Novo Drug Eluting da Abbott

O tão anunciado drug eluting da Abbott a dar os primeiros passos.

FDA Approves Abbott's Everolimus Eluting Stent

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.

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 ...

Link: www.medgadget.com