1) Dr. Pahlajani discusses anticoagulation strategies for complex percutaneous coronary interventions (PCI) that require dual antiplatelet therapy (DAPT) and oral anticoagulation (OAC).
2) Studies have shown that major bleeding during acute coronary syndromes (ACS) is associated with significantly higher in-hospital mortality. Blood transfusions for non-ST elevation myocardial infarction (NSTEMI) patients are also linked to higher 30-day mortality.
3) When selecting anticoagulation and antiplatelet regimens, it is important to balance preventing ischemic events with avoiding major bleeding which can negate the benefits of antithrombotic therapy. Strategies discussed include
The document summarizes the results of a clinical trial studying the effects of blood pressure lowering treatment on secondary stroke prevention. The trial involved over 6,000 patients with a history of cerebrovascular disease across 10 countries. It found that treatment with perindopril (an ACE inhibitor) plus indapamide lowered blood pressure more than single drug therapy or placebo and reduced the risk of fatal or non-fatal stroke by 28%. Combination therapy also reduced major vascular events by 26% and was well-tolerated with few side effects. The results indicate that blood pressure lowering provides significant benefits for secondary stroke prevention, regardless of baseline blood pressure or medical history.
Noacs use in patients other than atrial fibrillationDIPAK PATADE
1) The document discusses trials evaluating the direct oral anticoagulants (DOACs) dabigatran, rivaroxaban, and apixaban for various indications.
2) The RE-NOVATE trials found dabigatran non-inferior to enoxaparin for VTE prevention after hip replacement with comparable bleeding risks.
3) The RE-COVER trials found dabigatran non-inferior to warfarin for VTE treatment and secondary prevention with lower bleeding risks.
4) The EINSTEIN trials found rivaroxaban non-inferior to enoxaparin/warfarin for VTE treatment and
This document provides an outline for a presentation on newer oral anticoagulants (NOACs). It discusses the properties and advantages of various NOACs including dabigatran, rivaroxaban, apixaban, and edoxaban compared to vitamin K antagonists. It summarizes the results of major clinical trials that compared these drugs to warfarin for stroke prevention in atrial fibrillation and treatment of venous thromboembolism. It also provides dosing guidelines and management of side effects for the different NOACs.
Secondary Prevention after ACS: Focused on Anticoagulant TherapyPERKI Pekanbaru
Dr. Nathania Marliani Kristanti, SpJP, FIHA. 3rd Pekanbaru Cardiology Update, August 25th 2013. Pangeran Hotel Pekanbaru. Learn more at PerkiPekanbaru.com
This document discusses oral anticoagulants (OACs) for preventing thromboembolic events in patients with atrial fibrillation (AF). It outlines the rationale for using OACs in AF patients, different types of OACs including vitamin K antagonists and novel oral anticoagulants (NOACs), and clinical trial results demonstrating the efficacy and safety of NOACs compared to warfarin. It also discusses calculating the net clinical benefit of OACs, guidelines for indications of anticoagulation treatment, factors to consider when selecting an OAC, and conclusions regarding the effectiveness and appropriate use of OACs in AF patients.
Overview of Non Vitamin K oral anticoagulantsNeeraj Varyani
Dabigatran, rivaroxaban, and apixaban are novel oral anticoagulants (NOACs) that are alternatives to warfarin for preventing strokes in atrial fibrillation and treating deep vein thrombosis. Large clinical trials found these NOACs to be as effective as warfarin with less risk of bleeding. Dabigatran 150mg twice daily was more effective than warfarin at preventing strokes while 110mg twice daily had similar efficacy but lower bleeding. Rivaroxaban and apixaban were noninferior to warfarin with similar or lower risks of bleeding. Edoxaban is another NOAC that was found noninferior to warfarin in
1) Dr. Pahlajani discusses anticoagulation strategies for complex percutaneous coronary interventions (PCI) that require dual antiplatelet therapy (DAPT) and oral anticoagulation (OAC).
2) Studies have shown that major bleeding during acute coronary syndromes (ACS) is associated with significantly higher in-hospital mortality. Blood transfusions for non-ST elevation myocardial infarction (NSTEMI) patients are also linked to higher 30-day mortality.
3) When selecting anticoagulation and antiplatelet regimens, it is important to balance preventing ischemic events with avoiding major bleeding which can negate the benefits of antithrombotic therapy. Strategies discussed include
The document summarizes the results of a clinical trial studying the effects of blood pressure lowering treatment on secondary stroke prevention. The trial involved over 6,000 patients with a history of cerebrovascular disease across 10 countries. It found that treatment with perindopril (an ACE inhibitor) plus indapamide lowered blood pressure more than single drug therapy or placebo and reduced the risk of fatal or non-fatal stroke by 28%. Combination therapy also reduced major vascular events by 26% and was well-tolerated with few side effects. The results indicate that blood pressure lowering provides significant benefits for secondary stroke prevention, regardless of baseline blood pressure or medical history.
Noacs use in patients other than atrial fibrillationDIPAK PATADE
1) The document discusses trials evaluating the direct oral anticoagulants (DOACs) dabigatran, rivaroxaban, and apixaban for various indications.
2) The RE-NOVATE trials found dabigatran non-inferior to enoxaparin for VTE prevention after hip replacement with comparable bleeding risks.
3) The RE-COVER trials found dabigatran non-inferior to warfarin for VTE treatment and secondary prevention with lower bleeding risks.
4) The EINSTEIN trials found rivaroxaban non-inferior to enoxaparin/warfarin for VTE treatment and
This document provides an outline for a presentation on newer oral anticoagulants (NOACs). It discusses the properties and advantages of various NOACs including dabigatran, rivaroxaban, apixaban, and edoxaban compared to vitamin K antagonists. It summarizes the results of major clinical trials that compared these drugs to warfarin for stroke prevention in atrial fibrillation and treatment of venous thromboembolism. It also provides dosing guidelines and management of side effects for the different NOACs.
Secondary Prevention after ACS: Focused on Anticoagulant TherapyPERKI Pekanbaru
Dr. Nathania Marliani Kristanti, SpJP, FIHA. 3rd Pekanbaru Cardiology Update, August 25th 2013. Pangeran Hotel Pekanbaru. Learn more at PerkiPekanbaru.com
This document discusses oral anticoagulants (OACs) for preventing thromboembolic events in patients with atrial fibrillation (AF). It outlines the rationale for using OACs in AF patients, different types of OACs including vitamin K antagonists and novel oral anticoagulants (NOACs), and clinical trial results demonstrating the efficacy and safety of NOACs compared to warfarin. It also discusses calculating the net clinical benefit of OACs, guidelines for indications of anticoagulation treatment, factors to consider when selecting an OAC, and conclusions regarding the effectiveness and appropriate use of OACs in AF patients.
Overview of Non Vitamin K oral anticoagulantsNeeraj Varyani
Dabigatran, rivaroxaban, and apixaban are novel oral anticoagulants (NOACs) that are alternatives to warfarin for preventing strokes in atrial fibrillation and treating deep vein thrombosis. Large clinical trials found these NOACs to be as effective as warfarin with less risk of bleeding. Dabigatran 150mg twice daily was more effective than warfarin at preventing strokes while 110mg twice daily had similar efficacy but lower bleeding. Rivaroxaban and apixaban were noninferior to warfarin with similar or lower risks of bleeding. Edoxaban is another NOAC that was found noninferior to warfarin in
http://www.theheart.org/web_slides/1225049.do
A randomized double-blind, double-dummy trial on MAGELLAN (VTE Prophylaxis in Medically Ill Patients) to show noninferiority of rivaroxaban to enoxaparin at 10 days and superiority at 35 days
Can newer antiplatelets replace clopidogrel Arindam Pande
- Clopidogrel is still the standard antiplatelet for many patients with stable IHD or ACS managed conservatively, as well as for primary PCI within 3 hours of chest pain onset, as prasugrel and ticagrelor have certain limitations for these groups.
- For PCI, a 600 mg loading dose of clopidogrel is recommended based on evidence from RCTs showing benefit compared to lower doses.
- Newer antiplatelets like ticagrelor have advantages over clopidogrel but also drawbacks like increased dyspnea and renal issues, while prasugrel requires caution in certain groups due to bleeding risks.
- Cangrelor's IV formulation
new oral anticoagulants versus warfarin-appraisalv3venu
1) A meta-analysis of 4 large randomized controlled trials compared novel oral anticoagulants to warfarin in patients with atrial fibrillation.
2) The analysis found that novel oral anticoagulants were associated with lower rates of stroke or systemic embolism and lower rates of major bleeding compared to warfarin.
3) Mortality was also lower in patients taking novel oral anticoagulants.
Lo mejor del Congreso ESC 2014 de Barcelona
Jueves, 04 de Septiembre de 2014
De 19h a 20:30h
http://esc2014.secardiologia.es
Lo mejor sobre Insuficiencia Cardiaca
Dr. Esteban López de Sá
Hospital Universitario La Paz, Madrid
https://twitter.com/elopezdesa
This document summarizes information about various oral anticoagulants including warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban. It discusses their pharmacokinetic properties, dosing, indications for preventing thromboembolic events in atrial fibrillation and venous thromboembolism, efficacy and safety based on clinical trials, and considerations for use in Asian populations and perioperative settings. Meta-analyses found NOACs reduce stroke, mortality, and intracranial hemorrhage compared to warfarin, though increase gastrointestinal bleeding. Guidelines recommend NOACs over warfarin for non-valvular atrial fibrillation in Asians.
