• SCAI Statement on FDA Circulatory System Devices Advisory Panel on Expanded Indication

     
     
     
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    1/27/2011

    The Society for Cardiovascular Angiography and Interventions (SCAI) welcomes today's recommendation by the Food and Drug Administration (FDA) Circulatory System Devices Advisory Panel to expand the availability of carotid artery stenting to patients at standard risk for adverse events while undergoing surgery. SCAI urges the FDA to approve this recommendation, so patients who are candidates for carotid revascularization will have access to a minimally invasive option for treatment of carotid artery disease. 

    If the panel's recommendation is confirmed by FDA approval, SCAI emphasizes the importance of:

    • Participation in registries to collect clinical data to study carotid artery stenting in real-world settings to benchmark outcomes for continuous quality improvement
    • Participation in accreditation programs requiring independent peer review of carotid artery stenting procedures
    • Creation of continuing medical education and physician training programs to develop more physicians skilled in carotid artery stenting

    SCAI supports the recommendation of the FDA panel based on the results of CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial; New Engl J Med, 2010;363(1)), the largest and most rigorous randomized stroke prevention clinical trial ever undertaken, which found carotid artery stenting was equally safe and effective as the surgical procedure called carotid endarterectomy (CEA) for stroke prevention, including four-year follow-up. Using a combined primary endpoint of stroke, heart attack and death, CREST found the overall safety and efficacy of stenting vs. surgery was largely the same. Men and women experienced equal benefits, as did patients who had previously had a stroke and for those who had not.

    Guidelines for secondary stroke prevention recently updated by the American Heart Association and American Stroke Association include broader recommendations for carotid artery stenting than those currently covered by Medicare.  Currently, Medicare and most insurers in the United States cover carotid artery stenting only for symptomatic patients at increased surgical risk, and those enrolled in clinical trials. All other patients must pay out of pocket for the procedure, receive medications only, or undergo carotid endarterectomy, where a surgeon makes an incision in the patient's neck to remove the plaque blockage in the carotid artery. 

    In contrast, carotid artery stenting is a minimally invasive procedure performed with a thin, flexible, balloon-tipped tube called a catheter. The physician makes a small incision in the groin and threads the catheter through the blood vessels to the blocked artery in the neck. The physician then inflates a balloon to push aside the plaque blocking the artery. Once the blockage is cleared, a tiny spring-like device called a stent is positioned inside the artery to help keep the artery open. At the same time, an umbrella-like device on the end of the catheter has collected debris from the blockage and is used to remove it from the body.

    About Carotid Artery Disease

    Carotid artery disease is a serious condition where the blood vessels in the neck that supply blood to the brain become blocked by cholesterol, calcium, fatty substances, and other materials known as plaque. These blockages can prevent blood from flowing to the brain, leading to a stroke, the third highest cause of death in the United States, behind only heart disease and cancer, and the leading cause of long-term disability in the country.

    About SCAI
    Headquartered in Washington, D.C., the Society for Cardiovascular Angiography and Interventions is a 4,000-member professional organization representing invasive and interventional cardiologists in approximately 70 nations. SCAI's mission is to promote excellence in invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI's patient and physician education program, Seconds Count, offers comprehensive information about cardiovascular disease. For more information about SCAI and Seconds Count, visit www.scai.org or www.SecondsCount.org.

    REMARKS FROM SCAI LEADERS:

    "SCAI urges the FDA to accept the panel's recommendation, as it would provide patients with a safe, effective, and minimally invasive treatment option for carotid artery disease," said Christopher J. White, MD, FSCAI, SCAI president-elect and chairman, Department of Cardiology, and director of the Ochsner Heart & Vascular Institute, Ochsner Medical Center in New Orleans. "This recommendation by the FDA panel to expand the labeled indication for the use of carotid artery stenting would be a step forward in preventing stroke, the third leading cause of death in the United States." 

    "The FDA panel's recommendation, supported principally by the data from CREST, reinforces the importance of scientifically rigorous clinical trials that study alternative treatment options for patients. Landmark trials such as CREST provide the evidence base that enables us to offer the right treatment to the right patients at the right time," said Dr. Tyrone Collins, MD, FSCAI, chair of SCAI's Carotid Stenting and Neurovascular Interventions Committee and director of Interventional Cardiology at the Ochsner Heart & Vascular Institute, Ochsner Medical Center in New Orleans.  "We are hopeful more patients who may be at risk of stroke will have the full range of treatment options available to them."