This document summarizes a study evaluating the role of rivaroxaban after revascularization for peripheral vascular disease. The VOYAGER PAD trial was a double-blind randomized controlled trial comparing rivaroxaban 2.5 mg twice daily plus aspirin to aspirin alone in over 8,000 patients with symptomatic peripheral artery disease who had undergone recent revascularization. The study found that rivaroxaban plus aspirin significantly reduced the risk of major adverse limb or cardiovascular events compared to aspirin alone, with acceptable bleeding risk. This suggests that rivaroxaban may be a suitable alternative to warfarin for preventing complications after peripheral revascularization.
Central Retinal Vein OcclUsIon (CRUISE) Study - Cruise trialLaxmi Eye Institute
Ranibizumab injections led to improved visual acuity and resolution of macular edema compared to sham injections in patients with central retinal vein occlusion. At 6 months, patients receiving 0.3 mg or 0.5 mg ranibizumab were twice as likely to have a visual acuity of 20/40 or better compared to the sham group. Ranibizumab also significantly reduced central foveal thickness within 7 days, suggesting retinal edema in CRVO is primarily VEGF-mediated. While ranibizumab was effective, longer term studies are needed to determine optimal duration of treatment and benefits in less severe cases.
Diabetes increases patients' risk of stroke, cardiovascular death, renal function decline, and major adverse limb events. Evidence suggests that patients with non-valvular atrial fibrillation (NVAF) and diabetes receiving rivaroxaban have not only a reduced risk of stroke and systemic embolism, but also experience fewer major limb amputations or revascularization procedures and less clinically significant renal function decline. Providing effective stroke prevention while also avoiding irreversible microvascular and macrovascular complications is possible for patients with NVAF and comorbid diabetes through the use of rivaroxaban.
Utilizing Doppler Flow to Investigate the Hemodynamic Effects of Anti-Cancer ...Scintica Instrumentation
Jeanette Woolard discussed utilizing Doppler flow to investigate the haemodynamic effects of anti-cancer therapies. She described how angiogenesis is regulated by vascular endothelial growth factor (VEGF) and its receptors. Anti-VEGF therapies can inhibit tumour growth but also have cardiovascular side effects like hypertension. Her research uses Doppler flowmetry and radiotelemetry in animal models to monitor regional blood flows and pressures over time in response to anti-VEGF drugs. The findings help elucidate the mechanisms by which these therapies impact haemodynamics and identify strategies to manage their side effects.
This network meta-analysis compared clinical outcomes of 5 coronary bifurcation PCI techniques based on 21 randomized trials including 5,711 patients. The techniques were provisional stenting, T/TAP stenting, crush, culotte, and double-kissing crush (DK-crush). When all techniques were considered, DK-crush was associated with fewer major adverse cardiovascular events (MACE), driven by lower rates of repeat revascularization, with no differences among techniques for death, myocardial infarction, or stent thrombosis. In non-left main bifurcations specifically, DK-crush reduced MACE compared to provisional stenting. No differences in MACE were found among provisional stenting, culotte,
Patients with peripheral arterial disease (PAD) and critical limb ischemia are at risk for limb amputation and require urgent management to restore blood flow. Patients with PAD often have several comorbidities, including chronic kidney disease, diabetes mellitus, and hypertension. Diagnostic and interventional angiography using iodinated contrast agents provides excellent image resolution but can be associated with contrast-induced nephropathy (CIN). The use of carbon dioxide (CO2) as a contrast agent reduces the volume of iodine contrast required for angiography and reduces the incidence of CIN. However, CO2 angiography has been underutilized due to concerns regarding safety and image quality. Modern CO2 delivery systems with advanced digital subtraction angiography techniques and hybrid angiography have improved imaging accuracy and reduced the incidence of CIN. Awareness of the need for optimal imaging conditions, contraindications, and potential complications have improved the safety of CO2 angiography. This review aims to highlight current technological advances in the delivery of CO2 in vascular angiography for patients with PAD and critical limb ischemia, which result in limb preservation while preventing kidney damage.
Jan-Malte Sinning: The role of pMCS – Which patients benefit from hemodynamic...Euro CTO Club
14th Experts Live CTO
September 2nd - 3rd, 2022 - Mainz, Germany
Main Session - Breakfast Symposium by Abiomed
The role of pMCS – Which patients benefit from hemodynamic support
Jan-Malte Sinning, Köln, Germany
Room:
Guteberg Hall (Auditorium) - Saturday 7:30
Chair:
Carlo di Mario, Florence, Italy
Management of AF patients with ACS undergoing PCI.pptxPraveen Nagula
- The AUGUSTUS trial compared apixaban to vitamin K antagonist (VKA) for prevention of thromboembolic events in patients with atrial fibrillation undergoing percutaneous coronary intervention or experiencing acute coronary syndrome.
- Over 4,600 patients were randomized to apixaban 5mg twice daily or adjusted-dose VKA plus a P2Y12 inhibitor with or without aspirin for 6 months.
- The primary outcome was major or clinically relevant non-major bleeding. Apixaban resulted in a 31% relative risk reduction in the primary outcome compared to VKA.
The 2023 Duke-ISCVID criteria update the diagnostic criteria for infective endocarditis (IE). Key changes include:
1. New microbiology diagnostics like PCR, sequencing, and fluorescence in situ hybridization are included.
2. Imaging such as PET/CT and cardiac CT are added.
3. Intraoperative inspection is a new major clinical criterion.
The document aims to standardize IE diagnosis given changes in epidemiology, diagnostics, and treatment since prior criteria from 1994 and 2000.
Central Retinal Vein OcclUsIon (CRUISE) Study - Cruise trialLaxmi Eye Institute
Ranibizumab injections led to improved visual acuity and resolution of macular edema compared to sham injections in patients with central retinal vein occlusion. At 6 months, patients receiving 0.3 mg or 0.5 mg ranibizumab were twice as likely to have a visual acuity of 20/40 or better compared to the sham group. Ranibizumab also significantly reduced central foveal thickness within 7 days, suggesting retinal edema in CRVO is primarily VEGF-mediated. While ranibizumab was effective, longer term studies are needed to determine optimal duration of treatment and benefits in less severe cases.
Diabetes increases patients' risk of stroke, cardiovascular death, renal function decline, and major adverse limb events. Evidence suggests that patients with non-valvular atrial fibrillation (NVAF) and diabetes receiving rivaroxaban have not only a reduced risk of stroke and systemic embolism, but also experience fewer major limb amputations or revascularization procedures and less clinically significant renal function decline. Providing effective stroke prevention while also avoiding irreversible microvascular and macrovascular complications is possible for patients with NVAF and comorbid diabetes through the use of rivaroxaban.
Utilizing Doppler Flow to Investigate the Hemodynamic Effects of Anti-Cancer ...Scintica Instrumentation
Jeanette Woolard discussed utilizing Doppler flow to investigate the haemodynamic effects of anti-cancer therapies. She described how angiogenesis is regulated by vascular endothelial growth factor (VEGF) and its receptors. Anti-VEGF therapies can inhibit tumour growth but also have cardiovascular side effects like hypertension. Her research uses Doppler flowmetry and radiotelemetry in animal models to monitor regional blood flows and pressures over time in response to anti-VEGF drugs. The findings help elucidate the mechanisms by which these therapies impact haemodynamics and identify strategies to manage their side effects.
