Exploratory end points included the occurrence of major bleeding defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria and the occurrence of severe bleeding defined according to the Global Utilization of Streptokinase and Tissue Plasminogen Factor for Occluded Coronary Arteries (GUSTO) criteria.Īll statistical analyses were performed with the use of SAS software, version 9.4 (SAS Institute). Secondary end points included the incidence of each component of the primary safety end point, as well as the following efficacy end points: the occurrence of a major adverse cardiovascular event (a composite of death from cardiovascular causes, myocardial infarction, or stroke), each component of the major adverse cardiovascular event end point, and stent thrombosis. The primary safety end point was the occurrence of clinically significant bleeding (a composite of major bleeding or minor bleeding according to Thrombolysis in Myocardial Infarction criteria or bleeding requiring medical attention for details, see the Supplementary Appendix) during the treatment period (which was defined as the time from the first administration of a trial drug to 2 days after the trial drugs were discontinued, through 12 months of therapy). Details of the trial design have been published previously. Complete lists of the members of the executive committee, PERFUSE study group, and data and safety monitoring board, as well as all investigators, can be found in the Supplementary Appendix, available at. An independent data and safety monitoring board monitored the scientific integrity and the safety of the trial. The trial was approved by national and institutional regulatory agencies and ethics committees. The authors vouch for the accuracy and completeness of the data and for adherence to the trial protocol, available with the full text of this article at. All the authors made the decision to submit the manuscript for publication. The academic members of the executive committee were solely responsible for drafting the manuscript and editing all versions. Although the sponsors coordinated the data management, all statistical analyses were performed independently by the PERFUSE study group, whose members used a copy of the complete raw database. The executive committee was responsible for the design and conduct of the trial. The trial was sponsored by Janssen Scientific Affairs and Bayer Pharmaceuticals. PIONEER AF-PCI was an international, multicenter, randomized, open-label trial. 9 We conducted the PIONEER AF-PCI trial (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) to compare the safety of the following three treatment strategies after PCI with stent placement in patients with paroxysmal, persistent, or permanent nonvalvular atrial fibrillation: a regimen established in the WOEST trial (What Is the Optimal Antiplatelet and Anticoagulant Therapy in Patients with Oral Anticoagulation and Coronary Stenting) 10 of low-dose rivaroxaban (15 mg once daily) plus a single P2Y 12 inhibitor, a regimen established in the ATLAS ACS 2–TIMI 51 trial of very-low-dose rivaroxaban (2.5 mg twice daily) plus DAPT, and standard triple therapy with a vitamin K antagonist plus DAPT. 8 Rivaroxaban also reduced the risk of death from cardiovascular causes, myocardial infarction, and stroke when administered as secondary prevention after an acute coronary syndrome in the ATLAS ACS 2–TIMI 51 trial (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome–Thrombolysis in Myocardial Infarction 51).

Rivaroxaban, an oral factor Xa inhibitor, has been associated with a lower risk of stroke and systemic embolism than vitamin K antagonists among patients with nonvalvular atrial fibrillation, with similar rates of major bleeding but significantly lower rates of intracranial hemorrhage and fatal bleeding. Novel oral anticoagulants may provide advantages over vitamin K antagonists.

Timi bleeding