Real-world CAS outcomes not as rosy as controlled trials

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 - Brain, neuro, carotid stenting

Carotid artery stenting (CAS) may benefit patients by reducing stroke risks in the long term, but recent data suggest that they may not be living long enough for that benefit to bear fruit. According to a study published online Jan. 12 in JAMA Neurology, 32 percent of elderly CAS patients died within two years of the procedure.

Jessica J. Jalbert, PhD, of the Division of Pharmacoepidemiology at Brigham and Women’s Hospital in Boston, and colleagues used Medicare data from 2005 through 2009 for their analysis. Of the 22,516 patients who underwent CAS in that period, they found that 47.4 percent were symptomatic and 97.4 percent had at least 70 percent carotid stenosis.

The finding during the mean of two years reflected both high rates of mortality among symptomatic and asymptomatic patients, 37.3 percent and 27.7 percent, respectively.

Thirty-day risk for mortality, MI and stroke or transit ischemic attack (TIA) were 1.7 percent, 2.5 percent and 3.3 percent, respectively. Over the subsequent mean follow-up of two years, the risk for stroke or TIA was 9.1 percent. Symptomatic patients bore an elevated risk at all time points for stroke or TIA, MI or death.

They also noted that in patients for whom the surgery was not elective, risks were significantly higher across the board.

In an editorial, Mark J. Alberts, MD, of the Department of Neurology and Neurotherapeutics at the University of Texas Southwestern Medical Center in Dallas, wrote, “These outcomes are much worse than the mortality of almost any type of ischemic stroke. This would obviously negate most, if not all, of the benefits of carotid stenting in at least one-third of treated patients.”

Jalbert et al compared their findings to those of the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) and CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) trials, noting a rift between the randomized, controlled clinical trial and real-world data. Many patients fit neither trial’s criteria for CAS. In comparison to the real-world study’s 1.7 percent 30-day patient mortality, SAPPHIRE and CREST reported 0.6 percent and 0.7 percent, respectively.

Nor did physicians meet SAPPHIRE or CREST minimum case volume requirements. Jalbert et al expressed concerns that many physicians performing CAS were not equally proficient in the procedure, driving to some degree the worse outcomes seen in their own Medicare-based analysis.

These findings are in line with other data from real-world studies of CAS.

With more patients in clinical practice having higher risk of complications and mortality within 30 days to two years of the procedure and an older, more symptomatic and nonelective patient group, Jalbert et al called for more population-based studies to back up findings. “The decision to perform CAS should be based on overall survival as well as on the risk of complications and their effect on quality of life,” they wrote.

For more on the subject, see "Carotid Artery Stenting: Making Progress Amid Reimbursement Purgatory."