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

Abstract Background/Introduction 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. Purpose To evaluate a 1-month dual antithrombotic regimen in HBR patients with and without OAC indication in a prespecified sub-analysis of the POEM trial. Methods 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=0.097). Secondary ischemic outcomes were similar. Major bleeding (BARC type 3–5) was infrequent (2.6% vs. 1.3%; p=0.369). The per-protocol analysis showed consistent results. Conclusion 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 deserving randomized investigation.Study design and main findingFor image description, please refer to the figure legend and surrounding text.