Data Presented From Pivotal Trial of Cordis' Nevo Stent

May 19, 2009—Cordis Corporation (Warren, NJ) announced that 6-month study results suggest the company's Nevo sirolimus-eluting coronary stent, incorporating RES reservoir technology, was superior to the Taxus Liberté stent (Boston Scientific Corporation, Natick, MA) in reducing tissue growth within the stent that can potentially lead to repeat procedures. In addition, no reports of stent thrombosis were reported in patients treated with Nevo through 6 months. The results of the NEVO RES I study comparing these two drug-eluting stents were presented at the EuroPCR conference in Barcelona, Spain.

According to the company, the Nevo stent had significantly lower in-stent late lumen loss, the primary endpoint of this prospective, randomized clinical trial. Specifically, late lumen loss was reduced by 64% in the Nevo arm as compared to the Taxus Liberté arm (0.13 mm vs 0.36 mm; P < .001). Nevo also showed angiographic results superior to the Taxus Liberté stent in reducing restenosis at 6 months. Angiographic restenosis was reduced 86% in Nevo compared to Taxus Liberté (1.1% vs 8%; P < .002). The incidence of major adverse coronary events (MACE) was reduced in the Nevo arm by more than 40% compared to the Taxus Liberté arm (4.1% vs 7%; P = .226). MACE occurring between hospital discharge and 6 months were reduced 67% with the Nevo compared to the Taxus Liberté (1.6% vs 4.8%; P = .08).

NEVO RES I was not designed to show differences in clinical outcomes; however, patients treated with Nevo compared to the Taxus Liberté had numerically lower rates of events with respect to target lesion revascularization (1.6% vs 3.2%; P = .33) and the composite of death or heart attack (2.6% vs 4.3%; P = .26). Based on the Academic Research Consortium definitions of stent thrombosis, there were no reports of stent thrombosis in the 202 patients receiving Nevo and two reports of stent thrombosis in the 192 patients receiving the Taxus Liberté stent, both of whom were on dual-antiplatelet therapy at the time.

In a prespecified subset analysis of the 65 patients with diabetes completing 6-month follow-up to date, there was a 60% reduction in in-stent late lumen loss with Nevo compared to the Taxus Liberté stent (0.17 mm vs 0.42 mm; P < .03). The difference seen in favor of Nevo compared to Taxus Liberté was similar to the 65% reduction seen in 277 nondiabetic patients (0.12 mm vs 0.34 mm; P < .001).

The NEVO RES I study is a randomized, multicenter comparison of the Nevo sirolimus-eluting coronary stent to the Taxus Liberté stent in de novo native coronary artery lesions. Key secondary endpoints include target lesion failure, target vessel failure, MACE, stent thrombosis, target lesion revascularization, target vessel revascularization, and angiographic in-stent and in-segment binary restenosis at 6 months. A subset of patients in each treatment arm was evaluated via intravascular ultrasound at 6 months. The study involved 394 patients at 40 sites throughout Europe, South America, Australia, and New Zealand. Patients received clinical follow-up at 30 days and 6 months and will be followed annually through 5 years. Data from this trial will support a regulatory filing for a CE Mark in countries outside the United States. The Nevo sirolimus-eluting coronary stent is an investigational device and is not yet approved or available for sale in any market, the company advised.

According to Cordis, upcoming clinical trials for the device are planned. NEVO II will be a global, randomized, noninferiority trial comparing the Nevo stent to the Xience V everolimus-eluting coronary stent (Abbott Vascular, Santa Clara, CA). The study will enroll several thousand patients with coronary artery disease and will include expanded enrollment in multiple patient subgroups. The primary endpoint of the study is target lesion failure at 12-months. Patrick Serruys, MD, Stephen Windecker, MD, and Manual Sabate, MD, will lead the study. Results from this trial will provide long-term data in support of a premarket approval application with the US Food and Drug Administration. NEVO III will be a nonrandomized, single-arm trial evaluating clinical outcomes in approximately 1,200 patients throughout the United States and Canada. The primary endpoint will be target lesion failure at 12 months. In NEVO III, led by Dan Simon, MD, and David Kandzari, MD, the Nevo stent will be compared to the Cypher stent control arm of Cordis' CYPHER Stent/DAPT (dual-antiplatelet therapy) trial. The trial will enroll approximately 2,000 patients and will compare clinical outcomes in a broad range of patients receiving dual-antiplatelet therapy for 12 months versus 30 months after receiving a Cypher stent.