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Clopidogrel Monotherapy After 1-Month DAPT in Patients With High Bleeding Risk or Complex PCI
Ko Yamamoto1, Hirotoshi Watanabe1, Takeshi Morimoto2
1Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Insights
Short dual antiplatelet therapy (DAPT) is effective regardless of high bleeding risk (HBR) or complex percutaneous coronary intervention (PCI). One-month DAPT showed a numerically greater reduction in bleeding events for HBR patients compared to standard 12-month DAPT.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- High bleeding risk (HBR) and complex percutaneous coronary intervention (PCI) are key factors influencing the duration of dual antiplatelet therapy (DAPT).
- Determining optimal DAPT duration is crucial for balancing antithrombotic efficacy and bleeding complications.
- Previous studies have not definitively established the impact of HBR and complex PCI on DAPT duration strategies.
Purpose of the Study:
- To evaluate the comparative effects of short-term (1-month) versus standard (12-month) DAPT in patients undergoing PCI.
- To specifically assess the influence of high bleeding risk (HBR) and complex PCI on the outcomes of short versus standard DAPT durations.
- To determine if HBR or complex PCI should guide DAPT duration decisions.
Main Methods:
- Subgroup analyses were performed within the STOPDAPT-2 trial cohort.
- Patients were categorized based on Academic Research Consortium (ARC)-defined HBR and complex PCI.
- The study compared 1-month DAPT (clopidogrel monotherapy) with 12-month DAPT (aspirin plus clopidogrel) after PCI, assessing a composite primary endpoint of cardiovascular events or bleeding at 1 year.
Main Results:
- The primary composite endpoint and cardiovascular endpoint showed no significant difference between 1-month and 12-month DAPT, irrespective of HBR or complex PCI status.
- Bleeding events were significantly lower with 1-month DAPT compared to 12-month DAPT across all subgroups.
- The numerical benefit of 1-month DAPT in reducing bleeding was more pronounced in patients with HBR compared to those without HBR.
Conclusions:
- The efficacy and safety of 1-month DAPT compared to 12-month DAPT are consistent across patients with and without high bleeding risk (HBR) or complex percutaneous coronary intervention (PCI).
- Short-term DAPT (1 month) demonstrates a favorable bleeding profile, particularly in HBR patients.
- Complex PCI may not be a suitable criterion for dictating DAPT duration after PCI.
Background:
High bleeding risk (HBR) and complex percutaneous coronary intervention (PCI) are major determinants for dual antiplatelet therapy (DAPT) duration.
Objectives:
The aim of this study was to evaluate the effects of HBR and complex PCI on short vs standard DAPT.
Methods:
Subgroup analyses were conducted on the basis of Academic Research Consortium-defined HBR and complex PCI in the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Verulam's-Eluting Cobalt-Chromium Stent-2) Total Cohort, which randomly compared clopidogrel monotherapy after 1-month DAPT with 12-month DAPT with aspirin and clopidogrel after PCI. The primary endpoint was the composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) or bleeding (Thrombolysis In Myocardial Infarction [TIMI] major or minor) endpoints at 1 year.
Results:
Regardless of HBR (n = 1,893 [31.6%]) and complex PCI (n = 999 [16.7%]), the risk of 1-month DAPT relative to 12-month DAPT was not significant for the primary endpoint (HBR, 5.01% vs 5.14%; non-HBR, 1.90% vs 2.02%; P interaction = 0.95) (complex PCI, 3.15% vs 4.07%; noncomplex PCI, 2.78% vs 2.82%; P interaction = 0.48) and for the cardiovascular endpoint (HBR, 4.35% vs 3.52%; and non-HBR, 1.56% vs 1.22%; P interaction = 0.90) (complex PCI, 2.53% vs 2.52%; noncomplex PCI, 2.38% vs 1.86%; P interaction = 0.53), while it was lower for the bleeding endpoint (HBR, 0.66% vs 2.27%; non-HBR, 0.43% vs 0.85%; P interaction = 0.36) (complex PCI, 0.63% vs 1.75%; noncomplex PCI, 0.48% vs 1.22%; P interaction = 0.90). The absolute difference in the bleeding between 1- and 12-month DAPT was numerically greater in patients with HBR than in those without HBR (-1.61% vs -0.42%).
Conclusions:
The effects of 1-month DAPT relative to 12-month DAPT were consistent regardless of HBR and complex PCI. The absolute benefit of 1-month DAPT over 12-month DAPT in reducing major bleeding was numerically greater in patients with HBR than in those without HBR. Complex PCI might not be an appropriate determinant for DAPT durations after PCI. (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2 [STOPDAPT-2], NCT02619760; Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2 for the Patients With ACS [STOPDAPT-2 ACS], NCT03462498).
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