According to a recent study published in JACC: Cardiovascular Interventions during elective carotid artery stenting the use of either distal filter embolic protection devices (F-EPDs) or proximal embolic protection devices (P-EPDs) results in lower rates of in-hospital stroke and death.
Results from the study, conducted by a research team at the Perelman School of Medicine at the University of Pennsylvania, show that although P-EPDs have theoretical advantages that may make them superior to distal F-EPDs for stroke prevention during carotid artery stenting (CAS), there were no significant differences between the two devices.
Carotid artery stenting is a procedure in which the vascular surgeon inserts a slender, metal-mesh tube called a stent, which expands inside the carotid artery to increase blood flow in areas blocked by plaque. However, during the procedure, there is a risk of releasing small amounts of debris into the brain’s circulation. To address this issue, two types of EPDs were developed: F-EPDs have a small filter to catch debris; while P-EPDs stop blood flow to the brain in the carotid artery being stented, removing debris-containing blood before normal blood flow can be resumed.
“These study results challenge the notion that proximal EPDs are significantly superior to distal EPDs, or that they can serve as a ‘magic bullet’ for stroke prevention during carotid artery stenting,” said first author Jay Giri, MD, MPH, assistant professor of clinical medicine at Penn in a recent news release. “Even for patients who had recent symptoms of stroke or mini-stroke — who have been thought to get more benefit from proximal EPD — this study showed no statistical difference in device effectiveness.”
In the study titled “Proximal Versus Distal Embolic Protection for Carotid Artery Stenting,” the researchers compared the stroke/death rates between proximal embolic protection devices (P-EPDs) and distal filter embolic protection devices (F-EPDs) in elective carotid artery stenting (CAS). Between January 2009 and March 2013, the team examined 10,246 CAS procedures performed with embolic protection in the NCDR CARE (Carotid Artery Revascularization and Endarterectomy) registry.
P-EPDs were used in 590 of 10,246 cases (5.8%). Results revealed that patients who were treated with P-EPDs had higher rates of symptomatic lesion status (46.8% vs. 39.7%), atrial fibrillation/flutter (16.1% versus. 13.0%), and history of a neurological event (51.2% versus. 46.6%).
The researchers found no significant statistical differences in in-hospital stroke/death between P-EPD and F-EPD cohorts (1.5% versus. 2.4% and 1.6% versus. 2.0%, respectively). The results also showed that 30-day adverse events’ rates were similar for P-EPDs and F-EPDs before (2.5% versus. 4.2%) and after (2.7% versus. 4.0%, p = 0.22) propensity matching.
“There is certainly no signal of harm with use of proximal EPDs, and our study cannot rule out a small benefit of these devices. The choice of EPD type in a given case really comes down to physician discretion,” added Giri in the news release.
Based on the results, the researchers believe that although a large randomized controlled trial comparing these devices might be convenient, its viability is questionable due to the necessary scope.