September 4, 2007 - Analysis of clinical trials showed the Cypher Sirolimus-eluting coronary stent was associated with significantly lower risks of blood clots and the need for reintervention, compared to the Taxus stent out to 30 months after an angioplasty procedure.
This meta-analysis of 16 randomized clinical trials and 8,695 patients, the largest analysis of its kind to date, is posted on the Journal of the American College of Cardiology Website and is expected in print later in the year.
"Over the past year, concerns have been raised regarding the long-term safety of all drug-eluting stents," said professor Albert Schomig, M.D., from Deutsches Herzzentrum, Technische Universitat in Munich, Germany, one of the authors of the study. "In this meta-analysis of randomized controlled trials, the Cypher stent was associated with a significant reduction in the risks of stent thrombosis and reintervention compared to the Taxus stent. This reinforces the notion that there are marked differences between the Cypher stent and the Taxus stent and that the safety of these drug-eluting stents must be assessed separately."
Schomig added, "We find these data compelling because they are consistent with other documented meta-analyses and reflect data from all of the randomized clinical trials directly comparing these drug-eluting stents."
He said the primary safety endpoint of the meta-analysis was protocol-defined stent thrombosis, while the secondary safety endpoints were death and heart attack. The primary efficacy endpoint was the need for reintervention (target lesion revacularization or TLR).
According to this comprehensive analysis of all head-to-head clinical studies between the Cypher stent and the Taxus stent, a blood clot (stent thrombosis) is 34 percent less likely to form in patients implanted with the Cypher stent than in patients who receive the Taxus stent.
While the overall risk of death was not significantly different between the two drug-eluting stents, the authors of the meta-analysis identified a trend toward a lower risk of heart attack with the Cypher stent versus the Taxus, especially after the first year of follow-up.
"This meta-analysis substantially enriches the large body of evidence that interventional cardiologists have at their disposal to make the right choice for their patients," said David E. Kandzari, MD, FACC, FSCAI, chief medical officer, Cordis Corporation.
The meta-analysis comprised studies of simple cases, studies that included all types of patients and studies that focused on specific and complex patient populations, such as patients with diabetes, patients treated for disease in long lesions or small vessels, patients presenting with a heart attack and patients being treated for repeat disease in a previously placed bare-metal stent, some of which are not within the approved labeling for the products.
For more information: www.cordis.com