Author + information
- Received March 22, 2016
- Revision received April 25, 2016
- Accepted April 25, 2016
- Published online July 25, 2016.
- Sung-Jin Hong, MDa,b,
- Dong-Ho Shin, MD, MPHb,
- Jung-Sun Kim, MDb,
- Byeong-Keuk Kim, MDb,
- Young-Guk Ko, MDb,
- Donghoon Choi, MDb,
- Ae-Young Her, MDc,
- Yong Hoon Kim, MDc,
- Yangsoo Jang, MDb,d,e,
- Myeong-Ki Hong, MDb,d,e,∗ (, )
- IVUS-XPL Investigators
- aDepartment of Internal Medicine, Sanggye Paik Hospital, Inje University, Seoul, South Korea
- bDivision of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea
- cSchool of Medicine, Kangwon National University, Chuncheon, Korea
- dSeverance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, South Korea
- eCardiovascular Research Institute, Yonsei University College of Medicine, Seoul, South Korea
- ↵∗Reprint requests and correspondence:
Dr. Myeong-Ki Hong, Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Yonsei-ro 50-1, Seodaemun-gu, Seoul 03722, South Korea.
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)
This study was supported by a grant from the Korea Healthcare Technology Research & Development Project, Ministry for Health & Welfare, Republic of Korea (A085136 and HI15C1277), the Mid-Career Researcher Program through a National Research Foundation grant funded by the Ministry of Education, Science and Technology, Republic of Korea (2015R1A2A2A01002731), Abbott Vascular, and the Cardiovascular Research Center (Seoul, South Korea). All authors have reported they have no relationships relevant to the contents of this paper to disclose.
- Received March 22, 2016.
- Revision received April 25, 2016.
- Accepted April 25, 2016.
- American College of Cardiology Foundation