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

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

doi:10.1016/j.ejvs.2024.10.047

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

Eur J Vasc Endovasc Surg. 2024 Nov 8:S1078-5884(24)00922-5. doi: 10.1016/j.ejvs.2024.10.047. Online ahead of print.

Authors

Kadri Eerik¹, Teele Kasepalu², Holger Post³, Jaan Eha², Mart Kals⁴, Jaak Kals⁵

Affiliations

¹ Endothelial Research Centre, University of Tartu, Tartu, Estonia; Department of Surgery, Institute of Clinical Medicine, University of Tartu, Tartu, Estonia; Heart Clinic, Tartu University Hospital, Tartu, Estonia. Electronic address: kadri.eerik@kliinikum.ee.
² Endothelial Research Centre, University of Tartu, Tartu, Estonia; Heart Clinic, Tartu University Hospital, Tartu, Estonia; Department of Cardiology, Institute of Clinical Medicine, Tartu, Estonia.
³ Endothelial Research Centre, University of Tartu, Tartu, Estonia; Department of Surgery, Institute of Clinical Medicine, University of Tartu, Tartu, Estonia.
⁴ Estonian Genome Centre, Institute of Genomics, University of Tartu, Tartu, Estonia.
⁵ Endothelial Research Centre, University of Tartu, Tartu, Estonia; Department of Surgery, Institute of Clinical Medicine, University of Tartu, Tartu, Estonia; Surgery Clinic, Tartu University Hospital, Tartu, Estonia.

PMID: 39522584
DOI: 10.1016/j.ejvs.2024.10.047

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 improved 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 pre-specified primary outcome was a change in the maximum 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.

Keywords: Intermittent claudication; Lower extremity arterial disease; Randomised controlled trial; Remote ischaemic preconditioning.

Associated data

ClinicalTrials.gov/NCT05084066