Hui-Sheng Chen1, Yu Cui1, Xiao-Qiu Li1, Xin-Hong Wang1, Yu-Tong Ma2, Yong Zhao3, Jing Han4, Chang-Qing Deng5, Mei Hong6, Ying Bao7, Li-Hong Zhao8, Ting-Guang Yan9, Ren-Lin Zou10, Hui Wang11, Zhuo Li4, Li-Shu Wan12, Li Zhang13, Lian-Qiang Wang14, Li-Yan Guo15, Ming-Nan Li16, Dong-Qing Wang17, Qiang Zhang18, Da-Wei Chang19, Hong-Li Zhang20, Jing Sun21, Chong Meng22, Zai-Hui Zhang23, Li-Ying Shen24, Li Ma25, Gui-Chun Wang26, Run-Hui Li25, Ling Zhang27, Cheng Bi5, Li-Yun Wang28, Duo-Lao Wang29. 1. Department of Neurology, General Hospital of Northern Theatre Command, Shenyang, China. 2. Department of Neurology, Beipiao Central Hospital, Beipiao, China. 3. Department of Neurology, Haicheng Chinese Medicine Hospital, Haicheng, China. 4. Department of Neurology, Panjin Central Hospital, Panjin, China. 5. Department of Neurology, Dandong Central Hospital, Dandong, China. 6. Department of Neurology, China Railway 19th Bureau Group Central Hospital, Liaoyang, China. 7. Department of Neurology, Fuxin Second People's Hospital, Fuxin, China. 8. Department of Neurology, Dandong People's Hospital, Dandong, China. 9. Department of Neurology, Chaoyang Central Hospital, Chaoyang, China. 10. Department of Neurology, Wafangdian Third Hospital, Dalian, China. 11. Department of Neurology, Chinese People's Liberation Army 230 Hospital, Dandong, China. 12. Department of Neurology, Dandong First Hospital, Dandong, China. 13. Department of Neurology, Suizhong County Hospital, Huludao, China. 14. Department of Neurology, Liaoyang County Stroke Hospital, Liaoyang, China. 15. Department of Neurology, Fushun Second Hospital, Fushun, China. 16. Department of Neurology, Huanren Manchu Autonomous County People's Hospital, Benxi, China. 17. Department of Neurology, Panjin People's Hospital, Panjin, China. 18. Department of Neurology, Fushun Central Hospital, Fushun, China. 19. Department of Neurology, Sujiatun Stroke Hospital, Shenyang, China. 20. Department of Neurology, Taian County Chinese Medicine Hospital, Anshan, China. 21. Department of Neurology, Anshan Hospital, The First Affiliated Hospital of China Medical University, Anshan, China. 22. Department of Neurology, Liaoyang County Central Hospital, Liaoyang, China. 23. Department of Neurology, Xiuyan County Central Hospital, Anshan, China. 24. Department of Neurology, Tieling County Central Hospital, Tieling, China. 25. Department of Neurology, The Affiliated Central Hospital of Shenyang Medical College, Shenyang, China. 26. Department of Neurology, Changtu County Central Hospital, Tieling, China. 27. Department of Neurology, Dengta Central Hospital, Dengta, China. 28. Department of Neurology, Liaoyang Petrochemical General Hospital, Liaoyang, China. 29. Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.
