Thin strut chrome-cobalt stent implantation for treatment of de-novo lesions in small coronary vessels: results of the RISICO Italian Registry (Registro Italiano Mini VISION nei piccolo Vasi) utilizing the Mini VISION coronary stent platform.

OBJECTIVES: The Registro Italiano Mini VISION nei piccoli Vasi registry is a prospective, multicenter, observational study, aimed at assessing immediate and long-term angiographic and clinical outcomes of a small-vessel cobalt-chrome super alloy-dedicated stent (Multi-Link RX VISION) in de-novo and long lesions.
BACKGROUND: Small artery size is an important determinant of poor outcomes in percutaneous coronary interventions.
METHODS: Patients with ischemic heart disease were included. The primary end point was procedural success. Secondary end points included clinical restenosis (need for target lesion revascularization ), incidence of major adverse cardiac events at 6 months, and cost-effectiveness analysis.
RESULTS: Between September 2004 and October 2005, 143 patients (mean age 67 +/- 11 years; 22% diabetes) were enrolled; 6-month follow-up was completed in May 2006. Average lesion length, mean stent length and diameter were 16.8 +/- 7.1, 17.01 +/- 3.9 and 2.41 +/- 0.14 mm, respectively. Procedural success was 96%. At 6-month follow-up, the hierarchical major adverse cardiac event rate was 11.6%, 2.9% deaths, 2.9% myocardial infarction and 5.8% target lesion revascularization. Cost-effectiveness analysis will be reported in a further publication.
CONCLUSION: Small-vessel disease treatment with Mini VISION stents permits an elevated procedural success rate with low incidence of clinical restenosis and major adverse cardiac events at mid-term follow-up. Such results require confirmation by means of a randomized controlled study against drug-eluting stents.