Effect of Intravascular Ultrasound-Guided Drug-Eluting Stent Implantation: 5-Year Follow-Up of the IVUS-XPL Randomized Trial

• Published in: JACC. Cardiovascular interventions Vol. 13; no. 1; pp. 62 - 71
• Main Authors: Hong, Sung-Jin, Mintz, Gary S, Ahn, Chul-Min, Kim, Jung-Sun, Kim, Byeong-Keuk, Ko, Young-Guk, Kang, Tae-Soo, Kang, Woong-Chol, Kim, Yong Hoon, Hur, Seung-Ho, Hong, Bum-Kee, Choi, Donghoon, Kwon, Hyuckmoon, Jang, Yangsoo, Hong, Myeong-Ki
• Format: Journal Article
• Language: English
• Published: United States 13-01-2020
• Subjects: coronary artery disease; intravascular ultrasound; drug-eluting stent
• ISSN: 1876-7605
• DOI: 10.1016/j.jcin.2019.09.033

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.
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.
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.
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).
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).