“Typical” heart patients not represented in trials

By Martha Kerr

NEW YORK (Reuters Health) – 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.