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目的 研究雷帕霉素药物洗脱支架对国人自身冠状动脉第一次进行介入治疗的病变减少再狭窄的效果及安全性。方法 本试验为在 2个中心进行的开放、前瞻性研究。入选标准包括对单一病变 (2 5mm≤靶病变直径≤ 3 0mm)进行治疗 ,长度≤ 30mm ,至少TIMI 1级血流。排除标准包括无保护的左主干病变、开口部病变、左室射血分数≤ 2 5 %、完全闭塞病变 (TIMI 0级 )以及分叉病变侧支直径≥ 2 5mm者。术后 1、3和 6个月进行临床随访 ,术后 6个月造影随访 ,核心试验室 (纽约心血管研究基金会 )进行QCA分析。结果 4 1例患者入选本研究 ,其中男性 30例 (占 73 2 % ) ,平均年龄 (5 8 6± 11 0 )岁 ,合并糖尿病患者 12例 (占 2 9 3% )。基础冠状动脉造影示参考血管直径(2 5 8± 0 35 )mm ,最小管腔直径 (MLD) (0 77± 0 33)mm ,直径狭窄 (DS % )为 (6 9 77± 12 16 ) % ,病变长度 (14 2 7± 3 72 )mm。支架置入后 ,MLD支架内 (2 4 4± 0 2 8)mm ,节段内 (2 15± 0 38)mm ;DS %支架内 (8 5 8± 9 18) % ,节段内 (19 92± 9 99) %。 6个月造影随访 ,MLD支架内 (2 4 7±0 32 )mm ,节段内 (2 0 6± 0 38)mm ;DS %支架内 (6 6 9± 10 5 3) % ,节段内 (2 2 5 9± 10 2 1) % ;晚期管腔丧失支架内为 ( 0
Objective To study the effect and safety of rapamycin-eluting stent in the reduction of restenosis in the first interventional treatment of Chinese coronary artery. Methods This is an open-ended, prospective study in two centers. Inclusion criteria included treatment of a single lesion (2 mm ≤ target lesion diameter ≤ 30 mm), length ≤ 30 mm, and at least TIMI grade 1 blood flow. Exclusion criteria included unprotected left main disease, open lesion, left ventricular ejection fraction ≤ 25%, complete occlusion (grade TIMI 0), and bifurcation collateral diameters ≥ 2 5 mm. Follow-up was performed at 1, 3, and 6 months postoperatively, angiographic follow-up was performed 6 months after surgery, and QCA analysis was performed in the core laboratory (New York Cardiovascular Research Foundation). Results A total of 41 patients were enrolled in this study. Among them, 30 males (73.2%) and mean age (586 ± 11 0) years old had diabetes mellitus (12.3%). The baseline coronary angiography showed a reference vessel diameter of 25 58 ± 0 35 mm, a minimum luminal diameter of (0 77 ± 0 33) mm and a diameter stenosis of (DS%) of (6 9 77 ± 12 16)% , The length of the lesion was (14 2 7 ± 3 72) mm. After the stent was placed in the MLD stent, the internal diameter of the MLD stent was (224 ± 028) mm, and the internal diameter of the MLD stent was (215 ± 038) mm; 92 ± 9 99)%. The follow-up of 6 months was performed in MLD stent (247 ± 032) mm, within the segment (206 ± 038) mm; within DS% stent (6 6 9 ± 10 5 3)%, (2 2 5 9 ± 10 2 1)%; late stent loss within the stent (0