A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: The Randomized, phase II study to Evaluate the sAfety and.

Slides:

Advertisements

Similar presentations

Georges Ghanem MD, FESC, FACC Associate Professor, Chief of Cardiology UMC-RH/LAU-SOM Beirut, Lebanon.

Advertisements

Guillaume Pare MD Genetic determinants of dabigatran plasma levels and their relation to bleeding On behalf of RE-LY Genetics: Guillaume Pare MD, Niclas.

Guillaume Pare MD Genetic determinants of dabigatran plasma levels and their relation to bleeding On behalf of RE-LY Genetics: Guillaume Pare MD, Niclas.

Comparison of Dabigatran and Warfarin in Patients With Atrial Fibrillation and Valvular Heart DiseaseClinical Perspective by Michael D. Ezekowitz, Rangadham.

Recurrence of pulmonary vein conduction and atrial fibrillation after pulmonary vein isolation for atrial fibrillation: A randomized trial of the ostial.

Atrial fibrillation and quality of life after pacemaker implantation for sick sinus syndrome: Data from the Mode Selection Trial (MOST) Kirsten E. Fleischmann,

An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin k antagonist.

Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN.

Utility of the Seattle Heart Failure Model in patients with cardiac resynchronization therapy and implantable cardioverter defibrillator referred for.

Rationale and design of the Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure (TAVR UNLOAD)

Long-Term Population-Based Cerebral Ischemic Event and Cognitive Outcomes of Direct Oral Anticoagulants Compared With Warfarin Among Long-term Anticoagulated.

Rationale and design of the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 Trial: A comparison of fractional flow reserve–guided.

A critical review of hemodynamic changes and left ventricular remodeling after surgical aortic valve replacement and percutaneous aortic valve replacement

Adjunctive therapy with low-molecular-weight heparin in patients with chronic heart failure secondary to dilated cardiomyopathy: One-year follow-up results.

Rationale and design of the FreezeAF trial: A randomized controlled noninferiority trial comparing isolation of the pulmonary veins with the cryoballoon.

Impact of weight reduction on pericardial adipose tissue and cardiac structure in patients with atrial fibrillation Hany S. Abed, BPharm, MBBS, PhD,

Variation among hospitals in selection of higher-cost, “higher-tech,” implantable cardioverter-defibrillators: Data from the National Cardiovascular Data.

RE-ALIGN: Dabigatran in Patients With a Mechanical Heart Valve Randomized, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dabIGatran.

Rationale and design of the ATTRACT Study: A multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention.

New-onset Atrial Fibrillation Predicts Heart Failure Progression

Efficacy and Safety of Dabigatran vs

Evaluating the safety and efficacy of sodium-restricted/Dietary Approaches to Stop Hypertension diet after acute decompensated heart failure hospitalization:

Transcatheter aortic valve replacement in patients with severe aortic stenosis who are at high risk for surgical complications: Summary assessment of.

Admission heart rate and in-hospital outcomes in patients hospitalized for heart failure in sinus rhythm and in atrial fibrillation Anh L. Bui, MD, Maria.

National evaluation of adherence to β-blocker therapy for 1 year after acute myocardial infarction in patients with commercial health insurance Judith.

Differences and trends in stroke prevention anticoagulation in primary care vs cardiology specialty management of new atrial fibrillation: The Retrospective.

Single-bolus tenecteplase plus heparin compared with heparin alone for normotensive patients with acute pulmonary embolism who have evidence of right.

Rationale and design of a randomized clinical trial to assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy: The.

Clinical event rates with the On-X bileaflet mechanical heart valve: A multicenter experience with follow-up to 12 years John B. Chambers, MD, FRCP,

Renato D. Lopes, MD, PhD, Li Li, MS, Christopher B

Lars G. Svensson, MD, PhD, Eugene H. Blackstone, MD

Endoscopic Robotic Mitral Valve Surgery

Timing the First Postoperative Dose of Anticoagulants

A meta-analysis of comparative studies of endovascular versus open repair for blunt thoracic aortic injury Hisato Takagi, MD, PhD, Norikazu Kawai, MD,

The persistent problem of new-onset postoperative atrial fibrillation: A single-institution experience over two decades Jeanne Shen, BS, Shelly Lall,

Do higher-risk patients benefit from off-pump coronary artery bypass grafting? Evidence from an ecologic analysis of randomized trials Oliver Kuss, PhD,

Net Clinical Benefit of Non-vitamin K Antagonist Oral Anticoagulants Versus Warfarin in Phase III Atrial Fibrillation Trials Giulia Renda, MD, PhD, Marta.

Timing the First Postoperative Dose of Anticoagulants

Major Gastrointestinal Bleeding Often Is Caused by Occult Malignancy in Patients Receiving Warfarin or Dabigatran to Prevent Stroke and Systemic Embolism.

Usefulness of microsimulation to translate valve performance into patient outcome: Patient prognosis after aortic valve replacement with the Carpentier–Edwards.

Prospective randomized comparison of CarboMedics and St

Papillary Fibroelastoma of the Subvalvular Apparatus of the Mitral Valve Found on Echocardiography after the Clinical Presentation of Embolic CVA Henry.

Bayesian stopping guidelines for heart valve premarket approval studies Gary L. Grunkemeier, PhD, YingXing Wu, MD, MS, Lian Wang, MS, Cody Hamilton, PhD

Margriet Fokkema, MD, Rodney P. Bensley, MD, Ruby C. Lo, MD, Allan D

Risk-corrected impact of mechanical versus bioprosthetic valves on long-term mortality after aortic valve replacement Ole Lund, MD, PhD, Martin Bland,

Mitral valve operation in patients with the Marfan syndrome

Probability of major bleeding event and ischaemic stroke/SEE versus trough plasma concentration of dabigatran. Calculated for a 72-year-old male patient.

