Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel Meeting on the Xience V Everolimus-Eluting Coronary Stent

Abstract

The Xience V Everolimus-Eluting Coronary Stent System (Abbott Vascular, Santa Clara, California) drug-eluting stent (DES) is the most recent stent to undergo an extensive evaluation based on the initial requirements for DES approval. Safety and efficacy data were presented in a public meeting of the Food and Drug Administration (FDA) Circulatory System Devices Panel in November 2007. The sponsor presented data from their pre-clinical program demonstrating polymeric biocompatibility and a pharmacokenitic profile with complete drug elution by 4 months. Both the sponsor and FDA presented clinical efficacy and safety data from the SPIRIT trials. The EES demonstrated consistent late loss across the SPIRIT trials both in-stent and in-segment, including among subgroups of patients and lesions. Within this trial series, the primary endpoints were met in all studies with the establishment of superiority to both bare metal stents (BMS) and paclitaxel-eluting stents (PES) with respect to late loss and non-inferiority to PES with respect to target vessel failure through 9 months. The safety profile was reviewed by both presenters, demonstrating no evidence of an abnormal DES class-effect increase in stent thrombosis up to and between 1 and 2 years for the available data. The sponsor outlined an extensive integrated pre- and post-approval clinical program to further monitor potential safety concerns surrounding this class of stents. The Panel voted in favor of approval with conditions similar to those posed to the other DES; with FDA subsequently approving the stent for US commercial sale on July 2, 2008.