目的: 报道VIVE试验的研究结果.

方法与结果: 我们组织的是一个观察性、前瞻性、多中心、非随机的上市后注册研究，目的是为了观察一种新型的裸金属支架(BMS) -MULTI-LINK (ML) VISION / ML MINIVISION支架的有效性。试验的主要终点是6个月内再次行靶病变血管血运重建的比率(TLR)。 次要终点主要是: (1)住院期间及6个月时的主要心血管不良事件(MACE) 及严重不良事件 (SAE); (2) 各种类型心绞痛患者的TLR。本试验从亚洲地区的14个中心共入选了430例患者，治疗的病变血管共为449个。参考血管直径为 3.0±0.5mm， 病变的平均长度为15.7±5.0 mm。 支架植入的成功率的为99.3%。有25%的病变未作预扩张而行直接支架植入。86%的病变植入的是ML VISION支架。 6个月时的TLR 为1.4%.，而 MACE， SAE 和 TVR分别为 6.8%， 3.5% 和 1.4%。

结论:作为一种新型的BMS， MULTI-LINK (ML) VISION / ML MINIVISION支架显示出了令人满意的即刻和远期效果。它尤其适用于靶病变参考直径为3.0mm ~ 4.0mm的高龄患者，或者是不能耐受长期口服氯吡格雷的患者。

MULTI-LINK VISION and MINIVISION Stent Registry (VIVE) in Asian Patients with Coronary Artery Disease- a prospective， multi-center study

Xu Yawei， Wei Yidong， Li Weiming， Tang Kai， Chen Yan-qing， Yu Xuejing
Department of Cardiology， Shanghai Tenth People’s Hospital， Tong Ji University， Shanghai 200072， China

Background: The fine mesh stents are associated with a significant reduction in both clinical and angiographic re-stenosis of the coronary arteries in recent studies.  In order to maintain a very satisfactory radio-opacity using the stents， Guidant has designed a new type of bare metal stents (BMS) -MULTI-LINK (ML) VISION / ML MINIVISION stent. We investigate the clinical outcomes of Asian patients with coronary artery disease after implanting the Multi-link Vision or MiniVision stent.
Methods: We conducted an observational， prospective， multi-center， non-randomized post marketing registry to demonstrate the efficacy of a new type of bare metal stents (BMS) -MULTI-LINK (ML) VISION / ML MINIVISION stent. The primary end point of the trial was clinical target lesion revascularization (TLR) at 6 months follow up. The major secondary end points included: (1) The rate of major adverse cardiac events (MACE) and serious adverse events (SAE) in-hospital at 6 months. (2) The rate of clinical TLR was as a function of the type of angina. There were totally 429 Asian populations with 449 lesions from 14 sites enrolled to this study. The average reference diameter was 3.0±0.5mm， and mean lesion length was 15.7±5.0 mm. 

Results: Successful rate of procedure was 99.3%. Twenty-five percents of lesions were treated by direct stenting without pre-dilation. Eighty-six of lesions were implanted with ML VISION. After 6-months follow up， clinical TLR was 1.4%. The MACE， SAE and TVR were 6.8%， 3.5% and 1.4%.

Conclusions: The current registry showed the excellent procedural outcomes， early and late clinical outcomes of Asian patients with CAD treated with MULTI-LINK VISION / ML MINIVISION stents.