25 Apr Carotid Artery Stenting: Comparison Of Embolic-Prevention Devices
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Giri: Carotid artery stents are placed by vascular surgeons or interventional cardiologists to decrease the risk of long-term stroke in patients with severe atherosclerotic disease of the carotid artery. When these procedures are performed, there is a risk of releasing small amounts of debris into the brain’s circulation, causing a stroke around the time of the procedure (peri-procedural stroke). In order to mitigate this issue, embolic protection devices (EPD) have been developed to decrease the chances of small debris reaching the brain.
Two types of EPD exist. The first is a small filter meant to catch the debris released by placement of the carotid stent (distal filter EPD).
The second is a more complex device type that leads to transient halting of blood flow to the brain in the carotid artery being stented (proximal EPD). Debris-containing blood is removed from the body prior to allowing normal blood flow to proceed back to the brain after stent placement.
Our prior research has shown that nearly all (>95%) of domestic carotid stenting procedures are performed with utilization of one of these devices. We sought to compare important clinical outcomes of stroke and death between these 2 device types within a large national sample of patients undergoing carotid stenting.
Some small prior studies have investigated whether the total amount of debris reaching the brain is less with proximal embolic protection devices. These studies have shown mixed results. However, no prior study has investigated important clinical outcomes of stroke and death in relation to these devices.
We found that overall uptake of proximal embolic protection devices utilization in America has not been robust. Less than 7% of all domestic CAS procedures are performed with this technology. Our analysis showed that in-hospital and 30-day stroke/death rates with proximal EPD and distal filter EPD were similar (1.6% vs. 2.0%, p = 0.56 and 2.7% vs. 4.0%, p = 0.22, respectively).
MedicalResearch: What should clinicians and patients take away from your report?
Dr. Giri: Use of proximal EPD during CAS was associated with low rates of in-hospital stroke/death similar to those with distal filter embolic protection devices. We cannot rule out a small benefit of proximal embolic protection devices and it certainly did not appear harmful. As such, we believe operator discretion should be used to select between the devices in given circumstances.
MedicalResearch: What recommendations do you have for future research as a result of this study?
Dr. Giri: Given our results, we have concluded that it is unlikely that a large controlled trial randomizing patients to these 2 devices will be feasible. This is because population-wide differences between the devices are small, so the scope of such a trial would be have to be very large (greater than 6,000 patients all followed for at least 30 days after the procedure).
Giri J, Parikh SA, Kennedy KF, et al. Proximal Versus Distal Embolic Protection for Carotid Artery Stenting: A National Cardiovascular Data Registry Analysis. J Am Coll Cardiol Intv. 2015;8(4):609-615. doi:10.1016/j.jcin.2015.02.001.
MedicalResearch.com Interview with Jay Giri, MD MPH (2015). Carotid Artery Stenting: Comparison Of Embolic-Prevention Devices