Abstract
Importance: Preclinical and clinical studies have suggested a neuroprotective effect of remote ischemic conditioning (RIC), which involves repeated occlusion/release cycles on bilateral upper limb arteries; however, robust evidence in patients with ischemic stroke is lacking. Objective: To assess the efficacy of RIC for acute moderate ischemic stroke. Design, Setting, and Participants: This multicenter, open-label, blinded-end point, randomized clinical trial including 1893 patients with acute moderate ischemic stroke was conducted at 55 hospitals in China from December 26, 2018, through January 19, 2021, and the date of final follow-up was April 19, 2021. Interventions: Eligible patients were randomly assigned within 48 hours after symptom onset to receive treatment with RIC (using a pneumatic electronic device and consisting of 5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mm Hg) for 10 to 14 days as an adjunct to guideline-based treatment (n = 922) or guideline-based treatment alone (n = 971). Main Outcomes and Measures: The primary end point was excellent functional outcome at 90 days, defined as a modified Rankin Scale score of 0 to 1. All end points had blinded assessment and were analyzed on a full analysis set. Results: Among 1893 eligible patients with acute moderate ischemic stroke who were randomized (mean [SD] age, 65 [10.3] years; 606 women [34.1%]), 1776 (93.8%) completed the trial. The number with excellent functional outcome at 90 days was 582 (67.4%) in the RIC group and 566 (62.0%) in the control group (risk difference, 5.4% [95% CI, 1.0%-9.9%]; odds ratio, 1.27 [95% CI, 1.05-1.54]; P = .02). The proportion of patients with any adverse events was 6.8% (59/863) in the RIC group and 5.6% (51/913) in the control group. Conclusions and Relevance: Among adults with acute moderate ischemic stroke, treatment with remote ischemic conditioning compared with usual care significantly increased the likelihood of excellent neurologic function at 90 days. However, these findings require replication in another trial before concluding efficacy for this intervention. Trial Registration: ClinicalTrials.gov Identifier: NCT03740971.
Importance: Preclinical and clinical studies have suggested a neuroprotective effect of remote ischemic conditioning (RIC), which involves repeated occlusion/release cycles on bilateral upper limb arteries; however, robust evidence in patients with ischemic stroke is lacking. Objective: To assess the efficacy of RIC for acute moderate ischemic stroke. Design, Setting, and Participants: This multicenter, open-label, blinded-end point, randomized clinical trial including 1893 patients with acute moderate ischemic stroke was conducted at 55 hospitals in China from December 26, 2018, through January 19, 2021, and the date of final follow-up was April 19, 2021. Interventions: Eligible patients were randomly assigned within 48 hours after symptom onset to receive treatment with RIC (using a pneumatic electronic device and consisting of 5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mm Hg) for 10 to 14 days as an adjunct to guideline-based treatment (n = 922) or guideline-based treatment alone (n = 971). Main Outcomes and Measures: The primary end point was excellent functional outcome at 90 days, defined as a modified Rankin Scale score of 0 to 1. All end points had blinded assessment and were analyzed on a full analysis set. Results: Among 1893 eligible patients with acute moderate ischemic stroke who were randomized (mean [SD] age, 65 [10.3] years; 606 women [34.1%]), 1776 (93.8%) completed the trial. The number with excellent functional outcome at 90 days was 582 (67.4%) in the RIC group and 566 (62.0%) in the control group (risk difference, 5.4% [95% CI, 1.0%-9.9%]; odds ratio, 1.27 [95% CI, 1.05-1.54]; P = .02). The proportion of patients with any adverse events was 6.8% (59/863) in the RIC group and 5.6% (51/913) in the control group. Conclusions and Relevance: Among adults with acute moderate ischemic stroke, treatment with remote ischemic conditioning compared with usual care significantly increased the likelihood of excellent neurologic function at 90 days. However, these findings require replication in another trial before concluding efficacy for this intervention. Trial Registration: ClinicalTrials.gov Identifier: NCT03740971.
Authors: Peter Sandercock; Joanna M Wardlaw; Richard I Lindley; Martin Dennis; Geoff Cohen; Gordon Murray; Karen Innes; Graham Venables; Anna Czlonkowska; Adam Kobayashi; Stefano Ricci; Veronica Murray; Eivind Berge; Karsten Bruins Slot; Graeme J Hankey; Manuel Correia; Andre Peeters; Karl Matz; Phillippe Lyrer; Gord Gubitz; Stephen J Phillips; Antonio Arauz Journal: Lancet Date: 2012-05-23 Impact factor: 79.321