For patients undergoing elective carotid artery stenting, in-hospital and 30-day stroke and death rates were similar if they received proximal embolic protection devices (P-EPDs) or distal filter embolic protection devices (F-EPDs), according to a study that compared the efficacy of the devices.
Lead researcher Jay Giri, MD, MPH, of the University of Pennsylvania Perelman School of Medicine in Philadelphia, and colleagues published their findings online in the Journal of the American College of Cardiology: Cardiovascular Interventions on April 20.
The in-hospital stroke and death rates were 1.5 percent for the P-EPD group and 2.4 percent for the F-EPD group, while the 30-day stroke and death rates were 2.5 percent and 4.2 percent, respectively.
“There were very small trends in favor of the proximal protection devices in both cases, but we didn’t have the power to show that those differences were statistically significant,” Giri said in an interview with Cardiovascular Business. “We certainly did not see any significant signal of harm with the proximal protection device. We can’t rule out that there’s some small benefit, even. But if that benefit is there, it’s probably pretty small, and it’s going to be very hard to tease it out.”
Previous research found that approximately 95 percent of carotid stenting procedures in the U.S. were performed with an embolic protection device because Medicare mandates their use for reimbursement.
The researchers examined data from the Carotid Artery Revascularization and Endarterectomy Registry, which includes patients in the U.S. with carotid stenosis who have undergone revascularization with either carotid endarterectomy or carotid artery stenting. They examined 10,246 carotid artery stenting procedures between January 2009 and March 2013. The mean age of patients was 71 years.
In this study, only 5.8 percent of patients undergoing carotid stenting procedures received a P-EPD, while the rest received an F-EPD.
“Proximal protection is not something that represents this magic bullet for stroke prevention,” Giri said. “There’s no single magic bullet for stroke prevention where we use this new technology and now we don’t have strokes with carotid stenting. It still takes selecting the right patient, having an experienced operator and performing the procedure well. It’s up to that operator to make the decision between the devices. This study doesn’t support folks wholesale changing their practice when distal protection devices are much more widely used.”
Giri said he did not know why few operators chose to use a P-EPD. However, he said P-EPDs were approved in the U.S. later than F-EPDs, and the two devices are used in different manners, so there is a learning curve for operators when switching from an F-EPD to a P-EPD.
He added that carotid stenting in the U.S. is not as popular as in other countries because of strict reimbursement restrictions. He cited data that showed only 15 percent to 20 percent of carotid revascularizations in the U.S. are performed with stenting.
Giri said that it would be difficult to perform a randomized trial of the two devices because it would need to involve more than 6,000 patients who are followed for 30 days.
“It’s going to be very hard to show a difference between these two for stroke and death,” he said.