One-Year SPIRIT Small-Vessel Data Support Abbott Vascular's Xience Nano

October 1, 2012—Results from the SPIRIT Small-Vessel (SV) study were published by Louis A. Cannon, MD, et al in Catheterization and Cardiovascular Interventions (2012;80:546–553). SPIRIT SV  was designed to evaluate the safety and effectiveness of the 2.25-mm Xience V (Xience Nano, Abbott Vascular, Santa Clara, CA) everolimus-eluting coronary stent system in patients with small vessels and ischemic heart disease.

As summarized in Catheterization and Cardiovascular Interventions, the core sizes of the Xience V system are associated with low rates of restenosis and thrombosis in the general population, but the Xience Nano everolimus-eluting coronary stent system has not been tested in the United States. This prospective, single-arm, open-label study was conducted at 33 centers and in 150 patients in the United States. The primary endpoint was the target lesion failure (TLF) rate at 1 year, required to meet the prespecified performance goal of 20.4%, derived from historical data.

The investigators reported that the mean patient age was 63 years, 38% were women, 39.2% were diabetic, 49.3% had multivessel disease, and the reference vessel diameter was 2.13 ± 0.23 mm. The 1-year TLF rate was 8.1% with an upper limit of the one-sided 95% confidence interval of 13%, which met the performance goal of 20.4% (P < .0001). At 1 year, the rate of cardiac death was 1.5%, the target vessel myocardial infarction rate was 1.5%, and the clinically indicated target lesion revascularization rate was 5.1%. The 8-month angiographic in-stent late loss was 0.2 ± 0.4 mm, respectively. The 1-year Academic Research Consortium-defined definite/probable stent thrombosis rate was 1.5%.

Based on the 1-year clinical and 8-month angiographic SPIRIT SV data, the Xience Nano everolimus-eluting coronary stent system is considered safe and effective in the treatment of small vessels, concluded the investigators in Catheterization and Cardiovascular Interventions.