Safety and Efficacy of Remote Ischemic Conditioning in Patients With Intravenous Thrombolysis: The SERIC-IVT Trial.

BACKGROUND

Approximately half of the patients with acute ischemic stroke who receive intravenous thrombolysis (IVT) do not achieve an excellent outcome. Remote ischemic conditioning (RIC) as a promising neuroprotective treatment may improve clinical outcomes in this population. This study aimed to assess the efficacy and safety of RIC in patients with IVT.

METHODS

This multicenter, participant-blinded, blinded end point, randomized controlled clinical trial included 558 patients with acute ischemic stroke who underwent IVT in 18 hospitals from August 2021 to May 2023. After IVT, patients were randomized 1:1 to the RIC (unilateral upper limb; cuff pressure, 200 mm Hg, twice daily for 7 days) or sham RIC groups (the same procedure; cuff pressure, 60 mm Hg). The primary efficacy outcome was an excellent functional outcome (modified Rankin Scale score, 0-1) at 90 days after IVT.

RESULTS

In total, 558 eligible patients were randomized, and 11 (2.0%) were excluded because they did not receive an RIC or sham RIC. Thus, 547 patients (RIC, n=274; sham RIC, n=273) were included in the modified intention-to-treat analysis, of whom 15 patients were lost to follow-up and 532 (95.3%) completed the trial. At 90 days, 62.7% of patients in the RIC group and 56.8% in the sham RIC group had an excellent functional outcome (unadjusted risk ratio, 1.10 [95% CI, 0.96-1.27]; P=0.169). The proportion of patients with any adverse events was 11.2% in the RIC group and 8.1% in the sham RIC group, with no significant difference (P=0.221).

CONCLUSIONS

RIC was safe in patients with acute ischemic stroke who received IVT. However, it did not significantly improve excellent functional outcome.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04980625.