High Mortality After Carotid Stenting Raises Concern

January 15, 2015

A mortality rate of 32% at 2 years after carotid artery stenting (CAS) in a new study has raised concerns about the risk-benefit of this procedure, especially in older patients.

The researchers, led by Jessica J. Jalbert, PhD, Harvard Medical School, Boston, Massachusetts, say their findings "raise questions about whether carotid stenting is justified if periprocedural risks are too high or if patients do not live long enough to benefit from the main advantage of CAS, which is stroke prevention."

"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 conclude. "The higher risk of periprocedural complications and burden of competing risks owing to age and comorbidity burden must be carefully considered when deciding between carotid stenosis treatments for Medicare beneficiaries."

The analysis was published online January 12 in JAMA Neurology.

The researchers analyzed data from 22,516 US Medicare beneficiaries (average age, 76 years) who underwent CAS between 2005 and 2009.

At 30 days, 1.7% of patients had died, 3.3% had had a stroke or transient ischemic attack (TIA), and 2.5% had experienced a myocardial infarction. Older age, symptomatic carotid stenosis, and nonelective hospital admission were associated with increased risk for death and stroke or TIA during and after the periprocedural period.

Mortality at a mean follow-up duration of 2 years was 32.0% in the whole population. This rose to 37.3% in symptomatic patients; asymptomatic patients had a mortality rate at 2 years of 27.7%.

The authors point out that two randomized trials (SAPPHIRE [Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy] and CREST [Carotid Revascularization Endarterectomy vs Stenting Trial]) have suggested similar outcomes for carotid stenting compared with carotid endarterectomy, but the situation in real-world patients may be different, especially because they are generally older, with more comorbidities, and are treated by less skilled operators.

This was indeed the case in the current study, where the average patient age was 76 years and there were high rates of comorbidities: Eighty-five percent had ischemic heart disease, 25% had heart failure, and 20% had cancer. In addition, most physicians did not meet proficiency requirements set by the CREST and SAPPHIRE trials.

"The generalizability of trials like the SAPPHIRE or CREST to the Medicare population may be limited, underscoring the need to evaluate real-world effectiveness of carotid stenosis treatments," the researchers conclude.

They stress that the higher risk for periprocedural complications and burden of competing risks owing to age and comorbidities must be carefully considered in deciding between carotid stenosis treatments for older patients, and that real-world observational studies comparing carotid stenting, carotid endarterectomy, and medical management are needed to determine the best treatment options.

Noting that carotid stenting is estimated to reduce the absolute 5-year stroke risk by 16% for patients with symptomatic carotid stenosis of at least 70% and by 5% for patients with symptomatic carotid stenosis of 50% to 69%, they point out that this benefit is likely to be greatly diminished or absent for patients who are at high risk for death from causes other than ischemic stroke.

Treating an Artery vs Treating a Patient

In an accompanying editorial, Mark J. Alberts, MD, University of Texas Southwestern Medical Center, Dallas, writes that this study "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."

He points out that without information on the cause of death, it is difficult to account for the high mortality rate. While the most likely explanation is the combination of advanced age and sicker patients with poorly controlled cardiovascular risk factors, it is possible that the process of stenting a large vessel triggers the release of various factors that leads to higher rates of cardiovascular events, including death.

"[P]atients will appreciate getting a carotid artery stented and avoiding a stroke," he concludes. "However, they will be even more appreciative if they live longer and get to enjoy their newly opened carotid artery."

This study was funded by grants from the US Department of Health and Human Services. Dr Jalbert and Dr Alberts have disclosed no relevant financial relationships.

JAMA Neurol. Published online January 12. Abstract Editorial

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