Abbott Vascular Presents Xience V Safety Data

May 25, 2010—Abbott Vascular (Santa Clara, CA) announced that two late-breaking clinical trials presented at the EuroPCR 2010 conference in Paris reinforced clinical data supporting the company's Xience V everolimus-eluting coronary stent system. In the XIENCE V USA study of more than 5,000 complex, real-world patients, the device demonstrated a low rate of stent thrombosis at 1 year (0.84% per Academic Research Consortium [ARC] definition of definite/probable stent thrombosis). In a subset of approximately 1,800 less complex, “standard-risk” patients, Xience V demonstrated a 1-year stent thrombosis rate of 0.34% per ARC definition of definite/probable stent thrombosis.

Abbott Vascular stated that the XIENCE V USA study also showed that stent thrombosis rates remained low even when dual-antiplatelet therapy (DAPT) was temporarily or permanently discontinued. In the overall XIENCE V USA population, patients who interrupted DAPT usage after 6 months showed a subsequent 0% rate of late stent thrombosis. In the subset of standardrisk patients, those who interrupted DAPT usage after 30 days also showed a subsequent 0% late stent thrombosis rate. DAPT compliance in the XIENCE V USA study was 79.4% at 1 year.

XIENCE V USA is a postmarket, single-arm registry evaluating outcomes in 5,054 Xience V patients based in the United States, with follow-up out to 5 years. The study is designed to examine the safety of the Xience V stent in an all-comers patient population from realworld clinical settings. The standard-risk subset included 1,827 patients. The primary endpoint of XIENCE V USA is a measure of stent thrombosis every year out to 5 years, as defined by ARC.

Abbott also presented data from the SPIRIT V Diabetes study, an international randomized clinical trial comparing Xience V to the Taxus Liberté paclitaxel- eluting coronary stent system (Boston Scientific Corporation, Natick, MA) in 324 patients with diabetes. In the trial's primary endpoint of in-stent late loss, Xience V demonstrated superiority to the Taxus Liberté (0.19 vs 0.39 mm; P = .0001).

The SPIRIT V Diabetes trial also showed observational evidence of low event rates for diabetic patients treated with Xience V. The clinical outcomes from the SPIRIT V Diabetes trial are observational, because the trial was not powered to analyze statistical differences in any of the clinical endpoints. The following data were reported:

• In the composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization, Xience V demonstrated an observed 10% reduction compared to Taxus Liberté (11.2% vs 12.5%; P = .71).
• In the composite endpoint of cardiac death and target vessel myocardial infarction, Xience V demonstrated an observed 61% reduction compared to Taxus Liberté (3.7% vs 9.6%; P = .04).
• In the endpoint of cardiac death, Xience V demonstrated an observed rate of 0.5% compared to 2.9% for Taxus Liberté (P = .1).
• In the endpoint of ischemia-driven TLR, Xience V demonstrated an observed rate of 8.4% compared to 3.8% for Taxus Liberté (P = .16).
• In the endpoint of target vessel myocardial infarction, XIENCE V demonstrated an observed rate of 2.8% compared to 8.7% for Taxus Liberté (P = .04).
• In the endpoint of stent thrombosis, Xience V demonstrated no cases of stent thrombosis (ARC definite/probable) at 1 year compared to 1.9% for Taxus Liberté (P = .11).
• Xience V and Abbott's next-generation Xience Prime everolimus-eluting coronary stent systems have received CE Mark approval. Xience V is marketed in the United States, Europe, Japan, and other international markets. Xience Prime is an investigational device in the United States and is not available for sale.