This network meta-analysis compared clinical outcomes of 5 coronary bifurcation PCI techniques based on 21 randomized trials including 5,711 patients. The techniques were provisional stenting, T/TAP stenting, crush, culotte, and double-kissing crush (DK-crush). When all techniques were considered, DK-crush was associated with fewer major adverse cardiovascular events (MACE), driven by lower rates of repeat revascularization, with no differences among techniques for death, myocardial infarction, or stent thrombosis. In non-left main bifurcations specifically, DK-crush reduced MACE compared to provisional stenting. No differences in MACE were found among provisional stenting, culotte,
Patients with peripheral arterial disease (PAD) and critical limb ischemia are at risk for limb amputation and require urgent management to restore blood flow. Patients with PAD often have several comorbidities, including chronic kidney disease, diabetes mellitus, and hypertension. Diagnostic and interventional angiography using iodinated contrast agents provides excellent image resolution but can be associated with contrast-induced nephropathy (CIN). The use of carbon dioxide (CO2) as a contrast agent reduces the volume of iodine contrast required for angiography and reduces the incidence of CIN. However, CO2 angiography has been underutilized due to concerns regarding safety and image quality. Modern CO2 delivery systems with advanced digital subtraction angiography techniques and hybrid angiography have improved imaging accuracy and reduced the incidence of CIN. Awareness of the need for optimal imaging conditions, contraindications, and potential complications have improved the safety of CO2 angiography. This review aims to highlight current technological advances in the delivery of CO2 in vascular angiography for patients with PAD and critical limb ischemia, which result in limb preservation while preventing kidney damage.
Jan-Malte Sinning: The role of pMCS – Which patients benefit from hemodynamic...Euro CTO Club
14th Experts Live CTO
September 2nd - 3rd, 2022 - Mainz, Germany
Main Session - Breakfast Symposium by Abiomed
The role of pMCS – Which patients benefit from hemodynamic support
Jan-Malte Sinning, Köln, Germany
Room:
Guteberg Hall (Auditorium) - Saturday 7:30
Chair:
Carlo di Mario, Florence, Italy
Management of AF patients with ACS undergoing PCI.pptxPraveen Nagula
- The AUGUSTUS trial compared apixaban to vitamin K antagonist (VKA) for prevention of thromboembolic events in patients with atrial fibrillation undergoing percutaneous coronary intervention or experiencing acute coronary syndrome.
- Over 4,600 patients were randomized to apixaban 5mg twice daily or adjusted-dose VKA plus a P2Y12 inhibitor with or without aspirin for 6 months.
- The primary outcome was major or clinically relevant non-major bleeding. Apixaban resulted in a 31% relative risk reduction in the primary outcome compared to VKA.
The 2023 Duke-ISCVID criteria update the diagnostic criteria for infective endocarditis (IE). Key changes include:
1. New microbiology diagnostics like PCR, sequencing, and fluorescence in situ hybridization are included.
2. Imaging such as PET/CT and cardiac CT are added.
3. Intraoperative inspection is a new major clinical criterion.
The document aims to standardize IE diagnosis given changes in epidemiology, diagnostics, and treatment since prior criteria from 1994 and 2000.
This document provides an overview of SGLT2 inhibitors (SGLT2is) for the treatment of heart failure and diabetes. It discusses key considerations for using SGLT2is such as evaluating appropriate patients, monitoring safety parameters like blood pressure and kidney function, and managing SGLT2i-associated euglycemic diabetic ketoacidosis. The document reviews clinical trial data on the benefits of SGLT2is in acute and chronic heart failure. It also presents two case studies on initiating SGLT2is during hospitalization and treating euglycemic ketoacidosis with insulin therapy.
Evaluation of Cardiac Complications in Pateint Undergoing COVID 19 Treatment:...DrHeena tiwari
This study evaluated cardiac complications in 45 COVID-19 patients admitted to the intensive care unit. Electrocardiography and Holter monitoring found various arrhythmias in patients, with atrial fibrillation, premature ventricular contraction, and tachycardia being most common. The mortality rate of arrhythmias in COVID-19 patients was 17.77%. Although arrhythmias are not very frequent in COVID-19, they can be fatal and have a high mortality rate. Early detection of arrhythmias can help prevent deaths.
This document discusses a study assessing the impact of routine follow-up arteriography on the management and outcomes of patients with acute blunt cerebrovascular injuries (BCVIs). The study found that most grade I and II BCVI lesions changed over time, with over half of grade I injuries healing but some progressing to require intervention. Routine follow-up arteriography 7-10 days later allowed physicians to modify management for over 60% of patients based on changes in the injuries. The study concludes that follow-up arteriography is warranted for patients with grade I or II BCVIs to guide appropriate treatment.
The document summarizes three studies related to amputation prevention programs:
1) A retrospective analysis found that a comprehensive amputation prevention program at a community hospital decreased amputation rates from an average of 8.2% before the program to an average of 2.54% after, as more patients received diagnostic testing and interventions.
2) A treatment protocol for diabetic foot ulcers and Charcot deformities achieved successful limb salvage in 92% of patients through staged reconstruction and proper pre-operative vascular evaluation.
3) Implementing skin perfusion pressure (SPP) testing identified 80% of patients as having peripheral artery disease who had normal ankle-brachial indices, allowing for improved treatment and no major amputations
1) Ozurdex (dexamethasone intravitreal implant) is effective for treating recalcitrant or non-responsive cases of diabetic macular edema (DME) and retinal vein occlusion (RVO).
2) Ensuring patient compliance with regular treatment is a major challenge in managing DME, and Ozurdex's long duration of action can help control disease progression through improved compliance.
3) Case reports demonstrate that Ozurdex can improve vision in DME and RVO patients who were previously non-responsive or partial responders to anti-VEGF therapies like ranibizumab and aflibercept.
Breaking the barriers in the management of neovascular AMDAjayDudani1
The document summarizes key details from two phase 3 clinical trials called HAWK and HARRIER that compared the anti-VEGF drug brolucizumab to aflibercept for treating neovascular age-related macular degeneration (nAMD). The trials involved over 1700 patients across multiple international sites. Patients were randomly assigned to receive either brolucizumab 3mg or 6mg, or aflibercept 2mg. The primary endpoint was change in vision from baseline at week 48, with assessments continuing through week 96. Brolucizumab demonstrated non-inferiority to aflibercept and an ability to be dosed as infrequently as every 12 weeks after the initial
This document presents a comparative analysis of endovenous laser ablation (EVLA) versus conventional surgery for treating varicose veins in the lower limbs. It provides background on varicose veins and discusses current treatment methods like compression therapy, surgical interventions, and minimally invasive endovenous procedures. The study aims to evaluate treatment outcomes of patients with CEAP class C2-C6 varicose veins who underwent either EVLA or conventional surgery, focusing on recurrence rates, time to symptom improvement, complications, and hospital stay duration. A literature review is presented on previous comparative studies evaluating EVLA, ultrasound-guided foam sclerotherapy, and conventional surgery. The methodology outlines a prospective comparative study of patients receiving EVLA or conventional
Assessment of risk of failure following infrainguinal vein2Reza Mofidi
1) Infrainguinal vein grafts are commonly used for lower limb revascularization but are at risk of failure in 20-25% of cases.
