Study Shows Reductions In Risks Of Blood Clots With CYPHER Sirolimus-eluting Coronary Stent
CYPHER Sirolimus-eluting Coronary Stent
In an extensive analysis of clinical trials known as a meta-analysis, the CYPHER(R) 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 now 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(R) 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(R) Stent and the Taxus Stent and that the safety of these drug-eluting stents must be assessed separately."
Professor 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. Meta-analyses like this are an important and well-accepted statistical method among clinicians worldwide for documenting similarities and differences between two treatment modalities. We understand and appreciate that such studies are open to various interpretations by researchers and clinicians."
The primary safety endpoint of the meta-analysis was protocol-defined stent thrombosis while the secondary safety endpoints were death and heart attack (myocardial infarction or MI). 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(R) Stent and the Taxus Stent, a blood clot (stent thrombosis) is 34 percent less likely to form in patients implanted with the CYPHER(R) Stent than in patients who receive the Taxus Stent -- a