Utilizing intensive BP lowering safely reduced intracerebral hemorrhage in patients with acute ischemic stroke, according to data from the ENCHANTED trial presented at the International Stroke Conference.
Craig Anderson, MD, PhD, of The George Institute for Global Health in Beijing and University of New South Wales, Sydney, and Thompson G. Robinson, MD, of the Cardiovascular Research Centre at the University of Leicester in the United Kingdom, presented an assessment of the efficacy and safety of intensive BP lowering in thrombolysis-treated acute ischemic stroke.
“High systolic blood pressure ([systolic] BP >185 mm Hg) is a contraindication to thrombolysis in acute ischemic stroke, but the target [systolic] BP level for optimal outcome is uncertain,” the authors wrote in an abstract.
Anderson and Robinson analyzed data from the ENCHANTED trial, randomly assigning thrombolysis-eligible patients with acute ischemic stroke (< 6 hours of onset) to intensive (target systolic BP 130-140 mm Hg within 1 hour) vs. guideline-recommended (systolic BP < 180 mm Hg) BP lowering over 72 hours, with the primary outcome of functional status at 90 days, measured by shift in modified Rankin scale scores, using unadjusted ordinal logistic regression.
The researchers analyzed 2,196 patients with acute ischemic stroke (mean age, 67 years; 38% women) from 110 hospitals in 15 countries. The intensive BP-lowering group (n = 1,081) and guideline BP-lowering group (n = 1,115) were well-balanced at baseline.
Most of the patients in the study were recruited in Asia (73.7%; 65% in China). The median NIH Stroke Scale score was 7 (range, 0-42; interquartile range, 4-12).
According to Anderson and Robinson, 46.2% of participants reported receiving treatment for hypertension on hospital admission, with a mean systolic BP before treatment of 165 mm Hg. The median time from onset to randomization was 3.3 hours (interquartile range, 2.6-4.1)
There was no difference between the groups in the primary outcome at 90 days (OR = 1.01; 95% CI, 0.87-1.17), nor did the results vary by subgroup, including by quartiles of NIH Stroke Scale score, according to the researchers.
However, the safety outcome of intracranial or intracerebral hemorrhage was lower in the intensive group at 90 days (14.8% vs. 18.7%; OR = 0.75; 95% CI, 0.6-0.94), and the same was true for serious intracranial hemorrhage (5.5% vs. 9%; OR = 0.59; 95% CI, 0.42-0.82).
There were no differences between the groups in other efficacy and safety outcomes, including death, death or dependency, length of stay, quality of life, death or neurological decline at 72 hours and 7 days and serious adverse events.
“These findings highlight the need for more research to better understand the underlying mechanism of benefit and harm of early intensive blood pressure lowering in the patients receiving modern reperfusion therapy with thrombolysis and devices, given that the reduction in brain hemorrhage failed to translate into improvements in overall recovery for patients,” Robinson said in a press release. – by Earl Holland Jr.
Anderson C, et al. LB6. Presented at: International Stroke Conference; Feb 6-8, 2019; Honolulu.
Anderson C, et al. Lancet. 2019;doi:10.1016/S0140-6736(19)30038-8.
Disclosures: Anderson reports he has financial ties with Amgen, Boehringer Ingelheim and Takeda. Please see the study for all other authors’ relevant financial disclosures.