Author + information
- Received October 16, 2017
- Revision received November 8, 2017
- Accepted November 9, 2017
- Published online April 2, 2018.
- Mathieu Kerneis, MDa,
- C. Michael Gibson, MS, MDa,∗ (, )
- Gerald Chi, MDa,
- Roxana Mehran, MDb,
- Fahad AlKhalfan, MDa,
- Usama Talib, MDa,
- Seyedmahdi Pahlavani, MDa,
- Mahshid Mir, MDa,
- Christoph Bode, MDc,
- Jonathan L. Halperin, MDb,
- Tarek Nafee, MDa,
- Eric D. Peterson, MD, MPHd,
- Freek W.A. Verheugt, MDe,
- Peter Wildgoose, PhDf,
- Martin van Eickels, MDg,
- Gregory Y.H. Lip, MDh,i,
- Keith A.A. Fox, MBChBj,k and
- Marc Cohen, MDl
- aDivision of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
- bCardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, New York
- cHeart Center, Department for Cardiology and Angiology I, University of Freiburg, Freiburg, Germany
- dDuke Clinical Research Institute, Durham, North Carolina
- eOnze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, the Netherlands
- fJanssen Pharmaceuticals, Inc., Beerse, Belgium
- gBayer Pharmaceuticals, Inc., Berlin, Germany
- hInstitute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom
- iAalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
- jCentre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom
- kRoyal Infirmary of Edinburgh, Edinburgh, United Kingdom
- lDivision of Cardiology, Newark Beth Israel Medical Center, Newark, New Jersey
- ↵∗Address for correspondence:
Dr. C. Michael Gibson, Beth Israel Deaconess Medical Center, Cardiovascular Division, 20 Overland Street, Boston, Massachusetts 02215.
Objectives This study sought to assess whether there were significant interactions of procedural access strategies and lesion characteristics with bleeding and ischemic events among atrial fibrillation (AF) patients anticoagulated with rivaroxaban or warfarin following a percutaneous coronary intervention.
Background Among stented AF patients, the impact of procedural access strategies or lesion characteristics on antithrombotic safety and efficacy outcomes is unclear.
Methods In the PIONEER AF-PCI (An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention) trial, 2,124 patients were randomized to 3 groups and followed for 12 months: 1) rivaroxaban 15 mg once daily plus a P2Y12 inhibitor (n = 709); 2) rivaroxaban 2.5 mg twice a day plus dual antiplatelet therapy (DAPT) (n = 709); and 3) dose-adjusted warfarin plus DAPT (n = 706). Kaplan-Meier rates of clinically significant bleeding and major adverse cardiovascular events were compared between treatments stratified by subgroups of procedure type and lesion characteristics.
Results Compared with warfarin, both rivaroxaban regimens consistently reduced clinically significant bleeding across subgroups of radial versus femoral arterial access and by vascular closure device use. Treatment effect of rivaroxaban on major adverse cardiovascular events did not vary when stratified by ischemia-driven revascularization, urgency of revascularization, location of culprit artery, presence of bifurcation lesion, presence of thrombus, type, and length of stent or number of stents (interaction p > 0.05 for all subgroups).
Conclusions Among stented AF patients requiring long-term oral anticoagulation, there was no effect modification by procedure or lesion characteristics of either clinically significant bleeding or major adverse cardiovascular events. Rivaroxaban-based therapy was superior to warfarin plus DAPT in bleeding outcomes regardless of the type of stent or arterial access during the index coronary revascularization. (A Study Exploring Two Strategies of Rivaroxaban [JNJ39039039; BAY-59-7939] and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention [PIONEER AF-PCI]; NCT01830543)
- atrial fibrillation
- coronary artery
- percutaneous coronary intervention
- randomized controlled trials as topic
The PIONEER AF-PCI trial was supported by Janssen Scientific Affairs and Bayer, the sponsors of the study. Dr. Kerneis has received research grant support from Sanofi, Institut Servier, and Federation Française de Cardiologie; and has received consulting fees from Bayer and AstraZeneca. Dr. Gibson has received research grant support from Johnson & Johnson, Janssen, and Portola; and has served as a consultant for Janssen and Bayer. Dr. Chi has received institutional research grant support from Portola, Bayer, and Janssen Research. Dr. Mehran has received consulting fees paid to her institution from Abbott Laboratories, CardioKinetix, and Spectranetics; has a spouse that has served as a consultant for Abiomed and The Medicines Company; has received institutional research funding from AstraZeneca, Bayer, Beth Israel Deaconness, Bristol-Myers Squibb, CSL Behring, and Eli Lilly/Daiichi Sankyo; has served as a consultant for Boston Scientific, Shanghai BraccoSine Pharmaceutical, CSL Behring, and Medscape; has received advisory board funding to the institution from Bristol-Myers Squibb; has received a medical monitor paid to the institution from Claret Medical; owns equity in Claret Medical and Elixir Medical; has served on the executive committee for Janssen Pharmaceuticals, Osprey Medical; and has served on the data safety and monitoring board for Watermark. Dr. Bode has received consulting fees from Bayer, Boehringer Ingelheim, Daiichi Sankyo, and Bristol-Myers Squibb. Dr. Halperin has served as a consultant for Bayer Healthcare Pharmaceuticals, Ortho-McNeil-Janssen, Boehringer Ingelheim, Pfizer, and Medtronic. Dr. van Eickels owns stock (<$10,000) from Bayer. Dr. Lip has served as a consultant for Bayer/Janssen, Bristol-Myers Squibb/Pfizer, Biotronik, Medtronic, Boehringer Ingelheim, Microlife, and Daiichi Sankyo; and has served as a speaker for Bayer, Bristol-Myers Squibb/Pfizer, Medtronic, Boehringer Ingelheim, Microlife, Roche, and Daiichi Sankyo. Dr. Fox has received grants from Bayer/Janssen; and honoraria Bayer/Janssen, AstraZeneca, and Sanofi/Regeneron. Dr. Cohen has served on the Speakers Bureau and on the advisory board for Janssen. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 16, 2017.
- Revision received November 8, 2017.
- Accepted November 9, 2017.
- 2018 American College of Cardiology Foundation