Adjunctive cilostazol versus double-dose clopidogrel after drug-eluting stent implantation: the HOST-ASSURE randomized trial (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Safety & Effectiveness of Drug-Eluting Stents & Anti-platelet Regimen)
Kyung Woo Park, Si-Hyuck Kang, Jin Joo Park, Han-Mo Yang, Hyun-Jae Kang, Bon-Kwon Koo, Byoung-Eun Park, Kwang Soo Cha, Jay Young Rhew, Hui-Kyoung Jeon, Eun Seok Shin, Ju Hyeon Oh, Myung-Ho Jeong, Sanghyun Kim, Kyung-Kuk Hwang, Jung-Han Yoon, Sung Yun Lee, Tae-Ho Park, Keon Woong Moon, Hyuck-Moon Kwon, In-Ho Chae, Hyo-Soo Kim, Kyung Woo Park, Si-Hyuck Kang, Jin Joo Park, Han-Mo Yang, Hyun-Jae Kang, Bon-Kwon Koo, Byoung-Eun Park, Kwang Soo Cha, Jay Young Rhew, Hui-Kyoung Jeon, Eun Seok Shin, Ju Hyeon Oh, Myung-Ho Jeong, Sanghyun Kim, Kyung-Kuk Hwang, Jung-Han Yoon, Sung Yun Lee, Tae-Ho Park, Keon Woong Moon, Hyuck-Moon Kwon, In-Ho Chae, Hyo-Soo Kim
Abstract
Objectives: This study sought to test the noninferiority of triple antiplatelet therapy (TAT) versus double-dose clopidogrel dual antiplatelet therapy (DDAT) in patients undergoing percutaneous coronary intervention (PCI).
Background: Antiplatelet regimen is an integral component of medical therapy after PCI. A 1-week duration of doubling the dose of clopidogrel was shown to improve outcome at 1 month compared with the conventional dose in patients with acute coronary syndrome undergoing PCI. Yet in Asia, the addition of cilostazol is used more commonly than DDAT in high-risk patients.
Methods: We randomly assigned 3,755 all-comers undergoing PCI to either TAT or DDAT, which was continued for 1 month, to test the noninferiority of TAT versus DDAT. The primary outcome was the cumulative incidence of net clinical outcome at 1 month post-PCI defined as the composite of cardiac death, nonfatal myocardial infarction, stent thrombosis, stroke, and PLATO (Platelet Inhibition and Patient Outcomes) major bleeding.
Results: TAT was noninferior to DDAT with respect to the primary outcome, which occurred in 1.2% and 1.4% of patients, respectively (-0.22% absolute difference, 0.34% 1-sided 97.5% confidence interval, p = 0.0007 for noninferiority; hazard ratio: 0.85; 95% confidence interval: 0.49 to 1.48; p = 0.558 for superiority). The individual risks of cardiac death, nonfatal myocardial infarction, stent thrombosis, stroke, and PLATO major bleeding did not differ significantly between the 2 groups. There were no significant between-group differences in the treatment effect with regard to the rate of the primary outcome.
Conclusions: The adjunctive use of cilostazol was noninferior to doubling the dose of clopidogrel for 1 month in all-comers undergoing PCI with exclusively drug-eluting stents. (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen [HOST-ASSURE]; NCT01267734).
Keywords: ACS; CI; DDAT; HOPR; MI; OPR; PCI; TAT; acute coronary syndromes; antiplatelet therapy; cliostazol; clopidogrel; confidence interval; double-dose clopidogrel dual antiplatelet therapy; high on-treatment platelet reactivity; myocardial infarction; on-treatment platelet reactivity; percutaneous coronary intervention; randomized controlled trial; triple antiplatelet therapy.
Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed