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At six months, the Nevo™ sirolimus-eluting coronary stent, incorporating RES Technology™, was superior to the Taxus® Liberte® stent in reducing tissue growth within the stent that can potentially lead to repeat procedures, in new clinical study results. In addition, no reports of stent thrombosis were reported in patients treated with Nevo through six months.
The results of the NEVO RES I study comparing these two drug-eluting stents were presented during Late Breaking Clinical Trials at EuroPCR, the leading medical conference in Europe for physicians specialising in interventional cardiovascular medicine.
“We are extremely pleased with the results from this trial and believe Nevo has the potential to return Cordis to global leadership in the drug-eluting stent market,” said Seth Fischer, company group chairman and worldwide franchise chairman, Cordis Corporation.
Nevo is the first drug-eluting stent utilising RES Technology, which incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This unique design allows drug delivery from a stent with a surface that is 75% bare metal upon insertion and which becomes purely bare metal following drug delivery and polymer bioresorption in approximately three months based on in-vivo data. By contrast, currently marketed drug-eluting stents have 100% of their surfaces coated with drug and polymer and the polymer is never fully bioabsorbed.
The Nevo stent had significantly lower in-stent late lumen loss, the primary endpoint of this prospective, randomised clinical trial. Specifically, late lumen loss was reduced by 64% in the Nevo arm as compared with the Taxus Liberte arm (0.13mm compared with 0.36mm, p<0.001). In-stent late lumen loss reduces the diameter of the lumen, thus restricting blood flow through the stent, and can potentially lead to major adverse coronary events (MACEs).
In addition, Nevo also showed superior angiographic results to the Taxus Liberte stent in reducing restenosis at six months. Angiographic restenosis was reduced by 86% (1.1% restenosis rate in the NEVO™ arm compared with 8.0% in the Taxus Liberte arm, p<0.002).
Nevo also reduced the incidence of MACEs by more than 40% percent compared with the Taxus Liberte Stent (4.1% vs 7.0% percent respectively, p=0.226). MACEs occurring between hospital discharge and six months were reduced by 67% percent from 4.8% with the Taxus Liberte Stent to 1.6% with Nevo (p=0.08).
NEVO RES I was not designed to show differences in clinical outcomes. However, patients treated with Nevo had numerically lower rates of events with respect to target lesion revascularisation (1.6% for NEVO™ vs 3.2% for the Taxus Liberte, p=0.33) and the composite of death or heart attack (2.6% vs 4.3% respectively, p=0.26) compared with patients receiving the Taxus Liberte stent.
Stent thrombosis can be a significant clinical issue with coronary stents and frequently results in heart attacks or death. Based on the ARC (Academic Research Consortium) definitions of stent thrombosis, which have been adopted by the interventional cardiology community, there were no reports of stent thrombosis in the 202 patients receiving Nevo, while there were two reports of stent thrombosis in the 192 patients receiving the Taxus Liberte stent, both of whom were on dual antiplatelet therapy at the time.
“In this trial, Nevo was superior to Taxus Liberte in a number of key safety and efficacy measures, including the primary end-point of late lumen loss,” said Christian Spaulding, MD, FACC, professor of cardiology, Assistance Publique-Paris Decartes University Hospitals, Paris, France, and one of the three primary investigators of the NEVO RES I trial. “We also saw an emerging safety profile with Nevo that adds to our enthusiasm about the potential of this drug-eluting stent for patients with coronary artery disease.”
Campbell Rogers, MD, chief scientific officer and global head, research and development, Cordis Corporation, noted: “Not only did Nevo significantly outperform Taxus Liberte in important measures, but these results also indicate that … the potential for a strong safety profile with Nevo is quite promising. Nevo is designed to improve patient outcomes by providing a unique vascular safety profile, the proven efficacy of sirolimus and excellent deliverability.”