Multifactorial cardiovascular disease prevention in patients aged 75 years and older: A randomized controlled trial: Drugs and Evidence Based Medicine in the Elderly (DEBATE) Study.

Background: The number of patients aged 75+ years with cardiovascular diseases (CVD) is increasing, but few studies of secondary prevention in this age group exist. The aim of the Drug and Evidence Based Medicine in the Elderly (DEBATE) study is to test the applicability and effectiveness of established CVD treatments in elderly patients.

Methods: From 1998 to 2000, population-based postal surveys were performed in Helsinki, Finland, including the age groups 75, 80, 85, 90, and 95 years (n = 4821). Of the 812 individuals reporting any atherosclerotic disease, 400 patients (66% of those eligible) were included in a randomized trial. In the intervention group, CVD treatments will be individualized according to current guidelines. A control group will receive the usual care. The trial period will last 2 years with a 3-year extension. The primary end point will be a composite of major CVD. In addition, a number of secondary end points will be recorded, including permanent institutionalization, decline in cognitive and physical function, and quality of life.

Results: During 2000, 400 home-dwelling patients were randomized to the intervention (n = 199) and control (n = 201) groups. The mean age is 80.2 years and 65.3% are women. Of the participants, 82% have coronary heart disease (41% with history of myocardial infarction), 37% history of stroke, 19% non-insulin-dependent diabetes mellitus, and 45% hypertension, and 6% are current smokers. Before randomization, 67% used aspirin, 40% b-blockers, 14% angiotensin-converting enzyme inhibitors, 36% nitrates, and 20% lipid-lowering drugs. The groups were well balanced at baseline.

Conclusion: We have successfully randomized elderly patients with a high degree of comorbidity into a multifactorial CVD prevention trial.