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冠状动脉斑块旋切术后药物洗脱支架的应用:多中心经验结果 - ROTALINK I研究

Drug-eluting stent use after coronary atherectomy: results from a multicentre experience - The ROTALINK I study.

作者信息

Cortese Bernardo, Aranzulla Tiziana C, Godino Cosmo, Chizzola Giuliano, Zavalloni Dennis, Tavasci Emanuela, De Benedictis Mauro, Ettori Federica, Presbitero Patrizia, Colombo Antonio

机构信息

aUnit of Interventional Cardiology, A.O. Fatebenefratelli, Milan bDepartment of Interventional Cardiology, Ospedale Mauriziano Umberto I, Torino cDepartment of Cardio-Thoracic-Vascular Department, San Raffaele Institute, Milan dDepartment of Interventional Cardiology, Spedali Civili, Brescia eDepartment of Interventional Cardiology, Cliniche Humanitas, Milan fDepartment of Interventional Cardiology, Ospedale Moriggia-Pelascini, Gravedona, Italy.

出版信息

J Cardiovasc Med (Hagerstown). 2016 Sep;17(9):665-72. doi: 10.2459/JCM.0000000000000227.

DOI:10.2459/JCM.0000000000000227
PMID:25575276
Abstract

AIMS

Until now, there is no medium- to long-term clinical evidence of the best treatment after rotational atherectomy.

METHODS

From the databases of seven high-volume centres, years 2005-2010, we retrospectively analysed the long-term outcome of patients who had undergone rotational atherectomy followed by plain-balloon angioplasty or implantation of drug-eluting stent (DES) or bare metal stent (BMS). Primary endpoint was the incidence of major adverse cardiovascular events (MACE: death, myocardial infarction, target-lesion-revascularization) at longest available follow-up.

RESULTS

In this registry, we enrolled 1397 patients with 1605 lesions, followed for 28.4 ± 21 months. DES-treated patients were more frequently diabetic, had more lesions treated and received a higher number of stents. In-hospital MACEs were significantly higher in DES patients (7.6 vs. 2.6 vs. 2.9%, respectively, P = 0.0001 for both), mainly due to a higher incidence of myocardial infarction (6.4 vs. 1.2 vs. 2.1%, P = 0.0001). The 2-year follow-up showed a significantly lower incidence of MACE in DES patients (15.1 vs. 24.2 vs. 20.8%, P = 0.001 for both), driven by a lower incidence of target-lesion revascularization (8 vs. 14.6 vs. 13.9%, P = 0.002). Myocardial infarction rate was lower in the DES group as well (0.4 vs. 3.1% in BMS, P = 0.001). At multivariate analysis, BMS implantation and balloon angioplasty were independent predictors of long-term MACE. DES implantation was associated with a lower risk of long-term myocardial infarction [hazard ratio 0.15, 95% confidence interval (95% CI) 0.04-0.67] and target-lesion revascularization (hazard ratio 0.42, 95% CI 0.21-0.82). Male sex and DES use were independent predictors of the absence of MACE.

CONCLUSION

After rotational atherectomy, DES implantation appears to be a preferable strategy, as it is associated with lower long-term MACE, despite an unexpected increase in periprocedural myocardial infarction.

摘要

目的

到目前为止,尚无关于旋磨术后最佳治疗方案的中长期临床证据。

方法

我们从7个高容量中心2005年至2010年的数据库中,回顾性分析了接受旋磨术,随后行普通球囊血管成形术或植入药物洗脱支架(DES)或裸金属支架(BMS)的患者的长期结局。主要终点是最长可获得随访期内主要不良心血管事件(MACE:死亡、心肌梗死、靶病变血运重建)的发生率。

结果

在该注册研究中,我们纳入了1397例患者的1605处病变,随访时间为28.4±21个月。接受DES治疗的患者糖尿病发病率更高,治疗的病变更多,且植入的支架数量更多。DES组患者的院内MACE发生率显著更高(分别为7.6%、2.6%和2.9%,两者比较P=0.0001),主要原因是心肌梗死发生率更高(6.4%、1.2%和2.1%,P=0.0001)。2年随访显示,DES组患者的MACE发生率显著更低(分别为15.1%、24.2%和20.8%,两者比较P=0.001),这是由更低的靶病变血运重建发生率(8%、14.6%和13.9%,P=0.002)驱动的。DES组的心肌梗死发生率也更低(与BMS组的3.1%相比为0.4%,P=0.001)。多因素分析显示,植入BMS和球囊血管成形术是长期MACE的独立预测因素。植入DES与更低的长期心肌梗死风险相关[风险比0.15,95%置信区间(95%CI)0.04-0.67]和靶病变血运重建风险(风险比0.42,95%CI 0.21-0.82)。男性和使用DES是无MACE的独立预测因素。

结论

旋磨术后,植入DES似乎是一种更优策略,因为尽管围手术期心肌梗死意外增加,但它与更低的心梗长期MACE发生率相关。

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