Clinical and angiographic outcomes after Tsunami coronary stent placement.

STUDY AIM: The aim of this study was to determine six months restenosis rate measured by off-line quantitative coronary angiography, and to assess the efficacy and safety of newly developed six cells Tsunami stent system for the treatment of symptomatic, de novo, native coronary artery lesions. STUDY DESIGN AND METHODS: Between January and August 2001, 100 patients with 120 lesions were included at four clinical sites in this prospective, non-randomized, single arm study. In 35% of the patients two or more stents were implanted, 15% of the lesions were stented with more than one stent and 46% of the lesions were in small vessels (

Randomized study to compare balloon angioplasty and elective stent implantation in venous bypass grafts: the Venestent study.

The aim of the study was to compare acute and long-term angiographic and clinical outcome of balloon angioplasty and elective stenting in de novo lesions in the body of a saphenous vein graft (SVG). A total of 150 patients, with de novo lesions in SVG, were randomly assigned to balloon angioplasty or elective Wiktor I stent implantation. The angiographic restenosis rate at 6-month follow-up was 32.8% in the balloon group and 19.1% in the stent group (P = 0.069). At 1-year follow-up, target vessel revascularization rate was 31.4% vs. 14.5% (P < 0.05), and event-free survival was 60.0% vs. 76.3% (P < 0.05) for the balloon and stent group, respectively. Elective stent implantation in de novo SVG lesions is associated with a significant lower target vessel revascularization rate and a significant higher event-free survival at 1-year follow-up as compared to balloon angioplasty.