An independent safety-monitoring group stopped the trial earlier than expected, on November 20, 2001, when data showed the survival rates were substantially better for those receiving ICDs. A detailed analysis showed that after following each patient for an average of 20 months, the death rate for patients with an ICD was 14.2 percent, versus 19.8 percent for those who did not have an ICD. Statistically, this survival difference translates into a 31-percent reduction in mortality for the group that received defibrillators.
Indianapolis-based Guidant Corp., a maker of cardiovascular medical devices, funded the $7 million trial. Guidant is awaiting FDA approval for use of preventive ICD therapy in patients with heart failure. Two other companies, St. Jude Medical Inc. and Medtronic Inc., also manufacture implantable defibrillators.
However, with a price tag of about $20,000 each, the researchers note in the New England Journal article that the cost to the health care system would be substantial, if large numbers of patients began using ICDs prophylactically. They hope market forces bring the cost down. Moss also maintains that other therapies, particularly surgery, are just as costly but have not always demonstrated through objective research that they save lives.
We want doctors to be vigilant, Moss says. Just because you have one therapy that prevents death doesnt mean you should ignore other therapies. The significant thing, though, is that no other single therapy for this population has been shown to reduce mortality by nearly one
Contact: Leslie Orr
University of Rochester Medical Center