雷帕霉素洗脱支架治疗多支冠状动脉病变的临床研究

Clinical Research of Rapamycin-Eluting Stent in Treatment of Multi-Vessel Coronary Disease

目的:探讨多支冠状动脉病变患者置入雷帕霉素洗脱支架(Cypher支架)预防再狭窄的疗效及安全性。方法:2001年12月-2004年5月连续725例接受多支冠状动脉支架置入术的冠心病患者,剔除急性心肌梗死及再次血运重建患者。Cypher支架组187例,普通金属支架(普通支架)组538例。比较两组支架术后的近期及远期结果。结果:除糖尿病患者比例在Cypher支架组较高外,两组患者冠心病危险因素、心功能、冠状动脉病变严重程度、介入手术成功率及并发症发生率均无显著差异。690例患者平均随访(18.8±11.7)个月,Cypher支架组和普通支架组造影随访率分别为52.4%vs58.2%(P>0.05)。尽管Cypher支架组患者冠心病危险因素多、平均年龄63.5岁、不稳定性心绞痛占66.3%、糖尿病占41.6%、3支血管病变占57.8%、B2/C型复杂病变占86.2%,但造影复查再狭窄率和主要不良心脏事件(MACE)发生率均明显低于普通支架组(3.1%vs16.6%,5.5%vs16.7%,P均<0.01),心功能改善率高于普通支架组(63.1%vs30.6%,P<0.01)。两组完全血运重建率无显著差异(81.3%vs86.8%,P>0.05),但发生MACE的患者中,Cypher支架组不完全血运重建者比例高于普通支架组(60.0%vs23.5%,P<0.05);两组发生MACE的患者中完全血运重建患者比例均低于本组总的完全血运重建率(Cypher支架组:40.0%

Objective: To retrospectively investigate the effectiveness and safety of rapamycin-eluting stent ( Cypher stent) on prevention of restenosis in patients with multi-vessel coronary disease. Methods: From December 2001 to May 2004,a total of 725 patients with multi-vessel coronary disease were treated by multi-vessel stenting. The exclusion criteria were acute myocardial infarction and revascularization, among whom 187 patients were assigned to Cypher stent group and 538 patients to bare metal stent group. Acute and long-term outcomes were compared between the two groups. Results: Baseline clinical characteristics, including risk factors of coronary heart disease, coronary lesion type, heart function, rates of success and complication of Percutaneous coronary intervention (PCI) procedure in the two groups were comparable, except that the rate of diabetic patients was higher in Cypher stent group. Mean follow-up duration of 690 patients was 18. 8 ?11.7 months. Angiographic follow-up rate was similar in the two groups (52. 4% in Cypher stent group vs 58. 2% in bare metal stent group, p >0. 05). Although patients treated by Cypher stent had more risk factors with average age 63. 5 years, 66. 3% with ustable angina, 41.6% with diabetes, 57.8% with triple-vessel disease and 86.2% with complicated B2/C type lesions, the rates of angiographic restenosis and major adverse cardiac events( MACE) were significantly lower(3. 1% vs 16. 6% ,5. 5% vs 16. 7% ,p <0. 01 ) , and the improvement rate of heart function was significantly higher(63. 1% vs 30. 6% ,p <0. 01 ) in Cypher treated group compared with bare metal stent group. Complete revascularization rate was similar in the two groups (81.3% vs 86. 8% ,p >0. 05 ). However, incomplete revascularization rate of patients with MACE in Cypher stent group was significantly higher than that in bare metal stent group (60. 0% vs 23. 5 % , p < 0. 05). Complete revascularization rate of patients with MACE in each group was significantly lower than that in total complete revascularization rate in each group ( Rapamycin-eluting stent group: 40% vs 81. 3% , p <0. 01; Bare metal stent group: 76. 5% vs 86. 8% ,p <0. 05). Conclusions: The Cypther stent treatment implanted for patients with high risk, multi-vessel coronary disease with complicated lesions can achieve high procedural success rate, low rates of complication and restenosis and good long-term clinical outcome. Furthermore, patients with multi-vessel coronary disease, may achieve more benefits from complete revascularization.