PERSEUS Data Support Boston Scientific's Taxus Element in Diabetic Patients

September 22, 2010—Boston Scientific Corporation (Natick, MA) announced results from an analysis of 1,166 patients from its PERSEUS clinical program comparing the performance of the Taxus Element paclitaxel-eluting coronary stent system in diabetic versus nondiabetic patients. Results demonstrated that despite the known increased risk of restenosis for diabetics versus nondiabetics in patients undergoing coronary revascularization, the Taxus Element stent had comparable levels of target lesion revascularization (TLR) and late loss in both diabetic and nondiabetic patients. Louis A. Cannon, MD, coprincipal investigator of the PERSEUS clinical program, presented the analysis at the annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC.

“The PERSEUS diabetic subset data showed that the TAXUS Element Stent mitigated the impact of diabetes as a risk factor for restenosis following stenting procedures in the patients studied,” commented Dr. Cannon. “At 1 year, no significant differences in measures of stent efficacy were observed between the two patient groups. Diabetic status was not a predictor of reintervention in patients treated with the Taxus Element stent.”

According to the company, the PERSEUS diabetic analysis included clinical outcomes at 1 year among 314 diabetic patients and 852 nondiabetic patients treated with the Taxus Element stent from the PERSEUS Workhorse and the PERSEUS Small Vessel clinical trials. Due to significant disparity in baseline characteristics between diabetic and nondiabetic patients, propensity score analysis was used to allow for adjustment of baseline differences (other than the presence of diabetes) between the two groups.

The company reported that the Taxus Element stent maintained comparable rates of TLR at 1 year, whether adjusted or unadjusted, in the diabetic and nondiabetic patient populations (5.5% vs 4.1%; P = .43, adjusted). The adjusted and unadjusted rates of target lesion failure at 1 year (defined as ischemia-driven TLR, or myocardial infarction/cardiac death related to the target vessel) were also similar between the patient groups (7.5% vs 5.4%; P = .31, adjusted). Adjusted 1-year rates of major adverse cardiac events, cardiac death, myocardial infarction, and Academic Research Consortium definite/probable stent thrombosis showed no differences between the two populations (P values of .14, .12, .38, and .77, respectively).

Nine-month adjusted angiographic outcomes showed similar in-segment late loss in diabetics and nondiabetics (0.23 mm vs 0.19 mm; P = .52). Rates of late loss for the Taxus Element stent were numerically lower than rates in previous studies for the Taxus Express and Taxus Liberté stents.

Boston Scientific advised that the Taxus Element paclitaxel-eluting stent system received CE Mark approval in May 2010, which included a specific indication for the treatment of diabetic patients. The company expects regulatory approval for the Taxus Element in the United States in mid-2011 and in Japan in late 2011 or early 2012.