The risk and extent of neurologic events are equivalent for high-risk patients treated with transcatheter or surgical aortic valve replacement Thomas.

A time-related parametric risk factor analysis for postoperative atrial fibrillation after heart surgery Spencer J. Melby, MD, James F. George, PhD,

Ministernotomy versus conventional sternotomy for aortic valve replacement: A systematic review and meta-analysis Morgan L. Brown, MD, Stephen H. McKellar,

Pharmacokinetics of Multiple-Dose Levofloxacin in Hemodialysis Patients Shuichi Tsuruoka, MD, PhD, Noritsugu Yokota, MD, PhD, Tokie Hayasaka, RN, Tetsuo.

Integrated morphologic and functional assessment of the aortic root after different tissue valve root replacement procedures Ryo Torii, PhD, Ismail El-Hamamsy,

Michele Gallo, MD, Gino Gerosa, MD

Arterial lactate before initiation of venoarterial extracorporeal membrane oxygenation for postcardiotomy shock improves postimplant outcome prediction

Surgery for aortic and mitral valve disease in the United States: A trend of change in surgical practice between 1998 and 2005 Scott D. Barnett, PhD,

Kevin Bridge, MD, MSPH, Robert Saeid Farivar, MD, PhD

Probability of major bleeding event and ischaemic stroke/SEE versus trough plasma concentration of dabigatran. Calculated for a 72-year-old male patient.

Fenton H. McCarthy, MD, MS, Nimesh D. Desai, MD, PhD

Patient recovery after intermittent disc escape and spontaneous recession of a mechanical heart valve Francis Robicsek, MD, PhD, Joseph W. Cook, MD

Increase in size of the pulmonary autograft after the ross operation in children: Growth or dilation? Laszlo Solymar, MD, PhD, Göran Südow, MD, Daniel.

Commentary: Bioprosthetic aortic valve replacement: A high standard of comparison for transcatheter aortic valve implantation Aaron Martin, MD, Michael.

The harder one looks, the more one finds

Quality of life after aortic valve surgery: Replacement versus reconstruction Diana Aicher, MD, Annika Holz, Susanne Feldner, MD, Volker Köllner, MD,

Commentary: When a choice is not an echo

Reliability of risk algorithms in predicting early and late operative outcomes in high-risk patients undergoing aortic valve replacement Todd M. Dewey,

Vinay Badhwar, MD, John S. Ikonomidis, MD, PhD, Jeffrey P. Jacobs, MD

Clinical event rates with the On-X bileaflet mechanical heart valve: A multicenter experience with follow-up to 12 years John B. Chambers, MD, FRCP,

RE-ALIGN Randomized, Phase II Study to Evaluate the Safety and Pharmacokinetics of Oral Dabigatran Etexilate in Patients after Heart Valve Replacement.

National trends in utilization and in-hospital outcomes of mechanical versus bioprosthetic aortic valve replacements Abby J. Isaacs, MS, Jeffrey Shuhaiber,

Apremilast, an oral phosphodiesterase-4 inhibitor, in the treatment of palmoplantar psoriasis: Results of a pooled analysis from phase II PSOR-005 and.

Presentation transcript:

A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: The Randomized, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dabIGatran etexilate in patients after heart valve replacemeNt (RE-ALIGN) Frans Van de Werf, MD, Martina Brueckmann, MD, Stuart J. Connolly, MD, Jeffrey Friedman, MD, Christopher B. Granger, MD, Sebastian Härtter, PhD, Ruth Harper, MD, Arie Pieter Kappetein, MD, Thorsten Lehr, PhD, Michael J. Mack, MD, Herbert Noack, PhD, John W. Eikelboom, MD American Heart Journal Volume 163, Issue 6, Pages 931-937.e1 (June 2012) DOI: 10.1016/j.ahj.2012.03.011 Copyright © 2012 Mosby, Inc. Terms and Conditions

Figure 1 Model-predicted probability of ischemic stroke and systemic embolic event versus trough plasma concentration of total dabigatran by age in atrial fibrillation subjects receiving either dabigatran etexilate 110 mg twice a day or dabigatran etexilate 150 mg twice a day in the RELY study.20 American Heart Journal 2012 163, 931-937.e1DOI: (10.1016/j.ahj.2012.03.011) Copyright © 2012 Mosby, Inc. Terms and Conditions

Figure 2 A, Median concentration-time profiles at steady state of each of the virtual patients with their respective target dose. A is depicting the median concentration-time profiles at steady state of each of the virtual patients with their respective target dose. In addition, the 80% prediction interval (10th to 90th percentiles) of the typical RE-LY patient receiving dabigatran 150 mg twice a day (reference exposure profile) is provided as shaded area. The simulation revealed that the median profiles are similar and overlap widely. All median profiles are within the 80% prediction interval, indicating a similar exposure. B, 80% prediction intervals (10th to 90th percentiles) of dabigatran trough concentrations at steady state in RE-ALIGN in comparison with observed concentrations in RE-LY. American Heart Journal 2012 163, 931-937.e1DOI: (10.1016/j.ahj.2012.03.011) Copyright © 2012 Mosby, Inc. Terms and Conditions

Figure 3 Study plan for patients who got an aortic or mitral bileaflet valve during index hospitalization (A, recent surgery group) and patients who got a mechanical bileaflet valve >3 months before randomization (B, remote surgery group). A, RE-ALIGN trial design—recent surgery group. B, RE-ALIGN trial design—remote surgery group. American Heart Journal 2012 163, 931-937.e1DOI: (10.1016/j.ahj.2012.03.011) Copyright © 2012 Mosby, Inc. Terms and Conditions