News | April 22, 2015

Study Compares Outcomes of Two Devices Used in Carotid Artery Stenting

First comparative effectiveness study of protective devices showed little difference in outcomes

carotid artery stenting, F-EPD, P-EPD, ACC, embolic protection devices

April 22, 2015 — A study published in JACC: Cardiovascular Interventions showed that in-hospital and 30-day stroke or death rates were equally low with either a distal filter embolic protection device (F-EPD) or a proximal EPD (P-EPD) to protect patients from blood clots during carotid artery stenting. A small sample size for one device, however, raises questions on the study’s ability to detect potentially meaningful differences in outcomes.

The Centers for Medicare and Medicaid Services (CMS) mandates that cardiologists use one of these two devices in order to be reimbursed for carotid artery stenting. The F-EPD uses small baskets to catch any debris produced during angioplasty and stent placement, while the P-EPD uses balloons to arrest or reverse flow to the internal carotid artery. Although some argue that latter method is superior because the carotid artery is protected throughout the entire procedure, it is less popular among cardiovascular professionals.

Using data from the American College of Cardiology’s CARE Registry, researchers assessed records from 10,246 patients who had elective carotid stent procedures with embolic protection between January 2009 and March 2013. Of these procedures, practitioners used P-EPD in almost 6 percent of cases. These patients had higher rates of symptomatic lesions at the time of the procedure; higher rates of fast, irregular heartbeats; and a history of prior neurological events.

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.    

Due to the modest number of P-EPD devices used, 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, M.D., 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.”   

For more information: www.acc.org

Related Content

DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Sponsored Content | Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
Philips Showcases Integrated Vascular Solutions at VIVA 2017
News | Peripheral Artery Disease (PAD)| September 13, 2017
Philips announced its presence at the Vascular Interventional Advances (VIVA 17) Annual Conference in Las Vegas from...
Overlay Init