Objective To compare P2Y12 inhibitor monotherapy after 3-month dual antiplatelet therapy (DAPT) with 12-month DAPT according to the type of P2Y12 inhibitor in patients undergoing percutaneous coronary intervention (PCI).
Methods The Smart Angioplasty Research Team: Comparison Between P2Y12 Antagonist Monotherapy vs Dual Antiplatelet Therapy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents (SMART-CHOICE) randomised trial compared 3-month DAPT followed by P2Y12 inhibitor monotherapy with 12-month DAPT. In this trial, 2993 patients undergoing successful PCI with drug-eluting stent were enrolled in Korea. As a prespecified analysis, P2Y12 inhibitor monotherapy after 3-month DAPT versus 12-month DAPT were compared among patients receiving clopidogrel and those receiving potent P2Y12 inhibitor (ticagrelor or prasugrel), respectively. The primary endpoint was a composite of all-cause death, myocardial infarction or stroke at 12 months after the index procedure.
Results Among 2993 patients (mean age 64 years), 58.2% presented with acute coronary syndrome. Clopidogrel was prescribed in 2312 patients (77.2%) and a potent P2Y12 inhibitor in 681 (22.8%). There were no significant differences in the primary endpoint between the P2Y12 inhibitor monotherapy group and the DAPT group among patients receiving clopidogrel (3.0% vs 3.0%; HR: 1.02; 95% CI 0.64 to 1.65; p=0.93) as well as among patients receiving potent P2Y12 inhibitors (2.4% vs 0.7%; HR: 3.37; 95% CI 0.77 to 14.78; p=0.11; interaction p=0.1). Among patients receiving clopidogrel, P2Y12 inhibitor monotherapy compared with DAPT showed consistent treatment effects across various subgroups for the primary endpoint. Among patients receiving potent P2Y12 inhibitors, the rate of bleeding (Bleeding Academic Research Consortium types 2– 5) was significantly lower in the P2Y12 inhibitor monotherapy group than in the DAPT group (1.5% vs 5.0%; HR: 0.33; 95% CI 0.12 to 0.87; p=0.03).
Conclusions Compared with 12-month DAPT, clopidogrel monotherapy after 3-month DAPT showed comparable cardiovascular outcomes in patients undergoing PCI.
Trial registration number NCT02079194.
- percutaneous coronary intervention
- coronary artery disease
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JK and WJJ contributed equally.
Contributors Concept and design: JK, WJJ, J-YH, WSL, KHC, YBS, J-YL, Y-YK, JWC, JML, TKP, JHY, J-HC, S-HC and H-CG. Acquisition, analysis or interpretation of data: JK, WJJ, J-YH, YBS, J-HO, WJC, YHP, E-SI, J-OJ, BRC, SKO, KHY, D-KC, J-WB, WSL, HJY, SUL, JHC, WGC, S-WR, JML, TKP, JHY, S-HC, SHL, H-CG. Drafting of the manuscript: JK, WJJ, KHC, J-YH, YBS, J-YL, Y-YK, JWC, WGC, JML, J-HC, H-CG. Critical revision of the manuscript for important intellectual content: J-YH, WSL, YBS, J-HO, WJC, YHP, E-SI, J-OJ, BRC, SKO, KHY, D-KC, J-WB, HJY, SUL, JHC, S-WR, JML, TKP, JHY, S-HC, SHL, H-CG. Statistical analysis: JK, WJJ, KHC, YBS, JML, TKP, J-HC, H-CG. J-YH is the guarantor.
Funding This study was supported by grants from the Korean Society of Interventional Cardiology (grant 2013-3), Abbott Vascular, Biotronik, Boston Scientific and the Korea Health Technology R&D Project through the Korea Health Industry Development Institute funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI10C2020).
Disclaimer J-YH reports receiving grants from Abbott Vascular, Boston Scientific, Biotronik, Korean Society of Interventional Cardiology, and Medtronic; and speaker’s fees from AstraZeneca, Daiichi Sankyo, and sanofi-aventis. H-CG reports receiving research grants from Abbott Vascular, Boston Scientific, and Medtronic; and speaker’s fees from Abbott Vascular, Boston Scientific, and Medtronic.
Competing interests J-YH reports receiving grants from Abbott Vascular, Boston Scientific, Biotronik, Korean Society of Interventional Cardiology, and Medtronic; and speaker’s fees from AstraZeneca, Daiichi Sankyo and Sanofi-Aventis. H-CG reports receiving research grants from Abbott Vascular, Boston Scientific and Medtronic; and speaker’s fees from Abbott Vascular, Boston Scientific and Medtronic. All other authors declare that they have no conflicts of interest.
Patient consent for publication Not required.
Ethics approval The institutional review board at each participating centercentre approved the trial protocol.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No additional data available.
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