Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions
Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions
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DOI：
10.1161/01.cir.0000118474.71662.e3
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发表时间：
2004-03-16
期刊：
影响因子：
37.8
通讯作者：
Leon, MB
中科院分区：
文献类型：
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作者：
Colombo, A;Moses, JW;Leon, MB
背景-西罗莫司洗脱支架（Cypher, Cordis Corp）已报道可显著减少特定病变的再狭窄；包括冠状动脉分叉在内的高风险病变尚未得到研究。方法和结果：这项前瞻性研究评估了西罗莫司洗脱支架治疗冠状动脉分叉病变的安全性和有效性。患者被随机分配到双支支架术（A组）或主支支架术加侧支临时支架术（B组）。85例患者（86个病灶）入组。分岔处有1例设备未成功交付。考虑到高交叉，2个支架治疗的病变（n = 63）多于支架/球囊治疗（n = 22）。所有患者均完成6个月临床随访，A组53例（85.5%），B组21例（95.4%）进行血管造影随访。一名患者在手术后4.5个月突然死亡。支架内血栓形成3例（3.5%）。6个月时总再狭窄率为25.7%，双支架组（28.0%）与临时支架组（18.7%）差异无统计学意义。14例再狭窄发生在SB口，为局灶性再狭窄。靶区重建术7例；靶血管衰竭15例（17.6%）。结论：与使用裸金属支架的历史对照相比，这些结果有所改善。脑脊液再狭窄仍然是一个问题。此时，对于Cypher支架治疗分叉时使用的最合适的技术，没有任何声明。
Background - A sirolimus-eluting stent (Cypher, Cordis Corp) has been reported to markedly decrease restenosis in selected lesions; higher-risk lesions, including coronary bifurcations, have not been studied.Methods and Results - This prospective study evaluated the safety and efficacy of sirolimus-eluting stents for treatment of coronary bifurcation lesions. Patients were randomly assigned to either stenting of both branches ( group A) or stenting of the main branch with provisional stenting of the side branch (SB) ( group B). Eighty-five patients ( 86 lesions) were enrolled. There was 1 case of unsuccessful delivery of any device at the bifurcation site. Given the high crossover, more lesions were treated with 2 stents (n = 63) than with stent/balloon ( n = 22). Clinical follow-up at 6 months was completed in all patients and angiographic follow-up in 53 patients in group A (85.5%) and 21 in group B (95.4%). One patient died suddenly 4.5 months after the procedure. There were 3 cases of stent thrombosis (3.5%). The total restenosis rate at 6 months was 25.7%, and it was not significantly different between the double-stenting (28.0%) and the provisional SB-stenting (18.7%) groups. Fourteen of the restenosis cases occurred at the ostium of the SB and were focal. Target lesion revascularization was performed in 7 cases; target vessel failure occurred in 15 cases (17.6%).Conclusions - These results are an improvement compared with historical controls using bare metal stents. Restenosis at the SB remains a problem. At this time, no statement can be made regarding the most appropriate technique to use when treating bifurcations with the Cypher stent.