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Original Investigation
June 25, 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

Author Affiliations
  • 1Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
  • 2Department of Cardiology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea
  • 3Division of Cardiology, Dongsuwon General Hospital, Suwon, Korea
  • 4Chungnam National University Hospital, Daejeon, Korea
  • 5Division of Cardiology, Kangwon National University Hospital, Chuncheon, Korea
  • 6Department of Cardiovascular Medicine, Regional Cardiocerebrovascular Center, Wonkwang University Hospital, Iksan, Korea
  • 7Division of Cardiology, Department of Internal Medicine, Myongji Hospital, Goyang, Korea
  • 8Division of Cardiology, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
  • 9Department of Internal Medicine, Chosun University Hospital, Gwangju, Korea
  • 10Department of Internal Medicine, College of Medicine, Chungbuk National University Hospital, Cheongju, Korea
  • 11Eulji General Hospital, Seoul, Korea
  • 12Chung-Ang University Hospital, Seoul, Korea
  • 13Keimyung University Dongsan Medical Center, Daegu, Korea
  • 14Kwangju Christian Hospital, Gwangju, Korea
  • 15St Carollo Hospital, Suncheon, Korea
  • 16Konkuk University Chungju Hospital, Chungju, Korea
  • 17Korea University Guro Hospital, Seoul, Korea
JAMA. 2019;321(24):2428-2437. doi:10.1001/jama.2019.8146
Key Points

Question  Is P2Y12 inhibitor monotherapy for 9 months after 3 months of dual antiplatelet therapy (DAPT) noninferior to 12 months of DAPT in patients undergoing percutaneous coronary intervention?

Findings  In this randomized clinical trial including 2993 patients, the rate of all-cause death, myocardial infarction, or stroke at 12 months was 2.9% with P2Y12 inhibitor monotherapy and 2.5% for patients receiving DAPT. The 1-sided confidence limit of this difference was within the noninferiority margin of 1.8%.

Meaning  Although in this study P2Y12 inhibitor monotherapy after a short duration of DAPT resulted in a noninferior rate of major cardiovascular events compared with prolonged DAPT, further research is needed in other populations.

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 trial was 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 point was 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.

Trial Registration  ClinicalTrials.gov Identifier: NCT02079194

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