This document discusses NOAC anticoagulants and their reversal agents. It provides information on:
1. The advantages of NOACs over VKAs including their predictability, fewer drug interactions, and improved safety profile.
2. A meta-analysis found NOACs were associated with lower risks of major bleeding, fatal bleeding, and intracranial bleeding compared to VKAs.
3. Idarucizumab, a specific reversal agent for dabigatran, demonstrated 100% reversal of dabigatran's anticoagulant effect based on interim results from the RE-VERSE AD trial of 90 patients with uncontrolled bleeding or those requiring emergency surgery.
This document discusses and compares the properties, clinical trials, and safety profiles of the direct oral anticoagulants dabigatran, rivaroxaban, and apixaban. It summarizes the results of major clinical trials demonstrating the non-inferiority of these drugs compared to warfarin for treating and preventing venous thromboembolism. It also notes that monitoring of renal function is important when using these drugs due to renal clearance and dose adjustments.
CARDIOTalks: La IC vuelve a escena
22/05/2015 17:45h - 19:30h
Hotel Sevilla Center. Sala Giralda I, Sevilla (XII Reunión Anual de la Sección de Insuficiencia Cardiaca y Trasplante de la SEC)
http://cardiotalks.secardiologia.es
Top 3 Hits en Insuficiencia cardiaca en 2014
Dr. Nicolás Manito, Barcelona
- Describe the basic characteristics of new oral anticoagulants (OACs)
- Recognize potential candidates for new anticoagulants for atrial fibrillation and treatment of venous thrombosis
This document discusses various antiplatelet therapies used to prevent thrombus formation and treat cardiovascular conditions. It describes how aspirin works by inhibiting platelet COX-1, leading to reduced thromboxane A2 production. For patients who are resistant or nonresponsive to aspirin, other P2Y12 receptor antagonists like clopidogrel, prasugrel, ticagrelor and cangrelor are discussed. These irreversibly or reversibly bind the P2Y12 receptor to inhibit platelet aggregation. Clinical trials comparing these drugs to aspirin or clopidogrel are summarized. Other antiplatelet drugs mentioned include dipyridamole, sulfinpyrazone and the PAR-1 antagonist vor
there are several limitation in VKA,to over come these problem NOACs came in picture but still limited indication for NOACs currently,required further study inter and intra comparison between anticoagulants.
This document discusses the benefits of high-dose statin therapy for patients with acute coronary syndrome (ACS). It summarizes several studies that found high-dose statin therapy started very early (within 24 hours) for ACS patients was associated with reduced mortality. One study of over 10,000 ACS patients found very early statin therapy reduced 7-day and 30-day mortality. Another study found high-dose atorvastatin improved coronary flow and ST segment resolution in STEMI patients compared to low-dose atorvastatin. The document also notes that statin therapy duration is important, with one study finding risk of further cardiovascular events was lower the longer patients continued high-dose atorvastatin therapy.
The document summarizes the ARMYDA-5 clinical trial which compared administering a 600 mg clopidogrel loading dose in the catheterization lab versus 4-8 hours before the procedure. The trial found no significant differences in death, heart attack, or repeat procedures between the two groups within 30 days. Levels of biomarkers for heart damage and platelet reactivity also did not meaningfully differ. The in-lab clopidogrel strategy was concluded to be a safe and effective alternative to pre-treatment hours before the procedure.
Newer Oral Anticoagulants In Atrial Fibrillation - Dr Vivek BaligaDr Vivek Baliga
In this presentation, Dr Vivek Baliga, Baliga Diagnostics Bangalore, discusses the role of new oral anticoagulants in the management of non-valvular atrial fibrillation.
This document summarizes the PARADIGM-HF clinical trial which compared the angiotensin receptor-neprilysin inhibitor LCZ696 to the ACE inhibitor enalapril in patients with heart failure and reduced ejection fraction. The trial found that LCZ696 was superior to enalapril in reducing cardiovascular death and hospitalization for heart failure. Specifically, LCZ696 reduced the risk of the primary composite outcome of death from cardiovascular causes or hospitalization for heart failure by 16% compared to enalapril. LCZ696 also reduced deaths from any cause by 16% compared to enalapril.
1) The IMPROVE-IT trial investigated whether adding ezetimibe to simvastatin therapy provides additional cardiovascular benefit compared to simvastatin monotherapy in 18,144 high-risk patients who had an acute coronary syndrome.
2) At a median follow-up of 6 years, combination ezetimibe/simvastatin therapy resulted in a statistically significant 9% relative risk reduction in major cardiovascular events compared to simvastatin alone.
3) Combination therapy also significantly reduced the risk of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke by 10% compared to simvastatin monotherapy.
- The document summarizes research on cilostazol for the treatment of intermittent claudication from peripheral artery disease.
- Studies showed cilostazol significantly improved treadmill walking distance and quality of life measures compared to placebo over 6 months.
- The long-term CASTLE study of over 1400 patients found cilostazol did not increase cardiovascular risk over 3 years and may reduce stroke risk compared to placebo.
Que peut-on encore demander à l'échocardiographiste? (Dr C. Goffinet)Brussels Heart Center
This document discusses methods for measuring cardiac dyssynchrony and optimizing cardiac resynchronization therapy (CRT). It summarizes various echocardiography techniques for assessing interventricular, intraventricular, and atrioventricular dyssynchrony. It also reviews factors that influence response to CRT beyond dyssynchrony, such as QRS duration, viability, and lead positioning. The document then examines methods for optimizing CRT, including adjusting atrioventricular and interventricular delays using echocardiography and algorithms to maximize cardiac filling and reduce dyssynchrony.
Insuffisance cardiaque et fibrillation auriculaire - l'oeuf ou la poule (Pr L...Brussels Heart Center
1. Atrial fibrillation and congestive heart failure often occur together, but it is unclear which condition causes the other.
2. Studies show that developing atrial fibrillation after already having congestive heart failure carries a better prognosis than developing congestive heart failure after already having atrial fibrillation.
3. Upstream therapies like ACE inhibitors, statins, and omega-3 fatty acids may help prevent atrial fibrillation and improve outcomes, but data is primarily from retrospective studies. Maintaining sinus rhythm through drugs, cardioversion, or ablation can benefit patients with congestive heart failure, though cardioversion carries risks of embolism.
http://www.theheart.org/web_slides/1225049.do
A randomized double-blind, double-dummy trial on MAGELLAN (VTE Prophylaxis in Medically Ill Patients) to show noninferiority of rivaroxaban to enoxaparin at 10 days and superiority at 35 days
Can newer antiplatelets replace clopidogrel Arindam Pande
- Clopidogrel is still the standard antiplatelet for many patients with stable IHD or ACS managed conservatively, as well as for primary PCI within 3 hours of chest pain onset, as prasugrel and ticagrelor have certain limitations for these groups.
- For PCI, a 600 mg loading dose of clopidogrel is recommended based on evidence from RCTs showing benefit compared to lower doses.
- Newer antiplatelets like ticagrelor have advantages over clopidogrel but also drawbacks like increased dyspnea and renal issues, while prasugrel requires caution in certain groups due to bleeding risks.
- Cangrelor's IV formulation
new oral anticoagulants versus warfarin-appraisalv3venu
1) A meta-analysis of 4 large randomized controlled trials compared novel oral anticoagulants to warfarin in patients with atrial fibrillation.
2) The analysis found that novel oral anticoagulants were associated with lower rates of stroke or systemic embolism and lower rates of major bleeding compared to warfarin.
3) Mortality was also lower in patients taking novel oral anticoagulants.
Lo mejor del Congreso ESC 2014 de Barcelona
Jueves, 04 de Septiembre de 2014
De 19h a 20:30h
http://esc2014.secardiologia.es
Lo mejor sobre Insuficiencia Cardiaca
Dr. Esteban López de Sá
Hospital Universitario La Paz, Madrid
https://twitter.com/elopezdesa
This document summarizes information about various oral anticoagulants including warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban. It discusses their pharmacokinetic properties, dosing, indications for preventing thromboembolic events in atrial fibrillation and venous thromboembolism, efficacy and safety based on clinical trials, and considerations for use in Asian populations and perioperative settings. Meta-analyses found NOACs reduce stroke, mortality, and intracranial hemorrhage compared to warfarin, though increase gastrointestinal bleeding. Guidelines recommend NOACs over warfarin for non-valvular atrial fibrillation in Asians.
This document discusses NOAC anticoagulants and their reversal agents. It provides information on:
1. The advantages of NOACs over VKAs including their predictability, fewer drug interactions, and improved safety profile.
2. A meta-analysis found NOACs were associated with lower risks of major bleeding, fatal bleeding, and intracranial bleeding compared to VKAs.
3. Idarucizumab, a specific reversal agent for dabigatran, demonstrated 100% reversal of dabigatran's anticoagulant effect based on interim results from the RE-VERSE AD trial of 90 patients with uncontrolled bleeding or those requiring emergency surgery.
