TY - JOUR
T1 - Novel Oral Anticoagulant Based Versus Vitamin K Antagonist Based Double Therapy among Stented Patients with Atrial Fibrillation
T2 - Insights from the PIONEER AF-PCI Trial
AU - Kerneis, Mathieu
AU - Yee, Megan K.
AU - Mehran, Roxana
AU - Nafee, Tarek
AU - Bode, Christoph
AU - Halperin, Jonathan L.
AU - Peterson, Eric D.
AU - Verheugt, Freek W.A.
AU - Wildgoose, Peter
AU - Van Eickels, Martin
AU - Lip, Gregory Y.H.
AU - Cohen, Marc
AU - Fox, Keith A.A.
AU - Gibson, C. Michael
N1 - Funding Information:
Dr Kerneis reports receiving research grants from Institut Servier and Federation Francaise de Cardiologie, consulting fees from Bayer. Dr Mehran receiving fees for serving on a data and safety monitoring board from Watermark Research Partners, fees for serving on executive committees from Janssen Pharmaceuticals and Osprey Medical, consulting fees from AstraZeneca, the Medicines Company, Medscape, Boston Scientific, Merck & Company, Cardiovascular Systems, Inc (CSI), Sanofi, and Shanghai BraccoSine Pharmaceutical Corporation, and grant support to her institution from Eli Lilly/Daiichi-Sankyo, Bristol-Myers Squibb, AstraZeneca, the Medicines Company, Orbus Neich, Bayer, CSL Behring, Abbott Laboratories, Watermark Research Partners, Novartis Pharmaceuticals, Medtronic, and AUM Cardiovascular; Dr Bode, receiving travel support and fees for lectures and serving on advisory boards from Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, and Daiichi-Sankyo; Dr Halperin, receiving consulting fees from Bayer Healthcare, Boehringer Ingelheim, and Pfizer; Dr Wildgoose, being employees of Janssen, holding stock in Johnson & Johnson; Dr Van Eickels, being an employee of Bayer; Dr Lip, receiving consulting fees from Bayer/Jans-sen, Bristol-Myers Squibb/Pfizer, Biotronik, Boehringer Ingelheim, Medtronic, Microlife, and Daiichi-Sankyo, and lecture fees from Bayer, Bristol-Myers Squibb/ Pfizer, Boehringer Ingelheim, Medtronic,Microlife, Daiichi-Sankyo, and Roche; Dr Cohen, receiving lecture fees from Janssen; Dr Peterson, receiving consulting fees and travel support from Janssen and Bayer, and grant support from Janssen; and K.A.A. Fox, receiving fees for serving on advisory boards from Eli Lilly, Sanofi/ Regeneron, and GlaxoSmithKline, and lecture fees and grant support from As-traZeneca. Dr Vergheut served as an advisor or consultant for: Bayer HealthCare Pharmaceuticals; Bristol-Myers Squibb Company; Pfizer Inc, served as a speaker or a member of a speakers bureau for: Boehringer Ingelheim Pharmaceuticals, Inc; Daiichi Sankyo, Inc received grants for clinical research from: Bayer HealthCare Pharmaceuticals. Dr Gibson reports receiving consulting fees from the Medicines Company, Boston Scientific Research Institute, Eli Lilly, Gilead Sciences, Novo Nordisk, Pfizer, and WebMD and grant support from Angel Medical, Bayer, CSL Behring, Ikaria, Janssen, Johnson & Johnson, Portola Pharmaceuticals, Stealth Peptides, and St Jude Medical. The other authors report no conflicts.
Publisher Copyright:
© 2019 American Heart Association, Inc.
