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超长病变中的旋磨术:ROTATE注册研究结果

Rotational atherectomy in very long lesions: Results for the ROTATE registry.

作者信息

Iannaccone Mario, Barbero Umberto, D'ascenzo Fabrizio, Latib Azeem, Pennacchi Mauro, Rossi Marco Luciano, Ugo Fabrizio, Meliga Emanuele, Kawamoto Hiroyoshi, Moretti Claudio, Ielasi Alfonso, Garbo Roberto, Colombo Antonio, Sardella Gennaro, Boccuzzi Giacomo G

机构信息

"Citta' Della Scienza e della Salute", University of Turin, Italy.

Italy and EMO-GVM Centro Cuore Columbus, San Raffaele Scientific Institute, Milan, Milan, Italy.

出版信息

Catheter Cardiovasc Interv. 2016 Nov 15;88(6):E164-E172. doi: 10.1002/ccd.26548. Epub 2016 Apr 16.

DOI:10.1002/ccd.26548
PMID:27083771
Abstract

BACKGROUND

Rotational atherectomy (RA) is relatively contraindicated in patients with lesions ≥25 mm of length. Aim of this study was to evaluate RA safety and efficacy in this subset of patients with new technology and devices.

METHODS AND RESULTS

From April 2002 to August 2013, the ROTATE registry included all consecutive patients undergoing RA in 8 centres. They were divided into shorter lesion group (SLG, lesions < 25 mm) and longer lesion group (LLG, lesions ≥ 25 mm). The angiographic success (AS) was the primary end point. Procedural complications (PC), a composite end point of procedural perforation, slow flow/no flow, and in-hospital major acute cardiovascular events (MACE), were secondary end points, along with death, nonfatal MI, target lesion revascularization, and MACE during follow-up. Sensitivity analysis was performed according to generation of DES. 1186 patients were included: 51.5% in SLG and 48.4% in LLG. Mean age was 70.4 ± 9.3 years, 64.5% were male. AS and PC did not differ between the two groups (93% vs 91%, p = 0.24 and 9.8 vs 9.4%, p = 0.84). During follow-up (27.6 ± 22.9 months), MACE did not differ between the two groups (28% vs 29.1%, p = 0.95). At multivariate analysis chronic kidney disease, male gender increased risk of MACE (HR 1.94, IQR 1.29-2.0, p = 0.01, HR 0.52, IQR 0.34-0.79, p = 0.01) while second-generation DES seemed protective (HR 0.53, IQR 0.31-0.88, p = 0.02). Data were confirmed at sensitivity analysis for second-generation DES (759 pts, 63.9%). No differences were found in this subpopulation between the two groups in term of AS, PC, and long-term MACE (93.6% vs 93.5%, p = 0.28, 11.9% vs 9.4%, p = 0.32 and 25.5% vs 23.9%, p = 0.72, respectively).

CONCLUSIONS

Treating coronary lesions ≥ 25 mm length with RA does not impact short- and long-term outcome, in particular, in patients with second-generation DES. © 2016 Wiley Periodicals, Inc.

摘要

背景

对于病变长度≥25毫米的患者,旋磨术(RA)相对禁忌。本研究的目的是评估在这一亚组患者中使用新技术和设备进行旋磨术的安全性和有效性。

方法与结果

从2002年4月至2013年8月,ROTATE注册研究纳入了8个中心所有连续接受旋磨术的患者。他们被分为短病变组(SLG,病变长度<25毫米)和长病变组(LLG,病变长度≥25毫米)。血管造影成功(AS)是主要终点。手术并发症(PC)是手术穿孔、慢血流/无血流以及院内主要急性心血管事件(MACE)的复合终点,是次要终点,同时包括死亡、非致死性心肌梗死、靶病变血运重建以及随访期间的MACE。根据药物洗脱支架(DES)的代别进行敏感性分析。共纳入1186例患者:SLG组占51.5%,LLG组占48.4%。平均年龄为70.4±9.3岁,64.5%为男性。两组之间的AS和PC无差异(93%对91%;p=0.24以及9.8%对9.4%;p=0.84)。在随访期间(27.6±22.9个月),两组之间的MACE无差异(28%对29.1%;p=0.95)。多因素分析显示,慢性肾脏病、男性增加了MACE风险(风险比[HR]1.94,四分位间距[IQR]1.29 - 2.0,p=0.01;HR 0.52,IQR 0.34 - 0.79,p=0.01),而第二代DES似乎具有保护作用(HR 0.53,IQR 0.31 - 0.88,p=0.02)。在第二代DES的敏感性分析(759例患者,63.9%)中数据得到证实。在这一亚组人群中,两组在AS、PC和长期MACE方面未发现差异(分别为93.6%对93.5%;p=0.28,11.9%对9.4%;p=0.32以及25.5%对23.9%;p=0.72)。

结论

使用旋磨术治疗长度≥25毫米的冠状动脉病变不会影响短期和长期预后,尤其是在使用第二代DES的患者中。©2016威利期刊公司。

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