The availability of carotid stenting was the subject of one of Great Debates held at the International Symposium on Endovascular Therapy (ISET) in Hollywood, Florida. William Gray, MD, argued in favor of carotid stenting being available for all patients, while Anthony Comerota, MD, took the opposing stance. Before the debate began, moderator Barry T. Katzen, MD, polled the audience for their opinion on the issue and found that 65% of the audience believed that carotid stenting should be available for all patients now.
Dr. Gray began by pointing out that data over the last 40 years for outcomes of endarterectomy in symptomatic and asymptomatic patients show that stroke risks have improved from approximately 11% to 12% at the start of the dataset to a current range of 3% to 4%. Dr. Gray called carotid endarterectomy “without a doubt the gold standard. It’s an elegant and effective operation, and I’ve sent more patients for it today than before because I know that for certain patients carotid stenting is not appropriate.”
However, he pointed out that rates of stroke or death from carotid stenting have decreased significantly over the past decade from approximately 8% to 1%-1.5%. In a study Dr. Gray and his colleagues conducted, they looked at all the recent FDA CAS trials, which included about 3,000 high-risk patients, and found that stenting beat or met the competitive target of endarterectomy objective performance goal.
All these stent systems were approved by the FDA, and these approvals increased volume of use, which in turn decreased complication rates. Dr. Gray compared complication rates and risk of stroke or death within 30 days in IDE trials with the same rates after FDA approval, better knowledge, and better patient selection. The later procedures had about half the complication rate of the early procedures, he said.
He delved further into data from several major multicenter randomized trials of CAS vs CEA in symptomatic patients. Many of the early trials appeared to have bad outcomes for stenting, but they occurred in the early era of stenting. “This wasn’t a mature technology or surgery by then,” he said. He added, “Embolic protection was not mandated or even used in many cases, myocardial infarction ascertainment was zero in all cases, and operator experience was poor in many cases.”
The best trial for evaluating CAS is CREST, he noted. CREST was a large, well-done trial comparing CEA and CAS in 2,500 patients and was published in the New England Journal of Medicine. Results showed that there was no different between CEA and CAS for the primary endpoint to 4 years. There was also no difference in mortality, in ipsilateral stroke, or in target lesion revascularization at 4 years. There were differences in minor stroke, Dr. Gray acknowledged, but “these did not lead to any residual deficit in the vast majority of patients.” However, he emphasized that MI had a strong association with death at 4 years, as compared to patients who have had no event who have had minor strokes. “So the difference between stenting and surgery was really the difference between minor stroke and MI. MI had mortality outcomes,” he said.
Patient satisfaction scores favor stenting, said Dr. Gray, with better outcomes for stenting at 2 weeks and at 1 month, though outcomes were similar to CEA at 1 year. Lastly, prospective cost analysis revealed no difference in costs between stenting and endarterectomy at the time of index hospitalization to 1 year. Dr. Gray reviewed data from ACT-1, another randomized trial published in the New England Journal of Medicine, and explained that it reached similar conclusions to CREST.
“So why are we having this conversation? Because while the FDA has approved all of these procedures, in all patients, CMS has only approved high surgical risk patients,” he said. Based on the data, he believes that limitation is not warranted.
However, Dr. Gray acknowledged that there are still open questions, such as minor strokes in stenting, MI in endarterectomy, and symptomatic carotid disease in stenting. He concluded by stating that he believes that CAS should be available to everyone but should not be performed on everyone.
Dr. Comerota came to the podium to present the opposing argument. He began by praising CREST as “one of the most rigorous datasets available for this particular issue.”
He continued, “Isn’t it time for reasonable people to agree that non-fatal MI isn’t an appropriate primary endpoint when you are discussing these techniques that are designed to reduce future risk of stroke?” One patient out of 2,500 died from procedure-related MI in CREST, whereas more people died from stroke, he noted. Stroke and death therefore make better endpoints.
“If we did not have MI as a primary endpoint, you see that stroke and death were significantly lower in patients who were randomized to carotid endarterectomy, and you see death from MI within 30 days only one patient in CREST,” said Dr. Comerota. He added that when the data were analyzed out to 4 years, there was a significant increase in stroke and death in the patients randomized to carotid angioplasty and stenting.
Symptomatic status is also important to examine. Symptomatic patients in CREST had a significant increase in stroke or death in the carotid angioplasty and stenting group compared with the carotid endarterectomy group. The same observation was seen in asymptomatic patients, noted Dr. Comerota.
Differences in sex were also relevant, with symptomatic women having a 9.2% primary endpoint with CAS compared with 4% with CES. However, “Men did reach the primary endpoint in favor or CAS vs CES,” said Dr. Comerota. Age should also factor into the decision, with younger patients better served by CAS and those over 64 years better served with CEA.
Angiographic criteria are another consideration in the decision. “Sequential remote and long lesions have worse outcomes with CAS than with CEA,” said Dr. Comerota.
He concluded, “So to answer the question, based on the best available data, CAS should be available for symptomatic males less than 70 years old with a single short carotid lesion.”
Dr. Katzen then thanked both presenters and engaged the audience with the debate question again. The final poll showed a shift toward the “No,” answer, with 46% answering “no” and 54% answering “yes.”