Sung-Jin Hong1, Dong-Ho Shin2, Jung-Sun Kim2, Byeong-Keuk Kim2, Young-Guk Ko2, Donghoon Choi2, Ae-Young Her3, Yong Hoon Kim3, Yangsoo Jang4, Myeong-Ki Hong5. 1. Department of Internal Medicine, Sanggye Paik Hospital, Inje University, Seoul, South Korea; Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea. 2. Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea. 3. School of Medicine, Kangwon National University, Chuncheon, Korea. 4. Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea; Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, South Korea; Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, South Korea. 5. Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea; Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, South Korea; Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, South Korea. Electronic address: mkhong61@yuhs.ac.
Abstract
OBJECTIVES: The aim of this study was to investigate whether a 6-month dual-antiplatelet therapy (DAPT) duration was comparable with a 12-month duration in patients who underwent everolimus-eluting stent implantation. BACKGROUND: Well-designed studies that determine optimal DAPT strategies after everolimus-eluting stent implantation are limited. METHODS: A total of 1,400 patients (implanted mean total stent length >45 mm) were randomly assigned to receive 6-month (n = 699) or 12-month (n = 701) DAPT between October 2010 and July 2014 at 20 centers in Korea. The primary endpoint was the composite of cardiac death, myocardial infarction, stroke, or TIMI (Thrombolysis in Myocardial Infarction) major bleeding at 1 year, analyzed using an intention-to-treat approach. RESULTS: The primary endpoint occurred in 15 patients (2.2%) in the 6-month DAPT group and 14 patients (2.1%) in the 12-month DAPT group (hazard ratio [HR]: 1.07; p = 0.854). Definite or probable stent thrombosis occurred in 2 patients (0.3%) in the 6-month DAPT group and in 2 patients (0.3%) in the 12-month DAPT group (HR: 1.00; p = 0.999). There were no significant between-group differences in the primary endpoint in 686 patients withacute coronary syndrome (2.4% in both groups; HR: 1.00; p = 0.994) and in 506 patients with diabetes mellitus (2.2% [6-month] vs. 3.3% [12-month]; HR: 0.64; p = 0.428). CONCLUSIONS: Compared with 12-month DAPT, 6-month DAPT did not increase the composite events of cardiac death, myocardial infarction, stroke, or TIMI major bleeding at 1 year in patients who underwent everolimus-eluting stent implantation. (Impact of Intravascular Ultrasound Guidance on Outcomes of XIENCE PRIME Stents in Long Lesions [IVUS-XPL Study]; NCT01308281).
RCT Entities:
OBJECTIVES: The aim of this study was to investigate whether a 6-month dual-antiplatelet therapy (DAPT) duration was comparable with a 12-month duration in patients who underwent everolimus-eluting stent implantation. BACKGROUND: Well-designed studies that determine optimal DAPT strategies after everolimus-eluting stent implantation are limited. METHODS: A total of 1,400 patients (implanted mean total stent length >45 mm) were randomly assigned to receive 6-month (n = 699) or 12-month (n = 701) DAPT between October 2010 and July 2014 at 20 centers in Korea. The primary endpoint was the composite of cardiac death, myocardial infarction, stroke, or TIMI (Thrombolysis in Myocardial Infarction) major bleeding at 1 year, analyzed using an intention-to-treat approach. RESULTS: The primary endpoint occurred in 15 patients (2.2%) in the 6-month DAPT group and 14 patients (2.1%) in the 12-month DAPT group (hazard ratio [HR]: 1.07; p = 0.854). Definite or probable stent thrombosis occurred in 2 patients (0.3%) in the 6-month DAPT group and in 2 patients (0.3%) in the 12-month DAPT group (HR: 1.00; p = 0.999). There were no significant between-group differences in the primary endpoint in 686 patients with acute coronary syndrome (2.4% in both groups; HR: 1.00; p = 0.994) and in 506 patients with diabetes mellitus (2.2% [6-month] vs. 3.3% [12-month]; HR: 0.64; p = 0.428). CONCLUSIONS: Compared with 12-month DAPT, 6-month DAPT did not increase the composite events of cardiac death, myocardial infarction, stroke, or TIMI major bleeding at 1 year in patients who underwent everolimus-eluting stent implantation. (Impact of Intravascular Ultrasound Guidance on Outcomes of XIENCE PRIME Stents in Long Lesions [IVUS-XPL Study]; NCT01308281).
Authors: Thomas A Mavrakanas; Yiannis S Chatzizisis; Karim Gariani; Dean J Kereiakes; Giuseppe Gargiulo; Gérard Helft; Martine Gilard; Fausto Feres; Ricardo A Costa; Marie-Claude Morice; Jean-Louis Georges; Marco Valgimigli; Deepak L Bhatt; Laura Mauri; David M Charytan Journal: Clin J Am Soc Nephrol Date: 2019-04-22 Impact factor: 8.237