"Typical" heart patients not represented in trials

Patients enrolled in randomized clinical trials of coronary interventions are younger and have better cardiac risk profiles than the average patient in clinical practice, European heart doctors report. As such, they say, treatment "can only be partially evidence-based."

Dr. Eric Boersma from Erasmus Medical Center in Rotterdam, The Netherlands, and colleagues looked at the characteristics of 4713 heart patients in the Euro Heart Survey compared with those of 8,647 patients in 14 randomized heart treatment trials.

The investigators found that 64 percent of patients in their survey would not have met the strict enrollment criteria of the randomized clinical trials.

Compared with clinical trial patients, patients seen in everyday clinical practice are typically older, have more co-morbid illnesses, more likely to have single vessel disease, and more often have blockage of the left main coronary artery, Boersma and colleagues report.

"In the case in which the patient that is being treated is not represented in clinical trials, then his/her treatment can only be partly 'evidence based'," Boersma noted in comments to Reuters Health.

"In my view, treatment should then be based on a) observational studies; b) expert opinion; c) personal experience with certain treatment."

Once randomized clinical trials of strictly selected patients have been completed, it is time to conduct studies of more typical patients, Boersma asserted.

SOURCE: European Heart Journal March 2006.