BARCELONA, Spain — Presenting results of a first clinical trial for its new Nevo drug-eluting stent (DES), Cordis (Winter Park, Florida) came roaring back into the fight in this fiercely competitive market, slamming its arch-rival Boston Scientific (Natick, Massachusetts) and re-establishing credibility for its sirolimus coating formulation.
Nevo is a new stent platform featuring the reservoir technology Cordis acquired when it bought Conor Medsystems (Menlo Park, California) for $1.4 billion nearly two years ago (Medical Device Daily; Feb. 5, 2007).
This first study, Nevo Res-1, will be filed with European regulatory authorities as part of an application for winning the CE mark in 2010, and the addition of subsequent planned clinical trials will be part of an application to the FDA expected in 2011.
Even without regulatory approval or immediate commercial prospects, the Nevo Res-1 results put wind back in the sails of Cordis' flagging DES business that has suffered from superior results reported for Boston Scientific's Taxus Liberté and the emerging success for Medtronic (Minneapolis) with the Endeavor stent. (MDD; June 6, 2008).
"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, group chairman for Cordis.
Over 3,500 cardiologists packed the auditorium for the Cordis presentation during a signature session titled, "Late Breaking Trials," on the first day of EuroPCR 2009, the annual congress for some 11,000 physicians specializing in interventional cardiovascular medicine being held here this week.
Christian Spaulding, MD, head of cardiology at the prestigious Decartes University Hospitals (Paris), delivered a ringing hammer blow in his conclusion, "In this trial, Nevo was superior to Taxus Liberté in a number of key safety and efficacy measures, including the primary endpoint of late lumen loss."
The Nevo Res-1 study was designed as a head-to-head trial against Taxus Liberté and put on a fast-track to torpedo the market leader, completing a trial that was called "impeccable" by the EuroPCR review panel in less than 14 months.
Asked if he felt like Cordis carved a sharp stick to put in his eye, Keith Dawkins, who was a primary investigator for the Nevo Res-1 trial before joining Boston Scientific, told MDD, "Not the eye, maybe somewhere else."
Now a senior vice president and associate chief medical officer with Boston Scientific, Dawkins said the results of the Cordis study "is everything you would expect if you use late lumen loss as an endpoint. Sirolimus will always come in first if you study six-month results."
"What is needed, of course, is a larger study," he added.
Nevo RES-I was a randomized trial with 40 international cardiac centers participating that compared Nevo to the Taxus Liberté in de novo native coronary artery lesions with the primary endpoint being angiographic in-stent late lumen loss at six months.
The study enrolled 394 patients at the 40 sites with clinical follow-up at 30 days and again at six months.
The study produced an unprecedented 87% participation in the six-month follow up angiography, compared to an industry average of 42% reported by Medtronic in a following presentation at EuroPCR that pooled results of six different studies over four years.
Late lumen loss was reduced by 64% in the Nevo patients as compared with the Taxus Liberté patients.
Secondary results of the Nevo performance included superior angiographic results to Taxus Liberté in reducing restenosis, a reblockage in a stent, at six months and a reduction by more than 40% of major adverse cardiac events (MACE).
Nevo RES-I was not designed to show differences in clinical outcomes, reported Dr. Spaulding, who went on to add that patients treated with Cordis' new stent had lower rates of target lesion revascularisation (TLR) and the composite of death or heart attack.
Spaulding suggested the design of the stent may be a significant factor in the stellar perfomance of Nevo and that the safety profile emerging from the first clinical trial "adds to our enthusiasm" for the potential of the new platform.
Based on a redesign of the Conor technology, Nevo is a flexible cobalt-chromium stent incorporating hundreds of small reservoirs, each holding a drug-polymer composite, which allows the drug to be delivered while dramatically reducing the exposure of the polymer to blood vessel tissue.
Spaulding said that three-fourths of the Nevo stent is bare metal upon insertion, and that because the polymer is bioabsorable, it becomes, effectively, a bare-metal stent (BMS) after three months.
By contrast, he said, the surface of market-leading DES, for example the Taxus Liberté, are fully coated with a drug and polymer combination and that these polymers are never fully absorbed by the body.
He said this design suggests far less inflammation caused by the introduction of the stent, and thereby lower in-stent thrombosis.
The chief scientific officer and global head of R&D for Cordis, Dr. Campbell Rogers, hinted at plans for the new platform saying it holds a potential for patient-specific tailoring of drugs in the tiny reservoirs.
Cordis announced at EuroPCR two further trials.
NEVO II will compare Cordis' Nevo to the Xience V Everolimus-eluting stent from Abbott Laboratories (Abbott Park, Illinois), enrolling several thousand patients with coronary artery disease with a primary endpoint of the study of target lesion failure at 12-months.
Results from this trial will provide long-term data in support of a pre-market approval application with the FDA.
NEVO III will enroll roughly 1,200 patients throughout the U.S. and Canada to compare Nevo to Cordis' own Cypher stent in a control arm of the Cypher/DAPT (dual anti-platelet therapy) trial to meet an FDA requirement.