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Long-Term Aspirin vs Clopidogrel After Coronary Stenting by Bleeding Risk and Procedural Complexity
Jeehoon Kang1, Jaewook Chung1, Kyung Woo Park1
1Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Republic of Korea.
Insights
Clopidogrel monotherapy is more effective than aspirin monotherapy for patients with high bleeding risk or complex PCI, reducing both thrombotic and bleeding events. This finding holds true regardless of bleeding risk or PCI complexity.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Antiplatelet monotherapy in the chronic maintenance period after percutaneous coronary intervention (PCI) remains underexplored, particularly for patients with high bleeding risk (HBR) or complex PCI.
- Optimizing antiplatelet strategies is crucial for balancing thrombotic risk and bleeding complications in these patient populations.
Purpose of the Study:
- To compare the efficacy and safety of clopidogrel versus aspirin monotherapy in patients with HBR and/or complex PCI during the chronic maintenance phase.
- To evaluate the impact of these antiplatelet strategies on both thrombotic events and bleeding complications.
Main Methods:
- A post hoc analysis of the multicenter HOST-EXAM Extended study (NCT02044250) involving patients event-free on dual antiplatelet therapy (DAPT) for 6-18 months post-PCI.
- Patients were randomized to clopidogrel or aspirin monotherapy, with analyses stratified by HBR and PCI complexity.
- Coprimary endpoints included a composite of thrombotic events and any bleeding (BARC type 2-5).
Main Results:
- Clopidogrel monotherapy demonstrated lower rates of thrombotic events compared to aspirin, with hazard ratios of 0.62 (non-HBR) and 0.49 (complex PCI).
- Bleeding event rates were also consistently lower with clopidogrel compared to aspirin (HR 0.58 for non-HBR, HR 0.68 for non-complex PCI).
- These benefits were observed regardless of the presence of HBR or PCI complexity, with no significant interaction effects.
Conclusions:
- Clopidogrel monotherapy offers a consistent benefit over aspirin monotherapy in reducing thrombotic and bleeding events in patients post-PCI.
- The findings support clopidogrel as a preferred agent for antiplatelet monotherapy in the chronic maintenance phase, especially for patients with HBR or complex PCI.
- This strategy helps optimize the risk-benefit profile in long-term management of coronary artery disease.
Importance:
Antiplatelet monotherapy in the chronic maintenance period for patients with high bleeding risk (HBR) and those who have undergone complex percutaneous coronary intervention (PCI) has not yet been explored.
Objective:
To compare clopidogrel vs aspirin monotherapy in patients with HBR and/or PCI complexity.
Design, Setting, And Participants:
This post hoc analysis of the multicenter HOST-EXAM Extended study, an open-label trial conducted across 37 sites in South Korea, enrolled patients from 2014 to 2018 with up to 5.9 years of follow-up. The analysis was conducted from February to November 2023. Patients who maintained dual antiplatelet therapy (DAPT) event-free for 6 to 18 months following PCI were included.
Interventions:
Patients were randomized to receive either clopidogrel or aspirin in a 1:1 ratio. Those with sufficient data to assess HBR or complex PCI were analyzed.
Main Outcomes And Measures:
Coprimary end points were thrombotic composite end point (cardiovascular death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and definite/probable stent thrombosis) and any bleeding (Bleeding Academic Research Consortium type 2 to 5).
Results:
Of 3974 patients included (mean [SD] age, 63.4 [10.7] years; 2976 male [74.9%]), 866 had HBR (21.8%), and 849 underwent complex PCI (21.4%). Clopidogrel as compared with aspirin was associated with lower rates of thrombotic and bleeding events regardless of HBR and/or PCI complexity. For the thrombotic composite end point, the hazard ratio (HR) was 0.75 (95% CI, 0.53-1.04) among HBR vs 0.62 (95% CI, 0.48-0.80) among patients without HBR (P for interaction = 0.38) and 0.49 (95% CI, 0.32-0.77) among patients with complex PCI vs 0.74 (95% CI, 0.59-0.92) among patients with noncomplex PCI (P for interaction = 0.12). The reduction in bleeding by clopidogrel compared with aspirin was consistent among both patients with HBR (HR, 0.82; 95% CI, 0.56-1.21) and patients without HBR (HR, 0.58; 95% CI, 0.40-0.85; P for interaction = 0.20) and among patients undergoing complex PCI (HR, 0.79; 95% CI, 0.47-1.33) vs noncomplex PCI (HR, 0.68; 95% CI, 0.50-0.93; P for interaction = 0.62).
Conclusions And Relevance:
In this study, in patients who experienced PCI and were event-free during 6 to 18 months of DAPT, the beneficial impact of clopidogrel monotherapy over aspirin monotherapy was consistent, regardless of bleeding risk and/or PCI complexity.
Trial Registration:
ClinicalTrials.gov Identifier: NCT02044250.
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