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- Title
P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy After Deployment of a Drug-Eluting Stent: The SHARE Randomized Clinical Trial.
- Authors
Min, Pil-Ki; Kang, Tae Soo; Cho, Yun-Hyeong; Cheong, Sang-Sig; Kim, Byeong-Keuk; Kwon, Sung Woo; Park, Woo Jung; Lee, Jung-Hee; Kim, Wonho; Lee, Wang-Soo; Yoon, Young Won; Lee, Byoung Kwon; Kwon, Hyuck Moon; Hong, Bum-Kee
- Abstract
Key Points: Question: Is P2Y12 inhibitor monotherapy after 3 months of dual antiplatelet therapy (DAPT; a P2Y12 inhibitor plus aspirin) noninferior to 12 months of DAPT in terms of net adverse clinical events (a composite of major adverse cardiac and cerebrovascular events and major bleeding) after percutaneous coronary intervention? Findings: In this randomized clinical trial of 1387 patients in South Korea, the net adverse clinical events rate was 1.7% for the P2Y12 inhibitor monotherapy group and 2.6% for the DAPT group. The 1-sided confidence limit of this difference was within the noninferiority margin of 3.0%. Meaning: These findings suggest that early discontinuation of aspirin and P2Y12 monotherapy was not inferior to 12 months of DAPT, although further research is required in other populations. Importance: P2Y12 inhibitor monotherapy after dual antiplatelet therapy (DAPT; a P2Y12 inhibitor plus aspirin) for a brief duration has recently emerged as an attractive alternative for patients undergoing percutaneous coronary intervention (PCI) with a drug-eluting stent. Objective: To investigate whether P2Y12 inhibitor monotherapy after 3 months of DAPT was noninferior to 12 months of DAPT following PCI with a drug-eluting stent. Design, Setting, and Participants: The Short-Term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-Eluting Stent (SHARE) open-label, noninferiority randomized clinical trial was conducted from December 15, 2017, through December 14, 2020. Final 1-year clinical follow-up was completed in January 2022. This study was a multicenter trial that was conducted at 20 hospitals in South Korea. Patients who underwent successful PCI with bioabsorbable polymer everolimus-eluting stents were enrolled. Interventions: Patients were randomly assigned to receive P2Y12 inhibitor monotherapy after 3 months of DAPT (n = 694) or 12 months of DAPT (n = 693). Main Outcomes and Measures: The primary outcome was a net adverse clinical event, a composite of major bleeding (based on Bleeding Academic Research Consortium type 3 or type 5 bleeding) and major adverse cardiac and cerebrovascular events (cardiac death, myocardial infarction, stent thrombosis, stroke, or ischemia-driven target lesion revascularization) between 3 and 12 months after the index PCI. The major secondary outcomes were major adverse cardiac and cerebrovascular events and major bleeding. The noninferiority margin was 3.0%. Results: Of the total 1452 eligible patients, 65 patients were excluded before the 3-month follow-up, and 1387 patients (mean [SD] age, 63.0 [10.7] years; 1055 men [76.1%]) were assigned to P2Y12 inhibitor monotherapy (n = 694) or DAPT (n = 693). Between 3 and 12 months of follow-up, the primary outcome (using Kaplan-Meier estimates) occurred in 9 patients (1.7%) in the P2Y12 inhibitor monotherapy group and in 16 patients (2.6%) in the DAPT group (absolute difference, −0.93 [1-sided 95% CI, −2.64 to 0.77] percentage points; P <.001 for noninferiority). For the major secondary outcomes (using Kaplan-Meier estimates), major adverse cardiac and cerebrovascular events occurred in 8 patients (1.5%) in the P2Y12 inhibitor monotherapy group and in 12 patients (2.0%) in the DAPT group (absolute difference, −0.49 [95% CI, −2.07 to 1.09] percentage points; P =.54). Major bleeding occurred in 1 patient (0.2%) in the P2Y12 inhibitor monotherapy group and in 5 patients (0.8%) in the DAPT group (absolute difference, −0.60 [95% CI, −1.33 to 0.12] percentage points; P =.10). Conclusions and Relevance: In patients with coronary artery disease undergoing PCI with the latest generation of drug-eluting stents, P2Y12 inhibitor monotherapy after 3-month DAPT was not inferior to 12-month DAPT for net adverse clinical events. Considering the study population and lower-than-expected event rates, further research is required in other populations. Trial Registration: ClinicalTrials.gov Identifier: NCT03447379 This randomized clinical trial investigates whether P2Y12 inhibitor monotherapy after 3 months of dual antiplatelet therapy (DAPT) was noninferior to 12 months of DAPT following percutaneous coronary intervention with a drug-eluting stent.
- Subjects
COMBINATION drug therapy; RESEARCH funding; T-test (Statistics); STATISTICAL sampling; RANDOMIZED controlled trials; CHI-squared test; KAPLAN-Meier estimator; ACUTE coronary syndrome; CLOPIDOGREL; RESEARCH; PERCUTANEOUS coronary intervention; PLATELET aggregation inhibitors; CONFIDENCE intervals; DATA analysis software; CEREBROVASCULAR disease; DRUG-eluting stents; HEMORRHAGE
- Publication
JAMA Network Open, 2024, Vol 7, Issue 3, pe240877
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.0877