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ACTIVE I: Irbesartan failed to lower CV events in patients with AF

Yusuf S. N Engl J Med. 2011;364:928-938.

Issue: April 2011

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Among patients with atrial fibrillation, irbesartan, an angiotensin-receptor blocker, did not reduce the occurrence of CV events, including MI and death from vascular causes, compared with placebo, according to randomized, clinical trial data.

In the Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events (ACTIVE-I) trial, investigators enrolled patients (n=9,016; mean age, 69.6 years) who had permanent AF or at least two episodes of intermittent AF in the previous 6 months. Patients were then randomly assigned to receive either irbesartan (Avapro, Sanofi-Aventis/Bristol-Myers Squibb) or placebo. The first coprimary outcome was defined as MI, stroke or death from vascular causes, and the second was this composite outcome plus hospitalization for HF.

During a mean follow-up of 4.1 years, patients taking irbesartan had a mean reduction in systolic BP of 2.9 mm HG and diastolic BP of 1.9 mm Hg. There was no difference in the first coprimary endpoint between groups (5.4% each per 100 patient years), and only nonsignificant reduction in the second coprimary endpoint in the irbesartan group (7.3% vs. 7.7% per 100 patient years; P=.12).

When rates of hospitalization were looked at individually, researchers found that patients given irbesartan had a nominally significant reduction in first hospitalization for HF (HR=0.86; 95% CI, 0.76- 0.98), but not in the risk of hospitalization for AF (HR=0.95; 95% CI, 0.85-1.07).

“Among patients with AF, most of whom had well-controlled hypertension and 60% of whom were receiving an ACE inhibitor, the addition of irbesartan did not reduce the risk of death from CV causes, stroke or MI or this composite outcome plus hospitalization for HF,” the researchers wrote, later adding that it remains to be seen whether more aggressive lowering of BP would be effective in patients with AF.

The ACTIVE I trial was sponsored by Bristol-Myers Squibb and Sanofi-Aventis.

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