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Is Intensive Blood Pressure Lowering Beneficial in Acute Intracerebral Hemorrhage?

June 4, 2013

Is Intensive Blood Pressure Lowering Beneficial in Acute Intracerebral Hemorrhage?

  1. Seemant Chaturvedi, MDAU218

Equivocal outcomes from the INTERACT 2 trial

  1. Seemant Chaturvedi, MDAU218

The INTERACT 1 trial (JW Neurol Aug 14 2012) gave preliminary evidence that early, intensive blood pressure lowering might improve intracerebral hemorrhage (ICH) outcomes. Now, researchers report the findings of INTERACT 2. They enrolled patients with acute, spontaneous ICH whose blood pressure could be treated within 6 hours of symptom onset and lacked an overt structural cause, who were not in deep coma and not scheduled for immediate surgery. Patients were randomized to an intensive systolic blood pressure (SBP) target of <140 mm Hg within 1 hour of randomization, maintained for 7 days, or a conventional, guideline-determined SBP target of <180 mm Hg. The primary outcome was death or major disability at 90 days. A secondary analysis assessed improvement across the range of functional outcomes on the modified Rankin scale (ordinal analysis).

Among 2794 patients with 90-day outcome data (mean age, 63.5; 63% male; average blood pressure at enrollment, 179/101 mm Hg; 83.5% with deep ICH; 28.4% with intraventricular extension), the mean SBP at 6 hours after randomization was 139 mm Hg with intensive therapy versus 153 mm Hg with conventional treatment. The primary outcome was not significantly different between treatments (52.0% with intensive therapy, 55.6% with conventional therapy; odds ratio, 0.87; P=0.06). In the ordinal analysis, the odds of disability were a significant 13% lower with intensive than with conventional treatment. Death or major disability at 7 days and 28 days did not differ between groups. In a subgroup of patients with repeat imaging at 24 hours, hematoma growth did not differ between the two treatments.

Comment

In this large-scale trial, the primary outcome missed statistical significance, but there was a trend for improved outcomes, and functional outcomes showed a benefit with intensive blood pressure lowering. The authors achieved their blood pressure target of a 13 mm Hg reduction in systolic blood pressure, but the absolute difference in death and major disability was only 3.6%, not 7.0% as hypothesized, raising questions about whether the patients had too many preexisiting comorbidities or whether the earlier, pilot data were overly optimistic. The greater rate of care withdrawal with intensive versus conventional therapy (5.4% vs. 3.3%) and unreported differences in posthospitalization rehabilitation may have slightly diminished a potential treatment effect. For now, intensive lowering of blood pressure in acute intracerebral hemorrhage appears to be unharmful and may lead to a clinical benefit.

  • Disclosures for Seemant Chaturvedi, MD at time of publication Consultant / Advisory board Abbott Vascular; Boeringher-Ingelheim; Genentech; Thornhill Research Grant / research support Pfizer Editorial boards Neurology; Stroke Leadership positions in professional societies American Academy of Neurology (Vice Chair of Vascular Neurology Section)

Citation(s):

Reader Comments (8)

Mohamad Hamadeh Physician, Internal Medicine, University of Alberta Hospital

Although these data suggest benefit and do not show harm from intensive blood pressure management, the matter may not be resolved until the results of additional trials are released.

Mohamad Hamadeh Physician, Internal Medicine, University of Alberta hospital

What the guidelines recommend is that after the first 24 to 48 hours, oral antihypertensive agents can be initiated, but the goal is to actually keep blood pressure at intermediate levels, which they define as <160/100 mm Hg. Once you reach neurologic stability, which could be around 7 days, then they recommend being more aggressive, trying to keep the blood pressure <140/90 mm Hg, and in diabetics they would be more aggressive, to keep it <130/80 mm Hg. In our own experience, it takes around a month before you achieve these goals.

Alex Lazon Physician, Emergency Medicine, Hospital Almenara

Brain needs blood, and we should be carefull with pressure and tissue perfusion; I think this trial needs more support

MARK GRABER Physician, Emergency Medicine, University of Iowa

This study was somewhat of a sham. All of the data adjusted for initial stroke score, etc. was published ONLY in an online supplement. When they did the correct statistics there **was no difference**! THe editors should track this down before suggesting lowering blood pressure is good.

kirk andrus md Physician, VA

COST BENEFIT... # NEEDED TO TREAT FOR BENEFIT

Dr. V Kantariya MD Physician, Family Medicine/General Practice

First Do No HARM! Rethinking aggressive blood pressure treatment might be necessary. Neither all patients nor all therapies are the same. Individualizing is always good, and for Acute Intracerebral Hemorrhage, it is essential.

MARK GRABER Physician, Emergency Medicine, University of Iowa

This is the worst reporting I've seen. The online supplemental material makes it clear that when adjusted for confounders (such as baseline NIH stroke scale) THERE IS ABSOLUTELY NO DIFFERENCE IN OUTCOMES (sorry to shout) between the groups. This kind of stuff makes me grumpy.

Sweta Singla

Though it is most important for a clinician to how the clinical profile fared in intensive vs conventional BP lowering, it would be interesting to know the serial image correlates over a length of time in both of these groups.

Competing interests: None declared

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