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 - 11/10/23
, Byoung Geol Choi, PhD a, b, Woohyeun Kim, MD, PhD c, Woong Gil Choi, MD, PhD d, Seung Jin Lee, MD, PhD e, Jae Beom Lee, MD f, Ji Young Park, MD, PhD g, Sang Min Park, MD, PhD g, Myung Ho Jeong, MD,PhD h, Yong Hoon Kim, MD, PhD i, Ae-Young Her, MD, PhD i, Min Woong Kim, MD j, Kang-Yin Chen, MD, PhD k, Bae Keun Kim, MD l, Eun-Seok Shin, MD, PhD m, Jae-Bin Seo, MD, PhD n, Jihun Ahn, MD, PhD o, Se Yeon Choi, PhD b, Jae Kyeong Byun, PhD b, Jin Ah Cha, BS b, Su Jin Hyun, BS b, Cheol Ung Choi, MD, PhD a, Chang Gyu Park, MD, PhD aRésumé |
Background |
Previous studies reported that compared to conventional dual antiplatelet therapy (DAT; aspirin + clopidogrel), 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.
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| Please refer to this study by its ClinicalTrials.gov identifier: NCT01261832. |
Vol 265
P. 11-21 - novembre 2023 Retour au numéro
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