A cost-effectiveness analysis of the SAPPHIRE trial found that carotid artery stenting (CAS) with embolic protection may be more cost effective in the long run despite higher upfront costs when compared with carotid endarterectomy (CEA) in patients at a high risk for adverse clinical outcomes. However, one procedure may not outweigh the other in terms of becoming the gold standard of treatment, and the procedures may be complementary, not competitive.
Within the substudy published in this months' Catheterization and Cardiovascular Interventions, researchers from Saint Luke’s Mid America Heart and Vascular Institute in Kansas City, Mo., used data from the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) trial, which included 159 patients who underwent CAS and 151 patients who were randomized to CEA between August 2000 and July 2002, to analyze clinical outcomes, costs, resource usage and quality of life at one year.
Patients enrolled in the study had a mean age of 72, 68 percent were male, 26 percent had diabetes and 29 percent were symptomatic. Patients randomized to the stenting group had a higher rate of coronary artery disease, 85 percent versus 74 percent.
Researchers found that the initial procedural costs were higher for CAS when compared with CEA, a mean difference of $4,081 per patient.
Initial hospital costs were $559 per patient higher for CAS, and these higher costs were linked to the cost of disposables including the stent and embolic protection devices, David J. Cohen, MD, director of cardiovascular research at Saint Luke’s, told Cardiovascular Business News.
“There were cost savings during the rest of the hospitalization that really related to the reduction of complications and a shorter length of stay [1.9 vs. 2.9 days for CAS vs. CEA] for these high-risk patients,” says Cohen. “As a result, the costs were fairly comparable for the initial hospitalization, just about $500 higher for the stent procedure, as compared with surgery. During the follow-up period, the costs were quite similar but there was some continued separation in terms of clinical events.”
One-year follow-up costs and total one-year costs did not statistically differ and the cost-effectiveness ratio for stenting when compared to endarterectomy was $6,555 per quality-adjusted life years (QALYs) gained. “Well within the range of what we spend in the U.S. healthcare system,” Cohen offered.
At one year, the rates of death were also lower in the patients who received stenting as compared with endarterectomy, 6.9 percent versus 12.6 percent, respectively. These same rates for major stroke were also lower, 0.6 versus 4 percent, respectively. However, follow-up costs were $810 higher for carotid stenting.
While the study emulates that CAS with embolic protection may be a cost-effective alternative treatment option within the healthcare system, the results are not generalizable to patients at a low surgical risk.
And while Cohen offers that CAS is reasonably well adopted within the high-risk patient population, a major barrier of adoption to treat individuals at standard risk with CAS is laced within reimbursement.
“Until very recently there wasn’t great evidence of comparable outcomes for the two procedures in this patient population,” Cohen said. However, results of the CREST trial have built up the evidence surrounding CAS and CEA and showed that CAS is as equality safe and effective as CEA for stroke prevention in patients at a standard surgical risk.
“I think the data would suggest that they [CAS and CEA] are both excellent procedures, so I’m not sure one will be the gold standard over the other, but there clearly are advantages of CAS and advantages of CEA,” said Cohen.
CAS patients recover quicker and CREST also showed that CAS may offer better protection from MI, Cohen offered. However, the risk of stroke is less with CEA. Patients at a higher risk for this complication should most likely undergo surgery.
“I think that there isn’t going to be a single gold standard for this particular treatment, just like in coronary disease there isn’t a single gold standard type of revascularization, rather its balancing procedural risk and long-term benefits, as well as patient preferences,” he said.
In January, the FDA Circulatory System Devices Advisory Panel recommended expanding the availability of CAS to patients at a standard