Jia-Qi An1, Ya-Wen Cheng2, Yi-Chen Guo1, Meng Wei2, Min-Jie Gong2, Yong-Lan Tang2, Xing-Yun Yuan2, Wen-Feng Song2, Chun-Ying Mu2, Ai-Feng Zhang2, Ardan M Saguner2, Guo-Liang Li1, Guo-Gang Luo1. 1. From the Stroke Centre and Department of Neurology (J.-q.A., Y.-w.C., Y.-c.G., M.W., M.-j.G., Y.-l.T., X.-y.Y., W.-f. S., C.-y.M., G.-g.L.) and Atrial Fibrillation Centre and Department of Cardiovascular Medicine (J.-q.A., G.-l L.), First Affiliated Hospital of Xi'an Jiaotong University, China; Renal Division (A.-f.Z.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Department of Cardiology (A.M.S.), University Heart Center Zurich, Switzerland. lguogang@163.com liguoliang_med@163.com. 2. From the Stroke Centre and Department of Neurology (J.-q.A., Y.-w.C., Y.-c.G., M.W., M.-j.G., Y.-l.T., X.-y.Y., W.-f. S., C.-y.M., G.-g.L.) and Atrial Fibrillation Centre and Department of Cardiovascular Medicine (J.-q.A., G.-l L.), First Affiliated Hospital of Xi'an Jiaotong University, China; Renal Division (A.-f.Z.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Department of Cardiology (A.M.S.), University Heart Center Zurich, Switzerland.
Abstract
OBJECTIVE: To determine the effect of remote ischemic postconditioning (RIPC) on patients with acute ischemic stroke (AIS) undergoing IV thrombolysis (IVT). METHODS: A single-center randomized controlled trial was performed with patients with AIS receivingIVT. Patients in the RIPC group were administered RIPC treatment (after IVT) during hospitalization. The primary endpoint was a score of 0 or 1 on the modified Rankin scale (mRS) at day 90. The safety, tolerability, and neuroprotection biomarkers associated with RIPC were also evaluated. RESULTS: We collected data from both the RIPC group (n = 34) and the control group (n = 34). The average duration of hospitalization was 11.2 days. There was no significant difference between 2 groups at admission for the NIH Stroke Scale score (p = 0.364) or occur-to-treatment time (p = 0.889). Favorable recovery (mRS score 0-1) at 3 months was obtained in 71.9% of patients in the RIPC group vs 50.0% in the control group (adjusted odds ratio 9.85, 95% confidence interval 1.54-63.16; p = 0.016). We further found significantly lower plasmaS100-β (p = 0.007) and higher vascular endothelial growth factor (p = 0.003) levels in the RIPC group than in the control group. CONCLUSIONS: Repeated RIPC combined with IVT can significantly facilitate recovery of nerve function and improve clinical prognosis of patients with AIS. CLINICALTRIALSGOV IDENTIFIER: NCT03218293. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that RIPC after tissue plasminogen activator treatment of AIS significantly increases the proportion of patients with an MRS score of 0 or 1 at 90 days.
RCT Entities:
OBJECTIVE: To determine the effect of remote ischemic postconditioning (RIPC) on patients with acute ischemic stroke (AIS) undergoing IV thrombolysis (IVT). METHODS: A single-center randomized controlled trial was performed with patients with AIS receiving IVT. Patients in the RIPC group were administered RIPC treatment (after IVT) during hospitalization. The primary endpoint was a score of 0 or 1 on the modified Rankin scale (mRS) at day 90. The safety, tolerability, and neuroprotection biomarkers associated with RIPC were also evaluated. RESULTS: We collected data from both the RIPC group (n = 34) and the control group (n = 34). The average duration of hospitalization was 11.2 days. There was no significant difference between 2 groups at admission for the NIH Stroke Scale score (p = 0.364) or occur-to-treatment time (p = 0.889). Favorable recovery (mRS score 0-1) at 3 months was obtained in 71.9% of patients in the RIPC group vs 50.0% in the control group (adjusted odds ratio 9.85, 95% confidence interval 1.54-63.16; p = 0.016). We further found significantly lower plasma S100-β (p = 0.007) and higher vascular endothelial growth factor (p = 0.003) levels in the RIPC group than in the control group. CONCLUSIONS: Repeated RIPC combined with IVT can significantly facilitate recovery of nerve function and improve clinical prognosis of patients with AIS. CLINICALTRIALSGOV IDENTIFIER: NCT03218293. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that RIPC after tissue plasminogen activator treatment of AIS significantly increases the proportion of patients with an MRS score of 0 or 1 at 90 days.
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