ACTIVE-I: Irbesartan linked with reduced HF complications, embolic events in patients with AF
European
Society of Cardiology Congress 2009
Patients with atrial fibrillation assigned irbesartan
experienced BP-lowering and reductions in HF hospitalization and thromboembolic
events.
Researchers for the ACTIVE-I trial enrolled 9,016
patients with AF drawn from the ACTIVE-A and ACTIVE-W trials. Patients were
randomly assigned to receive either irbesartan (Avapro,
Sanofi-Aventis/Bristol-Meyers Squibb) plus conventional AF therapy (n=4,518) or
placebo (n=4,498). The co-primary endpoints included a reduction in major
vascular events (CV death, MI or stroke) and a reduction in major vascular
events plus HF hospitalization. Patients were followed-up for a mean of 4.1
years.
According to the study results, irbesartan was not
associated with a reduction in the first co-primary endpoint of major vascular
events (5.4% per year in each group, P=.846). There was a slight
reduction in the second co-primary endpoint of major vascular events plus HF
hospitalization (7.3% in the irbesartan group vs. 7.7% in the placebo group,
P=.122) due to a 14% reduction in the risk for HF hospitalization in the
irbesartan group vs. the placebo group (2.7% vs. 3.2%, P=.018).
Recurrence of the second co-primary endpoint of major vascular events plus HF
hospitalization was lower in the irbesartan group vs. placebo (39.6% vs. 44.3%;
RR=0.89; 95% CI, 0.82-0.98). A post hoc analysis revealed a 13% reduction in
the composite of stroke, non-central nervous system embolism and transient
ischemic attack in patients taking irbesartan vs. placebo (2.9% vs. 3.4%,
P=.02).
“The implications for this study are that patients
with AF have other complications, especially HF, that are common,”
Salim Yusuf, MD, a professor of medicine at McMaster University in
Ontario, concluded in his presentation. “It would be reasonable to lower
BP perhaps with an angiotensin receptor-blocker like irbesartan, and it is
quite possible that more aggressive BP lowering with multiple antihypertensive
agents used together might lead to substantial reduction in HF and several
vascular disease to a greater extent.”
In the discussant portion of the presentation, Josep
Brugada Terradellas, MD, a cardiologist at Hospital Clinic i Provincial de
Barcelona in Spain, said that despite the modest risk reductions achieved by
irbesartan, it did not add much to the range of BP-lowering therapies available
for patients with AF.
“In a population with normal BP and who remain in
AF, irbesartan lowers BP to a modest extent with no significant impact on
outcomes of stroke, MI, vascular death or HF hospitalization combined,”
Terradellas said in his presentation. “Treatment with irbesartan, in my
view, does not add to the treatment of a heterogeneous population with
differing forms of AF already treated with BP-lowering drugs.”
For more information:
- Yusuf S. Session
3586-3587. Presented at: European Society of Cardiology
Congress; Aug. 29-Sept. 2, 2009; Barcelona.
