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|Title:||Bivalirudin Versus Heparin Anticoagulation in Transcatheter Aortic Valve Replacement. A Randomized Phase 3 Trial|
|Authors:||Dangas, George D;Lefèvre, Thierry;Kupatt, Christian;Tchetche, Didier;Schäfer, Ulrich;Dumonteil, Nicolas;Webb, John G;Colombo, Antonio;Windecker, Stephan;Ten Berg, Jurriën M;Hildick-Smith, David;Mehran, Roxana;Boekstegers, Peter;Linke, Axel;Tron, Christoph|
|Keywords:||anticoagulation;bivalirudin;major bleeding;transcatheter aortic valve replacement|
|Abstract:||OBJECTIVE: To determine whether bivalirudin offers an alternative to heparin as procedural anticoagulation in patients undergoing transcatheter aortic valve replacement (TAVR).\n\nBACKGROUND: Anticoagulation is required during TAVR procedures; while the optimal regimen has not been studied, heparin has been mainly used. Direct thrombin inhibition with bivalirudin may be an effective alternative to heparin as procedural anticoagulation in this setting.\n\nMETHODS: We randomized 802 patients with aortic stenosis undergoing transfemoral TAVR to bivalirudin versus unfractionated heparin during the procedure. The two primary endpoints were major bleeding within 48 h or before hospital discharge, whichever occurred first, and 30-day net adverse clinical events, defined as the combination of major adverse cardiovascular events (all-cause mortality, myocardial infarction, or stroke) and major bleeding. This trial is registered with ClinicalTrials.gov, number NCT01651780.\n\nRESULTS: Anticoagulation with bivalirudin versus heparin did not meet superiority as it did not result in significantly lower rates of major bleeding at 48 h (6.9% vs 9.0%, relative risk 0.77, 95% confidence interval [CI] 0.48-1.23; p=0.27) or net adverse cardiovascular events at 30 days (14.4% vs 16.1%, relative risk 0.89, 95% CI 0.64-1.24 risk difference, -1.72, 95% CI -6.70, 3.25; p=0.50); regarding the latter, the prespecified non-inferiority hypothesis was met (pnon-inferiority<0.01). Rates of major adverse cardiovascular events at 48 h were not significantly different (3.5% vs 4.8%, relative risk 0.73, 95% CI 0.37-1.43; p=0.35).\n\nCONCLUSIONS: In this randomized trial on TAVR procedural pharmacotherapy, bivalirudin did not reduce rates of major bleeding at 48 h or net adverse cardiovascular events within 30 days in comparison to heparin. Although superiority was not shown, the non-inferiority hypothesis was met with respect to the latter. Given the lower cost, heparin should remain the standard of care, and bivalirudin can be an alternative anticoagulant in patients not able to receive heparin in TAVR. (NCT: NCT01651780).|
|More Information:||Volume : 66Issue : 25|
|Appears in Collections:||Journal of the American College of Cardiology|
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