Author + information
- Received September 11, 2019
- Revision received September 19, 2019
- Accepted September 19, 2019
- Published online January 6, 2020.
- Sung-Jin Hong, MDa,
- Gary S. Mintz, MDb,
- Chul-Min Ahn, MDa,
- Jung-Sun Kim, MDa,
- Byeong-Keuk Kim, MDa,
- Young-Guk Ko, MDa,
- Tae-Soo Kang, MDc,
- Woong-Chol Kang, MDd,
- Yong Hoon Kim, MDe,
- Seung-Ho Hur, MDf,
- Bum-Kee Hong, MDg,
- Donghoon Choi, MDa,
- Hyuckmoon Kwon, MDg,
- Yangsoo Jang, MDa,
- Myeong-Ki Hong, MDa,∗ (, )
- for the IVUS-XPL Investigators
- aSeverance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea
- bCardiovascular Research Foundation, New York, New York
- cDankook University College of Medicine, Cheonan, Korea
- dGil Hospital, Gachon University College of Medicine, Incheon, Korea
- eKangwon National University School of Medicine, Chuncheon, Korea
- fKeimyung University College of Medicine, Daegu, Korea
- gGangnam Severance Hospital, Seoul, Korea
- ↵∗Address for correspondence:
Dr. Myeong-Ki Hong, Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Yonsei-ro 50-1, Seodaemun-gu, 03722 Seoul, Korea.
Objectives The goal of this study was to evaluate whether the beneficial effect of use of intravascular ultrasound (IVUS) is sustained for long-term follow-up.
Background The use of IVUS promoted favorable 1-year clinical outcome in the IVUS-XPL (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions) trial. It is not known, however, whether this effect is sustained for long-term follow-up.
Methods The IVUS-XPL trial randomized 1,400 patients with long coronary lesions (implanted stent length ≥28 mm) to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation. Five-year clinical outcomes were investigated in patients who completed the original trial. The primary outcome was the composite of major adverse cardiac events, including cardiac death, target lesion–related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years, analyzed by intention-to-treat.
Results Five-year follow-up was completed in 1,183 patients (85%). Major adverse cardiac events at 5 years occurred in 36 patients (5.6%) receiving IVUS guidance and in 70 patients (10.7%) receiving angiographic guidance (hazard ratio: 0.50; 95% confidence interval: 0.34 to 0.75; p = 0.001). The difference was driven mainly by a lower risk for target lesion revascularization (31 [4.8%] vs. 55 [8.4%]; hazard ratio: 0.54; 95% confidence interval: 0.33 to 0.89; p = 0.007). By landmark analysis, major adverse cardiac events between 1 and 5 years occurred in 17 patients (2.8%) receiving IVUS guidance and in 31 patients (5.2%) receiving angiographic guidance (hazard ratio: 0.53; 95% confidence interval: 0.29 to 0.95; p = 0.031).
Conclusions Compared with angiography-guided stent implantation, IVUS-guided stent implantation resulted in a significantly lower rate of major adverse cardiac events up to 5 years. Sustained 5-year clinical benefits resulted from both within 1 year and from 1 to 5 years post-implantation. (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions [IVUS-XPL Study]: Retrospective and Prospective Follow-Up Study; NCT03866486)
This work was supported by grants from the Korea Health Technology Research & Development Project through the Korea Health Industry Development Institute, funded by the Ministry of Health & Welfare, Republic of Korea (HI17C0882, HI16C2211, and HI15C2782); the Bio & Medical Technology Development Program of the National Research Foundation funded by the Korean government (2015M3A9C6031514); and the Cardiovascular Research Center, Seoul, Korea. Dr. Mintz is a consultant to Boston Scientific, Philips/Volcano, and Terumo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 11, 2019.
- Revision received September 19, 2019.
- Accepted September 19, 2019.
- 2020 American College of Cardiology Foundation
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