Long-term Effects of P2Y12 Inhibitor Monotherapy after Percutaneous Coronary Intervention: 3-Year Follow-up of the SMART-CHOICE Randomized Clinical Trial

Ki Hong Choi, Yong Hwan Park, Young Bin Song, Taek Kyu Park, Joo Myung Lee, Jeong Hoon Yang, Jin Ho Choi, Seung Hyuk Choi, Ju Hyeon Oh, Woo Jung Chun, Woo Jin Jang, Eul Soon Im, Jin Ok Jeong, Byung Ryul Cho, Seok Kyu Oh, Kyeong Ho Yun, Deok Kyu Cho, Jong Young Lee, Young Youp Koh, Jang Whan BaeJae Woong Choi, Wang Soo Lee, Hyuck Jun Yoon, Seung Uk Lee, Jang Hyun Cho, Woong Gil Choi, Seung Woon Rha, Hyeon Cheol Gwon, Joo Yong Hahn

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1 Citation (Scopus)

Abstract

Importance: Although P2Y12 inhibitor monotherapy after a minimum period of dual antiplatelet therapy (DAPT) is a well-known way to reduce the risk of bleeding after percutaneous coronary intervention (PCI), data comparing long-term clinical outcomes between P2Y12 inhibitor monotherapy and extended DAPT in patients undergoing PCI have been unavailable. Objective: To identify the long-term safety and efficacy of P2Y12 inhibitor monotherapy following 3 months of DAPT after PCI. Design, Setting, and Participants: The Smart Angioplasty Research Team: Comparison Between P2Y12 Antagonist Monotherapy and Dual Antiplatelet Therapy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents (SMART-CHOICE) trial was an open-label, noninferiority, randomized clinical trial, enrolling patients who underwent PCI with drug-eluting stent at 33 hospitals in Korea from March 2014 through July 2017. Clinical follow-up was extended to 3 years and completed in August 2020. Interventions: Patients were randomly assigned to either P2Y12 inhibitor monotherapy after 3 months of DAPT or DAPT for 12 months or longer. 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 3 years. The secondary end points included the components of the primary end point, bleeding (defined as Bleeding Academic Research Consortium [BARC] types 2-5), and major bleeding (BARC types 3-5). Results: In total, 2993 patients were randomly assigned to receive P2Y12 inhibitor monotherapy after 3 months of DAPT (1495 patients [50%]; mean [SD] age, 64.6 [10.7] years; 1087 [72.7%] male) or prolonged DAPT (1498 patients [50%]; mean [SD] age, 64.6 [10.7] years; 1111 [74.2%] male) after PCI. At 3 years, the primary end point occurred in 87 individuals (6.3%) in the P2Y12 inhibitor monotherapy group and 83 (6.1%) in the prolonged DAPT group (hazard ratio [HR], 1.06 [95% CI, 0.79-1.44]; P =.69). P2Y12 inhibitor monotherapy significantly reduced the risk of bleeding (BARC types 2-5: 112 [3.2%] vs 44 [8.2%]; HR, 0.39 [95% CI, 0.28-0.55]; P <.001) and major bleeding (BARC types 3-5; 17 [1.2%] vs 31 [2.4%]; HR, 0.56 [95% CI, 0.31-0.99]; P =.048), compared with prolonged DAPT. The landmark analyses between 3 months and 3 years and per-protocol analyses showed consistent results. Conclusions and Relevance: Among patients who underwent PCI and completed 3-month DAPT, P2Y12 inhibitor monotherapy was associated with a lower risk of clinically relevant major bleeding than prolonged DAPT. Although the 3-year risk of ischemic cardiovascular events was comparable between the 2 groups, this result should be interpreted with caution owing to the limited number of events and sample size. Trial Registration: ClinicalTrials.gov Identifier: NCT02079194.

Original languageEnglish
Pages (from-to)1100-1108
Number of pages9
JournalJAMA Cardiology
Volume7
Issue number11
DOIs
Publication statusPublished - 2022 Nov 9
Externally publishedYes

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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