The FDA has issued approval to the XIENCE V everolimus eluting stent from Abbott, a product that the company supposedly has demonstrated in clinical trails to perform better that Boston Scientific’s TAXUS.
The FDA approved XIENCE V based, in large part, on superior results from the 1,002 patient SPIRIT III U.S. pivotal clinical trial, in which XIENCE V demonstrated statistical superiority to TAXUS on the study’s primary endpoint of in-segment late loss (vessel renarrowing) at eight months, with a statistically significant 50 percent reduction (mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS). XIENCE V also demonstrated statistical non-inferiority to TAXUS in the co-primary endpoint of target vessel failure (TVF, cardiac events related to the stented vessel) at nine months, with an observed 20 percent reduction (7.2 percent for XIENCE V vs. 9.0 percent for TAXUS). TVF is a composite clinical measure of safety and efficacy outcomes defined as cardiac death, heart attack (myocardial infarction or MI) or target vessel revascularization (TVR).
In May 2008, Abbott presented two-year data from the SPIRIT III trial demonstrating that XIENCE V continues to deliver positive clinical benefits for patients. At two years, the XIENCE V demonstrated the following key results:A 45 percent reduction in the risk of major adverse cardiac events (MACE) compared to TAXUS (7.3 percent for XIENCE V vs. 12.8 percent for TAXUS, p-value=0.004)*. MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (MI) or ischemia-driven target lesion revascularization (TLR, repeat procedures driven by lack of blood supply). A 32 percent reduction in the risk of TVF compared to TAXUS (10.7 percent for XIENCE V vs. 15.4 percent for TAXUS, p-value=0.04)*. Low rates of stent thrombosis between one and two years, defined as very late stent thrombosis, per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis (0.3 percent for XIENCE V and 1.0 percent for TAXUS) and per the SPIRIT III protocol (0.2 percent for XIENCE V and 1.0 percent for TAXUS). The ARC definition of late stent thrombosis was developed to eliminate variability in the definitions across various drug eluting stent trials. * Event rates are based on Kaplan-Meier estimates; p-values are for descriptive purposes only.
For more thought about the business behind the device, check out Jacob Goldstein’s post over at the WSJ’s Health Blog: Abbott Gets to Join Troubled Stent Market …
Press release with video: FDA Approves Abbott’s XIENCE™ V Drug Eluting Stent …
Product page: XIENCE V …