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真实世界人群中ABSORB生物可吸收血管支架与依维莫司洗脱支架植入早期临床结局的比较

Comparison of early clinical outcomes between ABSORB bioresorbable vascular scaffold and everolimus-eluting stent implantation in a real-world population.

作者信息

Costopoulos Charis, Latib Azeem, Naganuma Toru, Miyazaki Tadashi, Sato Katsumasa, Figini Filippo, Sticchi Alessandro, Carlino Mauro, Chieffo Alaide, Montorfano Matteo, 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. 2015 Jan 1;85(1):E10-5. doi: 10.1002/ccd.25569. Epub 2014 Jul 16.

DOI:10.1002/ccd.25569
PMID:24909303
Abstract

OBJECTIVES

To compare the early clinical outcomes between ABSORB bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA) and cobalt chromium everolimus-eluting stents in real-world patients with mostly complex disease.

BACKGROUND

BVS represents the most interesting development in the drug-eluting stent field over recent years with promising results emerging from clinical trials. Available data however on the use of the ABSORB in real-world patients is limited.

METHODS

All patients (n = 92) treated with BVS and 1296 patients treated with EES were included in this study. Propensity score matching was performed to adjust for differences in baseline clinical characteristics, yielding 92 patient pairs (BVS = 92 patients with 137 lesions and EES = 92 patients with 124 lesions). Clinical outcomes were examined between the 2 groups at 6-months.

RESULTS

In both groups, most lesions were classified as either B2 or C (83.9% vs. 77.4%, P = 0.19). Predilatation (97.8% vs. 75.8%, P < 0.01) as well as postdilation (99.3% vs. 77.4%, P < 0.01) was more common in the BVS group. Clinical outcomes at 6-months were similar between the two groups with respect to both target lesion revascularization (3.3% vs. 5.4%, P = 0.41) and major adverse cardiac events (defined as the composite of target vessel revascularization, follow-up myocardial infraction and all-cause death) (3.3% vs. 7.6%, P = 0.19).

CONCLUSIONS

ABSORB BVS for the treatment of complex lesions appears to be associated with good procedural and early clinical outcomes similar to those observed with conventional drug-eluting stents. Larger studies with long-term follow-up are required in order to fully assess the role of BVS in the treatment of such lesions and how this compares with that of conventional stents. © 2014 Wiley Periodicals, Inc.

摘要

目的

比较在患有大多数为复杂疾病的真实世界患者中,ABSO RB生物可吸收血管支架(BVS)(雅培血管,加利福尼亚州圣克拉拉)与钴铬依维莫司洗脱支架的早期临床结果。

背景

BVS是近年来药物洗脱支架领域最引人关注的进展,临床试验已出现有前景的结果。然而,关于在真实世界患者中使用ABSO RB的现有数据有限。

方法

本研究纳入了所有接受BVS治疗的患者(n = 92)和1296例接受依维莫司洗脱支架(EES)治疗的患者。进行倾向评分匹配以调整基线临床特征的差异,产生92对患者(BVS = 92例患者,有137处病变;EES = 92例患者,有124处病变)。在6个月时检查两组之间的临床结果。

结果

在两组中,大多数病变分类为B2或C(83.9%对77.4%,P = 0.19)。预扩张(97.8%对75.8%,P < 0.01)以及后扩张(99.3%对77.4%,P < 0.01)在BVS组中更常见。两组在6个月时的临床结果在靶病变血运重建(3.3%对5.4%,P = 0.41)和主要不良心脏事件(定义为靶血管血运重建、随访心肌梗死和全因死亡的复合事件)(3.3%对7.6%,P = 0.19)方面相似。

结论

用于治疗复杂病变的ABSO RB BVS似乎与良好的手术操作和早期临床结果相关,类似于传统药物洗脱支架所观察到的结果。需要进行更大规模的长期随访研究,以全面评估BVS在治疗此类病变中的作用以及与传统支架相比的情况。© 2014威利期刊公司

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