Effect of Remote Ischemic Conditioning in Ischemic Stroke Subtypes: A Post Hoc Subgroup Analysis From the RESIST Trial

Rolf Ankerlund Blauenfeldt; Janne Kaergaard Mortensen; Niels Hjort; Jan Brink Valentin; Anne-Mette Homburg; Boris Modrau; Birgitte Forsom Sandal; Martin Faurholdt Gude; Anne Brink Berhndtz; Søren Paaske Johnsen; David C Hess; Claus Ziegler Simonsen; Grethe Andersen

doi:10.1161/STROKEAHA.123.046144

Effect of Remote Ischemic Conditioning in Ischemic Stroke Subtypes: A Post Hoc Subgroup Analysis From the RESIST Trial

Rolf Ankerlund Blauenfeldt^*, Janne Kaergaard Mortensen, Niels Hjort, Jan Brink Valentin, Anne-Mette Homburg, Boris Modrau, Birgitte Forsom Sandal, Martin Faurholdt Gude, Anne Brink Berhndtz, Søren Paaske Johnsen, David C Hess, Claus Ziegler Simonsen, Grethe Andersen

^*Corresponding author for this work

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

3 Citations (Scopus)

Abstract

BACKGROUND: Remote ischemic conditioning (RIC) is a simple and noninvasive procedure that has proved to be safe and feasible in numerous smaller clinical trials. Mixed results have been found in recent large randomized controlled trials. This is a post hoc subgroup analysis of the RESIST trial (Remote Ischemic Conditioning in Patients With Acute Stroke), investigating the effect of RIC in different acute ischemic stroke etiologies, and whether an effect was modified by treatment adherence.

METHODS: Eligible patients were adults (aged ≥18 years), independent in activities of daily living, who had prehospital stroke symptoms with a duration of less than 4 hours. They were randomized to RIC or sham. The RIC treatment protocol consisted of 5 cycles with 5 minutes of cuff inflation alternating with 5 minutes with a deflated cuff. Acceptable treatment adherence was defined as when at least 80% of planned RIC cycles were received. The analysis was performed using the entire range (shift analysis) of the modified Rankin Scale (ordinal logistic regression).

RESULTS: A total of 698 had acute ischemic stroke, 253 (36%) were women, and the median (interquartile range) age was 73 (63-80) years. Median (interquartile range) overall adherence to RIC/sham was 91% (68%-100%). In patients with a stroke due to cerebral small vessel disease, who were adherent to treatment, RIC was associated with improved functional outcome, and the odds ratio for a shift to a lower score on the modified Rankin Scale was 2.54 (1.03-6.25); P=0.042. The association remained significant after adjusting for potential confounders. No significant associations were found with other stroke etiologies, and the overall test for interaction was not statistically significant (χ2, 4.33, P=0.23).

CONCLUSIONS: In patients with acute ischemic stroke due to cerebral small vessel disease, who maintained good treatment adherence, RIC was associated with improved functional outcomes at 90 days. These results should only serve as a hypothesis-generating for future trials.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03481777.

Original language	English
Journal	Stroke
Volume	55
Issue	4
Pages (from-to)	874-879
Number of pages	6
ISSN	0039-2499
DOIs	https://doi.org/10.1161/STROKEAHA.123.046144
Publication status	Published - Apr 2024

Keywords

cerebral small vessel diseases
humans
ischemic stroke
neuroprotection
stroke

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10.1161/STROKEAHA.123.046144

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Blauenfeldt, R. A., Mortensen, J. K., Hjort, N., Valentin, J. B., Homburg, A.-M., Modrau, B., Sandal, B. F., Gude, M. F., Berhndtz, A. B., Johnsen, S. P., Hess, D. C., Simonsen, C. Z., & Andersen, G. (2024). Effect of Remote Ischemic Conditioning in Ischemic Stroke Subtypes: A Post Hoc Subgroup Analysis From the RESIST Trial. Stroke, 55(4), 874-879. https://doi.org/10.1161/STROKEAHA.123.046144

