Oh Young Bang1, Jong-Won Chung2, Soo-Kyoung Kim2, Suk Jae Kim2, Mi Ji Lee2, Jaechun Hwang2, Woo-Keun Seo2, Yeon Soo Ha2, Sang Min Sung1, Eung-Gyu Kim2, Sung-Il Sohn2, Moon-Ku Han2. 1. From the Department of Neurology (O.Y.B., J.-W.C., M.J.L., W.-K.S.), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; Department of Neurology and Institute of Health Science (S.-K.K.), Gyeongsang National University College of Medicine, Jinju; Department of Neurology (S.J.K.), Hana General Hospital, Cheongju; Department of Neurology (J.H.), Kyungpook National University Chilgok Hospital, Daegu; Department of Neurology (Y.S.H.), Wonkwang University, School of Medicine, Iksan; Department of Neurology (S.M.S.), Pusan National University Hospital; Department of Neurology (E.-G.K.), Busan Paik Hospital, Inje University; Department of Neurology (S.-I.S.), Keimyung University School of Medicine, Daegu; and Department of Neurology (M.-K.H.), Seoul National University Bundang Hospital, Seongnam, Korea. ohyoung.bang@samsung.com. 2. From the Department of Neurology (O.Y.B., J.-W.C., M.J.L., W.-K.S.), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; Department of Neurology and Institute of Health Science (S.-K.K.), Gyeongsang National University College of Medicine, Jinju; Department of Neurology (S.J.K.), Hana General Hospital, Cheongju; Department of Neurology (J.H.), Kyungpook National University Chilgok Hospital, Daegu; Department of Neurology (Y.S.H.), Wonkwang University, School of Medicine, Iksan; Department of Neurology (S.M.S.), Pusan National University Hospital; Department of Neurology (E.-G.K.), Busan Paik Hospital, Inje University; Department of Neurology (S.-I.S.), Keimyung University School of Medicine, Daegu; and Department of Neurology (M.-K.H.), Seoul National University Bundang Hospital, Seongnam, Korea.
Abstract
OBJECTIVE: To evaluate the safety and efficacy of induced hypertension in patients with acute ischemic stroke. METHODS: In this multicenter randomized clinical trial, patients with acute noncardioembolic ischemic stroke within 24 hours of onset who were ineligible for revascularization therapy and those with progressive stroke during hospitalization were randomly assigned (1:1) to the control and intervention groups. In the intervention group, phenylephrine was administered intravenously to increase systolic blood pressure (SBP) up to 200 mm Hg. The primary efficacy endpoint was early neurologic improvement (reduction in NIH Stroke Scale [NIHSS] score of ≥2 points during the first 7 days). The secondary efficacy endpoint was a modified Rankin Scale score of 0 to 2 at 90 days. Safety outcomes included symptomatic intracranial hemorrhage/edema, myocardial infarction, and death. RESULTS: In the modified intention-to-treat analyses, 76 and 77 patients were included in the intervention and control groups, respectively. After adjustment for age and initial stroke severity, induced hypertension increased the occurrence of the primary (odds ratio 2.49, 95% confidence interval [CI] 1.25-4.96, p = 0.010) and secondary (odds ratio 2.97, 95% CI 1.32-6.68, p = 0.009) efficacy endpoints. Sixty-seven (88.2%) patients of the intervention group exhibited improvements in NIHSS scores of ≥2 points during induced hypertension (mean SBP 179·7 ± 19.1 mm Hg). Safety outcomes did not significantly differ between groups. CONCLUSION: Among patients with noncardioembolic stroke who were ineligible for revascularization therapy and those with progressive stroke, phenylephrine-induced hypertension was safe and resulted in early neurologic improvement and long-term functional independence. CLINICALTRIALSGOV IDENTIFIER: NCT01600235. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for patients with acute ischemic stroke, therapeutic-induced hypertension increases the probability of early neurologic improvement.
RCT Entities:
OBJECTIVE: To evaluate the safety and efficacy of induced hypertension in patients with acute ischemic stroke. METHODS: In this multicenter randomized clinical trial, patients with acute noncardioembolic ischemic stroke within 24 hours of onset who were ineligible for revascularization therapy and those with progressive stroke during hospitalization were randomly assigned (1:1) to the control and intervention groups. In the intervention group, phenylephrine was administered intravenously to increase systolic blood pressure (SBP) up to 200 mm Hg. The primary efficacy endpoint was early neurologic improvement (reduction in NIH Stroke Scale [NIHSS] score of ≥2 points during the first 7 days). The secondary efficacy endpoint was a modified Rankin Scale score of 0 to 2 at 90 days. Safety outcomes included symptomatic intracranial hemorrhage/edema, myocardial infarction, and death. RESULTS: In the modified intention-to-treat analyses, 76 and 77 patients were included in the intervention and control groups, respectively. After adjustment for age and initial stroke severity, induced hypertension increased the occurrence of the primary (odds ratio 2.49, 95% confidence interval [CI] 1.25-4.96, p = 0.010) and secondary (odds ratio 2.97, 95% CI 1.32-6.68, p = 0.009) efficacy endpoints. Sixty-seven (88.2%) patients of the intervention group exhibited improvements in NIHSS scores of ≥2 points during induced hypertension (mean SBP 179·7 ± 19.1 mm Hg). Safety outcomes did not significantly differ between groups. CONCLUSION: Among patients with noncardioembolic stroke who were ineligible for revascularization therapy and those with progressive stroke, phenylephrine-induced hypertension was safe and resulted in early neurologic improvement and long-term functional independence. CLINICALTRIALSGOV IDENTIFIER: NCT01600235. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for patients with acute ischemic stroke, therapeutic-induced hypertension increases the probability of early neurologic improvement.
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