Largest Study To Date Shows Significant Reductions In Risks Of Blood Clots And Reintervention With CYPHER® Sirolimus-Eluting Coronary Stent Compared To Taxus Stent

Miami Lakes, FL .– In an extensive analysis of clinical trials known as a meta-analysis, 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 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 Schömig, M.D., from Deutsches Herzzentrum, Technische Universität 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.”

Professor Schömig 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® 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 – a statistically significant difference [hazard ratio (HR) 0.66, 95 percent confidence interval (CI) 0.46 to 0.94, p=0.02]. In addition, the CYPHER® Stent significantly lowered the risk of reintervention by 26 percent versus the Taxus Stent (HR 0.74, CI 0.63 to 0.87, p0.001).

While the overall risk of death was not significantly different between the two drug-eluting stents (HR 0.92, CI 0.74 to 1.13, p=0.43), the authors of the meta-analysis identified a trend toward a lower risk of heart attack with the CYPHER® Stent versus the Taxus Stent (HR 0.84, CI 0.69 to 1.03, p=0.10), especially after the first year of follow-up.

Events occurring after the first year of stent placement have fueled the discussion surrounding the safety of drug-eluting stents. When only patient-level data were used, the authors were able to assess the occurrence of events after the first year of follow-up. In this analysis, there was a significant 70 percent reduction in blood clots (p=0.004) and a 55 percent reduction in repeat heart attacks (p=0.006) in patients who received the CYPHER® Stent compared to patients implanted with a Taxus Stent.

“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, M.D., F.A.C.C., F.S.C.A.I, Chief Medical Officer, Cordis Corporation. “Drug-eluting stents, like the CYPHER® Stent, continue to provide significant benefits for patients with coronary artery disease.”

For this analysis of randomized controlled trials, the gold standard of clinical evidence in medicine, individual patient data were obtained from 11 of the 16 included studies or 5,562 patients. The authors noted in the manuscript that the overall treatment effects were similar regardless of how the data were analyzed (total patient population or analysis of individual patient data).

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.