@article{1802324f32934dc9a69092f381173eea,

title = "Effect of Remote Ischemic Conditioning in Ischemic Stroke Subtypes: A Post Hoc Subgroup Analysis From the RESIST Trial",

abstract = "BACKGROUND: Remote ischemic conditioning (RIC) is a simple and noninvasive procedure that has proved to be safe and feasible in numerous smaller clinical trials. Mixed results have been found in recent large randomized controlled trials. This is a post hoc subgroup analysis of the RESIST trial (Remote Ischemic Conditioning in Patients With Acute Stroke), investigating the effect of RIC in different acute ischemic stroke etiologies, and whether an effect was modified by treatment adherence.METHODS: Eligible patients were adults (aged ≥18 years), independent in activities of daily living, who had prehospital stroke symptoms with a duration of less than 4 hours. They were randomized to RIC or sham. The RIC treatment protocol consisted of 5 cycles with 5 minutes of cuff inflation alternating with 5 minutes with a deflated cuff. Acceptable treatment adherence was defined as when at least 80% of planned RIC cycles were received. The analysis was performed using the entire range (shift analysis) of the modified Rankin Scale (ordinal logistic regression).RESULTS: A total of 698 had acute ischemic stroke, 253 (36%) were women, and the median (interquartile range) age was 73 (63-80) years. Median (interquartile range) overall adherence to RIC/sham was 91% (68%-100%). In patients with a stroke due to cerebral small vessel disease, who were adherent to treatment, RIC was associated with improved functional outcome, and the odds ratio for a shift to a lower score on the modified Rankin Scale was 2.54 (1.03-6.25); P=0.042. The association remained significant after adjusting for potential confounders. No significant associations were found with other stroke etiologies, and the overall test for interaction was not statistically significant (χ2, 4.33, P=0.23).CONCLUSIONS: In patients with acute ischemic stroke due to cerebral small vessel disease, who maintained good treatment adherence, RIC was associated with improved functional outcomes at 90 days. These results should only serve as a hypothesis-generating for future trials.REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03481777.",

keywords = "cerebral small vessel diseases, humans, ischemic stroke, neuroprotection, stroke",

author = "Blauenfeldt, {Rolf Ankerlund} and Mortensen, {Janne Kaergaard} and Niels Hjort and Valentin, {Jan Brink} and Anne-Mette Homburg and Boris Modrau and Sandal, {Birgitte Forsom} and Gude, {Martin Faurholdt} and Berhndtz, {Anne Brink} and Johnsen, {S{\o}ren Paaske} and Hess, {David C} and Simonsen, {Claus Ziegler} and Grethe Andersen",

year = "2024",

month = apr,

doi = "10.1161/STROKEAHA.123.046144",

language = "English",

volume = "55",

pages = "874--879",

journal = "Stroke",

issn = "0039-2499",

publisher = "Wolters Kluwer Health",

number = "4",

}

Blauenfeldt, RA , Mortensen, JK , Hjort, N, Valentin, JB, Homburg, A-M, Modrau, B, Sandal, BF, Gude, MF, Berhndtz, AB, Johnsen, SP, Hess, DC, Simonsen, CZ & Andersen, G 2024, 'Effect of Remote Ischemic Conditioning in Ischemic Stroke Subtypes: A Post Hoc Subgroup Analysis From the RESIST Trial', Stroke, vol. 55, no. 4, pp. 874-879. https://doi.org/10.1161/STROKEAHA.123.046144

Effect of Remote Ischemic Conditioning in Ischemic Stroke Subtypes: A Post Hoc Subgroup Analysis From the RESIST Trial. / Blauenfeldt, Rolf Ankerlund ; Mortensen, Janne Kaergaard ; Hjort, Niels et al.
In: Stroke, Vol. 55, No. 4, 04.2024, p. 874-879.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

