The second randomized controlled ENhanced Control of Hypertension ANd Thrombectomy strokE stuDy (ENCHANTED2):...

Area of Science:

• Neurology
• Cardiology
• Clinical Trials

Background:

• Optimal blood pressure management post-mechanical thrombectomy (MT) for acute ischemic stroke (AIS) remains uncertain.
• Large-vessel occlusion (LVO) AIS patients often experience persistent hypertension after MT.

Purpose of the Study:

• To assess the efficacy and safety of intensive blood pressure (BP) lowering after MT in LVO-AIS patients.
• To compare intensive BP control (target SBP ≤120 mmHg) versus less-intensive control (target SBP 140-180 mmHg).

Main Methods:

• The ENCHANTED2 trial was a prospective, randomized, open-label, blinded-endpoint study.
• It enrolled patients with reperfused LVO-AIS and hypertension at 60+ sites.
• Patients were randomized to intensive or less-intensive BP management for 72 hours.

Main Results:

• Recruitment was suspended due to safety concerns in the intensive BP-lowering group.
• Data from 817 patients in China indicated safety issues, leading to trial cessation.
• The trial's primary outcome was ordinal shift analysis of modified Rankin Scale (mRS) scores at 90 days.

Conclusions:

• The ENCHANTED2 trial was stopped prematurely due to safety concerns identified during interim analysis.
• Further evidence on intensive BP management post-MT for AIS is needed.
• The Trial Steering Committee will decide on potential protocol modifications and trial restart.