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背景:尽管多项研究证实药物洗脱支架能在病变静脉桥血管中应用,但作者所查目前报道资料较少。目的:回顾性观察药物洗脱支架和裸支架在病变静脉桥血管治疗中管腔晚期丢失和心脏事件发生的关系。设计、时间及地点:分组对照,随访观察,于2002-01/2007-02在北京市通州区潞河医院和北京市安贞医院进行。对象:选择静脉桥血管患者97例,其中药物洗脱支架治疗50例,裸支架治疗47例。方法:行标准的经皮支架置入,置入后即刻进入临床随访,置入后12个月复查桥血管造影。主要观察指标:管腔晚期丢失,心脏事件(死亡,心肌梗死,靶血管和/或靶血管重建)。结果:两组性别、年龄、桥血管年龄、合并症等基线资料比较,差异无显著性意义(P>0.05),具有可比性。①药物洗脱支架组50例患者,在59处病变中置入了71枚药物支架,裸支架组47例患者在59处病变中置入了62枚裸支架。药物洗脱支架组操作成功率为94.0%,裸支架组为93.6%(P=0.43)。②12个月临床随访,药物洗脱支架组心脏事件发生率明显低于裸支架组(12.0%vs.29.8%,P=0.03)。共有54例患者进行了造影随访,其中药物洗脱支架组26例,裸支架组28例,药物洗脱支架组管腔晚期丢失明显低于裸支架组[(0.32±0.65)mmvs.(0.79±1.23)mm,P=0.01]。药物洗脱支组架靶血管重建率为6.0%,裸支架组为19.1%(P=0.05)。③Cox回归分析表明12个月随访时心脏事件的独立预测因子是裸支架(OR:2.86;CI:0.98to8.34;P=0.05),每一处病变所置入的支架数目(OR:2.92;CI:1.25to6.82;P=0.01)和糖尿病(OR:2.37;CI:0.95to5.88;P=0.064)。结论:和裸支架相比,药物洗脱支架治疗病变静脉桥血管可以明显地降低晚期管腔丢失,从而减少心脏事件的发生。
BACKGROUND: Although many studies have demonstrated that drug-eluting stents can be used in diseased venous bridging vessels, there are few reports of data reported by the authors. OBJECTIVE: To retrospectively observe the relationship between the late loss of lumen and the occurrence of cardiac events in drug-eluting stents and bare stents. DESIGN, TIME AND SETTING: Grouping control and follow-up observation were performed at Luhe Hospital, Tongzhou District, Beijing and Anzhen Hospital, Beijing from January 2002 to February 2007. PARTICIPANTS: Ninety-seven patients with venous bridging were selected, of whom 50 were treated with drug-eluting stents and 47 were treated with bare stents. Methods: The standard percutaneous stent implantation, into the clinical follow-up immediately after implantation 12 months after the review of the bridge angiography. MAIN OUTCOME MEASURES: Late luminal loss, cardiac events (death, myocardial infarction, target vessel and / or target vessel remodeling). Results: There was no significant difference between the two groups in baseline data such as sex, age, bridge age and comorbidity (P> 0.05). ① In the 50 drug-eluting stents group, 71 drug stents were placed in 59 lesions, and 47 patients in the bare stent group had 62 bare stents in 59 lesions. The successful rate was 94.0% for the drug-eluting stent group and 93.6% for the bare-metal stent group (P = .43). ②12 months clinical follow-up, the incidence of cardiac events in the drug-eluting stent group was significantly lower than that in the bare stent group (12.0% vs.29.8%, P = 0.03). A total of 54 patients underwent angiographic follow-up. Among them, there were 26 cases in the drug-eluting stent group and 28 cases in the bare stent group. The late luminal loss in the drug-eluting stent group was significantly lower than that in the bare-stent group [(0.32 ± 0.65) mm vs 0.79 ± 1.23) mm, P = 0.01]. The target vessel remodeling rate was 6.0% for drug-eluting stents and 19.1% for bare-stent stents (P = 0.05). Cox regression analysis showed that the independent predictors of cardiac events at 12-month follow-up were bare-stents (OR: 2.86; CI: 0.98 to 8.34, P = 0.05) CI: 1.25 to 6.82; P = 0.01) and diabetes (OR: 2.37; CI: 0.95 to 5.88; P = 0.064). Conclusion: Compared with bare stent, drug-eluting stents can significantly reduce the loss of late lumen and reduce the incidence of cardiac events.