Boston Scientific Corporation announced that an independent meta-analysis of more than 3,500 patients from five clinical trials, conducted by the Cardiovascular Research Foundation, confirmed the Company's own analysis that the TAXUS paclitaxel-eluting coronary stent is safe and effective. The new analysis was presented by Gregg W. Stone, M.D., Vice Chairman of the Cardiovascular Research Foundation and Professor of Medicine, Columbia University Medical Center in New York, at a symposium hosted by Boston Scientific in conjunction with the eighteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
The patient-level meta-analysis reported data on the TAXUS stent from the TAXUS I, II, IV, V and VI trials that studied 3,506 patients. A parallel patient-level meta-analysis was also performed on the Cypher® stent from the RAVEL, SIRIUS, E-SIRIUS AND C-SIRIUS trials that studied 1,748 patients, and will be presented in full by Dr. Stone on Tuesday.
The results presented today showed similar rates of freedom from stent thrombosis and similar rates of stent thrombosis beyond one year for both the TAXUS and Cypher stents.
For the TAXUS stent, the rate of freedom from stent thrombosis at up to four years was 98.7 percent (1.3 percent thrombosis rate), compared to a 99.1 percent rate of freedom from stent thrombosis (0.9 percent stent thrombosis rate) in the bare-metal control group. This meta-analysis showed a small but statistically significant (0.40 percent, p = 0.033) increase in the incidence of stent thrombosis after one year for the TAXUS stent as compared to the bare-metal control stent. However, there was no corresponding increase in death or myocardial infarction (MI).