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Early oral anticoagulation monotherapy after PCI: Insights from the POEM trial
Carlo A Pivato1, Gianluca Mincione1, Leon Gramss1
1Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Cardio Center, IRCCS Humanitas Research Hospital, Milan, Italy.
Insights
For high-bleeding-risk patients after percutaneous coronary intervention, a 1-month oral anticoagulation (OAC) regimen showed low ischemic and bleeding risks. This supports early OAC monotherapy as a viable strategy for further study.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Percutaneous coronary intervention (PCI) in high-bleeding-risk (HBR) patients necessitates shortening dual antiplatelet therapy (DAPT).
- Optimal antithrombotic strategies for HBR patients requiring oral anticoagulation (OAC) post-PCI remain unclear.
- The POEM trial investigated a 1-month dual antithrombotic regimen in HBR patients, with a focus on those needing OAC.
Purpose of the Study:
- To evaluate a 1-month dual antithrombotic regimen in HBR patients undergoing PCI.
- To compare outcomes in HBR patients with and without an OAC indication.
- To assess the feasibility of early OAC monotherapy in this patient population.
Main Methods:
- The POEM trial enrolled HBR patients treated with a bioresorbable polymer everolimus-eluting stent.
- Patients were divided into non-OAC (1-month DAPT then single antiplatelet) and OAC (1-month OAC + P2Y12 inhibitor then OAC monotherapy) groups.
- Time-to-event outcomes were analyzed using Cox regression, with intention-to-treat and per-protocol analyses.
Main Results:
- The primary endpoint (cardiac death, MI, stent thrombosis) occurred in 6.1% of the non-OAC group vs. 2.6% of the OAC group at 1 year (HR 0.41).
- Secondary ischemic outcomes were similar between groups.
- Bleeding events (BARC type 3-5) were infrequent and comparable (2.6% vs. 1.3%).
Conclusions:
- Transitioning to OAC monotherapy at 1 month in HBR patients post-PCI was associated with low ischemic and bleeding risks.
- This strategy demonstrated outcomes comparable to single antiplatelet therapy.
- Early OAC monotherapy appears feasible and warrants further randomized investigation.
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.
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