Early oral anticoagulation monotherapy after PCI: Insights from the POEM trial

Abstract

Background: In high-bleeding-risk (HBR) patients undergoing percutaneous coronary intervention (PCI), shortening dual antiplatelet therapy (DAPT) is essential, but the optimal approach in those requiring oral anticoagulation (OAC) is uncertain. We evaluated a 1-month dual antithrombotic regimen in HBR patients with and without OAC indication in a prespecified sub-analysis of the POEM trial.

Method: POEM enrolled HBR patients treated with a bioresorbable polymer everolimus-eluting stent. Patients were stratified by OAC indication: the non-OAC group (n = 281) received 1-month DAPT followed by single antiplatelet therapy; the OAC group (n = 158) received 1-month OAC plus a P2Y12 inhibitor followed by OAC monotherapy. Time-to-event outcomes were analyzed using the log-rank test, and hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated using Cox regression models. The primary analysis was conducted according to the intention-to-treat principle. A per-protocol analysis, excluding patients with DAPT duration >1 month, was performed as a sensitivity analysis.

Results: At 1 year, the primary endpoint, a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis, occurred in 6.1% of the non-OAC group versus 2.6% of the OAC group (HR 0.41, 95% CI 0.14-1.22; P = .097). Secondary ischemic outcomes were similar. BARC type 3-5 bleeding was infrequent (2.6% vs 1.3%; P = .369). The per-protocol analysis showed consistent results.

Conclusions: In HBR patients after PCI, transition to OAC monotherapy at 1 month was associated with low ischemic and bleeding risks, comparable to single antiplatelet therapy. These findings support early OAC monotherapy as a feasible strategy warranting randomized investigation.

Trial registration: EudraCT Number: 2016-004510-99; clinicaltrials.gov: NCT03112707.