TIMI BLEEDING TRIAL

TIMI BLEEDING TRIAL

Trial Registration: Identifier: NCT02415400.ДЄIMS: We evaluated the relation between baseline and new-onset atrial fibrillation (AF) and outcomes, and assessed whether vericiguat modified the likelihood of new-onset AF in patients with worsening heart failure (HF) with reduced ejection fraction in VICTORIA. Although aspirin may have some benefit in patients with prior stroke, our findings support the use of apixaban and a P2Y12 inhibitor without aspirin for the majority of patients with AF and ACS and/or PCI, regardless of prior stroke/TIA/TE status. Aspirin increased major or CRNM bleeding, particularly in patients without prior stroke/TIA/TE. Conclusions and Relevance: The safety and efficacy of apixaban compared with VKA was consistent with the AUGUSTUS findings, irrespective of prior stroke/TIA/TE. Aspirin was associated with numerically lower rates of death or ischemic events than placebo in patients with (HR, 0.71 95% CI, 0.42-1.20) and without (HR, 0.93 95% CI, 0.72-1.21) prior stroke/TIA/TE (not statistically significant). Patients without prior stroke/TIA/TE receiving aspirin vs placebo had higher rates of bleeding this difference appeared less substantial among patients with prior stroke/TIA/TE (P =. Apixaban was associated with lower rates of major or CRNM bleeding and death or hospitalization than VKA in patients with (hazard ratio, 0.69 95% CI, 0.46-1.03) and without (HR, 0.68 95% CI, 0.57-0.82) prior stroke/TIA/TE. Patients with vs without prior stroke/TIA/TE were older had higher CHA2DS2-VASC and HAS-BLED scores and more frequently had prior bleeding, heart failure, diabetes, and prior oral anticoagulant use. Results: Of 4581 patients included, 633 (13.8%) had prior stroke/TIA/TE. Main Outcomes and Measures: Major or clinically relevant nonmajor (CRNM) bleeding. Interventions: Apixaban (5 mg or 2.5 mg twice daily) or VKA and aspirin or placebo. Patients with AF, recent ACS or PCI, and planned use of P2Y12 inhibitors for 6 months or longer were included 33 patients with missing data about prior stroke/TIA/TE were excluded. Design, Setting, and Participants: In this prospective, multicenter, 2-by-2 factorial, randomized clinical trial, post hoc parallel analyses were performed to compare randomized treatment regimens according to presence or absence of prior stroke/TIA/TE using Cox proportional hazards models. Objective: Determine the efficacy and safety of apixaban or vitamin K antagonists (VKA) and aspirin or placebo according to prior stroke, transient ischemic attack (TIA), or thromboembolism (TE). Importance: Data are limited regarding the risk of cerebrovascular ischemic events and major bleeding in patients with atrial fibrillation (AF) and recent acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI).

Timi bleeding