This document discusses and compares the properties, clinical trials, and safety profiles of the direct oral anticoagulants dabigatran, rivaroxaban, and apixaban. It summarizes the results of major clinical trials demonstrating the non-inferiority of these drugs compared to warfarin for treating and preventing venous thromboembolism. It also notes that monitoring of renal function is important when using these drugs due to renal clearance and dose adjustments.
CARDIOTalks: La IC vuelve a escena
22/05/2015 17:45h - 19:30h
Hotel Sevilla Center. Sala Giralda I, Sevilla (XII Reunión Anual de la Sección de Insuficiencia Cardiaca y Trasplante de la SEC)
http://cardiotalks.secardiologia.es
Top 3 Hits en Insuficiencia cardiaca en 2014
Dr. Nicolás Manito, Barcelona
- Describe the basic characteristics of new oral anticoagulants (OACs)
- Recognize potential candidates for new anticoagulants for atrial fibrillation and treatment of venous thrombosis
This document discusses various antiplatelet therapies used to prevent thrombus formation and treat cardiovascular conditions. It describes how aspirin works by inhibiting platelet COX-1, leading to reduced thromboxane A2 production. For patients who are resistant or nonresponsive to aspirin, other P2Y12 receptor antagonists like clopidogrel, prasugrel, ticagrelor and cangrelor are discussed. These irreversibly or reversibly bind the P2Y12 receptor to inhibit platelet aggregation. Clinical trials comparing these drugs to aspirin or clopidogrel are summarized. Other antiplatelet drugs mentioned include dipyridamole, sulfinpyrazone and the PAR-1 antagonist vor
there are several limitation in VKA,to over come these problem NOACs came in picture but still limited indication for NOACs currently,required further study inter and intra comparison between anticoagulants.
This document discusses the benefits of high-dose statin therapy for patients with acute coronary syndrome (ACS). It summarizes several studies that found high-dose statin therapy started very early (within 24 hours) for ACS patients was associated with reduced mortality. One study of over 10,000 ACS patients found very early statin therapy reduced 7-day and 30-day mortality. Another study found high-dose atorvastatin improved coronary flow and ST segment resolution in STEMI patients compared to low-dose atorvastatin. The document also notes that statin therapy duration is important, with one study finding risk of further cardiovascular events was lower the longer patients continued high-dose atorvastatin therapy.
The document summarizes the ARMYDA-5 clinical trial which compared administering a 600 mg clopidogrel loading dose in the catheterization lab versus 4-8 hours before the procedure. The trial found no significant differences in death, heart attack, or repeat procedures between the two groups within 30 days. Levels of biomarkers for heart damage and platelet reactivity also did not meaningfully differ. The in-lab clopidogrel strategy was concluded to be a safe and effective alternative to pre-treatment hours before the procedure.
Newer Oral Anticoagulants In Atrial Fibrillation - Dr Vivek BaligaDr Vivek Baliga
In this presentation, Dr Vivek Baliga, Baliga Diagnostics Bangalore, discusses the role of new oral anticoagulants in the management of non-valvular atrial fibrillation.
This document summarizes the PARADIGM-HF clinical trial which compared the angiotensin receptor-neprilysin inhibitor LCZ696 to the ACE inhibitor enalapril in patients with heart failure and reduced ejection fraction. The trial found that LCZ696 was superior to enalapril in reducing cardiovascular death and hospitalization for heart failure. Specifically, LCZ696 reduced the risk of the primary composite outcome of death from cardiovascular causes or hospitalization for heart failure by 16% compared to enalapril. LCZ696 also reduced deaths from any cause by 16% compared to enalapril.
1) The IMPROVE-IT trial investigated whether adding ezetimibe to simvastatin therapy provides additional cardiovascular benefit compared to simvastatin monotherapy in 18,144 high-risk patients who had an acute coronary syndrome.
2) At a median follow-up of 6 years, combination ezetimibe/simvastatin therapy resulted in a statistically significant 9% relative risk reduction in major cardiovascular events compared to simvastatin alone.
3) Combination therapy also significantly reduced the risk of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke by 10% compared to simvastatin monotherapy.
- The document summarizes research on cilostazol for the treatment of intermittent claudication from peripheral artery disease.
- Studies showed cilostazol significantly improved treadmill walking distance and quality of life measures compared to placebo over 6 months.
- The long-term CASTLE study of over 1400 patients found cilostazol did not increase cardiovascular risk over 3 years and may reduce stroke risk compared to placebo.
Que peut-on encore demander à l'échocardiographiste? (Dr C. Goffinet)Brussels Heart Center
This document discusses methods for measuring cardiac dyssynchrony and optimizing cardiac resynchronization therapy (CRT). It summarizes various echocardiography techniques for assessing interventricular, intraventricular, and atrioventricular dyssynchrony. It also reviews factors that influence response to CRT beyond dyssynchrony, such as QRS duration, viability, and lead positioning. The document then examines methods for optimizing CRT, including adjusting atrioventricular and interventricular delays using echocardiography and algorithms to maximize cardiac filling and reduce dyssynchrony.
Insuffisance cardiaque et fibrillation auriculaire - l'oeuf ou la poule (Pr L...Brussels Heart Center
1. Atrial fibrillation and congestive heart failure often occur together, but it is unclear which condition causes the other.
2. Studies show that developing atrial fibrillation after already having congestive heart failure carries a better prognosis than developing congestive heart failure after already having atrial fibrillation.
3. Upstream therapies like ACE inhibitors, statins, and omega-3 fatty acids may help prevent atrial fibrillation and improve outcomes, but data is primarily from retrospective studies. Maintaining sinus rhythm through drugs, cardioversion, or ablation can benefit patients with congestive heart failure, though cardioversion carries risks of embolism.
Stroke prevention for nonvalvular AF, summary of evidence-based guidelinesErsifa Fatimah
Ternyata... guideline yang ngebahas prevensi stroke pada nonvalvular AF tu banyak banget! Yang dirilis komunitas Neuro maupun Cardio, yang internasional maupun yang lokal. Dan pertanyaan besarnya tetep: What's the best strategy?
*Bonus special issue: manajemen prevensi stroke infark dengan antikoagulan pasca brain hemorrhage.
This document describes a logic puzzle where the goal is to fill in a 5x5 grid of countries based on clues about borders and country names/characteristics. It provides 12 stages of reasoning to arrive at the solution, determining the country that belongs in each grid space through a process of elimination based on the clues and what countries must border each other.
This document presents a logic puzzle involving correctly identifying countries based on the length of their names and the colors of their flags. It provides clues about the countries that can be identified from unique color combinations or by eliminating other options based on length of name and color patterns. The clues are used to systematically identify each of the 16 countries in the puzzle.
This document discusses guidelines for lead extraction procedures. It outlines classifications for indications of lead extraction, including mandatory, necessary, and discretionary indications. It describes common techniques for lead extraction such as direct manual traction, telescoping sheaths, rotational cutting blades, excimer laser sheaths, and surgical removal. It provides details on preoperative, intraoperative, and postoperative patient management. It discusses complications that can occur during lead extraction and lists risk factors. It reviews success rates and complication rates from the literature for different lead extraction techniques.
This logic game uses clues about the alphabetical order, capital cities, and other characteristics of 25 US states to determine where each state belongs on a 5x5 grid without guessing. The clues are pieced together to systematically eliminate states and place them one-by-one until all 25 states are correctly positioned on the grid.
Traitement de la FA vu par le chirurgien cardiaque : state of the art. (Dr J....Brussels Heart Center
This document summarizes a presentation given by Dr. Remes on the surgical treatment of atrial fibrillation. It discusses the pathophysiology of AF and reviews studies on the Cox Maze procedure. Dr. Remes presents data on success rates of different Cox Maze variations and predictors of recurrence. Minimally invasive surgical approaches for AF ablation including pulmonary vein isolation are discussed. Energy sources for ablation like bipolar radiofrequency are highlighted. Guidelines for lone AF surgery are reviewed. In conclusion, the document provides an overview of the state of the art in surgical treatment of AF.
Prevencion de complicaciones en fibrilacion atrialDaniel Meneses
This document discusses atrial fibrillation (AF), a common arrhythmia. It notes that the number of AF patients is currently around 5 million worldwide but is expected to increase significantly by 2050. AF contributes to over 80,000 deaths annually and increases the lifetime risk of developing it for those over age 40 to 1 in 4. The costs associated with AF are estimated to be $26 billion annually. The document discusses complications of AF and treatments to help prevent complications like stroke, including newer oral anticoagulants that have been shown to be as effective as or more effective than warfarin with a better safety profile in terms of bleeding risks.
Ponencia presentada por el Dr. Raúl Moreno Gómez en el directo online ‘Anticoagulación de cine en el paciente mayor’, realizado el 13 de febrero de 2020 en la Casa del Corazón.
Direct oral anticoagulants (DOACs) have similar efficacy to vitamin K antagonists (VKAs) for treating venous thromboembolism based on evidence from phase 3 trials. DOACs significantly reduce the risk of major bleeding, intracranial bleeding, and fatal or clinically relevant non-major bleeding compared to VKAs. The efficacy and safety of DOACs are maintained in key subgroups including those with cancer, obesity, renal impairment or advanced age. DOACs offer an improved benefit-risk profile for venous thromboembolism treatment compared to VKAs.
