Efficacy and safety of cilostazol-based triple antiplatelet therapy compared with clopidogrel-based dual antiplatelet therapy in patients with acute ST-elevation myocardial infarction undergoing percutaneous coronary intervention: A multicenter, randomized, open-label, phase 4 trial
- Authors
- Park, Soohyung; Rha, Seung-Woon; Choi, Byoung Geol; Kim, Woohyeun; Choi, Woong Gil; Lee, Seung Jin; Lee, Jae Beom; Park, Ji Young; Park, Sang Min; Jeong, Myung Ho; Kim, Yong Hoon; Her, Ae-Young; Kim, Min Woong; Chen, Kang-Yin; Kim, Bae Keun; Shin, Eun-Seok; Seo, Jae-Bin; Ahn, Jihun; Choi, Se Yeon; Byun, Jae Kyeong; Cha, Jin Ah; Hyun, Su Jin; Choi, Cheol Ung; Park, Chang Gyu
- Issue Date
- Nov-2023
- Publisher
- MOSBY-ELSEVIER
- Citation
- AMERICAN HEART JOURNAL, v.265, pp 11 - 21
- Pages
- 11
- Journal Title
- AMERICAN HEART JOURNAL
- Volume
- 265
- Start Page
- 11
- End Page
- 21
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/25490
- DOI
- 10.1016/j.ahj.2023.06.015
- ISSN
- 0002-8703
1097-6744
- Abstract
- Background Previous studies reported that compared to conventional dual antiplatelet therapy (DAT; aspirin + clopi-dogrel), triple antiplatelet therapy (TAT), involving the addition of cilostazol to DAT, had better clinical outcomes in patients with ST-elevation myocardial infarction (STEMI). However, the optimal duration of TAT is yet to be determined.Methods In total, 985 patients with STEMI who underwent primary percutaneous coronary intervention (PCI) with drug -eluting stents (DESs) were prospectively enrolled in 15 PCI centers in South Korea and China. We randomly assigned patients into 3 groups: DAT (aspirin and clopidogrel for 12 months), TAT 1M (aspirin, clopidogrel, and cilostazol for 1 month), and TAT 6M (aspirin, clopidogrel, and cilostazol for 6 months). The primary endpoint was 1-year major adverse cardiovascular events (MACEs), defined as a composite of all-cause death, recurrent myocardial infarction, stroke, or repeat revascularization.Results The primary endpoint did not differ among the 3 groups (8.8% in DAT, 11.0% in TAT 1M, and 11.6% in TAT 6M; hazard ratio for TAT 1M vs DAT, 1.302; 95% confidence interval [CI], 0.792-2.141; P = .297; hazard ratio for TAT 6M vs DAT, 1.358; 95% CI, 0.829-2.225; P = .225). With respect to in-hospital outcomes, more bleeding events occurred in the TAT group than in the DAT group (1.3% vs 4.7% vs 2.6%, P = .029), with no significant differences in major bleeding events. Additionally, the TAT group had a higher incidence of headaches (0% vs 1.6% vs 2.6%, P = .020).Conclusions The addition of cilostazol to DAT did not reduce the incidence of 1-year MACEs compared with DAT alone. Instead, it may be associated with an increased risk of drug intolerance and side effects, including in-hospital bleeding and headaches. (Am Heart J 2023;265:11-21.)
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