2) Vein graft failure can be classified as early (<6 weeks), intermediate, or late (>2 years) based on timing and has multifactorial causes including intimal hyperplasia, progression of disease, and technical issues.
3) Surveillance of vein grafts is controversial but may identify threatened grafts for repair through endovascular or surgical techniques, with the goal of reducing graft failure and risk of amputation.
An elderly diabetic and hypertensive male presented with acute renal failure and rhabdomyolysis. He experienced cardiac arrest with moderate hyperkalemia despite medical treatment and hemodialysis. Telemetry changes were retrospectively studied and found to have significant rhythm changes that occurred just less than 10 minutes prior to the cardiac arrest.
Ocular Manifestations In Sickle Cell Disease – A Preventable Cause Of Blindness?iosrjce
This document discusses ocular manifestations in patients with sickle cell disease. It conducted a study of 35 sickle cell disease patients to examine the relationship between hematological parameters and ophthalmic manifestations. The study found that 70% of patients with hemoglobin levels of 6g/dL or less had some ocular abnormality. Common ocular findings included changes to major retinal vessels, hemorrhages in the periphery, and neovascularization. The study concludes that regular ophthalmic exams should be conducted for sickle cell patients to prevent risks of vision loss and blindness from conditions like sickle cell retinopathy.
The document discusses kidney involvement in COVID-19 patients. It notes that acute kidney injury (AKI) occurs in 3-9% of early COVID-19 patients, rising to 19-50% of ICU patients. AKI is associated with higher mortality, between 35-90% among those with COVID-19. Pathological findings include collapsing glomerulopathy and acute tubular injury. Viral particles have been found in podocytes and tubular cells on postmortem and kidney biopsy studies.
Invasive coronary physiology to select patients for coronary revascularisation has become established in contemporary guidelines for the management of stable coronary artery disease. Compared to revascularisation based on angiography alone, the use of coronary physiology has been shown to improve clinical outcomes and cost efficiency. However, recent data from randomised controlled trials have cast doubt upon
the value of ischaemia testing to select patients for revascularisation. Importantly, 20-40% of patients have
persistence or recurrence of angina after angiographically successful percutaneous coronary intervention
(PCI). This state-of-the-art review is focused on the transitioning role of invasive coronary physiology from
its use as a dichotomous test for ischaemia with fixed cut-points, towards its utility for real-time guidance of PCI to optimise physiological results. We summarise the contemporary evidence base for ischaemia testing
in stable coronary artery disease, examine emerging indices which allow advanced physiological guidance
of PCI, and discuss the rationale and evidence base for post-PCI physiological assessments to assess the success of revascularisation.
This document provides an overview of acute graft-versus-host disease (GVHD) including current approaches, progress, and future directions. It discusses a patient case of a 65-year-old female who developed grade IV acute GVHD after a stem cell transplant. It then covers the clinical presentation and pathophysiology of acute GVHD, biomarkers for predicting outcomes, and approaches for treating acute GVHD such as systemic corticosteroids and second-line therapies for steroid-resistant disease.
DuraGraft is a treatment designed to prevent vascular graft disease and reduce complications from graft failure following coronary artery bypass graft (CABG) surgery. A retrospective study of over 2400 patients undergoing CABG surgery at a Boston hospital between 1996-2004 found that patients who received DuraGraft treatment during surgery had significantly reduced risks of non-fatal heart attack, repeat procedures to reopen blocked arteries, and major cardiovascular events over both 5 years and longer-term follow-up compared to patients who did not receive DuraGraft treatment. The study provides evidence that DuraGraft treatment during CABG surgery may provide important short- and long-term clinical benefits for patients.
Intraocular safety OF ANTIVEGF INJECTIONS IN THE EYEAjayDudani1
This document provides information about the intraocular safety of anti-VEGF agents:
- Aflibercept has a well-established safety profile across clinical trials and real-world use, with rare rates of intraocular inflammation (IOI), endophthalmitis, and retinal vasculitis reported.
- Recent communications from the American Society of Retina Specialists (ASRS) have reported cases of IOI and occlusive retinal vasculitis following administration of brolucizumab.
- A review of safety data from trials of brolucizumab found higher rates of serious ocular adverse events like IOI compared to aflibercept, raising concerns about its intraocular safety profile
This document discusses a prototype technology called CoVa that uses capnography to detect increased carbon dioxide levels after injecting sodium bicarbonate intravenously. This allows clinicians to confirm correct placement of intravenous catheters. The technology has been tested on 200 patients in a phase 3 clinical trial with statistically significant results. It could help prevent complications from malpositioned catheters like extravasation and infiltration, which are common problems that result in high costs to hospitals. Regulatory approval pathways are straightforward and initial development costs are estimated at $500,000 over 2 years to start sales.
The study evaluated the efficacy and safety of rivaroxaban compared to vitamin K antagonists for stroke prevention in patients with rheumatic heart disease-associated atrial fibrillation (RHD-AF). Over 4565 patients from 24 countries were randomized to receive either rivaroxaban 20 mg daily or a vitamin K antagonist such as warfarin, with a mean follow up of 3.1 years. The primary outcome occurred in 560 patients (8.21% per year) in the rivaroxaban group and 446 patients (6.49% per year) in the vitamin K antagonist group, showing rivaroxaban to be less effective with a hazard ratio of 1.25. There were no significant
Dr. Osama El-Shahat discusses various aspects of acute kidney injury (AKI) management including staging, modalities of renal replacement therapy, and general principles. The document covers (1) staging systems like RIFLE and AKIN to classify AKI severity, (2) modalities like intermittent hemodialysis, slow continuous ultrafiltration, and continuous renal replacement therapy, and (3) general guidelines around initiating renal replacement therapy, vascular access, solutions, anticoagulation, and dose of therapy. The overall message is that managing AKI requires an individualized approach and more high-quality research is still needed.
Persistent monocytosis and CAL in Kawasaki disease, Ho-Chang Kuo, MD (郭和昌醫師 川崎症)Ho-Chang Kuo (郭和昌 醫師)
This study investigated whether changes in complete blood counts (CBC), differential counts (DC), and C-reactive protein (CRP) levels before and after intravenous immunoglobulin (IVIG) therapy were correlated with the development of coronary artery lesions (CALs) in 147 patients with Kawasaki disease. The study found that persistent monocytosis after IVIG treatment was the only factor significantly correlated with CAL formation. Specifically, 29% of patients developed CALs, and multivariate analysis showed those with ongoing monocytosis following IVIG had a higher risk of CALs. This suggests monitoring monocyte levels could help predict and prevent CAL complications in Kawasaki disease.