4 dan atar - anticoagulation af pci - what do trials saywebevo5
Professor Dan Atar presented on anticoagulation for atrial fibrillation and percutaneous coronary intervention based on recent trial results. The WOEST trial found that dual therapy with a vitamin K antagonist (VKA) and clopidogrel reduced bleeding compared to triple therapy with a VKA, aspirin, and clopidogrel, with a potential mortality benefit. The PIONEER AF-PCI trials found that rivaroxaban dual or triple therapy was associated with significantly less bleeding than VKA triple therapy, with comparable efficacy. The RE-LY-DUAL PCI study found dabigatran dual therapy significantly reduced bleeding compared to warfarin triple therapy. Guidelines recommend balancing the risks of bleeding from
1) The document presents a summary of a presentation on using oral anticoagulants in patients with acute coronary syndrome.
2) It reviews several clinical trials that evaluated adding direct oral anticoagulants to antiplatelet therapy after ACS and found it reduced ischemic events but increased bleeding risk.
3) A meta-analysis of over 29,000 patients from 6 trials found the benefits of adding a DOAC were greater for those with STEMI compared to NSTEMI, with a lower risk of ischemic events outweighing the higher bleeding risk for STEMI patients.
Prevention of recurrent stroke in atrial fibrillation Jacek StaszewskiJacek Staszewski
Prevention of recurrent stroke in atrial fibrillation. Comaprison of NOAC vs VKA. Riks of hemorrhagic stroke. When anticoagulation should be initiated following acute stroke.
The ENVISAGE-TAVI trial compared edoxaban to warfarin for stroke prevention in patients with atrial fibrillation following transcatheter aortic valve replacement (TAVR). The trial randomized 1426 patients 1:1 to edoxaban 60 mg daily or dose-adjusted warfarin. The primary endpoint was a composite of death, myocardial infarction, ischemic stroke, systemic embolism, valve thrombosis or major bleeding (net adverse clinical events). Edoxaban was found to be noninferior to warfarin for the primary endpoint with a hazard ratio of 0.82 (95% CI 0.65-1.04). Rates of major bleeding were also similar between the groups. The
This document provides an outline on the topic of novel oral anticoagulants (NOACs) including:
1) An introduction to NOACs and their advantages over vitamin K antagonists.
2) Details on the properties, indications, dosing, and trial results of specific NOACs including Dabigatran, Rivaroxaban, Apixaban, and Edoxaban.
3) Guidance on switching between anticoagulant regimens, dealing with dosing errors, and follow-up of patients on NOACs.
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
22/11/2016 19:30h Casa del Corazón, Madrid
http://manejofa.secardiologia.es
#manejoFA
Pacientes con FA que sufren un SCA y son sometidos a intervención coronaria percutánea. Guías y preguntas abiertas
Dr. Antonio Fernández Ortiz, Hospital Universitario Clínico San Carlos (Madrid)
1) The document discusses new oral anticoagulants (NOACs) for stroke prevention in patients with atrial fibrillation (AF), comparing them to warfarin.
2) NOACs like apixaban, rivaroxaban, and dabigatran are preferable to warfarin due to their more predictable dosing, fewer drug and food interactions, and lack of required monitoring.
3) Clinical trials found NOACs to have similar or better efficacy in stroke prevention compared to warfarin, with lower risks of intracranial hemorrhage and death.
Speaker 1_Clinical Care of Elderly Patients with NVAF-1.pptxSharatVijapur1
Mr. Narayan, an 86-year-old man with atrial fibrillation and a large left atrial thrombus, was prescribed apixaban at a reduced dose of 2.5 mg twice daily due to his age and renal dysfunction. Over 11 weeks, this resulted in a significant reduction in thrombus size and no serious bleeding complications. Guidelines recommend oral anticoagulation for elderly patients like Mr. Narayan to prevent stroke, and clinical trials have shown that NOACs like apixaban provide effective stroke prevention while maintaining a favorable safety profile in this population.
Venous Thromboembolism (VTE): Recent Advances in Reducing the Disease BurdenNBCA
- Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is a major cause of morbidity and mortality worldwide. It is estimated that there are 900,000 cases of VTE per year in the US.
- Recent clinical trials have found that the direct oral anticoagulants rivaroxaban, apixaban, edoxaban and dabigatran are non-inferior to standard therapy for treating VTE and reduce the risk of recurrence, while having a similar or lower risk of bleeding.
- The EINSTEIN DVT and EINSTEIN PE trials found that rivaroxaban was non-infer
Anticoagulation in chronic kidney diseaseFarragBahbah
Based on the information provided:
- Her stroke risk can be assessed using CHA2DS2-VASc score:
C = 1 (Congestive heart failure)
H = 1 (Hypertension)
A = 1 (Age 65-74)
D = 1 (Diabetes)
S = 1 (Stroke/TIA/TE)
V = 0
A = 0
S = 1 (Sex category)
c = 1 (CKD with eGFR 30-59)
Total score = 6
- A score of 6 corresponds to high risk of stroke (>4%/year)
- Given her high stroke risk, anticoagulation would be recommended.
-
Novel oral anticoagulants in CKD review, Moh'd sharshirMoh'd sharshir
This document discusses the use of novel oral anticoagulants (NOACs) for stroke prevention and venous thromboembolism in patients with chronic kidney disease (CKD). It reviews recent trials that have re-analyzed data focusing on patients with reduced kidney function. Network meta-analyses found that NOACs were associated with lower risks of stroke, systemic embolism, and major bleeding compared to warfarin in CKD patients. Observational studies also suggest NOACs like apixaban, rivaroxaban, and dabigatran are similar or superior alternatives to warfarin for safety and efficacy in real-world CKD populations. However, more research is still needed, as
Role of anticoagulant in cardioembolic stroke-final.pdfhongyaeent
1. Anticoagulants such as warfarin and novel oral anticoagulants (NOACs) are used for secondary prevention of cardioembolic ischemic stroke.
2. The optimal timing to start anticoagulant therapy after an ischemic stroke is unclear but should be based on individual risk assessment considering factors like stroke severity, imaging findings, and risk of hemorrhagic transformation.
3. Clinical trials found that NOACs without prior bridging therapy may have a more favorable risk-benefit profile compared to warfarin in patients with ischemic stroke and atrial fibrillation.
Deep vein thrombosis and pulmonary embolism are serious conditions that can be fatal if not properly treated. This document discusses the etiology, diagnosis, treatment and prevention of venous thromboembolism. It notes that venous thromboembolism affects millions of people worldwide each year and carries high economic costs. Diagnosis involves assessment of clinical probability followed by D-dimer and ultrasound testing. Treatment involves anticoagulation medications like low molecular weight heparins or novel oral anticoagulants. Catheter-directed thrombolysis may be considered in some cases to help restore blood flow.
AF 2023 ACC guidelines half atrial fibrillationRajeshPonnada3
This document summarizes guidelines for atrial fibrillation (AF) from 2023. It finds that the incidence and prevalence of AF are increasing due to an aging population and rising obesity rates. Having AF increases the risk of mortality, stroke, dementia, heart failure, myocardial infarction, chronic kidney disease, peripheral artery disease, and sudden cardiac death. Risk factor modification through treating conditions like obesity, diabetes, and hypertension can help prevent AF. Anticoagulation medication is recommended for AF patients based on their risk of stroke as assessed by tools like CHA2DS2-VASc score. Doacs have been shown to be as effective as warfarin for stroke prevention with lower risks of bleeding.
This document discusses direct oral anticoagulants (DOACs), including their mechanism of action, pharmacological properties, and comparisons to standard anticoagulants. It addresses the use of DOACs in special situations, reversal of their effects, preoperative use, and combinations with antiplatelet drugs. Guidance is provided on switching between anticoagulants and managing DOACs in various clinical scenarios.
Similar to La gestion du traitement par NOAC chez le patient avec une cardiopathie ischémique (Pr C. Hermans) (20)
CRTP ou CRTD? Quels arguments pour notre choix? (Pr C. Leclercq)Brussels Heart Center
1) Studies have shown that 35-50% of deaths in heart failure patients are due to sudden cardiac death.
2) Medical treatments like ACE inhibitors, beta-blockers, and aldosterone antagonists can reduce mortality in heart failure patients, but their effect on sudden cardiac death is limited.
3) Guidelines do not make strict recommendations for CRT-D vs CRT-P, preferring to offer guidance based on clinical condition, device complications, and cost. The document discusses factors to consider for individual patients.
Insuffisance cardiaque et resynchronisation : Peut-on mieux faire? (Pr C. Lec...Brussels Heart Center
This document discusses ways to optimize cardiac resynchronization therapy (CRT) to increase the rate of responders. It suggests focusing on improving patient selection by avoiding those with high non-response potential, and selecting those with non-ischemic cardiomyopathy, wide QRS, and left bundle branch block. Other areas to optimize include left ventricular lead placement and pacing programming, medical treatment, device programming algorithms, and using remote monitoring. Remote monitoring is shown to reduce heart failure hospitalizations compared to standard follow-up without remote monitoring. Overall, the document outlines strategies for optimizing various aspects of CRT delivery and follow-up to improve clinical outcomes.
