Key result
Clopidogrel monotherapy significantly reduced the primary composite endpoint compared to aspirin in patients with diabetes (6.3% vs 9.2%; HR 0.69; 95% CI 0.49-0.96; P=0.03).
Why the study?
Studies evaluating the efficacy and safety of clopidogrel versus aspirin for long-term maintenance after percutaneous coronary intervention in patients with diabetes are lacking.
Does clopidogrel monotherapy reduce the composite of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and major bleeding compared to aspirin monotherapy in patients who have completed 6 to 18 months of event-free dual antiplatelet therapy after percutaneous coronary intervention?
RCT (n=5,438)
Open-label
1:1
Yes
Does clopidogrel monotherapy reduce the composite of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and major bleeding compared to aspirin monotherapy in patients who have completed 6 to 18 months of event-free dual antiplatelet therapy after percutaneous coronary intervention?
Hazard Ratio: 0.69 (95% CI 0.49–0.96)
Absolute Event Rate: 6.3% vs 9.2%
Absolute Risk Reduction: 2.7%
Number Needed to Treat: 37
p-value: p=.03
Clopidogrel monotherapy is superior to aspirin monotherapy for long-term maintenance therapy after uncomplicated dual antiplatelet therapy post-PCI, regardless of the patient's diabetes status.
Supports clopidogrel over aspirin for maintenance therapy in diabetic patients post-PCI; extends evidence for P2Y12 monotherapy in this subgroup.
Importance: Selecting the optimal antiplatelet agent in patients who have received percutaneous coronary intervention is especially important in those with diabetes due to the heightened risk of ischemic events in this population. Studies on the efficacy and safety of clopidogrel vs aspirin for long-term maintenance after percutaneous coronary intervention in patients with diabetes are lacking. Objective: To investigate cardiovascular outcomes with clopidogrel vs aspirin in patients with and without diabetes. Design, Setting, and Participants: This was a post hoc analysis of the HOST-EXAM randomized clinical trial, an investigator-initiated, prospective, randomized, open-label, multicenter trial performed at 37 centers in Korea. Patients who received dual antiplatelet therapy without clinical events for 6 to 18 months after percutaneous coronary intervention with drug-eluting stents were enrolled from March 2014 to May 2018 with follow-up at 6, 12, 18, and 24 months. All 5438 patients in the original trial were included in this analysis, which was conducted from June to October 2021. Interventions and Exposures: Enrolled patients were randomized 1:1 to clopidogrel or aspirin monotherapy. Subgroup analyses were performed by the presence of diabetes. Main Outcomes and Measures: The main outcome was primary composite end point of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and major bleeding (Bleeding Academic Research Consortium type 3 or 5) at 24-month follow-up. Results: Of 5438 patients (mean [SD] age, 63.5 [10.7] years; 1384 [25.5%] female), 1860 (34.2%) had diabetes (925 in the clopidogrel arm and 935 in the aspirin arm), and 5338 (98.2%) completed follow-up. The rate of the primary composite end point was significantly lower in the clopidogrel group compared to the aspirin group in patients with diabetes (6.3% vs 9.2%; hazard ratio [HR], 0.69; 95% CI, 0.49-0.96; P = .03; absolute risk difference [ARD], 2.7%; number needed to treat [NNT], 37) and without diabetes (5.3% vs 7.0%; HR, 0.76; 95% CI, 0.58-1.00; P = .046; ARD, 1.6%, NNT, 63; P for interaction = .65). The presence of diabetes was not associated with a difference in benefit observed with clopidogrel monotherapy over aspirin for the thrombotic composite end point (HR, 0.68; 95% CI, 0.45-1.04 for patients with diabetes vs HR, 0.68; 95% CI, 0.49-0.93 for those without; P for interaction = .99) and any bleeding with Bleeding Academic Research Consortium 2, 3, or 5 (HR, 0.65; 95% CI, 0.39-1.09 for patients with diabetes vs HR, 0.74; 95% CI, 0.48-1.13 for those without; P for interaction = .71). Conclusion and Relevance: In this study, clopidogrel monotherapy was associated with a lower rate of the primary composite end point compared to aspirin monotherapy as long-term maintenance therapy after dual antiplatelet therapy for coronary stenting in both patients with and without diabetes. Clopidogrel might thus be considered rather than aspirin in patients who have undergone coronary stenting and successfully completed dual antiplatelet therapy, regardless of diabetes status. Trial Registration: ClinicalTrials.gov Identifier: NCT02044250.
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Rhee et al. (2023) conducted an RCT in Percutaneous coronary intervention (n=5,438). Clopidogrel monotherapy vs. Aspirin monotherapy was evaluated on primary composite end point of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and major bleeding (Bleeding Academic Research Consortium type 3 or 5) at 24-month follow-up (HR 0.69, 95% CI 0.49-0.96, p=.03). Clopidogrel monotherapy significantly reduced the primary composite endpoint compared to aspirin in patients with diabetes (6.3% vs 9.2%; HR 0.69; 95% CI 0.49-0.96; P=0.03).
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