Comparison of 3- to 6-Month Versus 12-Month Dual Antiplatelet Therapy After Coronary Intervention Using the Contemporary Drug-Eluting Stents With Ultrathin Struts: The HOST-IDEA Randomized Clinical Trial

• Published in: Circulation (New York, N.Y.) N.Y.), 2023-05, Vol.147 (18), p.1358-1368
• Main Authors: Han, Jung-Kyu, Hwang, Doyeon, Yang, Seokhun, Park, Sang-Hyeon, Kang, Jeehoon, Yang, Han-Mo, Park, Kyung Woo, Kang, Hyun-Jae, Koo, Bon-Kwon, Hur, Seung-Ho, Kim, Weon, Kim, Seok Yeon, Park, Sang-Hyun, Han, Seung Hwan, Kim, Sang-Hyun, Shin, Sanghoon, Kim, Yong Hoon, Park, Kyungil, Lee, Namho, Lee, Seung Jin, Kim, Jin Won, Kim, Hyo-Soo
• Format: Article
• Language: English
• Subjects: Aged; Death; Drug-Eluting Stents; Hemorrhage - chemically induced; Humans; Male; Middle Aged; Myocardial Infarction - drug therapy; Percutaneous Coronary Intervention - adverse effects; Platelet Aggregation Inhibitors - therapeutic use; Sirolimus; Treatment Outcome
• ISSN: 0009-7322; 1524-4539
• DOI: 10.1161/CIRCULATIONAHA.123.064264

Limited data are available on short-term dual antiplatelet therapy (DAPT) after percutaneous coronary intervention using third-generation drug-eluting stents with ultrathin struts and advanced polymer technology. We investigated whether 3- to 6-month DAPT was noninferior to 12-month DAPT after implantation of drug-eluting stents with ultrathin struts and advanced polymer technology. We performed an open-label, randomized trial at 37 centers in South Korea. We enrolled patients undergoing percutaneous coronary intervention using the Orsiro biodegradable-polymer sirolimus-eluting stents or the Coroflex ISAR polymer-free sirolimus-eluting stents. Patients with ST-segment-elevation myocardial infarction were excluded. Patients were randomly assigned to receive either 3- to 6-month or 12-month DAPT after percutaneous coronary intervention. The choice of antiplatelet medications was at the physician's discretion. The primary outcome was a net adverse clinical event, a composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization, stent thrombosis, or major bleeding, defined as Bleeding Academic Research Consortium type 3 or 5 at 12 months. The major secondary outcomes were target lesion failure, a composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization, and major bleeding. A total of 2013 patients (mean age, 65.7±10.5 years; 1487 males [73.9%]; 1110 [55.1%] presented with acute coronary syndrome) were randomly assigned to 3- to 6-month DAPT (n=1002) or 12-month DAPT (n=1011). The primary outcome occurred in 37 (3.7%) patients in the 3- to 6-month DAPT group and 41 (4.1%) in the 12-month DAPT group. The noninferiority of the 3- to 6-month DAPT group to the 12-month DAPT group was met (absolute risk difference, -0.4% [1-sided 95% CI, -∞% to 1.1%];