Dr Peter Goethals: Sport en plotse dood - Screening elektrocardiogram (BHC Sy...Brussels Heart Center
1) A study found that young competitive athletes ages 12-35 had a 2.8 times higher relative risk of sudden cardiovascular death compared to non-athletes, while the relative risk of non-cardiovascular sudden death was only 1.7 and not statistically significant.
2) Screening ECGs in competitive athletes can help identify rare heart conditions that increase risk of sudden cardiac death, but the low incidence of 1 in 50,000 and questions around cost-effectiveness, appropriate protocols, and follow-up for abnormal results require further consideration.
3) While some ECG abnormalities in athletes are common and related to training, others can indicate underlying heart disease and cardiomyopathy. Screening ECG
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central19various
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kol...rightmanforbloodline
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Versio
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Version
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Version
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
La gestion du traitement par NOAC chez le patient avec une cardiopathie ischémique (Pr C. Hermans)
1. LA GESTION DU TRAITEMENT
PAR NOAC
CHEZ LE PATIENT
AVEC UNE CARDIOPATHIE
ISCHÉMIQUE
Professeur Cedric HERMANS, MD, PhD, MRCP (Lon), FRCP (Lon, Edin)
Haemostasis and Thrombosis Unit
Haemophilia Clinic
Division of Haematology
Cliniques Universitaires Saint-Luc
Catholic University of Louvain
1200 Brussels, Belgium
Cedric.hermans@uclouvain.be Bruxelles Novembre 2014
2. OLD VERSUS NEW ANTICOAGULANTS :
MULTIPLE- VERSUS SINGLE-FACTOR INHIBITION
VKAs LMWHs Anti-Xa
Anti-IIa
Mode of action Interference with Vit K
recycling
Potentiation of
antithrombin
Direct inhibition
Targets FII, FVII, FIX, FX
Reduced synthesis
Indirect inhibition of
FXa and FIIa
Selective inhibition
of FXa or FIIa
Efficacy Universal anticoagulants
including Mechanical Cardiac
Valve
Universal anticoagulants
Acute phase of PE
Prevention and treatment
of VTE
Prevention of stroke in AF
…
3. LES NOUVEAUX ANTICOAGULANTS ORAUX (DIRECTS)
INHIBITION DIRECTE ET CIBLÉE DU FXA OU DU FIIA (THROMBINE)
Fibrinogène Fibrine
IIa
Prothrombine
Xa + Va
X
Tissue Factor-VIIa
IXaIX
VIIIaRivaroxaban (Xarelto) (Bayer)
Apixaban (Eliquis) (BMS / PFIZER)
Edoxaban (Lixiana) (Daiichi Sankyo)
Dabigatran Etexilate (Pradaxa)
(Boehringer-Ingelheim)
Pradaxa / Dabigatran : anti-thrombine
E Liqui S : E pour equilibrium - Liqui pour liquid and S pour Stability
Xarelto : Xa, RELiable, Treatment, Oral Cedric HERMANS UCL 2014
4. COMPARAISON DES NOUVEAUX ANTICOAGULANTS ORAUX
Apixaban
ELIQUIS
Rivaroxaban
XARELTO
Dabigatran
PRADAXA
Mécanisme d’action Inhibition directe FXa Inhibition directe FXa Inhibition directe FIIa
Biodisponibilité orale ~50 % 80 % 6.5 %
Voie d’administration orale orale orale
Posologie 2x/jour
1x/jour (FA, MTEV)
1x/jour (prévention
MTEV)
2x/jour (MTEV, FA)
Pro-drogue Non Non Oui
Interférence alimentaire Non Non Non
Elimination rénale ~27 % 36 % 85 %
Demi-vie (T1/2) ~12h 7–11 h 14–17 h
Tmax 3 h 2–4 h 0.5–2 h
Interférences
médicamenteuses
Inhibiteurs CYP 3A4 et
P-gp
Inducteurs CYP 3A4
Inhibiteurs CYP 3A4 et
P-gp
Inducteurs CYP 3A4
Inhibiteurs P-gp
Inducteurs P-gp
5. PROPRIÉTÉS DES NOUVEAUX
ANTICOAGULANTS ORAUX (NACOS)
• Administration orale
• Rapidité de l’effet anticoagulant
• Inhibition directe et ciblée des facteurs Xa ou IIa
• Demi-vie courte (12h)
• Effet prévisible
• Pas d’interférence alimentaire et peu
d’interférences médicamenteuses
• Plus facile à manipuler
• Elimination rénale
6. DEVELOPMENT AND VALIDATION OF NOACS
DVT/VTE
Prophylaxis
Orthopaedic
Surgery
DVT/VTE
Treatment
AF/Stroke
Prevention
DVT/VTE
Prophylaxis
Medical
patients
Acute coronary
syndrome
Cedric HERMANS UCL 2014
9. Age: 73
Presentation:
• ACS diagnosed in ED
• Underlying paroxysmal NVAF
identified
• Transferred to cardiac
catheterization lab for diagnostic
coronary angiography & PCI with
DES
Additional information:
• CHA2DS2-VASc = 3
• HAS-BLED = 2
Current medications:
• ASA
Maria has arrived at the emergency
department with severe chest pain
10. Atrial fibrillation
and coronary artery disease
• New onset AF in a patient with a
history of coronary heart disease
– Recent ACS (< 1 year)
– Remote ACS (> 1 year)
• ACS in an AF patient (on NOAC)
12. 1. Dans AL et al. Circulation 2013;127:634–40; 2. Patel MR et al. N Engl J Med 2011;365:883–91;
3. Goodman SG et al. J Am Coll Cardiol 2014;63:891–900; 4. Granger CB et al. N Engl J Med 2011;365:981–92
Concomitant use antiplatelet agents in patients with AF
treated with NOACs
ROCKET-AF (rivaroxaban)
• 36% of patients received concomitant ASA; clopidogrel contraindicated2
• Prior ASA independently associated with increased risk of major bleeding3
RE-LY® (dabigatran)
• 38.4% of patients received antiplatelets, including ASA alone (32.0%), clopidogrel
alone (1.9%), or both (4.5%)
• Benefits of dabigatran vs warfarin consistent irrespective of concomitant antiplatelets1
ARISTOTLE (apixaban)
• 31% of patients received concomitant ASA; clopidogrel contraindicated4
• Benefits of apixaban vs warfarin consistent irrespective of concomitant ASA4
20. Feb 2014
RE-LY® myocardial ischaemic events
subanalysis (2012): cardiac outcomes (1)
Numerical imbalance in rate of MI: not statistically significant for
either dose of dabigatran compared with warfarin
– No imbalance for silent MI or fatal MI
HR = hazard ratio
Hohnloser SH et al. Circulation 2012;125:669–76
20
Event rate (%/yr) D110 vs warfarin D150 vs warfarin
D110 D150 W HR (95% CI) P value HR (95% CI) P value
Total MI 0.82 0.81 0.64 1.29 (0.96–1.75) 0.09 1.27 (0.94–1.71) 0.12
Clinical MI 0.73 0.74 0.56 1.30 (0.95–1.80) 0.10 1.32 (0.96–1.81) 0.09
Silent MI 0.09 0.07 0.08 1.22 (0.50–2.93) 0.66 0.87 (0.34–2.27) 0.72
Fatal MI 0.13 0.11 0.10 1.32 (0.63–2.80) 0.46 1.06 (0.49–2.33) 0.88
AF – warfarin comparator
21. 2013 RELY-ABLE®: Long-term Benefits
Long Term Multi-Center Extension
of Dabigatran Treatment in
Patients with Atrial Fibrillation
Patients taking dabigatran etexilate
were followed for up to a further
4.3yrs after completion of the
RE-LY® trial
Patients continued to receive the
same blinded dose of dabigatran
etexilate as in the RE-LY® trial
1. Connolly SJ. et al. Circulation .2013;128:237–43.
DOSES BLINDED
22. RE-LY® & RELY-ABLE® : Benefits maintained long-term
In the combined RE-LY®/RELY-ABLE® analysis, there were :
• Lower rates of ischaemic and haemorrhagic stroke/SE on dabigatran 150 mg twice
daily versus 110mg twice daily
• Low rates of hemorrhagic stroke on both dosages
• Rates of major bleeding consistent to data from RE-LY®
• Very low rates of intracranial bleeding
• No new safety signals
Data from the RELY-ABLE® analysis is consistent with the findings from RE-LY®
The combined data validate that both doses of dabigatran etexilate are clinically
effective for long-term stroke prevention for patients with non-valvular AF, with a
favourable safety profile sustained during up to 6.7 years of ongoing treatment
1. Connolly SJ. et al. Circulation .2013;128:237–43.
23. Benefit–risk profile of dabigatran confirmed in FDA study of >134 000
Medicare patients
Primary findings for dabigatran are based on analysis of both 75 mg and 150 mg together without stratification by dose. Warfarin is the reference group. CI = confidence interval;
HR = hazard ratio; MI = myocardial infarction; Available at: www.fda.gov/Drugs/DrugSafety/ucm396470.htm (accessed May 2014)
Incidence rate per 1000 person-years
Adjusted HR
(95% CI)
Dabigatran Warfarin
Ischaemic stroke 11.3 13.9 0.80 (0.67-0.96)
Intracranial haemorrhage 3.3 9.6 0.34 (0.26-0.46)
Major gastrointestinal
bleeding
34.2 26.5 1.28 (1.14-1.44)
Acute myocardial infarction 15.7 16.9 0.92 (0.78-1.08)
Mortality 32.6 37.8 0.86 (0.77-0.96)
Dabigatran was associated with a lower risk of ischaemic stroke,
intracranial haemorrhage and death than warfarin.