This document summarizes the results of a journal club presentation on using stellate ganglion block (SGB) to treat electrical storm. The following key points were discussed:
1. SGB significantly reduced the number of ventricular arrhythmia episodes and defibrillator shocks per day compared to before SGB.
2. The efficacy of SGB in reducing arrhythmias was independent of left ventricular function, presence or type of cardiomyopathy, and subtype of ventricular arrhythmia.
3. While SGB shows promise as an effective treatment for electrical storm, larger prospective randomized studies are still needed due to limitations of current retrospective studies.
The AALL1331 trial compared blinatumomab to chemotherapy as consolidation therapy after re-induction in pediatric patients with first relapse B-cell acute lymphoblastic leukemia. The open-label, randomized controlled trial found that blinatumomab significantly improved disease-free survival compared to chemotherapy, with 3-year disease-free survival rates of 45% for blinatumomab versus 27% for chemotherapy. Blinatumomab was generally well-tolerated though adverse events included cytokine release syndrome and neurotoxicity. The results support using blinatumomab as consolidation therapy to bridge pediatric B-ALL patients to hematopoietic stem cell transplant.
Coronary artery disease remains the leading cause of death in the US. Acute coronary syndromes are caused by a sudden reduction in coronary blood flow due to atherosclerosis. There are three presentations of ACS: unstable angina, NSTEMI, and STEMI. Treatment involves stabilizing the patient, risk stratification, and determining reperfusion strategy which may involve fibrinolysis, PCI, or CABG. Long term management focuses on preventative therapies including antiplatelets, statins, beta blockers, ACE inhibitors, and other secondary prevention medications.
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This document provides an overview of SGLT2 inhibitors (SGLT2is) for the treatment of heart failure and diabetes. It discusses key considerations for using SGLT2is such as evaluating appropriate patients, monitoring safety parameters like blood pressure and kidney function, and managing SGLT2i-associated euglycemic diabetic ketoacidosis. The document reviews clinical trial data on the benefits of SGLT2is in acute and chronic heart failure. It also presents two case studies on initiating SGLT2is during hospitalization and treating euglycemic ketoacidosis with insulin therapy.
Evaluation of Cardiac Complications in Pateint Undergoing COVID 19 Treatment:...DrHeena tiwari
This study evaluated cardiac complications in 45 COVID-19 patients admitted to the intensive care unit. Electrocardiography and Holter monitoring found various arrhythmias in patients, with atrial fibrillation, premature ventricular contraction, and tachycardia being most common. The mortality rate of arrhythmias in COVID-19 patients was 17.77%. Although arrhythmias are not very frequent in COVID-19, they can be fatal and have a high mortality rate. Early detection of arrhythmias can help prevent deaths.
This document discusses a study assessing the impact of routine follow-up arteriography on the management and outcomes of patients with acute blunt cerebrovascular injuries (BCVIs). The study found that most grade I and II BCVI lesions changed over time, with over half of grade I injuries healing but some progressing to require intervention. Routine follow-up arteriography 7-10 days later allowed physicians to modify management for over 60% of patients based on changes in the injuries. The study concludes that follow-up arteriography is warranted for patients with grade I or II BCVIs to guide appropriate treatment.
The document summarizes three studies related to amputation prevention programs:
1) A retrospective analysis found that a comprehensive amputation prevention program at a community hospital decreased amputation rates from an average of 8.2% before the program to an average of 2.54% after, as more patients received diagnostic testing and interventions.
2) A treatment protocol for diabetic foot ulcers and Charcot deformities achieved successful limb salvage in 92% of patients through staged reconstruction and proper pre-operative vascular evaluation.
3) Implementing skin perfusion pressure (SPP) testing identified 80% of patients as having peripheral artery disease who had normal ankle-brachial indices, allowing for improved treatment and no major amputations
1) Ozurdex (dexamethasone intravitreal implant) is effective for treating recalcitrant or non-responsive cases of diabetic macular edema (DME) and retinal vein occlusion (RVO).
2) Ensuring patient compliance with regular treatment is a major challenge in managing DME, and Ozurdex's long duration of action can help control disease progression through improved compliance.
3) Case reports demonstrate that Ozurdex can improve vision in DME and RVO patients who were previously non-responsive or partial responders to anti-VEGF therapies like ranibizumab and aflibercept.
Breaking the barriers in the management of neovascular AMDAjayDudani1
The document summarizes key details from two phase 3 clinical trials called HAWK and HARRIER that compared the anti-VEGF drug brolucizumab to aflibercept for treating neovascular age-related macular degeneration (nAMD). The trials involved over 1700 patients across multiple international sites. Patients were randomly assigned to receive either brolucizumab 3mg or 6mg, or aflibercept 2mg. The primary endpoint was change in vision from baseline at week 48, with assessments continuing through week 96. Brolucizumab demonstrated non-inferiority to aflibercept and an ability to be dosed as infrequently as every 12 weeks after the initial
This document presents a comparative analysis of endovenous laser ablation (EVLA) versus conventional surgery for treating varicose veins in the lower limbs. It provides background on varicose veins and discusses current treatment methods like compression therapy, surgical interventions, and minimally invasive endovenous procedures. The study aims to evaluate treatment outcomes of patients with CEAP class C2-C6 varicose veins who underwent either EVLA or conventional surgery, focusing on recurrence rates, time to symptom improvement, complications, and hospital stay duration. A literature review is presented on previous comparative studies evaluating EVLA, ultrasound-guided foam sclerotherapy, and conventional surgery. The methodology outlines a prospective comparative study of patients receiving EVLA or conventional
Assessment of risk of failure following infrainguinal vein2Reza Mofidi
1) Infrainguinal vein grafts are commonly used for lower limb revascularization but are at risk of failure in 20-25% of cases.
2) Vein graft failure can be classified as early (<6 weeks), intermediate, or late (>2 years) based on timing and has multifactorial causes including intimal hyperplasia, progression of disease, and technical issues.
3) Surveillance of vein grafts is controversial but may identify threatened grafts for repair through endovascular or surgical techniques, with the goal of reducing graft failure and risk of amputation.
An elderly diabetic and hypertensive male presented with acute renal failure and rhabdomyolysis. He experienced cardiac arrest with moderate hyperkalemia despite medical treatment and hemodialysis. Telemetry changes were retrospectively studied and found to have significant rhythm changes that occurred just less than 10 minutes prior to the cardiac arrest.
Ocular Manifestations In Sickle Cell Disease – A Preventable Cause Of Blindness?iosrjce
This document discusses ocular manifestations in patients with sickle cell disease. It conducted a study of 35 sickle cell disease patients to examine the relationship between hematological parameters and ophthalmic manifestations. The study found that 70% of patients with hemoglobin levels of 6g/dL or less had some ocular abnormality. Common ocular findings included changes to major retinal vessels, hemorrhages in the periphery, and neovascularization. The study concludes that regular ophthalmic exams should be conducted for sickle cell patients to prevent risks of vision loss and blindness from conditions like sickle cell retinopathy.
