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

作者:Xu, Ya-wei; Wei, Yi-dong; Tang, Kai; Chen, Yan-qing; Li, Wei-ming; Yu, Xue-jing; Qin, Yong-wen; Qi, Guo-xian; Qu, Peng; Hou, Yu-qing; Jain, Ashok; Grant, Parvez; Gudapati, Ramesh; Basavappa, Ramesh; Piamsomboon, Chumpol; Kuanprasert, Srun; Gwon, Hyeon-Cheol; Cho, Yoon Haeng; Kamar, Haizal Haroon; Huang, Cong-xin*
来源:Chinese Medical Journal, 2007, 120(12): 1093-1096.
DOI:10.1097/00029330-200706020-00012

摘要

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 stants, 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.