Risk of MI was similar for dabigatran and warfarin.
2014
24. RE-LY®2–4 >18 000 patients
0.41
1. www.fda.gov/Drugs/DrugSafety/ucm396470.htm.
2. Connolly SJ et al. N Engl J Med 2009;361:1139–51; 3. Connolly SJ et al. N Engl J Med. 2010;363:1875–6; 4. Pradaxa®: EU SPC 2014
Favourable benefit-risk profile of dabigatran confirmed
in independent FDA study of >134 000 patients
Medicare1 >134 000 patients
0.86 1.28
0.92
0.80
0.34
0.88
1.48
1.27
0.75
In the USA, the licensed doses for dabigatran etexilate are 150 mg BID and 75 mg BID for the prevention of stroke and systemic embolism in adult patients with nonvalvular AF
Numbers on bars denote hazard ratios vs warfarin
110 mg BID, indicated for certain patients,
was shown to be as effective as warfarin in preventing stroke or systemic embolism in RE-LY®, which was a
PROBE (prospective, randomized, open-label with blinded endpoint evaluation) trial
25. CABG, coronary artery bypass graft; UA, unstable angina
Hohnloser SH et al. Circulation 2012;125:669–76
Benefits of dabigatran vs warfarin consistent in patients
with or without prior MI or CAD
1.51.00.5 1.51.00.52.0 2.0
P(inter)
0.28
0.72
0.49
0.85
0.66
0.45
0.95
0.91
0.35
0.61
P(inter)
Dabigatran 110 mg BID
vs warfarin
Dabigatran 150 mg BID
vs warfarin
Stroke/SE
MI
MI, UA, PCI,
CABG, CV arrest,
cardiac death
Major bleeding
Net clinical benefit
No prior CAD/MI Prior CAD/MI Prior CAD/MI
0.0 0.0
Favours dabigatran Favours warfarin Favours dabigatran Favours warfarin
26. For medical non-promotional reactive use only
APIXABAN IN PATIENTS WITH
ATRIAL FIBRILLATION AND
PRIOR CORONARY ARTERY
DISEASE
Insights from the ARISTOTLE Trial
Bahit et al. Circulation 2012;126:A13026
27. 27For medical non-promotional reactive use only
Results of the subpopulation with prior CAD
Of the total study patient population, 36.5% of patients
(n=6639) had prior CAD
Patients with prior CAD were more often male and had
prior stroke, diabetes mellitus and hypertension compared
with patients without prior CAD
Patients with prior CAD were more likely to be on aspirin
at baseline (42.2% vs 24.5%; p<0.001) when compared
with patients without prior CAD
Bahit et al. Circulation 2012;126:A13026 CAD, coronary artery disease.
28. 28For medical non-promotional reactive use only
Adapted from Bahit et al. Circulation 2012;126:A13026
Prior CAD
All-cause death
4.21 4.40 0.96 (0.81–1.13)
No prior CAD 3.11 3.68 0.85 (0.73–0.98)
Prior CAD
Intracranial bleeding
0.27 0.73 0.36 (0.20–0.66)
No prior CAD 0.37 0.85 0.44 (0.30–0.65)
Prior CAD
ISTH major bleeding
2.39 3.05 0.78 (0.62–0.98)
No prior CAD 1.99 3.12 0.64 (0.53–0.76)
Prior CAD
Myocardial infarction
0.95 1.00 0.95 (0.66–1.35)
No prior CAD 0.29 0.39 0.75 (0.47–1.20)
Prior CAD
Stroke or SE
1.47 1.55 0.95 (0.71–1.27)
No prior CAD 1.15 1.63 0.70 (0.56–0.89)
Rate (%/yr) HR 95% CI
p value for
interaction
0.2786
0.5867
0.1724
0.4491
0.1148
0.2 0.5 1 2
Favours apixaban Favours warfarin
Results
Apixaban Warfarin
CAD, coronary artery disease; CI, confidence interval;
HR, hazard ratio; SE, systemic embolism.
29. 29For medical non-promotional reactive use only
Conclusions
In patients with atrial fibrillation, apixaban reduces stroke
or systemic embolism and causes less bleeding and
death compared with warfarin
These treatment effects were consistent in patients with
and without a history of coronary artery disease
Bahit et al. Circulation 2012;126:A13026
31. Lip GY et al. Thromb Haemost 2010;103:13–28
AF + ACS requires treatment with both anticoagulant and
antiplatelet therapy
31
~30% of patients with AF and an indication for continuous OAC have
co-existing CAD and may require PCI
An estimated 1–2 million anticoagulated patients in Europe are
candidates for PCI procedures
Long-term anticoagulant
therapy is essential for
prevention of recurrent
ischaemic events
Initial antiplatelet
therapy is essential for
prevention of stent
thrombosis following PCI
32.
33.
34.
35.
36. 573 patients receiving OAC and undergoing PCI in open-label, randomized WOEST trial
TVR, target vessel revascularisation; ST, stent thrombosis; TIMI, thrombolysis in myocardial infarction bleeding criteria
Dewilde WJ et al. Lancet 2013;381:1107–15
WOEST: exclusion of ASA from combination therapy is
associated with improved outcomes vs triple therapy
OAC + clopidogrel associated with significant reduction in major bleeding and no
increase in thrombotic events vs triple therapy with OAC + clopidogrel + ASA
Total number of TIMI bleeding events Death, MI, TVR, stroke, ST
Time (days)
100
80
60
40
30
0
30 60 120 180 270 365
Cumulativeincidence(%)
19.4%
44.4%
HR: 0.36 (95% CI: 0.26‒0.50) P<0.0001
17.6%
11.1%
HR: 0.60 (95% CI: 0.38‒0.94) P=0.025
90
70
50
10
20
0 90
Triple-therapy group
Double-therapy group
100
80
60
40
30
0
30 60 120 180 270 365
90
70
50
10
20
0 90
Time (days)
Triple-therapy group
Double-therapy group
210
253
194
244
181
241
173
236
159
226
140
208
284
279
186
241
272
276
270
273
261
266
252
263
242
258
223
234
284
279
266
270
Triple therapy
Double therapy
Number at risk
Cumulativeincidence(%)
38. XARELTO AND ACS
Indication Dose and
regimen
Duration of therapy Patient
population
Prevention of
atherothrombotic
events in patients
with elevated cardiac
biomarkers after
an ACS in
combination
with antiplatelet
therapy
2.5 mg bid
co-administered
with ASA alone or
with ASA plus
clopidogrel
or ticlopidine
Extension of treatment
>12 months should be
done on an individual
patient basis (limited
experience up to
24 months)
Patients after an
ACS with elevated
cardiac biomarkers
*Moderate renal impairment = CrCl: 30–49 ml/min; severe renal impairment = CrCl: 15–29 ml/min
Bayer Pharma AG. Xarelto® (rivaroxaban) Summary of Product Characteristics. 2013. Available at: http://www.xarelto.com/en/information-on-xarelto/summary-of-product-
characteristics/ [accessed 24 January 2014].
