Author + information
- Received September 11, 2019
- Revision received September 19, 2019
- Accepted September 19, 2019
- Published online September 29, 2019.
- Sung-Jin Hong, MD1,
- Gary S. Mintz, MD2,
- Chul-Min Ahn, MD1,
- Jung-Sun Kim, MD1,
- Byeong-Keuk Kim, MD1,
- Young-Guk Ko, MD1,
- Tae-Soo Kang, MD3,
- Woong-Chol Kang, MD4,
- Yong Hoon Kim, MD5,
- Seung-Ho Hur, MD6,
- Bum-Kee Hong, MD7,
- Donghoon Choi, MD1,
- Hyuckmoon Kwon, MD7,
- Yangsoo Jang, MD1,
- Myeong-Ki Hong, MD1,∗ (, )
- for the IVUS-XPL Investigators
- 1Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea
- 2Cardiovascular Research Foundation, New York, NY, USA
- 3Dankook University College of Medicine, Cheonan, Korea
- 4Gachon University College of Medicine, Incheon, Korea
- 5Kangwon National University School of Medicine, Chuncheon, Korea
- 6Keimyung University College of Medicine, Daegu, Korea
- 7Gangnam Severance Hospital, Seoul, Korea
- ↵∗Address for Correspondence: Myeong-Ki Hong, MD, PhD 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 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 ≥28mm) to receive IVUS- (n=700) or angiography-guided (n=700) everolimus-eluting stent implantation. Five-year clinical outcomes were investigated in patients who completed the original trial. 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 angiography-guidance (hazard ratio [HR]=0.50, 95% confidence interval [CI]=0.34−0.75, P=0.001). The difference was mainly driven by a lower risk of target lesion revascularization (31 [4.8%] vs. 55 [8.4%], HR=0.54; 95% CI=0.33−0.89, 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 angiography-guidance (HR=0.53, 95% CI=0.29-0.95, 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.
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 (No. HI17C0882, HI16C2211, and HI15C2782); the Bio & Medical Technology Development Program of the National Research Foundation funded by the Korean government (No. 2015M3A9C6031514); and the Cardiovascular Research Center, Seoul, Korea.
Mintz is a consultant to Boston Scientific, Philips/Volcano, and Terumo.
The remaining authors have no disclosures to report.
Tweet: The results of the five-year follow-up study of IVUS-XPL randomized trial being presented as a late breaking clinical trial at TCT 2019.
- Received September 11, 2019.
- Revision received September 19, 2019.
- Accepted September 19, 2019.
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