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Safety profiles of CAS, carotid endarterectomy differ
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Carotid artery stenting and carotid endarterectomy are comparable for long-term stroke prevention, but each procedure is associated with risk for different periprocedural adverse events, published data suggest.
“CAS was associated with a higher risk of stroke in the initial 30 days after the procedure. Carotid endarterectomy was associated with greater risks of MI and cranial nerve palsy, a variable condition that most often results in difficulty with swallowing or speaking, over this time frame,” Jay Giri, MD, of the Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center at the University of Pennsylvania in Philadelphia, told Cardiology Today’s Intervention.
Study findings
Giri, a Cardiology Today Next Gen Innovator, and colleagues conducted a meta-analysis of the five most recent randomized controlled trials comparing CAS with carotid endarterectomy. A total of 6,526 patients with carotid artery stenosis — of whom 3,636 were randomly assigned to CAS and 2,890 to endarterectomy — were included in the analysis. Two trials included symptomatic patients only, one trial included asymptomatic patients only and two trials included symptomatic and asymptomatic patients. Average follow-up was 5.3 years.
Results revealed no significant difference in the composite outcome of periprocedural death, stroke, MI or nonperiprocedural ipsilateral stroke between CAS and endarterectomy (OR = 1.22; 95% CI, 0.94-1.59). However, the risk for periprocedural stroke plus nonperiprocedural ipsilateral stroke was higher with CAS (OR = 1.5; 95% CI, 1.22-1.84), which was primarily attributable to an increased risk for minor stroke (OR = 2.43; 95% CI, 1.71-3.46). CAS was also linked to lower risk for periprocedural MI (OR = 0.45; 95% CI, 0.27-0.75), cranial nerve palsy (OR = 0.07; 95% CI, 0.04-0.14) and the composite outcome of death, stroke, MI or cranial nerve palsy during the periprocedural period (OR = 0.75; 95% CI, 0.6-0.93).
“Our results argue that these procedures are not competitive but complementary with equal long-term efficacy but differing safety profiles. If a patient is to undergo one of these treatments for carotid stenosis, the selection of which procedure is chosen should be based on an individualized assessment of their unique risk factors and anatomic characteristics,” Giri said in an interview. “Given the amount of high-quality randomized evidence present regarding this issue, any reliance on methodologically flawed observational analyses to make clinical decisions or set policy is very misguided.”
Important considerations
Despite research demonstrating comparable outcomes with CAS and carotid endarterectomy, these treatment options may not be equally available to patients due to other factors, Giri said.
“The current reimbursement restriction on CAS by CMS in the face of an FDA approval for these devices is also misguided. These arbitrary restrictions handcuff treating physicians from being able to make a personalized decision regarding carotid revascularization modality for an individual patient based on their unique risk factors and anatomy. Physician teams would be much better off having both options available to them with the ability to tailor the best therapy to an individual patient,” he said.
Giri also noted that there is little value in direct comparison of these therapies in additional randomized trials, although future study of treatment in this area is warranted.
“The most important question in this field remains unanswered. We do not know what the best management strategy is for patients who have severe carotid stenosis but have had no neurologic symptoms from the narrowing,” he said. “Perhaps these patients are better served with optimal medical therapies, including good BP/cholesterol control and smoking cessation rather than either of these two procedures. An ongoing trial — CREST 2 — is attempting to provide information in this important group of patients, and I believe it is imperative that physicians around the country offer enrollment in this trial to their patients.”
In an accompanying editorial comment, Robert D. Safian, MD, of the department of cardiovascular medicine at Beaumont Health in Royal Oak, Michigan, echoed Giri’s sentiments regarding the equipoise between CAS and carotid endarterectomy, the benefit of optimal medical therapy and the need for improved reimbursement from CMS.
“I hope that the ‘unknown unknowns’ will be based on real issues about patient care, and not on payment, politics and turf,” Safian wrote. – by Melissa Foster
Disclosure: Giri reports receiving a research grant to his institution from St. Jude Medical. Please see the full study for a list of the researchers’ relevant financial disclosures. Safian reports no relevant financial disclosures.
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