The document discusses kidney involvement in COVID-19 patients. It notes that acute kidney injury (AKI) occurs in 3-9% of early COVID-19 patients, rising to 19-50% of ICU patients. AKI is associated with higher mortality, between 35-90% among those with COVID-19. Pathological findings include collapsing glomerulopathy and acute tubular injury. Viral particles have been found in podocytes and tubular cells on postmortem and kidney biopsy studies.
Invasive coronary physiology to select patients for coronary revascularisation has become established in contemporary guidelines for the management of stable coronary artery disease. Compared to revascularisation based on angiography alone, the use of coronary physiology has been shown to improve clinical outcomes and cost efficiency. However, recent data from randomised controlled trials have cast doubt upon
the value of ischaemia testing to select patients for revascularisation. Importantly, 20-40% of patients have
persistence or recurrence of angina after angiographically successful percutaneous coronary intervention
(PCI). This state-of-the-art review is focused on the transitioning role of invasive coronary physiology from
its use as a dichotomous test for ischaemia with fixed cut-points, towards its utility for real-time guidance of PCI to optimise physiological results. We summarise the contemporary evidence base for ischaemia testing
in stable coronary artery disease, examine emerging indices which allow advanced physiological guidance
of PCI, and discuss the rationale and evidence base for post-PCI physiological assessments to assess the success of revascularisation.
This document provides an overview of acute graft-versus-host disease (GVHD) including current approaches, progress, and future directions. It discusses a patient case of a 65-year-old female who developed grade IV acute GVHD after a stem cell transplant. It then covers the clinical presentation and pathophysiology of acute GVHD, biomarkers for predicting outcomes, and approaches for treating acute GVHD such as systemic corticosteroids and second-line therapies for steroid-resistant disease.
DuraGraft is a treatment designed to prevent vascular graft disease and reduce complications from graft failure following coronary artery bypass graft (CABG) surgery. A retrospective study of over 2400 patients undergoing CABG surgery at a Boston hospital between 1996-2004 found that patients who received DuraGraft treatment during surgery had significantly reduced risks of non-fatal heart attack, repeat procedures to reopen blocked arteries, and major cardiovascular events over both 5 years and longer-term follow-up compared to patients who did not receive DuraGraft treatment. The study provides evidence that DuraGraft treatment during CABG surgery may provide important short- and long-term clinical benefits for patients.
Intraocular safety OF ANTIVEGF INJECTIONS IN THE EYEAjayDudani1
This document provides information about the intraocular safety of anti-VEGF agents:
- Aflibercept has a well-established safety profile across clinical trials and real-world use, with rare rates of intraocular inflammation (IOI), endophthalmitis, and retinal vasculitis reported.
- Recent communications from the American Society of Retina Specialists (ASRS) have reported cases of IOI and occlusive retinal vasculitis following administration of brolucizumab.
- A review of safety data from trials of brolucizumab found higher rates of serious ocular adverse events like IOI compared to aflibercept, raising concerns about its intraocular safety profile
This document discusses a prototype technology called CoVa that uses capnography to detect increased carbon dioxide levels after injecting sodium bicarbonate intravenously. This allows clinicians to confirm correct placement of intravenous catheters. The technology has been tested on 200 patients in a phase 3 clinical trial with statistically significant results. It could help prevent complications from malpositioned catheters like extravasation and infiltration, which are common problems that result in high costs to hospitals. Regulatory approval pathways are straightforward and initial development costs are estimated at $500,000 over 2 years to start sales.
The study evaluated the efficacy and safety of rivaroxaban compared to vitamin K antagonists for stroke prevention in patients with rheumatic heart disease-associated atrial fibrillation (RHD-AF). Over 4565 patients from 24 countries were randomized to receive either rivaroxaban 20 mg daily or a vitamin K antagonist such as warfarin, with a mean follow up of 3.1 years. The primary outcome occurred in 560 patients (8.21% per year) in the rivaroxaban group and 446 patients (6.49% per year) in the vitamin K antagonist group, showing rivaroxaban to be less effective with a hazard ratio of 1.25. There were no significant
Dr. Osama El-Shahat discusses various aspects of acute kidney injury (AKI) management including staging, modalities of renal replacement therapy, and general principles. The document covers (1) staging systems like RIFLE and AKIN to classify AKI severity, (2) modalities like intermittent hemodialysis, slow continuous ultrafiltration, and continuous renal replacement therapy, and (3) general guidelines around initiating renal replacement therapy, vascular access, solutions, anticoagulation, and dose of therapy. The overall message is that managing AKI requires an individualized approach and more high-quality research is still needed.
Persistent monocytosis and CAL in Kawasaki disease, Ho-Chang Kuo, MD (郭和昌醫師 川崎症)Ho-Chang Kuo (郭和昌 醫師)
This study investigated whether changes in complete blood counts (CBC), differential counts (DC), and C-reactive protein (CRP) levels before and after intravenous immunoglobulin (IVIG) therapy were correlated with the development of coronary artery lesions (CALs) in 147 patients with Kawasaki disease. The study found that persistent monocytosis after IVIG treatment was the only factor significantly correlated with CAL formation. Specifically, 29% of patients developed CALs, and multivariate analysis showed those with ongoing monocytosis following IVIG had a higher risk of CALs. This suggests monitoring monocyte levels could help predict and prevent CAL complications in Kawasaki disease.
This document summarizes the results of a journal club presentation on using stellate ganglion block (SGB) to treat electrical storm. The following key points were discussed:
1. SGB significantly reduced the number of ventricular arrhythmia episodes and defibrillator shocks per day compared to before SGB.
2. The efficacy of SGB in reducing arrhythmias was independent of left ventricular function, presence or type of cardiomyopathy, and subtype of ventricular arrhythmia.
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Final_ASandler_PVD_Anticoag patient case.pptx
1. Rerouting Anticoagulants
Evaluating the Role of Rivaroxaban Following
Revascularization for Peripheral Vascular Disease
Anna Sandler
PharmD Candidate, 2023
1
2. Learning Objectives
Review the epidemiology, pathophysiology, and
clinical presentation of peripheral vascular disease
(PVD)
Describe the current treatment of PVD, including
revascularization
Identify the role of anticoagulant therapy in PVD
Evaluate literature and apply findings to a patient
case
2
3. Patient case
MS is a 91 year old male who returns to the anticoagulation clinic for
off-site warfarin management. The patient has been taking 11.25 mg
weekly, and his home health RN reports an INR of 2.1. The patient is
instructed to continue with the same dose and return for follow-up in
three weeks.
3
09.13.2022 10.06.2022 10.18.2022-
What could the patient be
taking the warfarin for?
4. Patient case
MS returns to the anticoagulation clinic for off-site warfarin
management. The patient’s home RN calls to report recent INR
results. She states the patient has been very irritable and non-
compliant with his warfarin, taking more than instructed. The
patient does not want to take warfarin anymore.
