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腔内可生物降解聚合物生物雷帕霉素洗脱支架与持久聚合物依维莫司洗脱支架治疗冠状动脉分叉病变的比较。

Comparison of abluminal biodegradable polymer biolimus-eluting stents and durable polymer everolimus-eluting stents in the treatment of coronary bifurcations.

作者信息

Costopoulos Charis, Latib Azeem, Naganuma Toru, Sticchi Alessandro, Ferrarello Santo, Regazzoli Damiano, Chieffo Alaide, Figini Filippo, Carlino Mauro, Montorfano Matteo, Naim Charbel, Kawaguchi Masanori, Gerasimou Argyrios, Giannini Francesco, Godino Cosmo, Colombo Antonio

机构信息

Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy; Imperial College London, London, United Kingdom.

出版信息

Catheter Cardiovasc Interv. 2014 May 1;83(6):889-95. doi: 10.1002/ccd.25087. Epub 2013 Jul 19.

Abstract

OBJECTIVES

To compare biodegradable polymer biolimus-eluting (BES) with abluminal drug elution and durable polymer everolimus-eluting (EES) stents in the treatment of bifurcation lesions.

BACKGROUND

The persistence of a polymer in drug-eluting stents (DES) following drug elution has been viewed as a possible culprit for restenosis. DES with biodegradable polymer may thus be associated with improved clinical outcomes, especially in high-risk lesions such as those at bifurcation sites.

METHODS

We performed a retrospective study of consecutive de novo bifurcation lesions treated with EES between October 2006 and October 2011 and BES between February 2008 and March 2012. Study endpoints included major adverse cardiac events (MACE) defined as all-cause death, myocardial infarction (MI), including peri-procedural MI, and target vessel revascularization (TVR) as well as target lesion revascularization (TLR) separately.

RESULTS

We analyzed 236 bifurcation lesions treated with either BES (79 lesions in 69 patients) or EES (157 lesions in 154 patients). Patient and procedural characteristics were broadly similar between the two groups. Estimated MACE and TVR rates at 2-year follow-up were similar between the BES and EES groups (MACE = 13.6 ± 4.6% vs. 14.6 ± 3.2% (P = 0.871); TVR = 6.9 ± 3.5% vs. 8.0 ± 2.7% (P = 0.889). No significant differences were noted between the two groups following propensity-score matched analysis. There was no probable or definite stent thrombosis.

CONCLUSION

BES use in the treatment of bifurcation lesions appears to be associated with good clinical outcomes, comparable to those seen with EES, at long-term follow-up. These results are hypothesis-generating and need to be validated with larger studies.

摘要

目的

比较具有管腔外药物洗脱功能的可生物降解聚合物生物雷帕霉素洗脱(BES)支架与具有持久聚合物的依维莫司洗脱(EES)支架在分叉病变治疗中的效果。

背景

药物洗脱支架(DES)在药物洗脱后聚合物的持续存在被视为再狭窄的一个可能原因。因此,具有可生物降解聚合物的DES可能与更好的临床结果相关联,尤其是在诸如分叉部位病变等高风险病变中。

方法

我们对2006年10月至2011年10月期间接受EES治疗以及2008年2月至2012年3月期间接受BES治疗的连续性新发分叉病变进行了一项回顾性研究。研究终点包括主要不良心脏事件(MACE),定义为全因死亡、心肌梗死(MI),包括围手术期MI,以及分别的靶血管血运重建(TVR)和靶病变血运重建(TLR)。

结果

我们分析了236例接受BES(69例患者中的79个病变)或EES(154例患者中的157个病变)治疗的分叉病变。两组患者和手术特征大致相似。BES组和EES组在2年随访时估计的MACE和TVR率相似(MACE = 13.6±4.6% 对 14.6±3.2%(P = 0.871);TVR = 6.9±3.5% 对 8.0±2.7%(P = 0.889)。倾向评分匹配分析后两组间未观察到显著差异。未发生可能或明确的心梗后支架内血栓形成。

结论

在长期随访中,BES用于治疗分叉病变似乎与良好临床结果相关联,与EES所见结果相当。这些结果只是初步推测性结论,需要更大规模研究加以验证。

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