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evident
Original paper
2013NEJMNeurology

INTERACT2

Rapid blood-pressure lowering in patients with acute intracerebral hemorrhage

RCTIntracerebral hemorrhage

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Overview

Intensive SBP lowering below 140 mm Hg in acute ICH did not significantly reduce death or major disability versus a target below 180 mm Hg.

Clinical takeaway

INTERACT2 did not prove that an SBP target below 140 mm Hg reduces death or major disability after ICH, though ordinal function looked better.

Key result

Death or major disability (mRS 3-6) at 90 days was 52.0% with intensive treatment vs 55.6% with guideline care (OR 0.87; 95% CI 0.75-1.01; p=0.06).

Practice impact

Rapid SBP lowering toward less than 140 mm Hg is reasonable in acute ICH, but it is not a proven mortality or major-disability benefit.

Evidence

Study design

Randomized trial of intensive versus guideline-recommended blood-pressure lowering in acute intracerebral hemorrhage.

Enrollment

2,839

Follow-up

Death or major disability assessed at 90 days.

Geography

Not listed

Clinical question

Does rapidly lowering systolic blood pressure below 140 mm Hg reduce death or major disability after acute intracerebral hemorrhage?

Population

  • Patients with spontaneous intracerebral hemorrhage within 6 hours and elevated systolic blood pressure.

Intervention

Intensive treatment to a systolic blood pressure below 140 mm Hg within 1 hour, using agents of the physician's choosing.

Comparator

Guideline-recommended treatment to a systolic blood pressure below 180 mm Hg.

Primary outcome

Death or major disability, defined as a modified Rankin scale score of 3 to 6 at 90 days.

Intensive blood-pressure lowering did not significantly reduce the primary outcome of death or major disability.

Odds ratio / 0.87 / 95% CI 0.75-1.01 / p=0.06

Key results

  • The primary outcome occurred in 52.0% with intensive treatment vs 55.6% with guideline treatment (OR 0.87; 95% CI 0.75-1.01; p=0.06).
  • Ordinal analysis showed lower modified Rankin scores with intensive treatment (OR for greater disability 0.87; 95% CI 0.77-1.00; p=0.04).
  • Mortality was 11.9% with intensive treatment and 12.0% with guideline treatment.

Harms

  • Nonfatal serious adverse events occurred in 23.3% with intensive treatment and 23.6% with guideline treatment.

Clinical Use

Practice impact

  • Rapid SBP lowering toward less than 140 mm Hg is reasonable in acute ICH, but it is not a proven mortality or major-disability benefit.

Applicability

  • Most applicable to spontaneous intracerebral hemorrhage presenting within 6 hours with elevated systolic blood pressure.

Limitations

  • The primary dichotomized outcome missed statistical significance.
  • Blood-pressure agents were left to the treating physician, so the trial is a target strategy, not a drug trial.
  • The later ATACH-2 trial tested a still lower intensive target.

Common misinterpretations

  • A nonsignificant primary result is not proof that intensive lowering is useless, but it is not a positive primary win.
  • Similar serious-adverse-event rates do not mean every intensive target is equally safe.

Related evidence

ATACH-2 - Later Trial

Citation

Anderson CS, Heeley E, Huang Y, et al. Rapid blood-pressure lowering in patients with acute intracerebral hemorrhage. N Engl J Med. 2013;368(25):2355-2365. doi:10.1056/NEJMoa1214609

In patients with intracerebral hemorrhage, intensive lowering of blood pressure did not result in a significant reduction in the rate of the primary outcome of death or severe disability.