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用于治疗慢性完全闭塞病变的生物可吸收血管支架:一项国际多中心注册研究

Bioresorbable Vascular Scaffolds for the Treatment of Chronic Total Occlusions: An International Multicenter Registry.

作者信息

Mitomo Satoru, Naganuma Toru, Fujino Yusuke, Kawamoto Hiroyoshi, Basavarajaiah Sandeep, Pitt Michael, Yin Wei-Hsian, Tresukosol Damras, Colombo Antonio, Nakamura Sunao

机构信息

From the Department of Cardiology, New Tokyo Hospital, Chiba, Japan (S.M., T.N., Y.F., H.K., S.N.); Department of Interventional Cardiology, Heart of England NHS Trust, Birmingham, United Kingdom (S.B., M.P.); Division of Cardiology, Cheng Hsin Geneal Hospital, Taipei, Taiwan (W.-H.Y.); Division of Cardiology, Siriraj Hospital, Bangkok, Thailand (D.T.); Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy (H.K., A.C.); and Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy (H.K., A.C.).

出版信息

Circ Cardiovasc Interv. 2017 Jan;10(1). doi: 10.1161/CIRCINTERVENTIONS.116.004265.

DOI:10.1161/CIRCINTERVENTIONS.116.004265
PMID:28069611
Abstract

BACKGROUND

There are only limited studies reporting clinical outcomes after bioresorbable vascular scaffold (BVS; Absorb; Abbott Vascular, Santa Clara, CA) implantation for coronary chronic total occlusions (CTO). The aim of this study was to evaluate the real-world feasibility and safety of BVS implantation for the treatment of CTO.

METHODS AND RESULTS

We retrospectively evaluated CTO cases treated with BVS from a multicenter registry. The primary end point was target lesion failure defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization. From September 2012 to November 2015, 65 patients with CTO were successfully treated with BVS. The mean age of patients was 60.8±11.0 years; 89.2% were male and 40.0% diabetic. The mean ejection fraction was 57.7±10.8%. The mean reference vessel diameter and CTO lesion length were 3.0±0.4 and 20.2±3.0 mm, respectively. The mean number of BVS deployed per patient was 1.8±0.7, of which mean diameter and total length were 3.0±0.4 and 47.6±19.9 mm, respectively. Postdilatation with noncompliant balloons (mean diameter 3.3±0.3 mm) was performed at high pressures (18.6±5.3 atm) in all cases. Intravascular ultrasound (n=34) or optical coherence tomography (n=31) was performed in all cases. During the follow-up period (median: 453 days, 25th and 75th percentiles: 230 and 703), there were no occurrences of target lesion failure or scaffold thrombosis.

CONCLUSIONS

BVS implantation for the treatment of CTO seems feasible and safe. Appropriate lesion preparation, high-pressure postdilatation, and the use of intravascular imaging are recommended to obtain the best possible final result.

摘要

背景

仅有有限的研究报道了生物可吸收血管支架(BVS;Absorb;雅培血管,加利福尼亚州圣克拉拉)植入治疗冠状动脉慢性完全闭塞(CTO)后的临床结果。本研究的目的是评估BVS植入治疗CTO在现实世界中的可行性和安全性。

方法与结果

我们从一个多中心注册研究中回顾性评估了接受BVS治疗的CTO病例。主要终点是靶病变失败,定义为心源性死亡、靶血管心肌梗死和临床驱动的靶病变血运重建的复合终点。2012年9月至2015年11月,65例CTO患者成功接受了BVS治疗。患者的平均年龄为60.8±11.0岁;89.2%为男性,40.0%患有糖尿病。平均射血分数为57.7±10.8%。平均参考血管直径和CTO病变长度分别为3.0±0.4和20.2±3.0mm。每位患者植入BVS的平均数量为1.8±0.7枚,其中平均直径和总长度分别为3.0±0.4和47.6±19.9mm。所有病例均在高压(18.6±5.3个大气压)下使用非顺应性球囊(平均直径3.3±0.3mm)进行后扩张。所有病例均进行了血管内超声检查(n = 34)或光学相干断层扫描(n = 31)。在随访期间(中位数:453天,第25和75百分位数:230和703),未发生靶病变失败或支架血栓形成。

结论

BVS植入治疗CTO似乎是可行和安全的。建议进行适当的病变预处理、高压后扩张以及使用血管内成像以获得最佳的最终结果。

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Comparison between treatment of "established" versus complex "off-label" coronary lesions with Absorb bioresorbable scaffold implantation: results from the GABI-R registry.对比 Absorb 生物可吸收支架植入术治疗“已建立”与复杂“超适应证”冠状动脉病变:GABI-R 注册研究结果。
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