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This article is from NEJM Journal Watch
Remote Ischemic Conditioning Intervention After Moderate Ischemic Stroke
Distal ischemia preconditioning intervention after moderate ischaemic stroke
Reviewed by Anthony S.
Kim, MD
A proof-of-principle study suggests benefits, but there are some methodological problems
with the study.
Distal ischaemic preconditioning refers to a protective strategy circulating between ischaemia and reperfusion within a vascular region (e.
g.
, arm) with the goal of inducing ischaemic tolerance in distal target tissues (e.
g.
, brain) to improve outcomes
.
Small clinical trials were inconclusive
.
In the largest randomized controlled trial to date, the investigators recruited 1,893 patients with acute moderate ischemic stroke (National Institutes of Health Stroke Scale score, 6~16 points) in 55 medical centers in China in 55 medical centers in China, and randomized them into two groups, both receiving usual care according to guidelines, in addition to receiving or not receiving distal ischemia pretreatment
, respectively.
Patients receiving intravenous thrombolysis or embolectomy were excluded
.
Open-label interventions included the application of auto-pneumatic pressurized pneumatics twice daily, 5 cycles of cuff inflation and deflation of bilateral upper extremities, each cycle inflated for 5 minutes (up to 200 mmHg), followed by 5 minutes of deflation for 10~14 days
.
One hundred and one hundred and seventeen patients were excluded
after randomization.
Subsequently, 582 (67.
4%) of the 863 patients in the intervention group achieved excellent functional outcomes (modified Rankin scale score, 0 [asymptomatic] or 1 [mild symptoms without disability]) compared with 566 of 913 patients (62.
0%) in the control group, a significant difference of 5.
4% between the two groups (P = 0.
02).
Adverse events were numerically more numerous in the intervention group (59/863 vs.
51/913), but six adverse events judged to be relevant to the intervention were redness (3), petechiae (2) and dizziness (1).
comments
Given that 6% of patients were rapidly excluded after randomization, that results had not been reported by the primary intention-to-treat analysis pre-specified in the statistical analysis plan, and that the trial was open-label rather than sham designed, this is particularly concerning because of the importance of proof-of-principle trials evaluating novel therapies for stroke
.
However, if these results are validated and reproduced, this could become the basis for
a broadly applicable and significant neuroprotective approach.
Articles that were commented on
Chen H-S et al.
Effect of remote ischemic conditioning vs usual care on neurologic function in patients with acute moderate ischemic stroke: The RICAMIS randomized clinical trial.
JAMA 2022 Aug 16; 328:627.
(https://doi.
org/10.
1001/jama.
2022.
13123)
A collection of NEJM journals
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.
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