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P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy After Deployment of a Drug-Eluting Stent: The SHARE Randomized Clinical Trial

Authors
 Pil-Ki Min  ;  Tae Soo Kang  ;  Yun-Hyeong Cho  ;  Sang-Sig Cheong  ;  Byeong-Keuk Kim  ;  Sung Woo Kwon  ;  Woo Jung Park  ;  Jung-Hee Lee  ;  Wonho Kim  ;  Wang-Soo Lee  ;  Young Won Yoon  ;  Byoung Kwon Lee  ;  Hyuck Moon Kwon  ;  Bum-Kee Hong  ;  SHARE Investigators 
Citation
 JAMA NETWORK OPEN, Vol.7(3) : e240877, 2024-03 
Journal Title
JAMA NETWORK OPEN
Issue Date
2024-03
MeSH
Drug-Eluting Stents* ; Everolimus / therapeutic use ; Hemorrhage / chemically induced ; Hemorrhage / epidemiology ; Humans ; Male ; Middle Aged ; Percutaneous Coronary Intervention* ; Platelet Aggregation Inhibitors / therapeutic use ; Polymers
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.Trial registration: ClinicalTrials.gov Identifier: NCT03447379.
Files in This Item:
T202401897.pdf Download
DOI
10.1001/jamanetworkopen.2024.0877
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kwon, Hyuck Moon(권혁문) ORCID logo https://orcid.org/0000-0001-9901-5015
Kim, Byeong Keuk(김병극) ORCID logo https://orcid.org/0000-0003-2493-066X
Min, Pil Ki(민필기) ORCID logo https://orcid.org/0000-0001-7033-7651
Yoon, Young Won(윤영원) ORCID logo https://orcid.org/0000-0002-0907-0350
Lee, Byoung Kwon(이병권) ORCID logo https://orcid.org/0000-0001-9259-2776
Hong, Bum Kee(홍범기) ORCID logo https://orcid.org/0000-0002-6456-0184
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/198852
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