral A-P therapy
•Known intolerance / contraindication to trial medication
•Previous enrolment in this trial
41. • Dual oral anti-platelet therapy pre-procedure
• Heparin: 70 units/kg body weight pre-procedure
• Bivalirudin: Bolus 0.75 mg/kg
Infusion 1.75 mg/kg/hr - procedure duration
• GPI - Abciximab
• Selective (‘bailout’) use in both groups
• ESC guideline indications
42. At 28 days
Primary Efficacy Outcome Measure
• Major Adverse Cardiac Events (MACE) -
• All-cause mortality
• Cerebrovascular accident (CVA)
• Re-infarction
• Unplanned target lesion revascularisation (TLR)
43. At 28 days
Primary Efficacy Outcome Measure
• Major Adverse Cardiac Events (MACE)
Primary Safety Outcome Measure
•Major bleeding -
• Type 3-5 bleeding as per BARC definitions
44. 1917 patients scheduled for emergency angiography
29 (1.5%) already randomised in the trial
59 (3.0%) met one or more other exclusion criteria
1829 eligible for recruitment
45. 1917 patients scheduled for emergency angiography
29 (1.5%) already randomised in the trial
59 (3.0%) met one or more other exclusion criteria
1829 eligible for recruitment
1829 Randomised
Representative ‘Real-World’ Population
46. Assigned to Heparin 914 915 Assigned to Bivalirudin
Received allocated Rx 900
Received no study drug 14
Treatment cross-over 0
LMWH pre-procedure 3
907 Received allocated Rx
7 Received no study drug
1 Treatment cross-over
4 LMWH pre-procedure
47. Assigned to Heparin 914
Included in analysis 907
915 Assigned to Bivalirudin
905 Included in analysis
Consent not available
in surviving patients
Consent not available
in surviving patients
7 10
Received allocated Rx 900
Received no study drug 14
Treatment cross-over 0
LMWH pre-procedure 3
907 Received allocated Rx
7 Received no study drug
1 Treatment cross-over
4 LMWH pre-procedure
48. Characteristic Bivalirudin Heparin
Median age (years) 62.9 63.6
Female sex (%) 28.5 26.9
Caucasian race (%) 95.8 95.9
Diabetes mellitus (%) 12.6 15.1
Previous MI (%) 13.5 10.3
eGFR (ml/min/1.73m2) 80.0 80.0
Haemoglobin (g/dl) 13.6 13.7
49. Characteristic Bivalirudin (%) Heparin (%)
P2Y12 use - Any 99.6 99.5
- Clopidogrel 11.8 10.0
- Prasugrel 27.3 27.6
- Ticagrelor 61.2 62.7
GPI use 13.5 15.5
Radial arterial access 80.3 82.0
PCI performed 83.0 81.6
50. Characteristic Bivalirudin (%) Heparin (%)
Thrombectomy 59.1 57.6
Single vessel Tx 93.2 90.3
Any stent implant 92.8 92.2
DES implantation 79.8 79.9
TIMI III flow - post PCI 93.3 92.7
51.
52. Bivalirudin Heparin
n % % n
MACE 79 8.7 % v 5.7 % 52
Absolute risk increase = 3.0% (95% CI 0.6, 5.4)
Relative risk = 1.52 (95% CI 1.1 – 2.1) P=0.01
54. Bivalirudin Heparin
n % % n
Death 46 5.1 % v 4.3 % 39
CVA 15 1.6% v 1.2% 11
Reinfarction 24 2.7% v 0.9% 8
TLR 24 2.7% v 0.7% 6
Any MACE 79 8.7 % v 5.7 % 52
55. Bivalirudin Heparin
n % % n
Death 46 5.1 % v 4.3 % 39
CVA 15 1.6% v 1.2% 11
Reinfarction 24 2.7% v 0.9% 8
TLR 24 2.7% v 0.7% 6
Any MACE 79 8.7 % v 5.7 % 52
56. Bivalirudin Heparin
n % % n
Death 46 5.1 % v 4.3 % 39
CVA 11 1.2% v 0.6% 6
Reinfarction 21 2.3% v 0.8% 7
TLR 1 0.1% v 0% 0
Any MACE 79 8.7 % v 5.7 % 52
Censored by the most significant event - in order displayed
57. Bivalirudin Heparin
n % % n
Death 46 5.1 % v 4.3 % 39
CVA 11 1.2% v 0.6% 6
Reinfarction 21 2.3% v 0.8% 7
TLR 1 0.1% v 0% 0
Any MACE 79 8.7 % v 5.7 % 52
Censored by the most significant event - in order displayed
58. Bivalirudin Heparin
n % % n
All Events 24 3.4 % v 0.9 % 6
Relative risk = 3.91 (95% CI 1.6 - 9.5) P=0.001
ARC definite or probable stent thrombosis events
