An ECHANTED trial of thrombolysis indicated that intensive control of high BP, High blood pressure in case of intracranial haemorrhage did not lead to improved clinical outcome compared with guideline treatment in ischemic stroke patients eligible for thrombolytics. The findings of the study appeared in LANCET.
Systolic blood pressure of more than 185 mm Hg is a contraindication to thrombolytic treatment with intravenous alteplase in patients with acute ischaemic stroke, but the target systolic blood pressure for an optimal outcome is uncertain.
The prospective, open-label, blinded-endpoint trial included 2,227 patients eligible for alteplase (Activase) or treated for an acute ischemic stroke less than 4.5 hours after onset and who had a systolic blood pressure of at least 150 mm Hg.
These patients were randomized within 6 hours of stroke onset to intensive blood pressure lowering to 130-140 mm Hg systolic within 1 hour or guideline-directed blood pressure management to less than 180 mm Hg systolic, both for 72 hours atop background optimal care.
They found that while intensive management was safe, the trial provided no evidence to support a major change in the guidelines. The Modified Rankin Scale (mRS) scores were not shifted toward better function by targeting 130-140 mm Hg systolic pressure in the first hour after presentation compared with the standard limit of 180 mm Hg (OR 1.01, P=0.87). Similar findings emerged whether per protocol or adjusted for deviations and across stroke severity quartiles.
There was significantly less intracranial haemorrhage, though, in the intensively managed group (14.8% vs 18.7%, OR 0.75, P=0.0137), Craig Anderson, MD, PhD, of the University of Sydney, Australia, reported here at the American Heart Association’s International Stroke Conference.
There were several major limitations:
- There was only a 6 mm Hg difference pressure between groups in achieved blood, averaging 144 mm Hg with intensive lowering versus 150 with standard care in the first 24 hours.
- Most strokes were mild to moderate and few cases involved symptomatic intracerebral haemorrhage or proceeded to endovascular therapy.
- The open-label design left the potential for bias.
- Generalizability was questionable because most participants were from China and elsewhere in Asia, where intracranial atheroma and cerebral small vessel disease are bigger concerns than elsewhere in the world.
Mortality, poor outcome, length of stay, and overall serious adverse events were similar between groups.
The researchers concluded that Although intensive blood pressure lowering is safe, the observed reduction in intracranial haemorrhage did not lead to improved clinical outcome compared with guideline treatment.