In the Journals

Carotid artery stenting may be risky for older adults

Older patients and those with symptomatic carotid stenosis were at increased risk for mortality, stroke or transient ischemic attack during and after a carotid artery stenting procedure, according to results from a study of Medicare beneficiaries.

Researchers studied the incidence of outcomes during and after the periprocedural period among Medicare beneficiaries aged 66 years and older who underwent carotid artery stenting from 2005 to 2006.

Jessica J. Jalbert, PhD, and colleagues conducted an observational study of 22,516 fee-for-service Medicare beneficiaries (mean age, 76.3 years; 60.5% men; 93.8% white) undergoing carotid artery stenting who were linked to the CMS carotid artery stenting database. Mean follow-up was 2 years.

Outcomes included 30-day and long-term risks for mortality, stroke and TIA, as well as periprocedural MI. Jalbert and colleagues also compared patient and operator characteristics with enrollment criteria from the SAPPHIRE and CREST trials, which found that carotid artery stenting was noninferior to carotid endarterectomy.

According to the researchers, 91.2% of patients studied were at high surgical risk, 47.4% were symptomatic and 97.4% had carotid stenosis of at least 70%.

Crude 30-day risks were 1.7% (95% CI, 1.5-1.8) for mortality, 3.3% (95% CI, 3-3.5) for stroke or TIA and 2.5% (95% CI, 2.3-2.7) for MI.

High mortality rates

Overall mortality during the mean 2-year follow-up period was 32% (95% CI, 31-33). For symptomatic patients, overall mortality was 37.3% (95% CI, 35.8-38.7) and for asymptomatic patients it was 27.7% (95% CI, 26.4-28.9).

Periprocedural risks were highest for patients who were symptomatic (mortality, 2.3%; stroke or TIA, 4.3%), aged 80 years and older (mortality, 2.4%; stroke or TIA, 4.1%), had undergone nonelective carotid artery stenting (mortality, 3.2%; stroke or TIA, 4.5%) and were at high surgical risk with symptomatic carotid stenosis of at least 50% (mortality, 2.4%; stroke or TIA, 4.3%). Procedure site also was associated with risk. Procedural risks were highest for patients who had their procedure performed at a government-owned hospital (mortality, 2.6%; stroke or TIA, 3.4%), a teaching hospital (mortality, 1.8%; stroke or TIA, 3.7%), a hospital with a stroke center (mortality, 2%; stroke or TIA, 3.5%) or a hospital with at least 500 beds (mortality, 1.9%; stroke or TIA, 3.7%), according to the researchers.

In symptomatic patients, periprocedural mortality risks were highest in those aged 80 years and older (3.3%), those admitted for a nonelective procedure (4.1%) and those treated at a government-owned hospital (4%). In asymptomatic patients, no subgroup had a 30-day mortality rate higher than 1.5%.

During the mean 2-year follow-up period, mortality risks were highest for patients aged 80 years and older (41.5%), symptomatic patients (37.3%) and those admitted for a nonelective procedure (36.2%).

Approximately 80% of Medicare patients met the SAPPHIRE indication of symptomatic stenosis of at least 50% or asymptomatic stenosis of at least 80%, and approximately 50% met the indication of at least one of the SAPPHIRE trial high-surgical-risk criteria, according to the researchers. However, approximately 80% were treated by physicians who did not meet the SAPPHIRE proficiency requirements, including low periprocedural complication rates and minimum number of carotid artery stenting procedures. Patients who met the SAPPHIRE criteria had lower crude risks for periprocedural mortality (1.6%; 95% CI, 0.9-2.3), periprocedural stroke or TIA (2%; 95% CI, 1.2-2.8) and stroke or TIA after 30 days (8.2%; 95% CI, 6-10.4) compared with the overall cohort.

Outcome risks related to CREST could not be analyzed because only 96 patients met the CREST enrollment criteria, but only 15.5% of patients had procedures in centers similar to those in CREST and only 9.3% had their procedures performed by physicians meeting the CREST proficiency requirements, they wrote.

“Our findings underscore the need for new evidence to understand the benefits of [carotid artery stenting] outside of [randomized controlled trials] because few Medicare beneficiaries undergoing [carotid artery stenting] as per the National Coverage Determination were treated by providers with proficiency levels similar to those of physicians in the SAPPHIRE trial or CREST,” Jalbert, from the division of pharmacoepidemiology, Brigham & Women’s Hospital and Harvard Medical School, and colleagues wrote. “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.”

Explanations for high mortality

In a related editorial, Mark J. Alberts, MD, wrote that “it is unlikely that the symptom status of the vessel, or the skills of the interventionalist, can alone explain the high mortality because most of the deaths occurred well after the periprocedural period.” Alberts noted that the mortality rate was much higher than for other studies of carotid artery stenting.

Alberts, from the department of neurology and neurotherapeutics at the University of Texas Southwestern Medical Center, Dallas, acknowledged that the most likely explanation is “a combination of advanced age and poorly controlled CVD risk factors … [but] we should be open to other possibilities. Perhaps the process of stenting a large vessel triggers the release of various factors (inflammatory, proliferative and toxic) that initiates a cascade of processes that leads to higher rates of CVD events, including death.”

For more information:

Alberts MJ. JAMA Neurol. 2015;doi:10.1001/jamaneurol.2014.4142.

Jalbert JJ. JAMA Neurol. 2015;doi:10.1001/jamaneurol.2014.3638.

Disclosure: The researchers report financial ties with several device and pharmaceutical companies; see the full study for a list of relevant financial disclosures. Alberts reports no relevant financial disclosures.

