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在基于办公室的实验室进行的外周血管介入治疗的程序和 3 年结果:LIBERTY 360 子分析。

Procedural and 3-Year Outcomes of Peripheral Vascular Interventions Performed in Office-Based Labs: LIBERTY 360 Sub-Analysis.

机构信息

University of Colorado, 1600 N. Wheeling Street, Aurora, CO 80045 USA.

出版信息

J Invasive Cardiol. 2021 May;33(5):E365-E377. doi: 10.25270/jic/20.00594.

Abstract

OBJECTIVE

Few data are available on the safety of interventions for peripheral arterial disease (PAD) performed in the office-based laboratory (OBL) setting. Thus, the aim of this study was to investigate the short- and late-term outcomes of patients treated in OBL vs hospital settings.

METHODS

We included patients with PAD treated with any United States Food and Drug Administration approved or cleared devices for distal femoropopliteal and/or infrapopliteal disease. Data were retrieved from the LIBERTY 360 study. A propensity-scored, matched analysis was conducted and hazard ratios with the respective 95% confidence intervals were synthesized to examine the outcomes after interventions at OBL vs non-OBL settings.

RESULTS

A total of 710 propensity-scored patients (355 OBL patients and 355 non-OBL patients) with 907 treated lesions (454 OBL lesions and 453 non-OBL lesions), were included. For almost all subjects, balloon angioplasty was the preferred treatment approach (341 [96.1%] in the OBL group vs 353 [99.4%] in the non-OBL group; P<.01), with bail-out stenting necessary in 5.1% of the OBL group and 3.1% of the non-OBL group. Overall, significant angiographic complications occurred in 7.8% of all patients treated, with no differences between the 2 groups. The risk for all-cause death, target-vessel revascularization, and major amputation and death combined was similar between the 2 groups during 3-year follow-up.

CONCLUSIONS

Peripheral artery endovascular interventions in patients with chronic threatening ischemia or claudication, performed in the OBL setting, are safe and associated with favorable outcomes at 3 years of follow-up. These results demonstrate that treatment at OBLs is comparable to non-OBL settings. Further comparative studies and larger registries are needed to benchmark procedural quality and long-term outcomes.

摘要

目的

关于在门诊实验室(OBL)环境中进行的外周动脉疾病(PAD)干预措施的安全性,数据有限。因此,本研究旨在调查在 OBL 与医院环境中治疗的患者的短期和长期结局。

方法

我们纳入了接受任何经美国食品和药物管理局批准或批准用于治疗远侧股腘和/或腘下病变的设备治疗的 PAD 患者。数据来自 LIBERTY 360 研究。进行了倾向评分匹配分析,并综合了风险比及其相应的 95%置信区间,以检查 OBL 与非 OBL 环境下干预后的结局。

结果

共纳入 710 名经倾向评分匹配的患者(355 名 OBL 患者和 355 名非 OBL 患者),共治疗 907 处病变(454 处 OBL 病变和 453 处非 OBL 病变)。对于几乎所有患者,球囊血管成形术是首选的治疗方法(OBL 组 341 例[96.1%],非 OBL 组 353 例[99.4%];P<.01),OBL 组有 5.1%的患者需要紧急支架置入,而非 OBL 组为 3.1%。总体而言,所有患者的血管造影并发症发生率为 7.8%,两组之间无差异。在 3 年随访期间,两组患者的全因死亡、靶血管血运重建和主要截肢和死亡合并发生率相似。

结论

在慢性威胁性缺血或跛行患者中,在 OBL 环境中进行的外周动脉血管腔内介入治疗是安全的,并且在 3 年随访时具有良好的结局。这些结果表明,在 OBL 治疗与非 OBL 环境治疗相当。需要进一步的比较研究和更大的登记处来评估手术质量和长期结果。

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