Moderator of 2 Sessions
Presenter of 5 Presentations
Opening by Chairs
Latest Data on Blood Pressure Management in ICH
Closing by Chairs
Blood Pressure Management in Acute Stroke
THE SECOND ENHANCED CONTROL OF HYPERTENSION AND THROMBECTOMY STROKE STUDY (ENCHANTED2) RANDOMIZED CONTROLLED TRIAL RESULTS
Abstract
Background and Aims
We aimed to resolve uncertainty and determine the effectiveness and safety of blood pressure (BP) lowering after mechanical thrombectomy (MT) for acute ischemic stroke (AIS).
Methods
ENCHANTED2 (clinicaltrials.gov NCT04140110) was an investigator-initiated, multicenter, prospective, randomized, open, blinded-endpoint trial of intensive systolic BP (SBP) control in reperfused (extended thrombolysis in cerebral infarction classification 2b/2c/3) for any large-vessel occlusion (LVO)-AIS patients with persistent hypertension (SBP ≥140mmHg) at 45 hospitals in China. Eligible patients were centrally randomly allocated to more-intensive (target SBP ≤120mmHg within 1 hour) or less-intensive (target SBP 140-180mmHg) BP management over 72 hours. A sample size of 2257 patients was estimated to provide 90% power to detect a 6.48% absolute reduction in the primary outcome, a shift in modified Rankin scale scores at 90 days, from more-intensive BP lowering, using ordinal logistic regression.
Results
Recruitment started in July 2020. At a meeting of the Data Safety Monitoring Board in March 2022 to review primary outcome available for 347 patients, they recommended suspension of recruitment due to safety concerns in the more-intensive group; which was implemented by the Trial Steering Committee (TSC), with 817 randomized patients and mean SBP 125mmHg and 143mmHg at 1 hour (mean difference -18mmHg) in the more-intensive and less-intensive groups, respectively. As safety concerns persisted on further review of the data in June 2022, the TSC stopped recruitment to allow unblinding and presentation of the results.
Conclusions
ENCHANTED2 will provide key randomized evidence on the role of intensive BP lowering after reperfusion in MT-treated AIS patients.