Current
Medications
Assessment
PMH
Warfarin
dose/INR
4
• PVD s/p stent
(1/2011) and s/p
bypass graft
(2/2011)
• HLD
• Carotid Artery
disease s/p
endarterectomy
(4/2011)
• HTN
• Lisinopril 5 mg
daily
• Metoprolol 25 mg
daily
• Pentoxifylline 400
mg BID
• Warfarin
• Simvastatin 20 mg
QHS
• Irritable,
yelling at RN
• Has some small
oozing blood
from groin area
• 16.25 mg
/week
• INR 5.8
09.13.2022 10.06.2022 10.18.2022-
5. Patient case
MS returns to the anticoagulation clinic for off-site warfarin
management. The patient’s home RN calls to report recent INR
results. She states the patient has been very irritable and non-
compliant with his warfarin, taking more than instructed. The
patient does not want to take warfarin anymore.
5
09.13.2022 10.06.2022 10.18.2022-
What are some potential
reasons this patient does
not want to take warfarin
anymore?
6. 6
Patient case-PVD details
1/ 2011
Stent placement
on left lower
extremity
2/ 2011
Femoropopliteal graft 2/2
stent stenosis
Started warfarin
6/2022
Arterial duplex revealed
patent femoral-femoral
bypass and occluded left
femoral to posterior tibial
graft with two vessel runoff
10/2022
Patient hospitalized for bleeding
thigh wound and potential
infection of graft, team discussing
revascularization
Patient also had an amputation of
the left second toe in 2011, date
unknown
7. Patient case
MS presents to his primary care physician after a recent visit to the
ER 2/2 bleeding from his thigh wound. Based on labs and physical
exam, patient is sent to LGH for further evaluation of acute blood
loss anemia.
Labs Physical Exam
7
• Hgb 9.2
(baseline 14)
• INR 4.8
• Pale and very
weak
appearing
• Thigh wound
still bleeding
a bit
09.13.2022 10.06.2022 10.18.2022-
8. Background VOYAGER Study 2 Conclusions
8
• Chronic progressive atherosclerotic disease leading to
partial or total occlusion of peripheral vasculature
• ~ 200 million people affected globally
Peripheral Vascular Disease (PVD)
Gul F, Janzer SF. StatPearls. 2022. Accessed October 25, 2022.
Modernvascular. https://modernvascular.com/peripheral-artery-disease/. Accessed October 25, 2022
Risk factors
• Tobacco Use
• Diabetes
• HTN
• HLD
• > 50 y/o
• BMI > 30
• African
Americans
• Poverty
• Low education
High-risk groups
9. PVD Pathophysiology
Gul F, Janzer SF. StatPearls. 2022. Accessed October 25, 2022.
https://stock.adobe.com/hu/search/images?k=peripheral+artery+disease&asset_id=494776405. Accessed
October 25, 2022
Lipoprotein
accumulation
Oxidation and
fatty streaks
Fibrous
plaque
Accumulation
Stenosis &
Occlusion
9
Background VOYAGER Study 2 Conclusions
10. Clinical Presentation
•Exercise-induced cramping, fatigue, weakness, pressure
Intermittent Claudication (IC)
•Paresthesias, lower extremity weakness, cool extremities
Altered sensations
•Pain at rest, non-healing wounds or ulcers, gangrene
Critical limb ischemia
10
Gul F, Janzer SF. StatPearls. 2022. Accessed October 25, 2022.
https://blog.avinger.com/blog/peripheral-artery-disease-pad-symptoms. Accessed October 25, 2022.
Background VOYAGER Study 2 Conclusions
11. Diagnosis of PVD
• Assess for known risk factors
• Ankle-brachial index (ABI) assessment
• Systolic ankle pressure/systolic brachial pressure
Normal ABI ratio: 0.9-1.2
PVD ABI ratio: < 0.9
• Duplex US for determining location and severity of stenosis
• Magnetic resonance angiography (MRA) or CTA to image
vessels and hemodynamically significant lesions
Gul F, Janzer SF. StatPearls. 2022. Accessed October 25, 2022. 11
Background VOYAGER Study 2 Conclusions
12. Complications of PVD
12
Acute Limb Ischemia
Major amputation
Major adverse CV events
Twitter. https://twitter.com/cirbosque/status/1259513941467828226. Accessed October 28, 2022
Verywell Health. https://www.verywellhealth.com/types-of-lower-extremity-amputations-2696172.
Accessed October 28, 2022
Background VOYAGER Study 2 Conclusions
14. 14
•Exercise therapy
•Smoking cessation
•Cholesterol and BP control
•Blood sugar control
Risk-factor modification
•Cilostazol
•Pentoxifylline
Pharmacological for IC
Gul F, Janzer SF. StatPearls. 2022. Accessed October 25, 2022.
Mayo Clinic https://www.mayoclinic.org/diseases-conditions/peripheral-artery-disease/multimedia/graft-bypass/img-
20008584. Accessed October 25, 2022
Interventions:
• Revascularization
• Endovascular (lower-risk)
• Surgical/bypass (higher-risk)
• Amputation
Background VOYAGER Study 2 Conclusions
15. 15
Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016. Circulation. Accessed October 25, 2022.
Gul F, Janzer SF. StatPearls. 2022. Accessed October 25, 2022.
Therapy Agents Recommendation
Antiplatelet
therapies
ASA or
clopidogrel
daily
To reduce MI, stroke, or vascular death in patients with
symptomatic PVD (COR 1, LOE A)
Cholesterol
management
Statins Indicated for all PVD patients (COR I, LOE A)
IC sx control Cilostazol Effective therapy to improve sx and increase walking distance
in patients with claudication (COR I, LOE A)
IC sx control Pentoxifylline Not effective for IC tx (COR III, LOE B-R)
Anti-hypertensives ACE inhibitors
or ARBs
To reduce risk of CV ischemic events in patients with PVD
(COR IIa, LOE A)
Oral
anticoagulation
Warfarin
?DOACs
Useful to improve patency after lower extremity autogenous
vein or prosthetic bypass uncertain
(IIb, B-R)
Background VOYAGER Study 2 Conclusions
16. 16
Revascularization comes with its own
complications
• Loss of graft patency
• Severe claudication
• Limb-threatening ischemia
• Risk is 4X as high as that
among those who have
never undergone
revascularization
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
Hess CN, Rogers RK, Wang TY, et al. J Am Coll Cardiol 2018; 72: 999-1011. Accessed October 28, 2022
Hess CN, Wang TY, Weleski Fu J, et al. J Am Coll Cardiol 2020; 75: 498-508. Accessed October 28, 2022
Can we modify this risk?
Background VOYAGER Study 2 Conclusions
17. Back to Patient MS
17
What do we think he is taking
warfarin for?
09.13.2022 10.06.2022 10.18.2022-
18. Clinical Question
18
If MS undergoes
revascularization, can we select
an alternative to warfarin?
09.13.2022 10.06.2022 10.18.2022-
20. A short history lesson
20
2013 (TRA2P-TIMI 50)
• Vorapaxar reduces acute
limb ischemia in PVD pts.
2013 (ROCKET-AF)
• Rivaroxaban non-inferior to
warfarin in non-valvular
afib
2017 (COMPASS)
Rivaroxaban + ASA superior
to ASA in preventing major
events in limbs
2020 (VOYAGER-PAD
2022 DOACs vs. warfarin
in high-risk bypass
Background VOYAGER Study 2 Conclusions
21. A short history lesson
21
2013 (TRA2P-TIMI 50)
• Vorapaxar reduces acute
limb ischemia in PVD pts.
