Multi-link Vision and MiniVision stent registry in Asian patients with coronary artery disease: a prospective, multi-center study.

Background Recent studies have showed that the fine mesh stents are associated with a significant reduction in both clinical and angiographic re-stenosis of the coronary arteries.To maintain a very satisfactory radio-opacity using the stents,Guidant of the USA has designed a new type of bare metal stents (BMS)-Multi-link (ML) Vision/ML MiniVision stents.The clinical outcomes of Asian patients with coronary artery disease (CAD) after implanting the Multi-link Vision or MiniVision stent were investigated in this study. Methods An observational,prospective,multi-center,non-randomized post marketing registry was conducted to demonstrate the efficacy of the BMS- ML Vision/ML MiniVision stents.The primary end point of the registry was clinical target lesion revascularization (TLR) at a 6-month follow-up.The major secondary end points included the rate of major adverse cardiac events (MACE) and serious adverse events (SAE) in hospital and at 6 months;and the rate of clinical TLR as a function of the type of angina.A total of 429 Asian people with 449 lesions from 14 centers were selected for this study.The average reference diameter of the lesions was (3.0±0.5) mm,and the mean length was (15.7±5.0) mm. Results The successful rate of the procedure was 99.3%.Twenty-five percent of the lesions were treated by direct stenting without pre-dilation.Eighty-six percent of the lesions were implanted with ML Vision stent.After the 6-month follow-up,the rate of clinical TLR was 1.4%.The MACE,SAE and target vessel revascularization (TVR) were 6.8%,3.5% and 1.4% respectively. Conclusion The current registry showed the excellent 6-month clinical outcomes of ML Vision/ML MiniVision stents in Asian patients with CAD. Chin Med J 2007;120(12):1093-1096