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

Abstract 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.