Enhanced Control of Hypertension and Thrombolysis Stroke Study - ENCHANTED: Blood Pressure Reduction

Feb 25, 2019
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Health and Medical Research Council of Australia; UK Stroke Association; Ministry of Health and the National Council for Scientific and Technological Development of Brazil; Ministry for Health, Welfare, and Family Affairs of South Korea; Takeda.
Date Published:
02/07/2019
Date Updated:
02/25/2019
Original Posted Date:
02/25/2019
References

Contribution To Literature:

The ENCHANTED trial showed that intensive blood pressure lowering reduced intracranial hemorrhage; however, this did not result in improved functional status.

Description:

The goal of the trial was to evaluate intensive blood pressure lowering compared with usual care among patients receiving alteplase for acute ischemic stroke.

Study Design

  • Randomized
  • Parallel

Patients with acute ischemic stroke and receiving treatment with intravenous alteplase were randomized to intensive blood pressure lowering (n = 1,081) versus usual care (n = 1,115). In the intensive group, the target systolic blood pressure was 130-140 mm Hg within 1 hour of thrombolysis. In the usual care group, the target systolic blood pressure was <180 mm Hg within 72 hours of thrombolysis.

  • Total number of enrollees: 2,227
  • Duration of follow-up: 90 days
  • Mean patient age: 67 years
  • Percentage female: 37%
  • Percentage with diabetes: 21%

Inclusion criteria:

  • Acute ischemic stroke of mild to moderate severity
  • ≥18 years of age
  • Systolic blood pressure ≥150 mm Hg

Exclusion criteria:

  • Unlikely to benefit from or contraindication to thrombolysis
  • Systolic blood pressure >185 mm Hg
  • Poor prognosis
  • Pre-existing disability that would interfere with functional outcome assessment

Principal Findings:

The primary outcome, improvement in functional status at 90 days, was similar between treatment groups (odds ratio 1.01, p = 0.87). The finding was the same in multiple prespecified subgroups.

Secondary outcomes:

  • Any intracranial hemorrhage: 14.8% in the intensive group versus 18.7% in the usual care group (p < 0.014)
  • Fatal intracranial hemorrhage: 0.5% in the intensive group versus 1.3% in the usual care group (p = 0.054)
  • Serious adverse event: 19.4% in the intensive group versus 22.0% in the usual care group (p < 0.14)
  • On-treatment systolic blood pressure: 144 mm Hg in the intensive group versus 150 mm Hg in the usual care group (p < 0.0001)

Interpretation:

Among patients with acute ischemic stroke of mild to moderate severity undergoing intravenous alteplase therapy, intensive blood pressure lowering was not associated with an improvement in functional status at 90 days compared with usual care. However, intensive blood pressure lowering was associated with a reduction in any intracranial hemorrhage and a nonsignificant reduction in fatal intracranial hemorrhage. This trial was not able to comment on patients with systolic blood pressure >185 mm Hg on presentation, since they were excluded from enrollment. Lack of functional status improvement might have partly been attributed to minimal difference in on-treatment blood pressure between groups.

References:

Anderson CS, Huang Y, Lindley RI, et al. Intensive blood pressure reduction with intravenous thrombolysis therapy for acute ischaemic stroke (ENCHANTED): an international, randomised, open-label, blinded-endpoint, phase 3 trial. Lancet 2019;393:877-88.

Keywords: Blood Pressure, Blood Pressure Determination, Brain Ischemia, Hypertension, Hypotension, Intracranial Hemorrhages, Mechanical Thrombolysis, Primary Prevention, Stroke, Tissue Plasminogen Activator, Vascular Diseases


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