PY - 2019/11/1
Y1 - 2019/11/1
N2 - Background: Among stented patients with atrial fibrillation, double therapy with a novel oral anticoagulant plus single antiplatelet therapy (SAPT) reduces bleeding or cardiovascular rehospitalizations compared with a vitamin K antagonist (VKA) based triple therapy regimen. A recent study demonstrated that apixaban based double therapy reduced bleeding compared with VKA based double therapy. However, it remains unknown whether rivaroxaban based double therapy is superior to a VKA based double therapy. Methods: Patient with stented atrial fibrillation (n=2124) were randomized to 3 groups: rivaroxaban 15 mg od plus a P2Y12 inhibitor (Group 1, n=709); rivaroxaban 2.5 mg bid plus dual antiplatelet therapy (DAPT; Group 2, n=709); and warfarin plus DAPT (Group 3, n=706). Before randomization, subjects were stratified according to a prespecified duration of DAPT (1, 6, or 12 months). After the prespecified DAPT duration, subjects in Group 2 were switched to rivaroxaban 15 mg plus low dose aspirin, and those in Group 3 were switched to VKA plus low dose aspirin. The Wei, Lin, and Weissfeld time to multiple events method was used to compare the occurrence of all bleeding and cardiovascular rehospitalizations among subjects on a novel oral anticoagulant versus VKA based double therapy. Results: A total of 906 subjects were prespecified to a 1 or 6 months DAPT duration and received at least one dose of study drug. Twenty subjects (3.3%) assigned to novel oral anticoagulant+SAPT, and 15 (5.1%) subjects assigned to VKA+SAPT experienced multiple rehospitalizations. In total, 124 (20.3%) events occurred among subjects on novel oral anticoagulant+SAPT compared with 87 (29.6%) among subjects on VKA+SAPT (hazard ratio=0.65 [95% CI, 0.45-0.93], P=0.008). Conclusions: Among stented patients with atrial fibrillation, rivaroxaban plus SAPT was superior to warfarin plus SAPT in lowering total bleeding and cardiovascular rehospitalization.
AB - Background: Among stented patients with atrial fibrillation, double therapy with a novel oral anticoagulant plus single antiplatelet therapy (SAPT) reduces bleeding or cardiovascular rehospitalizations compared with a vitamin K antagonist (VKA) based triple therapy regimen. A recent study demonstrated that apixaban based double therapy reduced bleeding compared with VKA based double therapy. However, it remains unknown whether rivaroxaban based double therapy is superior to a VKA based double therapy. Methods: Patient with stented atrial fibrillation (n=2124) were randomized to 3 groups: rivaroxaban 15 mg od plus a P2Y12 inhibitor (Group 1, n=709); rivaroxaban 2.5 mg bid plus dual antiplatelet therapy (DAPT; Group 2, n=709); and warfarin plus DAPT (Group 3, n=706). Before randomization, subjects were stratified according to a prespecified duration of DAPT (1, 6, or 12 months). After the prespecified DAPT duration, subjects in Group 2 were switched to rivaroxaban 15 mg plus low dose aspirin, and those in Group 3 were switched to VKA plus low dose aspirin. The Wei, Lin, and Weissfeld time to multiple events method was used to compare the occurrence of all bleeding and cardiovascular rehospitalizations among subjects on a novel oral anticoagulant versus VKA based double therapy. Results: A total of 906 subjects were prespecified to a 1 or 6 months DAPT duration and received at least one dose of study drug. Twenty subjects (3.3%) assigned to novel oral anticoagulant+SAPT, and 15 (5.1%) subjects assigned to VKA+SAPT experienced multiple rehospitalizations. In total, 124 (20.3%) events occurred among subjects on novel oral anticoagulant+SAPT compared with 87 (29.6%) among subjects on VKA+SAPT (hazard ratio=0.65 [95% CI, 0.45-0.93], P=0.008). Conclusions: Among stented patients with atrial fibrillation, rivaroxaban plus SAPT was superior to warfarin plus SAPT in lowering total bleeding and cardiovascular rehospitalization.
KW - atrial fibrillation
KW - percutaneous coronary intervention
KW - rivaroxaban
KW - vitamin K
KW - warfarin
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U2 - 10.1161/CIRCINTERVENTIONS.119.008160
DO - 10.1161/CIRCINTERVENTIONS.119.008160
M3 - Article
C2 - 31707805
AN - SCOPUS:85074741662
SN - 1941-7640
VL - 12
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
IS - 11
M1 - e008160
ER -