Medicare beneficiaries who underwent carotid artery stenting (CAS) had a 32 percent mortality rate during an average two-year follow-up, suggesting the benefits of CAS may be limited for some patients, according to a study published online by JAMA Neurology.
CAS is an approach to treat narrowing of the carotid arteries called carotid stenosis. The Centers for Medicare & Medicaid Services in 2005 issued a national coverage determination so CAS would be covered for Medicare beneficiaries at high surgical risk. Randomized clinical trials (RCTs) have examined CAS. However, RCT results may not be generalizable to real-word patients and outcomes during the periprocedural (30-day) period and long-term have not been described in real-world Medicare beneficiaries, according to the study background.
Jessica J. Jalbert, Ph.D., of Harvard Medical School, Boston, and coauthors examined data for 22,516 Medicare beneficiaries who underwent CAS between 2005 and 2009. The average age of the patients was 76.3 years, 60.5 percent were male, 93.8 percent were white, 91.2 percent were at high surgical risk, 47.4 percent had clinical symptoms and 97.4 percent had carotid stenosis of at least 70 percent.
Authors found rates of crude 30-day mortality, stroke or transient ischemic attack, and myocardial infarction (heart attack) were 1.7 percent, 3.3 percent and 2.5 percent, respectively. Mortality during the two-year average follow-up was 32 percent, with rates of 37.3 percent among symptomatic patients and 27.7 percent among asymptomatic patients. All symptomatic patients, except for those younger than 75 years, had mortality risks that exceeded one-third; patients at least 80 years old and those admitted nonelectively were among those with the highest risks.
"Excess periprocedural risks and the presence of significant competing risks could negate the benefits of CAS and alter the benefit-risk assessment relative to carotid endarterectomy [surgery to remove artery plaque] in these patients. ... Real-world observational studies comparing CAS, carotid endarterectomy and medical management are needed to determine the performance of carotid stenosis treatment options for Medicare beneficiaries," the study concludes.
(JAMA Neurol. Published online January 12, 2015. doi:10.1001/jamaneurol.2014.3638. Available pre-embargo to the media at http://media.
Editor's Note: Authors made conflict of interest and funding/support disclosures. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Editorial: Why Treating an Artery May Not Treat the Patient
In a related editorial, Mark J. Alberts, M.D., of the University of Texas Southwestern Medical Center, Dallas, writes: "In summary, patients will appreciate getting a carotid artery stented and avoiding a stroke. However, they will be even more appreciative if they live longer and get to enjoy their newly opened carotid artery. More data are needed about the long-term cause of death for these patients. However, the present study by Jalbert and colleagues shows us that treating an artery may not treat the patient - at least not enough to keep him or her alive for more than a few years. With all the therapies at our disposal, we can and should do better. Our patients are counting on us."
(JAMA Neurol. Published online January 12, 2015. doi:10.1001/jamaneurol.2014.4142. Available pre-embargo to the media at http://media.
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Media Advisory: To contact corresponding author Soko Setoguchi, M.D., Dr.P.H., call Sarah Avery at 919-660-1306 or email firstname.lastname@example.org. To contact editorial author Mark J. Alberts, M.D., call Gregg Shields at 214-648-9354 or email email@example.com. A podcast with the authors will be available when the embargo lifts on the JAMA Neurology website: http://jama.