The IVUS-XPL trial showed for the first time that the use of intravascular ultrasound (IVUS) during percutaneous coronary intervention (PCI) results in lower rates of major adverse cardiac events compared to angiography-alone-guided PCI up to 5 years, according to results presented Sunday at Transcatheter Cardiovascular Therapeutics in San Francisco.
Myeong-Ki Hong, MD, PhD, professor of medicine at Yonsei University College of Medicine, Severance Cardiovascular Hospital, Seoul, presented the data.
IVUS-XPL was an investigator-initiated, randomized, multicenter study conducted at 20 centers across South Korea enrolling patients undergoing PCI in long lesions (greater than 28 mm) with an everolimus-eluting stent (Xience Prime, Abbott Vascular). In the IVUS subgroup, stent size and length were selected on the basis of IVUS findings. The use of an adjunctive high-pressure balloon was also allowed on the basis of IVUS findings at the operator’s discretion.
Unlike previous studies involving IVUS, which have only shown benefit up to 2 years, IVUS-XPL allowed extended follow-up of patients up to 5 years. A total of 1400 patients were enrolled, with 1183 patients completing 5-year follow-up. The primary composite outcome of cardiac death, target lesion-related myocardial infarction or ischemia-driven target lesion revascularization occurred in 36 patients (5.6%) implanted with IVUS guidance versus 70 patients (10.7%) implanted solely with angiography (hazard ratio, 0.50; 95% confidence interval, 0.33 to 0.89; p=0.007). The difference between the groups was mainly driven by lower rates of target lesion revascularization in the IVUS group (4.8%) versus the angiography group (8.4%).
Funding was provided 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; the Bio & Medical Technology Development Program of the National Research Foundation, funded by the Korean government; and the Cardiovascular Research Center, Seoul.