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Cerebral microbleeds and the effect of intensive blood pressure reduction on hematoma expansion and functional outcomes: A secondary analysis of the ATACH-2 randomized clinical trial

JAMA Neurology Apr 21, 2018

Shoamanesh A, et al. - This study described cerebral microbleeds (CMBs) in acute intracerebral hemorrhage (ICH) and analyzed the potential for interaction between underlying small vessel disease (as indicated by CMB number and location) and assignment to acute intensive blood pressure (BP) targeting for functional outcomes and hematoma expansion. Among patients with ICH, cerebral microbleeds were widespread, however, the response to acute intensive BP treatment did not appear to be impacted.

Methods

  • In the Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 (ATACH-2) trial, preplanned subgroup analyses were carried out.
  • The scheme of the ATACH-2 was an open-label international randomized clinical trial that evaluated the optimal acute BP lowering in 1,000 patients with acute ICH.
  • Analyses followed the intent-to-treat paradigm.
  • Eligible candidates at least 18 years of age were recruited between May 2011 and September 2015, with 3 months of follow-up.
  • Participants had ICH volumes less than 60 mL on computed tomography (CT) and a Glasgow Coma Scale score of at least 5 on initial assessment, and in whom the study drug could be initiated within 4.5 hours of symptom onset.
  • A total of 833 participants were excluded, leaving 167 who had an interpretable axial T2*-weighted gradient-recalled echo sequence on magnetic resonance imaging to evaluate CMBs for inclusion in these subgroup analyses.
  • Death or disability (modified Ranking Scale score, 4-6) at 3 months was the primary outcome.
  • The secondary outcome included hematoma volume expansion of at least 33% on a CT scan obtained 24 hours after randomization vs the entry scan.

Results

  • This study included 167 patients; their mean (SD) age was 61.9 (13.2) years, and 98 (58.7%) were male.
  • The presence of cerebral microbleeds was reported in 120 patients.
  • As per the data, 46 of 157 (29.3%) patients presented with poor outcome (modified Ranking Scale score, ≥4), and hematoma expansion was seen in 29 of 144 (20.1%) patients.
  • There was a similar risk of poor outcomes for those assigned to intensive vs standard acute BP lowering among patients with CMBs (relative risk, 1.19; 95% CI, 0.61-2.33; P=.61) and those without CMBs (relative risk, 1.42; 95% CI, 0.43-4.70; P=.57).
  • No notable interaction was seen (interaction coefficient, 0.18; 95% CI, -1.20 to 1.55; P=.80).
  • In addition, there was a similar risk of hematoma expansion, and no significant interaction between treatment and CMBs was seen (interaction coefficient, 0.62; 95% CI, -1.08 to 2.31; P=.48).
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