JAMA|对于股腘动脉重建,药物涂层装置不会增加患者的全因死亡率

发布时间:2019-02-25 22:12  

在近期的一项随机临床研究Meta分析中,在股腘动脉重建中使用紫杉醇药物涂层装置,与非药物涂层装置相比,长期全因死亡率更高。然而,这些发现并未在其他数据分析中看到同样的结果,而且可能会因患者的退出和失访产生混淆。为评估药物涂层装置与非药物涂层装置在股腘动脉重建中,对全因死亡率的影响。研究者进行了深入的研究,并于2019年2月12日在JAMA Cardiology 杂志网站上在线发布。

研究设计

该研究为全美境内、多中心回顾性对照研究,纳入了从2016年1月1日~2016年12月31日,16,560个医疗中心接受过动脉重建患者,并于2017年9月30日分析患者全因死亡率。研究中,采用药物涂层支架(DES)或药物涂层球囊(DCB)与非药物涂层装置(裸金属支架或无涂层经皮血管成形术球囊)进行比较。主要研究结果为对随访终点全因死亡率进行分析。

研究结果

对1,883家医院的16,560位接受治疗的患者开展研究,患者的平均年龄为72.9岁,7,734(46.7%)为男性,12,232(73.9%)为白人,8,222(49.7%)目前吸烟或有吸烟史,9,817(59.3%)有糖尿病,8,450(51.0%)有严重的肢体缺血(critical limb ischemia,CLI)。5,989位(36.2%)参与者使用药物涂层装置。中位随访时间为389天(四分位范围在277~508天之间)。在所有的患者中,术后600天内,使用药物涂层装置治疗,与非药物涂层装置相比全因死亡率的累积发生率更低(分别为32.5% vs 34.3%;P=0.007)。对单独使用DCB或DES(使用或不使用DCB)治疗分层时,也观察到类似的生存趋势。

经过多变量调整后,结果显示药物涂层装置与非药物涂层装置在全因死亡率方面无差异(HR 0.97;95%CI 0.91~1.04;P=0.43),无论合并CLI(HR 0.93;95%CI 0.85~1.01;P=0.09)或者无CLI(HR 0.94;95%CI 0.85~1.03;P=0.20),只用DCB治疗(HR 0.94;95%CI 0.86~1.03;P=0.17)或DES联合或不联合DCB(HR 0.97;95%CI 0.89~1.06;P=0.48),这些结果都是一致的。

结 论

在这项大型全国范围医疗中心的分析中得出的结果显示:对于股腘动脉重建,没有证据证明与非药物涂层装置相比,药物涂层装置会增加患者的全因死亡率。

参考文献

[1]Eric A. Secemsky, Harun Kundi, Ido Weinberg,  et al. Association of Survival With Femoropopliteal Artery Revascularization With Drug-Coated Devices. JAMA Cardiol. Published online February 12, 2019. doi:10.1001/jamacardio.2019.0325. 

Abstract

Importance  In a recent meta-analysis of randomized clinical trials, femoropopliteal artery revascularization with paclitaxel drug-coated devices was associated with increased long-term all-cause mortality compared with non–drug-coated devices. However, to our knowledge, these findings have not been replicated in other data sources and may be subject to confounding from missing data associated with patient withdrawal and loss to follow-up.

Objective  To evaluate differences in all-cause mortality between patients who were treated with drug-coated devices vs non–drug-coated devices for femoropopliteal artery revascularization.

Design, Setting, and Participants  This nationwide, multicenter retrospective cohort study included 16 560 Centers for Medicare and Medicaid Services beneficiaries who were admitted for femoropopliteal artery revascularization from January 1, 2016, to December 31, 2016. All-cause mortality was analyzed through September 30, 2017.

Exposures  Drug-coated devices (drug-eluting stent [DES] or drug-coated balloon [DCB]) compared with non–drug-coated devices (bare metal stent or uncoated percutaneous transluminal angioplasty balloon).

Main Outcomes and Measures  The primary outcome was all-cause mortality analyzed through the end of follow-up.

Results  Among 16 560 patients treated at 1883 hospitals, the mean (SD) age was 72.9 (11) years, 7734 (46.7%) were men, 12 232 (73.9%) were white, 8222 (49.7%) currently or had previously used tobacco, 9817 (59.3%) had diabetes, and 8450 (51.0%) had critical limb ischemia (CLI). Drug-coated devices were used in 5989 participants (36.2%). The median follow-up was 389 days (interquartile range, 277-508 days). Among all patients, treatment with drug-coated devices was associated with a lower cumulative incidence of all-cause mortality compared with treatment with non–drug-coated devices through 600 days postprocedure (32.5% vs 34.3%, respectively; log-rank P = .007). Similar survival trends were observed when treatment was stratified by using a DCB alone or DES with or without DCB. After multivariable adjustment, drug-coated devices were not associated with a difference in all-cause mortality compared with non–drug-coated devices (hazard ratio [HR], 0.97; 95% CI, 0.91-1.04; P = .43). These findings were consistent among those with CLI (HR, 0.93; 95% CI, 0.85-1.01; P = .09) or without CLI (HR, 0.94; 95% CI, 0.85-1.03; P = .20), and for those treated with DCB alone (HR, 0.94; 95% CI, 0.86-1.03; P = .17) or DES with or without DCB (HR, 0.97; 95% CI, 0.89-1.06; P = .48).