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Multi-link Vision and MiniVision stent registry in Asian patients with coronary artery disease: a prospective, multi-center study
Authors: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  Ramesh Gudapati  Ramesh Basavappa  Piamsomboon Chumpol  Kuanprasert Srun  Gwon Hyeon-Cheol  Cho Yoon Haeng  Kamar Haizal Haroon  Huang Cong-Xin
Affiliation:1. Department of Cardiology, Renmin Hospital of Wuhan University,Wuhan 430063, China
2. Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University, Shanghai 200072, China
3. Department of Cardiology, Chang Hai Hospital, Shanghai 200000,China
4. Department of Cardiology, First Affilated Hospital, Chinese Medical University, Shenyang 110000, China
5. Department of Cardiology, Second Affiliated Hospital, Dalian Medical University, Dalian 116000, China
6. Department of Cardiology, Nanfang Hospital, Guangzhou 510000,China
7. SDMH, Jaipur, India
8. Ruby Hall Clinic, Pune, India
9. Ushamullapudi Cardiac Center, Hyderabad, India
10. Sri Jayadeva Institute of Cardiology, Bangalore, India
11. Phramongkutklao Hospital(Army hospital), Bangkok, Thailand
12. Maharaj Nakom Chiang Mai Hospital, Chiang Mai University,Thailand
13. Samsung Medical Center, Seoul
14. Wonju Christian Hospital - Yonsei University, Seoul
15. University Malaya Medical Center, Kuala Lumpur, Malaysia
Abstract:
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.
Keywords:bare metal stents   registry study   Asian population
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