(Circulation. 2000;102:e9036.)
© 2000 American Heart Association, Inc.
Cardiovascular News |
Cardiovascular News
1 Circulation Newswriter
Direct Myocardial Revascularization a "Placebo Effect," According to Study Chief
The chief of the first blinded study of percutaneous direct myocardial revascularization said his results indicate that the controversial treatment has a profound placebo effect that has previously been confused with therapeutic benefit in unblinded studies. Martin Leon, MD, a cardiologist at Lenox Hill Heart and Vascular Institute in New York, NY, called the perceived benefits in previous studies "an exaggerated placebo effect."
Dr Leon revealed the results of the Direct Myocardial Revascularization in Regeneration of Endomyocardial Channels Trial (DIRECT) at Transcatheter Cardiovascular Therapeutics 2000, a meeting held in Washington, DC, on October 19, 2000. He was the principal investigator of the 14-center study in which 298 patients were randomly assigned to either low-dose or high-dose laser treatment or to a placebo trial in which laser treatment was realistically simulated. Patients did not know which treatment they received.
Dr Leon told the Wall Street Journal, "This was a dead-on negative trial." All patients reported an improvement in symptoms and achieved better scores on a treadmill test given 6 months later. However, there was no difference among the groups. In fact, he told the Journal, the placebo group did the best when measures of improvement in angina class were considered.
There are 2 methods of direct myocardial revascularization.
The first is surgical and involves opening the chest and punching holes
from outside the heart into the myocardium using a laser. A second
method uses a catheter to thread the laser into the heart and makes the
holes in the