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雷帕霉素药物释放支架在分支病变中表现优于裸
研究的全文发表在2004年2月23日出版的《循环》杂志上。
在分支病变中的支架植入策略
在早先的关于雷帕霉素药物释放支架的研究中，分支病变的患者是被排除在外的，包括在美国进行的SIRIUS研究。在更早一些研究中，裸支架显示了在分支病变中比球囊血管成形术更好的效果，但是否药物释放支架能够做得更好没有人知道，也没有相关的证据。
Colombo和他的同事们比较了85名患者（共86处病变）在使用两种支架后的表现。一半患者随机的只接受主支支架植入，同时在侧支中进行球囊扩张或临时支架植入（支架/PTCA）。另一半则在两个分支中都放置支架(支架/支架)。所采用的支架都是Cypher。
他们报告说在超过一半的支架/PTCA组患者中，单纯的球囊成形术不能在侧支血管中产生充分的血流，这类患者最终被转入到支架/支架组。而在支架/支架组中，只有两名患者转入了支架/PTCA组，理由是没有足够的放置支架的位置。
在随访中，再狭窄率在主支中相对较低（节段再狭窄率6.1%），这一数字与SIRIUS研究中的非分支病变节段再狭窄率相当。在侧支中的再狭窄率则相当高，这使得总体的节段再狭窄率达到了25.7%。尽管如此，这一数字仍比用裸支架进行的其他关于分支病变的研究低。用两个支架处理的患者在再狭窄方面未表现出比支架/PTCA术患者更明显的优势，比例分别为28%和18.7%，二者没有显著性差别。
在平均六个月的随访期间，一名患者发生了猝死，三名患者发生了支架内血栓，这些不良事件均发生在支架/支架组中。另外，靶血管失败率在支架/支架组中也高于支架/PTCA组。作者强调说这一在支架/支架组中高发的比例部分程度上反映的是那些从支架/PTCA组中转入的复杂病变患者的情况，球囊成形术不足以解决这样的问题。另外，主支的平均血管直径为2.6mm，侧支的为2.1mm，这从一个侧面证实了Cypher支架在小血管病变中的出众效果。
尚待解决的问题
目前处理分支病变的态度是只在主支中放置支架，但此项处理循证医学方面的证据不足。作者认为，正在实验的culotte（裙裤）和T型支架技术也许是解决这一问题的好方法。尽管Cypher在处理这类问题时比裸支架更有优势，但侧支中的高再狭窄率在临床中也将是一个很大的顾虑。
医心网摘译 2004-03-02
原文见Circulation. 2004 Feb 23 [Epub ahead of print]
附原文摘要：
Randomized Study to Evaluate Sirolimus-Eluting Stents Implanted at Coronary Bifurcation Lesions.
Colombo A, Moses JW, Morice MC, Ludwig J, Holmes DR Jr, Spanos V, Louvard Y, Desmedt B, Di Mario C, Leon MB.
EMO Centro Cuore Columbus, Milan, Italy.
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. 此文确实为药物支架应用与分叉病变提供了有力的依据，做了86例分叉病变实属不易。 [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-07-09 12:04
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