Young Bin Song1, Seok Kyu Oh2, Ju-Hyeon Oh3, Eul-Soon Im4, Deok-Kyu Cho5, Byung Ryul Cho6, Jong-Young Lee7, Joo Myung Lee1, Taek Kyu Park1, Jeong Hoon Yang1, Jin-Ho Choi1, Seung-Hyuck Choi1, Sang Hoon Lee1, Hyeon-Cheol Gwon8, Joo-Yong Hahn9. 1. Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 2. Department of Cardiovascular Medicine, Regional Cardiocerebrovascular Center, Wonkwang University Hospital, Iksan, Republic of Korea. 3. Department of Cardiology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea. 4. Division of Cardiology, Dongsuwon General Hospital, Suwon, Republic of Korea. 5. Division of Cardiology, Department of Internal Medicine, Myongji Hospital, Gyenggi-Do, Republic of Korea. 6. Division of Cardiology, Kangwon National University Hospital, Chuncheon, Republic of Korea. 7. Division of Cardiology, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 8. Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: hcgwon62@gmail.com. 9. Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: jyhahn@skku.edu.
Abstract
BACKGROUND AND RATIONALE: Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces thrombotic events in patients undergoing percutaneous coronary intervention (PCI), but these benefits come at the expense of increased risk of bleeding when compared with aspirin monotherapy. It is unclear whether P2Y12 inhibitor monotherapy might maintain anti-ischemic efficacy while reducing the bleeding risk compared with DAPT after implantation of the current generation of drug-eluting stents (DES). STUDY DESIGN: The SMART-CHOICE trial is a prospective, open-label, multi-center, and randomized study designed to test the non-inferiority of P2Y12 inhibitor monotherapy compared with aspirin plus a P2Y12 inhibitor after mandatory 3-month DAPT in patients undergoing PCI with current-generation DES. A total of 3000 patients will be randomized to 1 of the 2 antiplatelet treatment strategy groups. Randomization will be stratified by stent type (cobalt-chromium everolimus-eluting stents, platinum-chromium everolimus-eluting stents, and sirolimus-eluting stents with bioresorbable polymer), P2Y12 inhibitors (clopidogrel, prasugrel, and ticagrelor), clinical presentation (acute coronary syndrome and stable ischemic heart disease), and investigational centers. The primary end point is a composite of all-cause death, myocardial infarction, and cerebrovascular events at 12 months after the index procedure. The key secondary end points are definite/probable stent thrombosis defined by the Academic Research Consortium, and bleeding defined by Bleeding Academic Research Consortium type 2-5. CONCLUSIONS: The SMART-CHOICE trial aims to examine the non-inferiority of monotherapy with one of any available oral P2Y12 inhibitors versus conventional DAPT of an identical P2Y12 inhibitor plus aspirin in a broad spectrum of patients receiving representative current-generation DES.
RCT Entities:
BACKGROUND AND RATIONALE: Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces thrombotic events in patients undergoing percutaneous coronary intervention (PCI), but these benefits come at the expense of increased risk of bleeding when compared with aspirin monotherapy. It is unclear whether P2Y12 inhibitor monotherapy might maintain anti-ischemic efficacy while reducing the bleeding risk compared with DAPT after implantation of the current generation of drug-eluting stents (DES). STUDY DESIGN: The SMART-CHOICE trial is a prospective, open-label, multi-center, and randomized study designed to test the non-inferiority of P2Y12 inhibitor monotherapy compared with aspirin plus a P2Y12 inhibitor after mandatory 3-month DAPT in patients undergoing PCI with current-generation DES. A total of 3000 patients will be randomized to 1 of the 2 antiplatelet treatment strategy groups. Randomization will be stratified by stent type (cobalt-chromium everolimus-eluting stents, platinum-chromium everolimus-eluting stents, and sirolimus-eluting stents with bioresorbable polymer), P2Y12 inhibitors (clopidogrel, prasugrel, and ticagrelor), clinical presentation (acute coronary syndrome and stable ischemic heart disease), and investigational centers. The primary end point is a composite of all-cause death, myocardial infarction, and cerebrovascular events at 12 months after the index procedure. The key secondary end points are definite/probable stent thrombosis defined by the Academic Research Consortium, and bleeding defined by Bleeding Academic Research Consortium type 2-5. CONCLUSIONS: The SMART-CHOICE trial aims to examine the non-inferiority of monotherapy with one of any available oral P2Y12 inhibitors versus conventional DAPT of an identical P2Y12 inhibitor plus aspirin in a broad spectrum of patients receiving representative current-generation DES.