CARE Registry Study Compares Two CAS Devices
There is little difference in using a distal filter EPD (F-EPD) or a proximal EPD (P-EPD) to prevent an embolism during carotid artery stenting (CAS). Both work equally well and have similar low rates of in-hospital and 30-day stroke or death, according to a study published April 20 in JACC: Cardiovascular Interventions.
The first comparative effectiveness analysis on this topic, the study used data from the ACC’s CARE Registry, now the PVI Registry, and assessed records from 10,246 patients who had elective carotid stent procedures with embolism protection between January 2009 and March 2013. Of these procedures, practitioners used P-EPD in 590 cases (5.8 percent). These patients had higher rates of symptomatic lesions at the time of the procedure (about 46.8 percent vs.39.7 percent in the F-EPD group); higher rates of atrial fibrillation/flutter (16.1 percent vs. 13 percent); and a history of prior neurological events (51.2 percent vs. 46.6 percent).
The results showed little difference in either in-hospital stroke or death between the two groups: 1.6 percent for the P-EPD group compared to 2 percent for the F-EPD group. For the 76.5 percent of patients for whom 30-day follow-up data were available, 2.7 percent of the P-EPD group experienced stroke or death while 4 percent of the F-EPD group had these adverse outcomes. Furthermore, no differences in outcomes were found between symptomatic and asymptomatic patients treated with either device.
The authors note that although CARE is the largest national registry of carotid artery stent patients, the number of P-EPD devices used was modest. As a result, the study may not have been large enough to detect potentially meaningful differences in outcomes between the two devices.
“According to our calculations, a randomized trial of more than 6,000 patients would be needed to determine a statistically significant difference between P-EPD and F-EPD for 30-day adverse outcomes,” said Jay Giri, MD, MPH, the study’s lead author and an assistant professor of clinical medicine at the Hospital of the University of Pennsylvania. “There are no known plans to organize such an effort, so it is likely that the current data will remain the best available evidence for the foreseeable future.”
Keywords: Atrial Fibrillation, Carotid Arteries, Embolism, Follow-Up Studies, Registries, Stents, Stroke, National Cardiovascular Data Registries, PVI Registry
< Back to Listings