2013 (ROCKET-AF)
• Rivaroxaban non-inferior to
warfarin in non-valvular
afib
2017 (COMPASS)
Rivaroxaban + ASA superior
to ASA in preventing major
events in limbs
2020 (VOYAGER-PAD
2022 DOACs vs. warfarin
in high-risk bypass
Background VOYAGER Study 2 Conclusions
22. Literature Review:
22
Rivaroxaban in Peripheral
Artery Disease after
Revascularization
Marc P. Bonaca, Rupert M. Bauersachs, Sonia S.
Anand et al. 2020
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
Background VOYAGER Study 2 Conclusions
23. 23
•Evaluate safety and efficacy of rivaroxaban added to
aspirin compared to aspirin alone for the prevention of
major adverse limb and CV events in patients with PVD.
Objective
•Double-blind, superiority randomized controlled trial
Design
• Rivaroxaban 2.5 mg twice daily added to aspirin 100 mg
daily
Intervention
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
Background VOYAGER Study 2 Conclusions
24. •>/= 50 y/o
•Documented moderate-severe symptomatic lower extremity atherosclerotic
PVD (clinically + anatomically + ABI </= 0.80/0.85 depending on prior hx of
limb revascularization)
•Successful revascularization procedure within 10 days for PVD sx
Inclusion Criteria
•Planned DAPT or long-term tx with clopidogrel
•High bleeding risk
•Hx of clinically significant bleeding within 6 months prior to randomization
•Major tissue loss in either leg
•Patients requiring tx with ASA doses > 100 mg
Exclusion Criteria
24
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
Background VOYAGER Study 2 Conclusions
25. 25
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
Design-Randomization
Randomization
+ clopidogrel
Rivaroxaban
2.5 mg BID
Placebo
- clopidogrel
Rivaroxaban
2.5 mg BID
Placebo
1:1
1:1
Strata:
• Procedure type
• +/- clopidogrel
Background VOYAGER Study 2 Conclusions
26. 26
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
Design-Outcomes
1015 events 90% power
20%
reduction
One-sided α
0.025
Outcome Description
Primary
efficacy (ITT)
Composite:
• Acute limb ischemia, major amputation for vascular
causes
• MI
• Ischemic stroke
• Death from CV causes
Safety
(On-treatment)
• Major bleeding according to TIMI, ISRH, and BARC
classifications
Background VOYAGER Study 2 Conclusions
27. 27
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
Timeline
• Patients randomized Aug 2015- Jan 2018
• 542 sites, 34 countries
• North America
• South America
• Europe
• Asia
• Median f/u period: 28 months
Background VOYAGER Study 2 Conclusions
28. Results-Baseline Characteristics
28
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
Groups well balanced
Rivaroxaban N= 3286, Placebo N = 3278
• Median age: 67.0
• White (%): 81
• Asian (%): 15
• HTN (%): 81
• HLD (%): 60
• Current smoker (%): 35
• T2DM (%): 40
• eGFR < 60 (%): 20
• Endovascular procedure (%): 65
• Surgical procedure (%): 35
• Carotid artery disease (%): 9
• Previous amputation (%): 6
• Previous peripheral revascularization
(%): 36
• ASA at randomization (%): 99
• Clopidogrel at randomization (%): 50
• Statin at randomization (%): 80
Background VOYAGER Study 2 Conclusions
29. Results-Primary Outcome
Endpoint Riva (N=3286) Placebo (N=3278) HR (95% CI); P
Primary
outcome
508 (15.5) 584 (17.8) 0.85 (0.76-
0.96); P 0.009
29
Primary Outcome
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
• Lower rate of composite
outcome in rivaroxaban
group
• NNT ~ 44
Background VOYAGER Study 2 Conclusions
30. Results-Other outcomes
30
Secondary (Hierarchical)
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
• Statistically significant
lower incidences of:
Safety
Unplanned
revascularization
Hospitalization for
thrombosis
Limb ischemia +
amputation + MI +
death from any
cause
Death alone not
sig. reduced
• Higher TIMI major bleeding in
rivaroxaban group, not significantly
higher
• 62 patients vs. 44 patients (HR
1.43; 95% CI 0.97-2.10; P= 0.07)
• Higher ISTH major bleeding in
rivaroxaban group
• 140 patients vs. 100 patients
(HR 1.42; 95% CI, 1.10-1.84)
• NNH ~81
Background VOYAGER Study 2 Conclusions
31. Conclusions
31
Researchers
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
• Early benefit of
rivaroxaban addition to
aspirin for reducing
primary composite
outcome
• Higher major bleeding
rates with addition of
rivaroxaban without
increases in intracranial or
fatal bleeding
Background VOYAGER Study 2 Conclusions
32. Strengths and Weaknesses
32
• High discontinuation rates
• Only evaluated treatment
within 10 days of
revascularization
• Evaluated WITH ASA
• Lack of comparisons to
warfarin
• Low representation
• Surgical revascularization
• Carotid artery disease
Bonaca MP, Bauersachs RM, Anand SS, et al. N Engl J Med. 2020;382(21):1994-2004. Accessed October 25, 2022.
• Large, international
randomized control trial
• Endpoints independently
and blindly adjudicated
• Many comorbidities
represented
Background VOYAGER Study 2 Conclusions
33. Literature Review:
33
Meghpara MK, Tong Y, Sebastian A, et al. Ann Vasc Surg. 2022:S0890-5096(22)00329-6. Accessed 10/28/2022.
Effect of Direct Oral
Anticoagulants Versus Warfarin
on Patency in High-Risk Bypass
Patients
Melissa K. Meghpara, Yi Tong, Albertina
Sebastian et al. 2022
Background VOYAGER Study 2 Conclusions
34. 34
•Evaluate efficacy of DOACS compared to warfarin during
post-op period in patients undergoing lower extremity high-
risk bypass (HRB)
•Warfarin vs. apixaban or rivaroxaban
Objective
•Single-center, retrospective pilot study
Design
Meghpara MK, Tong Y, Sebastian A, et al. Ann Vasc Surg. 2022:S0890-5096(22)00329-6. Accessed 10/28/2022.
Background VOYAGER Study 2 Conclusions
35. •Lower extremity HRB graft patients undergoing femoral
to above/below knee bypass with adjunct procedure, or
below knee bypass
•Redo bypass
Inclusion Criteria
•Anti-platelet therapy
Exclusion Criteria
35
Meghpara MK, Tong Y, Sebastian A, et al. Ann Vasc Surg. 2022:S0890-5096(22)00329-6. Accessed 10/28/2022.
Background VOYAGER Study 2 Conclusions
36. Design-Outcomes
36
Meghpara MK, Tong Y, Sebastian A, et al. Ann Vasc Surg. 2022:S0890-5096(22)00329-6. Accessed 10/28/2022.
