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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.
ClinicalTrials.gov 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.
Glossary
- CI=
- confidence interval;
- DWI=
- diffusion-weighted imaging;
- EVT=
- endovascular therapy;
- IVT=
- IV thrombolysis;
- LVO=
- large vessel occlusion;
- NIHSS=
- NIH Stroke Scale;
- SAO=
- small artery occlusion;
- SBP=
- systolic blood pressure;
- SETIN-HYPERTENSION=
- Safety and Efficacy of Therapeutic Induced Hypertension in Acute Non-Cardioembolic Ischemic Stroke
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
↵* These authors contributed equally to this work.
Class of Evidence: NPub.org/coe
- Received December 27, 2018.
- Accepted in final form June 6, 2019.
- © 2019 American Academy of Neurology
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