By Ransdell Pierson and Bill Berkrot
WASHINGTON (Reuters) - A longstanding practice of giving steroids to patients during cardiopulmonary bypass surgery to reduce inflammation failed to help patients and actually increased the risk of heart attacks, according to results of a large clinical trial.
"This study shows that administering steroids during cardiac surgery requiring bypass can cause harm," said Dr. Richard Whitlock, a cardiologist with McMaster University in Hamilton, Ontario, who led the international trial. "Based on these results, we suggest that steroids should not be used prophylactically during cardiac surgeries that require the use of cardiopulmonary bypass."
Whitlock, who presented his findings on Monday at the annual scientific sessions of the American College of Cardiology in Washington, estimated that 25 percent of patients undergoing open heart surgery in the North America are given steroids.
"But the steroid use is much higher in Europe," he said, particularly in the Netherlands, Denmark and Germany. "In the Netherlands it's almost the standard of care."
The study is the largest ever conducted on cardiac surgery and involved more than 7,500 patients in 18 countries who underwent cardiac surgery with the use of the heart-lung machine, which temporarily takes over the function of the heart and lungs during surgery.
More than half a million cardiac procedures are performed each year in the United States, and they have become common operations throughout the world.
Although steroids have been shown to lower the body's inflammation during and after use of the heart-lung machine, no studies had ever tested whether the drugs achieve presumed benefits - such as protecting the heart.
In the new study, called SIRS, half the patients during surgery received methylprednisolone, a widely used steroid to prevent inflammation, and half received a placebo. Patients were then evaluated 30 days after surgery.
The trial failed both its primary goals. The overall death rate was no better for those receiving the steroid than those taking placebo. Nor was there any significant benefit from the steroid on a combination of measurements including death, heart attack, stroke, new renal failure or respiratory failure, compared with placebo.
Moreover, the combined rate of death and heart attack was 15 percent higher for those who received methylprednisolone, and the risk of heart attack alone was 21 percent higher.
Whitlock said heart surgeons became interested in steroids in the 1940s and 1950s "and have been playing with this idea ever since." Indeed, he said all cardiopulmonary bypass patients at his hospital in Canada have been routinely given steroids during surgery over the years.
"But I think that will begin to change starting today," Whitlock said, given results of his study and the large size of the trial. He noted, however, that the results do not suggest steroids should be discontinued in heart surgery patients who take the anti-inflammatory medicines for other reasons.
Dr. Athena Poppas, associate professor of medicine at Brown University Medical School, who was not involved in the trial, predicted its results will spread quickly to cardiologists around the world.
"This is an important study that is going to change practice," Poppas said.
(Reporting by Ransdell Pierson; editing by Andrew Hay)