By Day GreenbergThe Daily Northwestern
According to an Evanston Northwestern Healthcare study, angioplasty patients who receive stents for unapproved uses should have no fear.
About 1 million angioplasties are performed each year to treat patients with heart problems. This can be done by inserting a wire-mesh tube, or stent, into a patient’s coronary artery, and expanding that tube with a balloon. Some stents, called drug-eluting stents, release medicine into the patient’s artery to prevent scar tissue from forming.
In their study, doctors found that out of 5,541 patients who received drug-eluting stents and no other device, 47 percent were given stents for “off-label” or “untested” uses. The Food and Drug Administration lists approved uses for the stents.
The study, which used data from 140 different centers across the United States, found that a year after surgery, there was little difference in risk for patients who were given stents for on- and off-label reasons.
“When devices are approved, they are based on pivotal trials with very narrowly selected patients with very narrow indications,” said Dr. Nirat Beohar, the study’s principal investigator and lead author and a professor at NU’s Feinberg School of Medicine. “But in the real world, you have to deal with much more complex patients.”
Dr. Charles Davidson, another author of the study, said it began because the FDA had voiced concerns about whether stents that were used in unapproved ways would harm patients.
“Once the FDA approves the device the physician is allowed to apply that device to any indication he or she chooses,” Davidson said.
The answers for questions to safety and effectiveness were encouraging, Davidson said. He said the safety was equitable to on-label use-it “wasn’t really a concern” – and the efficacy and long-term durability was positive.
However, a study by doctors at the Baylor College of Medicine in Houston, saw a higher rate of adverse events in patients who received stents with “off-label characteristics.”
The Baylor team, which studied 3,323 patients, found a negative outcome in 5 percent of patients who received stents for on-label reasons and 10 percent of off-label patients. Off-label patients were about two times as likely to have to undergo further treatment or even to go back under the knife.
“These stents were approved for the first time in 2003 and were very encouraging. After the devices got approved, the physicians got very excited about using the devices in higher risk people,” said Dr. Angel Caldera, an author of the Baylor study.
Davidson, who read both studies, said although a difference in risk was seen between patients who received stents for approved and unapproved reasons, the percentage of problems after the surgery was still small enough to provide reassurance to the patient.
Reach Day Greenberg at [email protected].