39. Feb 2014
EXPERIENCE WITH DABIGATRAN IN ACS :
RE-DEEM™
• Dose-escalation Phase II trial in patients with recent ACS
Randomized to placebo or dabigatran (50 mg, 75 mg, 110 mg or 150 mg, all
BID)
At baseline, >99% of patients were also receiving dual antiplatelet therapy
• Overall, a low number of patients experienced cardiac events
Minor differences between treatment groups
In the composite outcome, there were fewer events at higher vs lower doses of
dabigatran
ACS = acute coronary syndromes; BID = twice daily; CV = cardiovascular; D110 = dabigatran 110 mg twice daily;
D150 = dabigatran 150 mg twice daily
Oldgren J et al. Eur Heart J 2011;32:2781–9 39
Placebo Dabigatran
Outcome, n (%)
(n=371)
50 mg BID
(n=369)
75 mg BID
(n=368)
110 mg BID
(n=406)
150 mg BID
(n=347)
CV death, non-fatal MI,
or non-haemorrhagic stroke
14 (3.8) 17 (4.6) 18 (4.9) 12 (3.0) 12 (3.5)
CV death 9 (2.4) 8 (2.2) 9 (2.4) 5 (1.2) 4 (1.2)
Non-fatal MI 4 (1.1) 9 (2.4) 8 (2.2) 7 (1.7) 8 (2.3)
Non-haemorrhagic stroke 3 (0.8) 0 (0.0) 1 (0.3) 0 (0.0) 0 (0.0)
Severe recurrent ischaemia 9 (2.4) 9 (2.4) 11 (3.0) 9 (2.2) 11 (3.2)
All-cause death 14 (3.8) 8 (2.2) 10 (2.7) 7 (1.7) 7 (2.0)
ACS – placebo comparator
40. Feb 2014
EXPERIENCE WITH DABIGATRAN IN ACS :
RE-DEEM™
• Dose-escalation Phase II trial in patients with recent ACS
Randomized to placebo or dabigatran (50 mg, 75 mg, 110 mg or 150 mg, all
BID)
At baseline, >99% of patients were also receiving dual antiplatelet therapy
• Overall, a low number of patients experienced cardiac events
Minor differences between treatment groups
In the composite outcome, there were fewer events at higher vs lower doses of
dabigatran
ACS = acute coronary syndromes; BID = twice daily; CV = cardiovascular; D110 = dabigatran 110 mg twice daily;
D150 = dabigatran 150 mg twice daily
Oldgren J et al. Eur Heart J 2011;32:2781–9 40
Placebo Dabigatran
Outcome, n (%)
(n=371)
50 mg BID
(n=369)
75 mg BID
(n=368)
110 mg BID
(n=406)
150 mg BID
(n=347)
CV death, non-fatal MI,
or non-haemorrhagic stroke
14 (3.8) 17 (4.6) 18 (4.9) 12 (3.0) 12 (3.5)
CV death 9 (2.4) 8 (2.2) 9 (2.4) 5 (1.2) 4 (1.2)
Non-fatal MI 4 (1.1) 9 (2.4) 8 (2.2) 7 (1.7) 8 (2.3)
Non-haemorrhagic stroke 3 (0.8) 0 (0.0) 1 (0.3) 0 (0.0) 0 (0.0)
Severe recurrent ischaemia 9 (2.4) 9 (2.4) 11 (3.0) 9 (2.2) 11 (3.2)
All-cause death 14 (3.8) 8 (2.2) 10 (2.7) 7 (1.7) 7 (2.0)
ACS – placebo comparator
In this high-risk patient population, no negative effect of dabigatran on
myocardial ischaemic events was reported
41. Feb 2014
EXPERIENCE WITH DABIGATRAN IN ACS :
RE-DEEM™
• Dose-escalation Phase II trial in patients with recent ACS
Randomized to placebo or dabigatran (50 mg, 75 mg, 110 mg or 150 mg, all
BID)
At baseline, >99% of patients were also receiving dual antiplatelet therapy
• Overall, a low number of patients experienced cardiac events
Minor differences between treatment groups
In the composite outcome, there were fewer events at higher vs lower doses of
dabigatran
ACS = acute coronary syndromes; BID = twice daily; CV = cardiovascular; D110 = dabigatran 110 mg twice daily;
D150 = dabigatran 150 mg twice daily
Oldgren J et al. Eur Heart J 2011;32:2781–9 41
Placebo Dabigatran
Outcome, n (%)
(n=371)
50 mg BID
(n=369)
75 mg BID
(n=368)
110 mg BID
(n=406)
150 mg BID
(n=347)
CV death, non-fatal MI,
or non-haemorrhagic stroke
14 (3.8) 17 (4.6) 18 (4.9) 12 (3.0) 12 (3.5)
CV death 9 (2.4) 8 (2.2) 9 (2.4) 5 (1.2) 4 (1.2)
Non-fatal MI 4 (1.1) 9 (2.4) 8 (2.2) 7 (1.7) 8 (2.3)
Non-haemorrhagic stroke 3 (0.8) 0 (0.0) 1 (0.3) 0 (0.0) 0 (0.0)
Severe recurrent ischaemia 9 (2.4) 9 (2.4) 11 (3.0) 9 (2.2) 11 (3.2)
All-cause death 14 (3.8) 8 (2.2) 10 (2.7) 7 (1.7) 7 (2.0)
ACS – placebo comparator
Although it was not the primary endpoint or objective of the study, there was a
trend towards fewer events with D110 and D150 than with placebo
42. Feb 2014
EXPERIENCE WITH DABIGATRAN IN ORTHOPAEDIC SURGERY
• ACS events were centrally adjudicated in three Phase III trials of
VTE prevention in orthopaedic surgery
RE-MODEL™, RE-NOVATE®, RE-MOBILIZE® (total >8000 patients)
• Rates of ACS (definite/likely) events were low and similar for
patients treated with dabigatran (150 mg or 220 mg OD combined)
and enoxaparin
OD = once daily
Eriksson BI et al. Thromb Res 2012;130:396–402; Clemens A et al. Vasc Health Risk Manag 2013;9:599–615 42
Adjudicated ACS events, n (%)
Dabigatran
(n=5419)
Enoxaparin
(n=2716)
Definite/likely 42 (0.8) 20 (0.7)
Definite 28 (0.5) 17 (0.6)
Primary VTE prevention – enoxaparin comparator
43. Feb 2014
EXPERIENCE WITH DABIGATRAN IN ORTHOPAEDIC SURGERY
• ACS events were centrally adjudicated in three Phase III trials of
VTE prevention in orthopaedic surgery
RE-MODEL™, RE-NOVATE®, RE-MOBILIZE® (total >8000 patients)
• Rates of ACS (definite/likely) events were low and similar for
patients treated with dabigatran (150 mg or 220 mg OD combined)
and enoxaparin
OD = once daily
Eriksson BI et al. Thromb Res 2012;130:396–402; Clemens A et al. Vasc Health Risk Manag 2013;9:599–615
43
Adjudicated ACS events, n (%)
Dabigatran
(n=5419)
Enoxaparin
(n=2716)
Definite/likely 42 (0.8) 20 (0.7)
Definite 28 (0.5) 17 (0.6)
Primary VTE prevention – enoxaparin comparator
No negative effect of dabigatran on myocardial ischaemic events was
reported
44. APIXABAN
1. The APPRAISE-2 study was a Phase III clinical trial in patients
with recent acute coronary syndrome treated with apixaban 5 mg
twice daily or placebo in addition to mono or dual antiplatelet
therapy.
2. This study was stopped early due to an increase in bleeding which
was not offset by clinically meaningful reductions in ischaemic
events.1
Alexander JH, et al; APPRAISE-2 Investigators. Apixaban with antiplatelet therapy after acute
coronary syndrome. N Engl J Med 2011;365:699-708.
46. Aug 2014
ESC Working Group consensus
Antithrombotic treatment following coronary artery stenting in AF
patients at moderate to high risk of TE (in whom OAC is required)
46
New antiplatelets such as prasugrel and ticagrelor have not yet been evaluated with OACs
BMS = bare metal stent; DES = drug-eluting stent; ESC = European Society of Cardiology;
RCT = randomized controlled trial; TE = thromboembolism
1. Lip GYH et al. Thromb Haemost 2010;103:13–28; 2. Heidbuchel H et al. Europace 2013;15:625–51
Short-term
• Triple therapy: warfarin + ASA + clopidogrel
• Duration varies from 2–4 weeks (high haemorrhagic risk, elective
PCI and BMS) to 6 months (low/intermediate haemorrhagic risk,
ACS, BMS/DES)
• Followed by warfarin + either clopidogrel or ASA for up to 12 months in
some patient groups (ACS or DES)
Lifelong
• Warfarin alone
47. Aug 2014
ESC Working Group consensus
Antithrombotic treatment following coronary artery stenting in AF
patients at moderate to high risk of TE (in whom OAC is required)
47
New antiplatelets such as prasugrel and ticagrelor have not yet been evaluated with OACs4
BMS = bare metal stent; DES = drug-eluting stent; ESC = European Society of Cardiology;
RCT = randomized controlled trial; TE = thromboembolism
1. Lip GYH et al. Thromb Haemost 2010;103:13-28; 2. Heidbuchel H et al. Europace 2013;15:625–51
Short-term
• Triple therapy: warfarin + ASA + clopidogrel
• Duration varies from 2–4 weeks (high haemorrhagic risk, elective
PCI and BMS) to 6 months (low/intermediate haemorrhagic risk,
ACS, BMS/DES)
• Followed by warfarin + either clopidogrel or ASA for up to 12 months in
some patient groups (ACS or DES)
Lifelong
• Warfarin alone
These recommendations are based on OAC being indicated for patients with AF
and stroke risk factors, and dual antiplatelet therapy being indicated after
ACS or PCI
48.
