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Abstract and Introduction
Abstract
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.
Introduction
Because oldest patients have often been excluded from clinical trials, there are still many uncertainties of the overall effectiveness of cardiovascular disease (CVD) prevention and medical therapies in older individuals. For example, patients 75 years or older have been underrepresented in randomized trials of acute cardiac syndromes. The American Heart Association Scientific Statement has recently updated the potential benefits of secondary prevention in the elderly and urged for greater use of preventive therapies. The DEBATE study was aimed at investigating the effect of multifactorial cardiovascular prevention in CVD patients 75 years or older in a randomized, controlled trial. DEBATE differed from previous studies in the elderly in several important ways: it was geriatrician-internist managed, was of longer duration (>3 years), and used intensively both lifestyle and drug treatments in accordance with current guidelines for CVD prevention and treatment. An important aspect of DEBATE was that this study is an example of a pragmatic clinical trial (practical clinical trial). We report here the principal results of DEBATE.
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