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Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention : The SMART-CHOICE Randomized Clinical Trial

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Author(s)
Joo-Yong HahnYoung Bin SongJu-Hyeon OhWoo Jung ChunYong Hwan ParkWoo Jin JangEul-Soon ImJin-Ok JeongByung Ryul ChoSeok Kyu OhKyeong Ho YunDeok-Kyu ChoJong-Young LeeYoung-Youp KohJang-Whan BaeJaeWoong ChoiWang Soo LeeHyuck Jun YoonSeung Uk LeeJang Hyun ChoWoong Gil ChoiSeung-Woon RhaJoo Myung LeeTaek Kyu ParkJeong Hoon YangJin-Ho ChoiSeung-Hyuck ChoiSang Hoon LeeHyeon-Cheol Gwon
Keimyung Author(s)
Yoon, Hyuck Jun
Department
Dept. of Internal Medicine (내과학)
Journal Title
JAMA
Issued Date
2019
Volume
321
Issue
24
Abstract
IMPORTANCE
Data on P2Y12 inhibitor monotherapy after short-duration dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention are limited.

OBJECTIVE
To determine whether P2Y12 inhibitor monotherapy after 3 months of DAPT is noninferior to 12 months of DAPT in patients undergoing PCI. DESIGN, SETTING, AND PARTICIPANTS The SMART-CHOICE trialwas an open-label, noninferiority, randomized study that was conducted in 33 hospitals in Korea and included 2993 patients undergoing PCI with drug-eluting stents. Enrollment began March 18, 2014, and follow-up was completed July 19, 2018.

INTERVENTIONS
Patients were randomly assigned to receive aspirin plus a P2Y12 inhibitor for 3 months and thereafter P2Y12 inhibitor alone (n = 1495) or DAPT for 12 months (n = 1498).

MAIN OUTCOMES AND MEASURES
The primary end pointwas major adverse cardiac and cerebrovascular events (a composite of all-cause death,myocardial infarction, or stroke) at 12 months after the index procedure. Secondary end points included the components of the primary end point and bleeding defined as Bleeding Academic Research Consortium type 2 to 5. The noninferiority margin was 1.8%.

RESULTS
Among 2993 patients who were randomized (mean age, 64 years; 795 women [26.6%]), 2912 (97.3%) completed the trial. Adherence to the study protocol was 79.3%of the P2Y12 inhibitor monotherapy group and 95.2%of the DAPT group. At 12 months, major adverse cardiac and cerebrovascular events occurred in 42 patients in the P2Y12 inhibitor monotherapy group and in 36 patients in the DAPT group (2.9% vs 2.5%; difference, 0.4% [1-sided 95%CI, – %to 1.3%]; P = .007 for noninferiority). There were no significant differences in all-cause death (21 [1.4%] vs 18 [1.2%]; hazard ratio [HR], 1.18; 95%CI, 0.63-2.21; P = .61),myocardial infarction (11 [0.8%] vs 17 [1.2%]; HR, 0.66; 95%CI, 0.31-1.40; P = .28), or stroke (11 [0.8%] vs 5 [0.3%]; HR, 2.23; 95%CI, 0.78-6.43; P = .14) between the 2 groups. The rate of bleeding was significantly lower in the P2Y12 inhibitor monotherapy group than in the DAPT group (2.0% vs 3.4%; HR, 0.58; 95%CI, 0.36-0.92; P = .02).

CONCLUSIONS AND RELEVANCE
Among patients undergoing percutaneous coronary intervention, P2Y12 inhibitor monotherapy after 3 months of DAPT compared with prolonged DAPT resulted in noninferior rates of major adverse cardiac and cerebrovascular events. Because of limitations in the study population and adherence, further research is needed in other populations.
Keimyung Author(s)(Kor)
윤혁준
Publisher
School of Medicine (의과대학)
Citation
Joo-Yong Hahn et al. (2019). Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention : The SMART-CHOICE Randomized Clinical Trial. JAMA, 321(24), 2428–2437. doi: 10.1001/jama.2019.8146
Type
Article
ISSN
1538-3598
Source
https://jamanetwork.com/journals/jama/fullarticle/2736564
DOI
10.1001/jama.2019.8146
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/42045
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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