49. Lip GYH et al. Eur Heart J. 2014;doi:10.1093/eurheartj/ehu298
Latest guidance for combination therapy in patients with
NVAF and ACS/PCI
In general, the period of triple therapy should be as short as
possible, followed by OAC plus a single antiplatelet therapy
(preferably clopidogrel 75 mg/d, or as an alternative, ASA
75–100 mg/d)
B
Level
I
Class
Long-term antithrombotic therapy with OAC (beyond 12
months) is recommended in all patients
Recommendation
CIIb
Where a NOAC is used in combination with clopidogrel and/or
low-dose ASA, the lower tested dose for stroke prevention in
AF (dabigatran 110 mg BID, rivaroxaban 15 mg OD, or
apixaban 2.5 mg BID) may be considered
General
recommendation
50. *Dual therapy with oral anticoagulation and clopidogrel may be considered in selected patients; **ASA as an alternative to
clopidogrel may be considered in patients on dual therapy (i.e. oral anticoagulation plus single antiplatelet); ***Dual therapy
with oral anticoagulation and an antiplatelet agent (ASA or clopidogrel) may be considered in patients at very high risk of
coronary events. DAPT, dual antiplatelet therapy; Lip et al Eur Heart J 2014 doi:10.1093/eurheartj/ehu298
Latest guidance for combination therapy in patients with
NVAF and ACS/PCI (2)
STEP 1 – Stroke risk
STEP 2 – Bleeding risk
STEP 3 – Clinical setting
STEP 4 –
Antithrombotic
therapy
Nonvalvular atrial fibrillation
CHA2DS2-VASc = 1 CHA2DS2-VASc ≥ 2
Low to intermediate
(e.g. HAS-BLED = 0–2)
High
(e.g. HAS-BLED ≥ 3)
Low to intermediate
(e.g. HAS-BLED = 0–2)
High
(e.g. HAS-BLED ≥ 3)
Stable CAD ACS Stable CAD ACS Stable CAD ACS Stable CAD ACS
Triple
or dual
therapy*
or DAPT
Triple
therapyO A C
A C
O A C
Dual
therapy
or DAPT
O C
Triple
or dual
therapy*
O A C
Triple
or dual
therapy*
O A C
Triple
therapy
O A C
O A COral anticoagulation ASA 75–100 mg daily Clopidogrel 75 mg daily
If PCI is
performed
If PCI is
performed
If PCI is
performed
If PCI is
performed
Time from PCI/ACS
Lifelong
12 months
6 months
4 weeks
0
Dual
therapy**
Dual
therapy**
or DAPT
O A or C
A C
O A or C
A C
Dual
therapy**
O A or C
Triple or
dual
therapy*
O A C
Triple
or dual
therapy*
O A C
Triple
or dual
therapy*
O A C
Dual
therapy**
Dual
therapy**
O A or C O A or C
Monotherapy***O
Dual
therapy**
O A or C
Monotherapy***O
51.
52.
53. Not head-to-head comparison; no clinical conclusions can be drawn
A2.5 = apixaban 2.5 mg BID; D110 = dabigatran etexilate 110 mg BID; R15 = rivaroxaban 15 mg OD
Lip GYH et al. Eur Heart J. 2014;doi:10.1093/eurheartj/ehu298
Use of low dose NOAC in recent AF trials
50% of
dabigatran group
received D110
n=6015
21% of
rivaroxaban group
received R15
n=1474
4.7% of
apixaban group
received A2.5
n=428
Tested among all eligible
patients in RE-LY®
May be considered on its
own merits
Prescribed only to a minority subset of patients in
clinical trials
May not necessarily provide adequate
antithrombotic protection for AF in patients without
the clinical features used for dose adjustment
54. TRIPLE THERAPY WITH A NOAC :
KEY MESSAGES
54
• Oral anticoagulation with VKA OR NOAC
• No preference within class of NOACs
• Use lower tested dose
• Dabigatran 110 mg is the only
lower dose with proven efficacy in
randomised patients
• Other measures to limit
bleeding risk during thriple
therapy:
• 1. Use of clopidogrel (Plavix)
instead of ticagrelor (Brilique),
prasugrel (Efient)
• 2. Low dose aspirin <100 mg OD
• 3. Radial access
• 4. Consider intiating PPI
55. ONGOING TRIALS IN PATIENTS WITH AF
UNDERGOING A PCI WITH STENTING
55
Studies Interventions
PIONEER AF-PCI Safety of two rivaroxaban regimens vs VKA
RE-DUAL PCI Efficacy and safety of dual therapy with
dabigatran vs. triple therapy with VKA
www.clinicaltrials.gov
56. 1160.186 - RE-DUAL PCI
A prospective Randomised, open label, blinded endpoint
(PROBE) study to Evaluate DUAL antithrombotic therapy with
dabigatran etexilate (110mg and 150mg b.i.d.) plus clopidogrel
or ticagrelor vs. triple therapy strategy with warfarin (INR 2.0 –
3.0) plus clopidogrel or ticagrelor and aspirin in patients with
non valvular Atrial Fibrillation (NVAF) that have undergone a
percutaneous coronary intervention (PCI) with stenting.
57. *Warfarin arm: 1 month after bare metal stent or 3 months after drug-eluting stent
Adapted from Cannon C. AHA 2013; and Boehringer Ingelheim data on file
RE-DUAL PCI™: two new approaches to improving care
for patients with AF undergoing PCI
Dual primary endpoints: Death, MI, stroke/SE and major bleeding
Patients with AF
undergoing PCI (n=8520)
R
Dabigatran 150 mg BID
+ clopidogrel/ticagrelor
Screening
0–72 hours
after PCI
Dabigatran 110 mg BID
+ clopidogrel/ticagrelor
Warfarin (INR 2.0–3.0)
+ clopidogrel/ticagrelor*
n=2840 patients
per arm
Minimum treatment duration: 6 months
58. PIONEER AF-PCI : OVERVIEW
PCI STUDY
Primary endpoint
Composite of TIMI major bleeding events, minor bleeding events and bleeding events
requiring medical attention
Key inclusion criteria
History of paroxysmal, persistent
or permanent non-valvular AF
Undergone PCI (with stent
placement) for primary
atherosclerotic disease
Key exclusion criteria
High bleeding risk or contraindication to
anticoagulation
Prior stroke/TIA
CrCl <30 ml/min
Hepatic disease
www.clinicaltrials.gov/ct2/show/NCT01830543 Back to programme overview
59. 59
PIONEER AF-PCI: OVERVIEW
PCI STUDY
Rivaroxaban 15 mg od#‡ + clopidogrel*
Objective: safety of two rivaroxaban regimens vs VKA after PCI (with stent placement)
in non-valvular AF
End of
treatment
(12 months)
Rivaroxaban 2.5 mg bid‡
+ DAPT**
VKA (INR 2.0–3.0)§
+ DAPT*
Rivaroxaban 15 mg od#
+ low-dose ASA
VKA + low-dose
ASA
N=2100
1:1:1 Intended DAPT duration
of 1, 6 or 12 months
Population:
Paroxysmal, persistent
or permanent AF,
undergoing PCI
(with stent placement)
R
* alternative use of prasugrel or ticagrelor allowed, but capped at 15%
** ASA (75–100 mg daily) + clopidogrel (75 mg daily) (alternative use of prasugrel or ticagrelor allowed, but capped at 15%); #CrCl
30–49 ml/min: 10 mg od; ‡First dose 72–96 hours after sheath removal; §First dose 12–72 hours after sheath removal
www.clinicaltrials.gov
60. Conclusions
• Management of NVAF patients with IHD is
complex
• Need for robust data on new antithrombotic
strategies (trials ongoing) (RE-DUAL PCI)
• Recent consensus recommendations are
useful
61. New onset AF / Recent ACS (< 1 year)
Low – moderate atherothrombotic
risk
VKA monotherapy after 1-6 months
NOAC (low-dose) = good alternative to VKA
High atherothrombotic risk VKA + Clopidogrel
NOAC (low-dose) = good alternative to VKA
Low CHA2DS2-VASC score and high
atherothrombotic risk
AAS + Clopidogrel
New onset AF / Remote ACS (> 1 year)
VKA alone is superior to Aspirin post-ACS > no antiplatelet needed for most patients
with AF and stable CAD
Advantages of NOCAs over VKAs are preserved in stable CAD patients with AF,
NOACs provide safe and effective alternatives to VKAs
62. *Dual therapy with oral anticoagulation and clopidogrel may be considered in selected patients; **ASA as an alternative to
clopidogrel may be considered in patients on dual therapy (i.e. oral anticoagulation plus single antiplatelet); ***Dual therapy
with oral anticoagulation and an antiplatelet agent (ASA or clopidogrel) may be considered in patients at very high risk of
coronary events. DAPT, dual antiplatelet therapy; Lip et al Eur Heart J 2014 doi:10.1093/eurheartj/ehu298
Latest guidance for combination therapy in patients with
NVAF and ACS/PCI (2)
STEP 1 – Stroke risk
STEP 2 – Bleeding risk
STEP 3 – Clinical setting
STEP 4 –
Antithrombotic
therapy
Nonvalvular atrial fibrillation
CHA2DS2-VASc = 1 CHA2DS2-VASc ≥ 2
Low to intermediate
(e.g. HAS-BLED = 0–2)
High
(e.g. HAS-BLED ≥ 3)
Low to intermediate
(e.g. HAS-BLED = 0–2)
High
(e.g. HAS-BLED ≥ 3)
Stable CAD ACS Stable CAD ACS Stable CAD ACS Stable CAD ACS
Triple
or dual
therapy*
or DAPT
Triple
therapyO A C
A C
O A C
Dual
therapy
or DAPT
O C
Triple
or dual
therapy*
O A C
Triple
or dual
therapy*
O A C
Triple
therapy
O A C
O A COral anticoagulation ASA 75–100 mg daily Clopidogrel 75 mg daily
If PCI is
performed
If PCI is
performed
If PCI is
performed
If PCI is
performed
Time from PCI/ACS
Lifelong
12 months
6 months
4 weeks
0
Dual
therapy**
Dual
therapy**
or DAPT
O A or C
A C
O A or C
A C
Dual
therapy**
O A or C
Triple or
dual
therapy*
O A C
Triple
or dual
therapy*
O A C
Triple
or dual
therapy*
O A C
Dual
therapy**
Dual
therapy**
O A or C O A or C
Monotherapy***O
Dual
therapy**
O A or C
Monotherapy***O