Cobalt-Chromium KAname? coRonary stEnt System in the treatment of patients with coronary artery disease (kare study)

摘要

Objectives To evaluate the safety and effectiveness of the Kaname? cobalt-chromium (Co-Cr), thin strut, bare metal stent (BMS) system for the treatment of coronary artery lesions.Background Despite widespread use of drug-eluting stents, a certain percentage of patients with coronary artery disease are still treated with BMS. Therefore, it is essential to evaluate their clinical performance.Methods Two hundred eighty-two patients were enrolled in this prospective, single-arm study including a predefined subset of 79 patients with small vessels. The primary end-point was freedom from target vessel failure (TVF) at 6 months. Key angiographic and intravascular ultrasound (IVUS) end-points were late loss, diameter stenosis, binary restenosis, and neointimal hyperplasia volume.Results Freedom from TVF at 6 months was 93.3% and at 1 year 90.8% in total population, and 92.4% and 87.3% in small vessels, respectively. Clinically driven target lesion revascularization (TLR) rates at 6 and 12 months were 4.3% and 6.4% in total population, and 3.8% and 7.6% in small vessels, respectively. At 6 months in-stent late loss was 0.75 plusmn; 0.43 mm and binary restenosis rate was 16.9% in total population, and 0.64 plusmn; 0.40 mm and 26.1% in small vessels, while IVUS assessed neointimal hyperplasia volume at 6 months was 128.9 plusmn; 42.6 mm3 for total population. There were no definite and probable stent thromboses up to 12 months.Conclusions Results indicate good safety and effectiveness of the Kaname? stent with clinically equivalent results in small and larger vessels, as such providing useful treatment option for patients with ischemic heart disease considered for BMS implantation. (J Interven Cardiol 2014;27:491-499)