Older patients and those with symptomatic carotid stenosis were at increased risk for mortality, stroke or transient ischemic attack during and after a carotid artery stenting procedure, according to results from a study of Medicare beneficiaries.

Researchers studied the incidence of outcomes during and after the periprocedural period among Medicare beneficiaries aged 66 years and older who underwent carotid artery stenting from 2005 to 2006.

Jessica J. Jalbert, PhD, and colleagues conducted an observational study of 22,516 fee-for-service Medicare beneficiaries (mean age, 76.3 years; 60.5% men; 93.8% white) undergoing carotid artery stenting who were linked to the CMS carotid artery stenting database. Mean follow-up was 2 years.

Outcomes included 30-day and long-term risks for mortality, stroke and TIA, as well as periprocedural MI. Jalbert and colleagues also compared patient and operator characteristics with enrollment criteria from the SAPPHIRE and CREST trials, which found that carotid artery stenting was noninferior to carotid endarterectomy.

According to the researchers, 91.2% of patients studied were at high surgical risk, 47.4% were symptomatic and 97.4% had carotid stenosis of at least 70%.

Crude 30-day risks were 1.7% (95% CI, 1.5-1.8) for mortality, 3.3% (95% CI, 3-3.5) for stroke or TIA and 2.5% (95% CI, 2.3-2.7) for MI.

High mortality rates

Overall mortality during the mean 2-year follow-up period was 32% (95% CI, 31-33). For symptomatic patients, overall mortality was 37.3% (95% CI, 35.8-38.7) and for asymptomatic patients it was 27.7% (95% CI, 26.4-28.9).

Periprocedural risks were highest for patients who were symptomatic (mortality, 2.3%; stroke or TIA, 4.3%), aged 80 years and older (mortality, 2.4%; stroke or TIA, 4.1%), had undergone nonelective carotid artery stenting (mortality, 3.2%; stroke or TIA, 4.5%) and were at high surgical risk with symptomatic carotid stenosis of at least 50% (mortality, 2.4%; stroke or TIA, 4.3%). Procedure site also was associated with risk. Procedural risks were highest for patients who had their procedure performed at a government-owned hospital (mortality, 2.6%; stroke or TIA, 3.4%), a teaching hospital (mortality, 1.8%; stroke or TIA, 3.7%), a hospital with a stroke center (mortality, 2%; stroke or TIA, 3.5%) or a hospital with at least 500 beds (mortality, 1.9%; stroke or TIA, 3.7%), according to the researchers.

In symptomatic patients, periprocedural mortality risks were highest in those aged 80 years and older (3.3%), those admitted for a nonelective procedure (4.1%) and those treated at a government-owned hospital (4%). In asymptomatic patients, no subgroup had a 30-day mortality rate higher than 1.5%.

During the mean 2-year follow-up period, mortality risks were highest for patients aged 80 years and older (41.5%), symptomatic patients (37.3%) and those admitted for a nonelective procedure (36.2%).

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Approximately 80% of Medicare patients met the SAPPHIRE indication of symptomatic stenosis of at least 50% or asymptomatic stenosis of at least 80%, and approximately 50% met the indication of at least one of the SAPPHIRE trial high-surgical-risk criteria, according to the researchers. However, approximately 80% were treated by physicians who did not meet the SAPPHIRE proficiency requirements, including low periprocedural complication rates and minimum number of carotid artery stenting procedures. Patients who met the SAPPHIRE criteria had lower crude risks for periprocedural mortality (1.6%; 95% CI, 0.9-2.3), periprocedural stroke or TIA (2%; 95% CI, 1.2-2.8) and stroke or TIA after 30 days (8.2%; 95% CI, 6-10.4) compared with the overall cohort.

Outcome risks related to CREST could not be analyzed because only 96 patients met the CREST enrollment criteria, but only 15.5% of patients had procedures in centers similar to those in CREST and only 9.3% had their procedures performed by physicians meeting the CREST proficiency requirements, they wrote.

“Our findings underscore the need for new evidence to understand the benefits of [carotid artery stenting] outside of [randomized controlled trials] because few Medicare beneficiaries undergoing [carotid artery stenting] as per the National Coverage Determination were treated by providers with proficiency levels similar to those of physicians in the SAPPHIRE trial or CREST,” Jalbert, from the division of pharmacoepidemiology, Brigham & Women’s Hospital and Harvard Medical School, and colleagues wrote. “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.”

Explanations for high mortality

In a related editorial, Mark J. Alberts, MD, wrote that “it is unlikely that the symptom status of the vessel, or the skills of the interventionalist, can alone explain the high mortality because most of the deaths occurred well after the periprocedural period.” Alberts noted that the mortality rate was much higher than for other studies of carotid artery stenting.

Alberts, from the department of neurology and neurotherapeutics at the University of Texas Southwestern Medical Center, Dallas, acknowledged that the most likely explanation is “a combination of advanced age and poorly controlled CVD risk factors … [but] we should be open to other possibilities. Perhaps the process of stenting a large vessel triggers the release of various factors (inflammatory, proliferative and toxic) that initiates a cascade of processes that leads to higher rates of CVD events, including death.”

For more information:

Alberts MJ. JAMA Neurol. 2015;doi:10.1001/jamaneurol.2014.4142.

Jalbert JJ. JAMA Neurol. 2015;doi:10.1001/jamaneurol.2014.3638.

Disclosure: The researchers report financial ties with several device and pharmaceutical companies; see the full study for a list of relevant financial disclosures. Alberts reports no relevant financial disclosures.