한빛사논문
- 조회153
Pil-Ki Min, MD1; Tae Soo Kang, MD2; Yun-Hyeong Cho, MD3; Sang-Sig Cheong, MD4; Byeong-Keuk Kim, MD5; Sung Woo Kwon, MD6; Woo Jung Park, MD7; Jung-Hee Lee, MD8; Wonho Kim, MD9; Wang-Soo Lee, MD10; Young Won Yoon, MD1; Byoung Kwon Lee, MD1; Hyuck Moon Kwon, MD1; Bum-Kee Hong, MD1; for the SHARE Investigators
1Cardiology Division, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
2Division of Cardiology, Dankook University Hospital, Cheonan, Republic of Korea
3Division of Cardiology, Myongji Hospital, Hanyang University College of Medicine, Goyang, Republic of Korea
4Department of Cardiology, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Republic of Korea
5Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
6Division of Cardiology, Inha University Hospital, Incheon, Republic of Korea
7Division of Cardiology, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea
8Division of Cardiology, Yeungnam University Medical Center, Daegu, Republic of Korea
9Eulji University School of Medicine, Daejeon, Republic of Korea
10Heart Research Institute, Chung-Ang University Hospital, Seoul, Republic of Korea
Corresponding Author: Bum-Kee Hong, MD
Abstract
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.
논문정보
- Research article
- 2024년 03월 (BRIC 등록일 2024-03-13)
- 국내 연구진
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