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An Overview of Long-term Randomized Controlled Trials

Nicolas Danchin, MD, FESC; Michel Cucherat, MD, PhD; Christian Thuillez, MD; Eric Durand, MD; Zena Kadri, MD; Philippe G. Steg, MD, FESC

Arch Intern Med. 2006;166:787-796.

Background  Results of randomized trials of angiotensin-converting enzyme inhibitors in patients with coronary artery disease (CAD) and preserved left ventricular function are conflicting. We undertook this study to determine whether long-term prescription of angiotensin-converting enzyme inhibitors decreases major cardiovascular events and mortality in patients who have CAD and no evidence of left ventricular systolic dysfunction.

Methods  We searched MEDLINE, EMBASE, and IPA databases, the Cochrane Controlled Trials Register (1990-2004), and reports from scientific meetings (2003-2004), and we reviewed secondary sources. Search terms included angiotensin-converting enzyme inhibitors, coronary artery disease, randomi(s)zed controlled trials, clinical trials, and myocardial infarction. Eligible studies included randomized controlled trials in patients who had CAD and no heart failure or left ventricular dysfunction, with follow-up of 2 years or longer. Of 1146 publications screened, 7 met our selection criteria and included a total of 33 960 patients followed up for a mean of 4.4 years.

Results  Five trials included only patients with documented CAD. One trial included patients with documented CAD (80%) or patients who had diabetes mellitus and 1 or more additional risk factors, and another trial included patients who had CAD, a history of transient ischemic attack, or intermittent claudication. Treatment with angiotensin-converting enzyme inhibitors decreased overall mortality (odds ratio, 0.86; 95% confidence interval, 0.79-0.93), cardiovascular mortality (odds ratio, 0.81; 95% confidence interval, 0.73-0.90), myocardial infarction (odds ratio, 0.82; 95% confidence interval, 0.75-0.89), and stroke (odds ratio, 0.77; 95% confidence interval, 0.66-0.88). Other end points, including resuscitation after cardiac arrest, myocardial revascularization, and hospitalization because of heart failure, were also reduced.

Conclusion  Angiotensin-converting enzyme inhibitors reduce total mortality and major cardiovascular end points in patients who have CAD and no left ventricular systolic dysfunction or heart failure.

Author Affiliations: Department of Cardiology, Hôpital Européen Georges Pompidou (Drs Danchin, Durand, and Kadri) and Hôpital Bichat-Claude Bernard (Dr Steg), Assistance Publique–Hôpitaux de Paris, Paris, Service de Biostatistique, Hôpitaux de Lyon, Lyon (Dr Cucherat), Service de Pharmacologie, Centre Hospitalier Universitaire, Hôpitaux de Rouen, Rouen (Dr Thuillez), France.

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