• Demographic and comorbidity data
obtained from medical records
Outcome Description
Primary • 12-month primary bypass patency:
< 50% stenosis of arterial graft during f/u appnts
Secondary/safety • 30-day reinterventions, bleeding complications,
CV or cerebrovascular complications (stroke, MI),
need for major amputation and mortality
Background VOYAGER Study 2 Conclusions
37. Results-Baseline Characteristics
37
Meghpara MK, Tong Y, Sebastian A, et al. Ann Vasc Surg. 2022:S0890-5096(22)00329-6. Accessed 10/28/2022.
Characteristic DOAC (N=26) Warfarin (N=18) P
Age (mean yrs) 69 68 0.661
Male (%): 65 61 1.000
White (%): 65 56 0.055
Black (%): 31 22 0.055
PVD (%): 92 83 0.386
HLD (%): 54 33 0.227
HTN (%): 85 83. 1.000
Previous stent (%): 50.0 50.0 1.000
Prior endarterectomy (%): 81 29 0.001
Adjunct endovascular
procedure
42.3 11.1 0.043
CAD (%): 65 28 0.031
Background VOYAGER Study 2 Conclusions
38. Results-Primary Outcome
Endpoint DOAC (N=26) Warfarin (N= 18) P (Log-
rank)
12-month
patency rate (%)
83.3 57.1 0.03
38
Primary Outcome
Meghpara MK, Tong Y, Sebastian A, et al. Ann Vasc Surg. 2022:S0890-5096(22)00329-6. Accessed 10/28/2022.
• Higher patency rates in
DOAC group
• Odds ratio after
controlling for > 30-day
reintervention: 6.59 (CI
1.06-41.09)
Length patency
DOAC
Warfarin
Probability
of
Patency
Background VOYAGER Study 2 Conclusions
39. Conclusions
39
Researchers
• No difference in post-op complications of
HRB patients with higher 12-month
patency rates in DOAC-treated patients
compared to warfarin group.
• Need for larger randomized controlled
trial to further study outcomes between
DOACs and warfarin perioperatively in
bypass patients.
Meghpara MK, Tong Y, Sebastian A, et al. Ann Vasc Surg. 2022:S0890-5096(22)00329-6. Accessed 10/28/2022.
Background VOYAGER Study 2 Conclusions
• No differences in post-
op outcomes and
complications between
DOAC and warfarin
patients
40. Strengths and Weaknesses
40
• Inclusion of similar
patients
• Prior stent,
bypass graft,
endarterectomy
hx
• Retrospective
• Single-center
• Low f/u rates-type I error
• Small n
• ?Underpowered
• Endovascular-oriented
era
• Some baseline differences
• More CAD in DOAC
group
Meghpara MK, Tong Y, Sebastian A, et al. Ann Vasc Surg. 2022:S0890-5096(22)00329-6. Accessed 10/28/2022.
Background VOYAGER Study 2 Conclusions
41. 41
Back to Our Patient
1/ 2011
Stent placement
on left lower
extremity
2/ 2011
Femoropopliteal graft 2/2
stent stenosis
Started warfarin
6/2022
Arterial duplex revealed
patent femoral-femoral
bypass and occluded left
femoral to posterior tibial
graft with two vessel runoff
10/2022
Patient hospitalized for bleeding
thigh wound and potential
infection of graft, team discussing
revascularization
Patient also had an amputation of
the left second toe in 2011, date
unknown
42. 42
Back to Our Patient 10/2022
Patient is not a candidate for
surgery due to advanced age and
debilitated state, ultimately
admitted to hospice
09.13.2022 10.06.2022 10.18.2022-
However, if MS had undergone revascularization…
43. 43
09.13.2022 10.06.2022 10.18.2022-
Rivaroxaban Indication:
On the basis of the data, I may or
may not recommend rivaroxaban for
post-revascularization
anticoagulation at this time.
UpToDate. Rivaroxaban: Drug Information. https://www.uptodate.com/contents/rivaroxaban-drug-
information?sectionName=Adult&anchor=F6724168&source=auto_suggest&selectedTitle=1~1---2~4---
rivaroxaban&showDrugLabel=true&search=rivaroxaban#. Accessed October 31, 2022.
Efficacy Safety
44. 44
09.13.2022 10.06.2022 10.18.2022-
Rivaroxaban Indication:
On the basis of the patient’s
condition, I would not
recommend rivaroxaban.
UpToDate. Rivaroxaban: Drug Information. https://www.uptodate.com/contents/rivaroxaban-drug-
information?sectionName=Adult&anchor=F6724168&source=auto_suggest&selectedTitle=1~1---2~4---
rivaroxaban&showDrugLabel=true&search=rivaroxaban#. Accessed October 31, 2022.
Efficacy
Safety
46. References
46
1. Bonaca MP, Bauersachs RM, Anand SS, et al. Rivaroxaban in Peripheral Artery Disease after Revascularization.
N Engl J Med. 2020;382(21):1994-2004. doi:10.1056/NEJMoa200005
2. Eikelboom JW, Connolly SJ, Bosch J, et al. Rivaroxaban with or without Aspirin in Stable Cardiovascular
Disease. N Engl J Med. 2017;377(14):1319-1330. doi:10.1056/NEJMoa1709118
3. Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the Management of Patients
With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of
Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135(12).
doi:10.1161/CIR.0000000000000470
4. Gul F, Janzer SF. Peripheral Vascular Disease. In: StatPearls. StatPearls Publishing; 2022. Accessed October
25, 2022. http://www.ncbi.nlm.nih.gov/books/NBK557482/
5. Hess CN, Rogers RK, Wang TY, et al. Major Adverse Limb Events and 1-Year Outcomes After
Peripheral Artery Revascularization. J Am Coll Cardiol. 2018;72(9):999-1011. doi:10.1016/j.jacc.2018.06.041
6. Hess CN, Wang TY, Weleski Fu J, et al. Long-Term Outcomes and Associations With Major Adverse Limb
Events After Peripheral Artery Revascularization. J Am Coll Cardiol. 2020;75(5):498-508.
doi:10.1016/j.jacc.2019.11.050
7. Meghpara MK, Tong Y, Sebastian A, et al. Effect of Direct Oral Anticoagulants Versus Warfarin on Patency in
High-Risk Bypass Patients. Ann Vasc Surg. Published online July 8, 2022:S0890-5096(22)00329-6.
doi:10.1016/j.avsg.2022.06.009
47. References
47
8. Morrow DA, Braunwald E, Bonaca MP, et al. Vorapaxar in the Secondary Prevention of Atherothrombotic Events.
N Engl J Med. 2012;366(15):1404-1413. doi:10.1056/NEJMoa1200933
9. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. N Engl J
Med. 2011;365(10):883-891. doi:10.1056/NEJMoa1009638
10. Provance JB, Smolderen KG, Mao J, et al. Abstract 11211: Guideline Directed Medical Therapy After Peripheral
Vascular Intervention and One-Year Mortality in Patients with Peripheral Artery Disease in the Vascular Quality
Initiative Medicare Linked Database. Circulation. 2021;144(Suppl_1). doi:10.1161/circ.144.suppl_1.11211
49. Rerouting Anticoagulants
Evaluating the Role of Rivaroxaban Following
Revascularization for Peripheral Vascular Disease
Anna Sandler
PharmD Candidate, 2023
49