Daily Remote Ischaemic Preconditioning for Intermittent Claudication: A Sham Controlled Randomised Trial.

IF 5.7 1区医学 Q1 PERIPHERAL VASCULAR DISEASE European Journal of Vascular and Endovascular Surgery Pub Date : 2024-11-08 DOI:10.1016/j.ejvs.2024.10.047

Kadri Eerik, Teele Kasepalu, Holger Post, Jaan Eha, Mart Kals, Jaak Kals

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Abstract

Objective: Remote ischaemic preconditioning (RIPC) is a promising non-invasive strategy in which brief episodes of ischaemia and reperfusion can increase skeletal muscle resistance to ischaemia and improve mobility. This study aimed to determine whether 28 consecutive days of RIPC improves intermittent claudication (IC) symptoms compared with sham intervention.

Methods: This single centre, parallel, randomised, sham controlled, double blind trial was conducted from January 2022 to April 2023 in outpatient settings. Forty two patients with stable IC Fontaine stage IIa or IIb were randomised to RIPC or sham for 28 days. The prespecified primary outcome was a change in the maximal walking distance (MWD) after 28 days measured with a treadmill test. A > 10% change in MWD was considered clinically significant. Change in intermittent claudication distance (ICD), time to relief from claudication (TRC), and health related quality of life (HRQoL) measured with the VascuQoL-6 questionnaire were the secondary outcomes (ClinicalTrials.gov ID: NCT05084066).

Results: Forty one men (RIPC = 23, sham = 18) aged 64.9 ± 7.4 years were analysed. A change of > 10% in MWD occurred in 14 patients in the RIPC group vs. eight patients in the sham group (relative risk 1.37, 95% confidence interval 0.74 - 2.25; p = .35). Changes in ICD, TRC, and HRQoL between the groups were not statistically significant.

Conclusion: In this trial, RIPC did not significantly improve MWD, ICD, or TRC compared with treatment with a sham device.

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间歇性跛行的每日远程缺血预处理：虚假对照随机试验

目的：远程缺血预处理（RIPC）是一种很有前景的非侵入性策略，通过短暂的缺血和再灌注可以增强骨骼肌对缺血的抵抗力，改善活动能力。本研究旨在确定与假干预相比，连续 28 天的 RIPC 是否能改善间歇性跛行（IC）症状：这项单中心、平行、随机、假对照、双盲试验于 2022 年 1 月至 2023 年 4 月在门诊环境中进行。42名方丹氏 IIa 期或 IIb 期稳定型 IC 患者被随机分配到 RIPC 或假干预中，为期 28 天。预设的主要结果是28天后通过跑步机测试测量的最大步行距离（MWD）的变化。MWD变化大于10%被认为具有临床意义。间歇性跛行距离（ICD）的变化、跛行缓解时间（TRC）以及用 VascuQoL-6 问卷测量的健康相关生活质量（HRQoL）是次要结果（ClinicalTrials.gov ID：NCT05084066）：对 41 名男性（RIPC = 23，假体 = 18）进行了分析，他们的年龄为 64.9 ± 7.4 岁。RIPC组有14名患者的MWD变化大于10%，而假体组有8名患者的MWD变化大于10%（相对风险1.37，95%置信区间0.74 - 2.25；P = .35）。两组间ICD、TRC和HRQoL的变化无统计学意义：在这项试验中，与使用假设备治疗相比，RIPC 对 MWD、ICD 或 TRC 没有明显改善。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Vascular and Endovascular Surgery 医学-外科

CiteScore

6.80

自引率

15.80%

发文量

471

审稿时长

66 days

期刊介绍： The European Journal of Vascular and Endovascular Surgery is aimed primarily at vascular surgeons dealing with patients with arterial, venous and lymphatic diseases. Contributions are included on the diagnosis, investigation and management of these vascular disorders. Papers that consider the technical aspects of vascular surgery are encouraged, and the journal includes invited state-of-the-art articles. Reflecting the increasing importance of endovascular techniques in the management of vascular diseases and the value of closer collaboration between the vascular surgeon and the vascular radiologist, the journal has now extended its scope to encompass the growing number of contributions from this exciting field. Articles describing endovascular method and their critical evaluation are included, as well as reports on the emerging technology associated with this field.