Multifactorial intervention to prevent recurrent cardiovascular events in patients 75 years or older: The Drugs and Evidence-Based Medicine in the Elderly (DEBATE) study: A randomized, controlled trial

Objective We aimed to examine whether better use of preventive methods and treatments of cardiovascular disease would reduce recurrent events in home-dwelling patients 75 years or older. Methods This was a randomized, controlled trial (a practical clinical trial, the DEBATE), conducted in 2000 to 2003 in Helsinki, Finland. We recruited 400 vascular patients with mean age of 80 years from the community, and they were randomly assigned to the intervention group (n = 199) where both nonpharmacological and pharmacological cardiovascular treatments were optimized by a geriatrician according to current guidelines. The control group (n = 201) received the usual care. Main outcome measures were major cardiovascular disease events and total mortality and changes in risk factors and medications. Results The groups were balanced at baseline. Mean duration of follow-up was 3.4 years. At 3 years, drug treatments had become more evidence-based in the intervention group. Consequently, total and low-density lipoprotein cholesterol levels (P <.0001) and systolic (P = .005) and diastolic (P = .009) blood pressure were significantly improved in the intervention group. However, neither primary end points (52 and 53 events in the intervention and control groups, respectively) nor total mortality (36 and 35 deaths) were significantly different between the two groups. No special adverse effects were encountered. Conclusion It was possible and safe to institute evidence-based cardiovascular treatments and improve risk factors in patients 75 years or older in a pragmatic setting. During 3.4 years, however, this was not converted to clinical benefits.