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

doi:10.1067/mhj.2001.119609

American Heart Journal

Volume 142, Issue 6, December 2001, Pages 945-951

https://doi.org/10.1067/mhj.2001.119609 Get rights and content

Abstract

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. (Am Heart J 2001;142:945-51.)

Section snippets

General design features

The DEBATE study was started in 1998 as a population-based survey to investigate aspects of aging and drug treatments, especially in the elderly living outside institutions.12, 13 The intervention part of the DEBATE study is a single-center, controlled clinical trial with a prospective, randomized, open-blinded end points (PROBE) design. It is designed to investigate the effects of multifactorial evidence-based cardiovascular care compared with the usual care on cardiovascular events and

Results

A flow diagram of the DEBATE study is shown in Figure 1.

. Overall design of the DEBATE study.

Altogether, we received questionnaires from 812 individuals assumed to have atherosclerotic disease and giving their consent to further contact. Of these 812 patients, 208 could not be recontacted, had died, or were ineligible for the study (did not have atherosclerotic disease, were no longer living at home, or were participating in another trial) by the time of contact, whereas 204 refused to

Discussion

We have successfully randomized 75- to 90-year-old atherosclerotic patients to a multifactorial intervention trial that aims to examine the overall effect of evidence-based procedures on cardiovascular end points in this age group. The DEBATE study has several strengths: it is population-based and, because exclusion criteria have been kept to the minimum, the patients have a high degree of comorbidity. The trial seeks to apply the best current evidence in the treatment of elderly people with

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To explore, whether a LW among the community-dwelling older people has an influence on intensity of end-of-life treatment, place of death, or length of the dying process.
A 10-year follow-up; data concerning place and cause of death, event history, intensity of care, decision-making process, and length of the dying process were collected from the death certificates.
In a community-based longitudinal cardiovascular prevention trial (DEBATE) in Helsinki, home-dwelling older people with an atherosclerotic disease (n = 378, mean age 80.2 years) were questioned about the pre-existence of a written LW at baseline (n = 44) in 2000. In 2010, all death certificates (n = 207) were analysed, comparing people with a LW (n = 30) at baseline with those without (n = 177).
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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
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Our initial calculations were based on a 45% primary end point rate during 2 years and a 30% relative difference in end points between the groups. These assumptions were considered realistic at start of trial.6 Some authorities have calculated that with modern secondary prevention measures, it would be possible to prevent up to 75% of recurrent events.29
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All possible end points (fatal and nonfatal) were reviewed and adjudicated by a blinded outside review board (19). For the present analyses, major cardiovascular end points were determined and categorized as follows: nonfatal myocardial infarction, hospitalization for congestive heart failure, cerebrovascular event, or any cardiovascular death, as originally stated in trial design (17). Cause of death was classified into 4 classes: coronary, other cardiovascular disease, cancer, or other causes.
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^☆: Supported by the Academy of Finland, the Lions Organization (Punainen Sulka-Red Feather), the Ragnar Ekberg Foundation, and the Helsinki University Central Hospital.

^☆☆: Reprint requests: T. Strandberg, MD, PhD, Department of Medicine, Geriatric Clinic, University of Helsinki, PO Box 340, FIN-00029 HUS, Finland. E-mail: [email protected]

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

Abstract

Section snippets

General design features

Results

Discussion

Lancet

Lancet

Lancet

Lancet

Am J Cardiol

Cardiovascular management of the elderly

Eur Heart J

Cardiovascular aging in health

Clin Geriatr Med

Hypertension in the elderly: implications and generalizability of randomized trials

JAMA

The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels

N Engl J Med

Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels

N Engl J Med

Cholesterol lowering in the elderly population

Arch Intern Med

Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients: the Heart Outcomes Prevention Evaluation Study Investigators

N Engl J Med

Prevention of coronary heart disease in clinical practice: recommendations of the Second Joint Task Force of European and Other Societies on Coronary Prevention

Eur Heart J

Trial Design
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☆,☆☆