Mathieu Kerneis1, C Michael Gibson2, Gerald Chi1, Roxana Mehran3, Fahad AlKhalfan1, Usama Talib1, Seyedmahdi Pahlavani1, Mahshid Mir1, Christoph Bode4, Jonathan L Halperin3, Tarek Nafee1, Eric D Peterson5, Freek W A Verheugt6, Peter Wildgoose7, Martin van Eickels8, Gregory Y H Lip9, Keith A A Fox10, Marc Cohen11. 1. Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. 2. Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. Electronic address: mgibson@bidmc.harvard.edu. 3. Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, New York. 4. Heart Center, Department for Cardiology and Angiology I, University of Freiburg, Freiburg, Germany. 5. Duke Clinical Research Institute, Durham, North Carolina. 6. Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, the Netherlands. 7. Janssen Pharmaceuticals, Inc., Beerse, Belgium. 8. Bayer Pharmaceuticals, Inc., Berlin, Germany. 9. Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. 10. Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Royal Infirmary of Edinburgh, Edinburgh, United Kingdom. 11. Division of Cardiology, Newark Beth Israel Medical Center, Newark, New Jersey.
Abstract
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 withrivaroxaban or warfarinfollowing 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 FibrillationWho 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).
RCT Entities:
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 AFpatients, 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 AFpatients 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).
Authors: David W Jones; Sheharyar Minhas; Joseph J Fierro; Devarshi Ardeshna; Aranyak Rawal; Brandon Cave; Samarth P Shah; Rami N Khouzam Journal: Ann Transl Med Date: 2019-09
Authors: Samer Al Said; Samer Alabed; Klaus Kaier; Audrey R Tan; Christoph Bode; Joerg J Meerpohl; Daniel Duerschmied Journal: Cochrane Database Syst Rev Date: 2019-12-19
Authors: Giuseppe Gargiulo; Christopher P Cannon; Charles Michael Gibson; Andreas Goette; Renato D Lopes; Jonas Oldgren; Serge Korjian; Stephan Windecker; Giovanni Esposito; Pascal Vranckx; Marco Valgimigli Journal: Eur Heart J Cardiovasc Pharmacother Date: 2021-04-09