59. Bivalirudin Heparin
n % % n
Definite 23 3.3 % v 0.7 % 5
Probable 1 0.1 % v 0.1 % 1
Acute 20 2.9 % v 0.9 % 6
Subacute 4 0.6% v 0% 0
ARC definite or probable stent thrombosis events
60. Bivalirudin Heparin
n % % n
Major Bleed 32 3.5 % v 3.1 % 28
Relative risk = 1.15 (95% CI 0.7 - 1.9) P=0.59
Major Bleed BARC grade 3-5
61. Bivalirudin Heparin
n % % n
Minor Bleed 83 9.2 % v 10.8 % 98
Major or Minor 113 12.5 % v 13.5 % 122
Minor Bleed P=0.25 Major or Minor P=0.54
Major Bleed BARC grade 3-5 Minor Bleed BARC grade 2
62. Subgroup Relative Risk (95% CI)
P Value for
interaction
All patients 1.52 (1.09, 2.13)
Arterial access site 0.87
Radial 1.58 (1.01, 2.48)
Femoral 1.45 (0.70, 2.98)
Diabetes 0.35
Yes 2.22 (1.04, 4.76)
No 1.54 (1.04, 2.28)
Age 0.11
≥75 1.09 (0.68, 1.77)
<75 1.97 (1.23, 3.16)
Favours Bivalirudin Favours Heparin
1
63. Subgroup Relative Risk (95% CI)
P Value for
interaction
P2Y12 agent used 0.78
Clopidogrel 1.34 (0.54, 3.31)
Prasugrel 1.91 (0.87, 4.21)
Ticagrelor 1.41 (0.93, 2.14)
Left Ventricular Function Impaired 0.67
Yes 1.28 (0.84, 1.95)
No 1.63 (0.64, 4.16)
PCI attempted 0.88
Yes 1.55 (1.06, 2.28)
No 1.45 (0.71, 2.96)
Favours Bivalirudin Favours Heparin
2
64. • Single centre
• Potential impact minimised by:
• Meticulous trial conduct
• Unselected representative population
• Study treatments are iv drugs (no ‘skill’ component)
• Multiple operators
• Outcomes as expected by national norms
65. • Single centre
• Open label
• Potential impact minimised by:
• Complete follow-up - No ‘lost’ cases
• Outcome measures were overt clinical events
• Most MI events involved angiographic imaging
• Independent blinded adjudication
• Open label used in HORIZONS and EUROMAX
66. • A unique study with 100% recruitment of eligible patients
67. • A unique study with 100% recruitment of eligible patients
Use of heparin rather than bivalirudin
• Reduced rate of major adverse events (NNT = 33)
• Fewer stent thromboses and reinfarction events
68. • A unique study with 100% recruitment of eligible patients
Use of heparin rather than bivalirudin
• Reduced rate of major adverse events (NNT = 33)
• Fewer stent thromboses and reinfarction events
• Consistent effect across pre-specified subgroups
69. • A unique study with 100% recruitment of eligible patients
Use of heparin rather than bivalirudin
• Reduced rate of major adverse events (NNT = 33)
• Fewer stent thromboses and reinfarction events
• Consistent effect across pre-specified subgroups
• No increase in bleeding complications
70. • A unique study with 100% recruitment of eligible patients
Use of heparin rather than bivalirudin
• Reduced rate of major adverse events (NNT = 33)
• Fewer stent thromboses and reinfarction events
• Consistent effect across pre-specified subgroups
• No increase in bleeding complications
• Potential for substantial saving in drug costs
Editor's Notes
This is a single-centre randomised controlled trial which recruited patients for 22 months in 2012 and 2013.
It compared bivalirudin and unfractionated heparin in STEMI patients, randomised at presentation – in their acute phase management with Primary PCI
This is a single-centre randomised controlled trial which recruited patients for 22 months in 2012 and 2013.
It compared bivalirudin and unfractionated heparin in STEMI patients, randomised at presentation – in their acute phase management with Primary PCI
This is a single-centre randomised controlled trial which recruited patients for 22 months in 2012 and 2013.
