IVUS-XPL Trial Compares IVUS Versus Angiography for Guiding EES Implantation

November 10, 2015—The IVUS-XPL (Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions) study was conducted to determine whether the long-term clinical outcomes of drug-eluting stent implantation guided by intravascular ultrasound are superior to outcomes of implantation guided by angiography in patients with long coronary lesions. Sung-Jin Hong, MD, et al published the findings in JAMA: Journal of the American Medical Association.

The background of the study is that use of IVUS has been shown to promote better clinical outcomes for coronary intervention in complex coronary lesions; however, randomized data demonstrating the clinical usefulness of IVUS are limited for lesions treated with drug-eluting stents.

As summarized in JAMA, the IVUS-XPL randomized, multicenter trial was conducted in 1,400 patients with long coronary lesions (implanted stent ≥ 28 mm in length) between October 2010 and July 2014 at 20 centers in Korea. Patients were randomly assigned to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation.

The study’s primary outcome measure was the composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 1 year, analyzed by intention-to-treat.

One-year follow-up was complete in 1,323 patients (94.5%). Major adverse cardiac events at 1 year occurred in 19 patients (2.9%) undergoing IVUS-guided and in 39 patients (5.8%) undergoing angiography-guided stent implantation (absolute difference, −2.97%; 95% confidence interval [CI], −5.14% to −0.79%) (hazard ratio [HR], 0.48; 95% CI, 0.28 to 0.83; P = .007). The difference was driven by a lower risk of ischemia-driven target lesion revascularization in patients undergoing IVUS-guided (17 [2.5%]) compared with angiography-guided (33 [5%]) stent implantation (HR, 0.51; 95% CI, 0.28 to 0.91; P = .02). 

Cardiac death and target lesion-related myocardial infarction were not significantly different between the two groups. For cardiac death, there were three patients (0.4%) in the IVUS-guided group and five patients (0.7%) in the angiography-guided group (HR, 0.6; 95% CI, 0.14 to 2.52; P = .48). Target lesion-related myocardial infarction occurred in 1 patient (0.1%) in the angiography-guided stent implantation group (P = .32).

The IVUS-XPL investigators concluded that among patients requiring long coronary stent implantation, the use of IVUS-guided everolimus-eluting stent implantation, compared with angiography-guided stent implantation, resulted in a significantly lower rate of the composite of major adverse cardiac events at 1 year. These differences were primarily due to lower risk of target lesion revascularization, noted the investigators in JAMA.