The everolimus-eluting stent, Xience V has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW), Abbott has announced. Japan is the second largest drug-eluting stent market worldwide, after the United States, with approximately 200,000 stent procedures performed each year. The company plans to launch Xience V in Japan in the upcoming weeks, immediately following final reimbursement authorisation.
“Xience V is flexible and easy to deliver through the coronary anatomy to the lesion site. These attributes combined with the strength of the safety and efficacy data supporting it give me confidence that Xience V is a true next-generation stent that has the potential to benefit heart patients in Japan,” said Shigeru Saito, director, Cardiology and Catheterisation Laboratories, Shonan Kamakura General Hospital, and principal investigator for the SPIRIT III Japan Registry.
The outstanding data for Xience V includes clinically superior long-term efficacy and safety results in the primary endpoints of the pivotal trials, and among the SPIRIT family of trials. The SPIRIT III Japan Registry of 88 patients demonstrated similar angiographic and clinical results to the outstanding outcomes from the SPIRIT III US trial. In the SPIRIT III Japan Registry, Xience V demonstrated a single-digit rate of major adverse cardiac events (MACE, 8%), and no cases of stent thrombosis (blood clots) out to one year.
In the SPIRIT III US trial, Xience V demonstrated an impressive low rate of very late stent thrombosis with no additional events between two and three years, and a 43% reduction in the risk of MACE compared to the Taxus Express paclitaxel-eluting coronary stent system at three years (9.1% for Xience V vs. 15.7% for Taxus, p-value=0.003).
In SPIRIT IV, one of the largest randomised trials comparing two drug-eluting stents, Xience V demonstrated a statistically significant 39% reduction in target lesion failure (TLF) compared to Taxus at one year (3.9% percent for XIENCE V vs. 6.6% for Taxus, p-value=0.0008). TLF is a composite measure of important efficacy and safety outcomes for patients and includes cardiac death, target vessel MI and ID-TLR. Xience V also had an exceptionally low rate of stent thrombosis out to one year, with a 74% reduction in definite/probable stent thrombosis per the Academic Research Consortium (ARC) definition compared to TAXUS (0.29% for Xience V and 1.1% percent for Taxus, p-value=0.004).