TY - JOUR

T1 - Effect of Remote Ischemic Conditioning in Ischemic Stroke Subtypes

T2 - A Post Hoc Subgroup Analysis From the RESIST Trial

AU - Blauenfeldt, Rolf Ankerlund

AU - Mortensen, Janne Kaergaard

AU - Hjort, Niels

AU - Valentin, Jan Brink

AU - Homburg, Anne-Mette

AU - Modrau, Boris

AU - Sandal, Birgitte Forsom

AU - Gude, Martin Faurholdt

AU - Berhndtz, Anne Brink

AU - Johnsen, Søren Paaske

AU - Hess, David C

AU - Simonsen, Claus Ziegler

AU - Andersen, Grethe

PY - 2024/4

Y1 - 2024/4

N2 - BACKGROUND: Remote ischemic conditioning (RIC) is a simple and noninvasive procedure that has proved to be safe and feasible in numerous smaller clinical trials. Mixed results have been found in recent large randomized controlled trials. This is a post hoc subgroup analysis of the RESIST trial (Remote Ischemic Conditioning in Patients With Acute Stroke), investigating the effect of RIC in different acute ischemic stroke etiologies, and whether an effect was modified by treatment adherence.METHODS: Eligible patients were adults (aged ≥18 years), independent in activities of daily living, who had prehospital stroke symptoms with a duration of less than 4 hours. They were randomized to RIC or sham. The RIC treatment protocol consisted of 5 cycles with 5 minutes of cuff inflation alternating with 5 minutes with a deflated cuff. Acceptable treatment adherence was defined as when at least 80% of planned RIC cycles were received. The analysis was performed using the entire range (shift analysis) of the modified Rankin Scale (ordinal logistic regression).RESULTS: A total of 698 had acute ischemic stroke, 253 (36%) were women, and the median (interquartile range) age was 73 (63-80) years. Median (interquartile range) overall adherence to RIC/sham was 91% (68%-100%). In patients with a stroke due to cerebral small vessel disease, who were adherent to treatment, RIC was associated with improved functional outcome, and the odds ratio for a shift to a lower score on the modified Rankin Scale was 2.54 (1.03-6.25); P=0.042. The association remained significant after adjusting for potential confounders. No significant associations were found with other stroke etiologies, and the overall test for interaction was not statistically significant (χ2, 4.33, P=0.23).CONCLUSIONS: In patients with acute ischemic stroke due to cerebral small vessel disease, who maintained good treatment adherence, RIC was associated with improved functional outcomes at 90 days. These results should only serve as a hypothesis-generating for future trials.REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03481777.

AB - BACKGROUND: Remote ischemic conditioning (RIC) is a simple and noninvasive procedure that has proved to be safe and feasible in numerous smaller clinical trials. Mixed results have been found in recent large randomized controlled trials. This is a post hoc subgroup analysis of the RESIST trial (Remote Ischemic Conditioning in Patients With Acute Stroke), investigating the effect of RIC in different acute ischemic stroke etiologies, and whether an effect was modified by treatment adherence.METHODS: Eligible patients were adults (aged ≥18 years), independent in activities of daily living, who had prehospital stroke symptoms with a duration of less than 4 hours. They were randomized to RIC or sham. The RIC treatment protocol consisted of 5 cycles with 5 minutes of cuff inflation alternating with 5 minutes with a deflated cuff. Acceptable treatment adherence was defined as when at least 80% of planned RIC cycles were received. The analysis was performed using the entire range (shift analysis) of the modified Rankin Scale (ordinal logistic regression).RESULTS: A total of 698 had acute ischemic stroke, 253 (36%) were women, and the median (interquartile range) age was 73 (63-80) years. Median (interquartile range) overall adherence to RIC/sham was 91% (68%-100%). In patients with a stroke due to cerebral small vessel disease, who were adherent to treatment, RIC was associated with improved functional outcome, and the odds ratio for a shift to a lower score on the modified Rankin Scale was 2.54 (1.03-6.25); P=0.042. The association remained significant after adjusting for potential confounders. No significant associations were found with other stroke etiologies, and the overall test for interaction was not statistically significant (χ2, 4.33, P=0.23).CONCLUSIONS: In patients with acute ischemic stroke due to cerebral small vessel disease, who maintained good treatment adherence, RIC was associated with improved functional outcomes at 90 days. These results should only serve as a hypothesis-generating for future trials.REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03481777.

KW - cerebral small vessel diseases

KW - humans

KW - ischemic stroke

KW - neuroprotection

KW - stroke

U2 - 10.1161/STROKEAHA.123.046144

DO - 10.1161/STROKEAHA.123.046144

M3 - Journal article

C2 - 38299363

SN - 0039-2499

VL - 55

SP - 874

EP - 879

JO - Stroke

JF - Stroke

IS - 4

ER -

Effect of Remote Ischemic Conditioning in Ischemic Stroke Subtypes: A Post Hoc Subgroup Analysis From the RESIST Trial

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Keywords

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