Abbott's XIENCE V® Approved in Japan
Second Largest Drug Eluting Stent Market Worldwide Launch in Japan to Begin Immediately Following Final Reimbursement Authorization
Abbott (Abbott Park, Illinois) announced in January that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its XIENCE V® Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. Japan is the second largest drug-eluting stent market in the world 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 authorization.
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 U.S. trial. In the SPIRIT III Japan Registry, XIENCE V demonstrated a single-digit rate of major adverse cardiac events (MACE, 8.0%), and no cases of stent thrombosis (blood clots) out to 1 year. MACE was defined as cardiac death, heart attack (all myocardial infarction or MI), or ischemia-driven target lesion revascularization (ID-TLR).
In the SPIRIT III U.S. trial, XIENCE V demonstrated an impressive low rate of very late stent thrombosis, with no additional events between 2 and 3 years, and a 43 percent reduction in the risk of MACE compared to the TAXUS® Express2 Paclitaxel-Eluting Coronary Stent System (TAXUS) at 3 years (9.1% for XIENCE V vs. 15.7%for TAXUS, p-value = 0.003).
In SPIRIT IV, one of the largest randomized trials comparing two DES, XIENCE V demonstrated a statistically significant 39% reduction in target lesion failure (TLF) compared to TAXUS at 1 year (3.9% for XIENCE V vs. 6.6%for TAXUS, p-value = 0.0008).[1] 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 1.10% for TAXUS, p-value = 0.004).
Additionally, in the investigator-initiated COMPARE trial of real-world patients, XIENCE V demonstrated significantly better outcomes in key safety and efficacy measures compared to the TAXUS® Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS). At 1 year, XIENCE V demonstrated a statistically significant 31% reduction in MACE compared to TAXUS (6.2% XIENCE V vs. 9.1% TAXUS, p-value = 0.023),[2] and a statistically significant 74% reduction in stent thrombosis compared to TAXUS (0.7% XIENCE V vs. 2.6% TAXUS, p-value = 0.002).[2] In the COMPARE trial, MACE is defined as all death, non-fatal MI and target vessel revascularization.
XIENCE V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions less than or equal to 28 mm). Additional information about XIENCE V, including important safety information, is available online at: www.xiencev.com
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1. Event rates are based on Kaplan-Meier estimates; p-values based on log-rank test.
2. Event rates are based on Kaplan-Meier estimates.