It compared bivalirudin and unfractionated heparin in STEMI patients, randomised at presentation – in their acute phase management with Primary PCI
Thus we had a single inclusion criterion and minimal grounds for exclusion - limited to active bleeding at presentation or other problems preventing the administration of oral anti-platelet therapy
All patients received dual anti-platelet therapy – with pre-procedural oral loading.
Heparin was administered as a bolus dose of 70 units per kilogram.
Bivalirudin dosing was in accordance with the recommended schedule. The infusion was stopped at the end of the PCI procedure
We used abciximab as our GPI agent. This was reserved for bailout use in both groups - in accordance with the indications described in the ESC guidelines
The primary efficacy outcome measure was a MACE composite – comprising;
All-cause mortality, CVA, Recurrent infarction and additional, unplanned target lesion revascularisation
The primary safety outcome measure was the rate of major bleeding, defined as BARC ‘Type 3 – 5’ events
Over the recruitment period 1917 patients entered the cath labs in the context of a PPCI activation.
Only 3% of these were excluded leaving 1829 eligible patients.
All of these patients were randomised – to create an unselected ‘Real-World’ population
Patients were randomised in equal proportions.
Almost all received the study drug – as allocated at randomisation.
There was only a single treatment cross-over
Only 4 patients refused consent. We lost contact with 13 others before consent could be obtained.
We know from national tracking that none of these patients died in the subsequent 28 days.
The final – intention to treat - analysis population was 1812 patients
Baseline characteristics were well matched between the two groups. The population was predominantly Caucasian: The median age was 63 and about 14% were diabetics
Dual antiplatelet therapy was essentially universal
GPI use was similar with 13 – 15 % use in both groups
Most procedures were performed with radial access and PCI was performed in over 80% of cases
Of the Cases managed with PCI – the key aspects of procedure performance matched institutional and national norms and were well-matched between the groups.
The Primary Efficacy MACE outcome was assessed at 28 days.
MACE events were significantly more common in the Bivalirudin arm at 8.7% compared to 5.7% in patients randomised to heparin - an absolute risk increase of 3%
The relative risk of an event with bivalirudin was 1.52
The event curves demonstrate an early separation reflecting the substantial early hazard in the PPCI setting.
Some patients experience more than one event. This table lists all the observed MACE events.
Heparin advantage is seen in all elements of the composite
I need to draw you attention to the reinfarction and TLR figures
You will notice that, in both arms, event counts for reinfarction and TLR are similar
If we now show a modified table ……
…….. This time showing only the most significant MACE event experienced by each patient …
we see that .. all but one TLR events occur in the setting of reinfarction
The key implications of this are that:
TLR events make no real contribution to the primary outcome and
Almost all reinfarction events were substantiated by angiography
This difference is driven by an four-fold increase in the rate of stent thrombosis observed with bivalirudin therapy.
Almost all of these events were - by ARC criteria - definite events occurring in the first 24 hours after stent implantation.
For the safety outcomes – there was no difference in the rate of major bleeding
Rates of minor bleeding – and rate of combined major or minor bleeding were also similar
We had a number of pre-specified subgroups. This figure shows – for each group - the relative risk of a primary outcome MACE event and the associated 95% confidence intervals. Results to the right of the line of unity favour heparin.
We see consistent heparin advantage – on this slide 0 demonstrated for the arterial access site (radial or femoral): For the presence or absence of treated diabetes and for age with a dichotomous cut off at 75 years.
The effect is also independent of the oral P2Y12 inhibitor used and the subsequent left ventricular function.
Interestingly, heparin advantage is also seen in patients who were not managed with immediate PCI.
This is a single centre study but may have avoided many of the problems often associated with this design
The study treatments involve a standard dose regime and were applied in an unselected population, typical for the UK.
The outcomes were as expected and match national and international norms
We used an open label design but the outcome measures were overt clinical events, supported by objective clinical findings – even in the case of re-infarction.
All events were subject to blinded evaluation.
Finally – I would note that an open label design is the norm in this setting and was used in HORIZONS and EUROMAX
In summary then, this is a unique study achieving 100% recruitment of eligible patients
Patients randomised to heparin experienced fewer major adverse events mainly in terms if a reduced rate of acute stent thrombosis and re-infarction.
This effect was consistent across all pre-specified subgroups and I have reserve slides for this if required.
Bleeding complications were similar for both study groups.
More widespread use of heparin could offer the potential for better clinical outcomes with substantial cost saving.
Thank you for your attention.