The highly anticipated first results of the RESOLUTE All Comers study were presented on 25 May during the late-breaking clinical trial session of the 2010 EuroPCR meeting. In this 2,292-patient randomised trial, the Resolute zotarolimus-eluting stent (Medtronic) was found to be as safe and effective as the Xience V everolimuseluting stent (Abbott).
This is the first major device study to directly compare the Resolute drug eluting stent to the current market leading platform. The design of the RESOLUTE All Comers study included patients that are not typically enrolled in comparative clinical studies, making the results highly representative of realworld clinical practice.
At one year, Resolute was shown to be as effective as Xience V in reducing the need for repeat procedures, and both second-generation stents were associated with low and similar rates of death from cardiac causes and heart attacks attributed to the treated vessel.
Available in many countries outside the United States and Japan, the Resolute drug-eluting stent is indicated for improving coronary luminal diameter and reducing restenosis in patients with symptomatic ischaemic heart disease in de novo coronary artery lesions in native coronary arteries with a reference vessel diameter of 2.25mm to 4mm.
The primary endpoint of the study was target lesion failure (TLF) – a composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularisation. The Resolute stent posted TLF rates of 8.2% vs. 8.35% for the Xience V (non-inferiority p≤0.001). The results of the RESOLUTE All Comers trial have been published in the New England Journal of Medicine.
“These compelling results were achieved in a challenging patient population that is representative of everyday clinical practice,” said Patrick Serruys, director of the Thoraxcenter at Erasmus University in Rotterdam, The Netherlands, and one of three principal investigators for RESOLUTE All Comers. “Given the rigorous design and conduct of this novel, multicentre randomised clinical trial, it is clear that the Resolute drug-eluting stent has distinguished itself as an important treatment option for a wide range of patients undergoing percutaneous coronary intervention.”
RESOLUTE All Comers is one part of the comprehensive Resolute clinical programme, which will enrol a total of more than 6,000 patients worldwide across a series of single-arm and randomised controlled trials, including RESOLUTE, RESOLUTE US, RESOLUTE International and RESOLUTE Japan. The Resolute clinical programme is a collaborative effort involving hundreds of medical centres in more than 25 countries across Europe, Asia, the Pacific Rim, the Middle East, Africa, Latin America and North America.