Equivalent Stroke, Death Rates Achievable Between Carotid Stenting, Surgery

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A rigorous training program combined with well-defined patient selection criteria enabled a high-volume center to achieve low, equivalent stroke and death rates with carotid artery stenting (CAS) and surgery, according to a retrospective study in the February 8, 2011, issue of the Journal of the American College of Cardiology. Despite some obstacles, such a program can be instituted at other centers, the researchers maintained.

Investigators led by Paola De Rango, MD, of the University of Perugia, Hospital S.M. Misericordia (Perugia, Italy), looked at over 2,000 carotid revascularization procedures performed at their institution from January 2001 to March 2009. Patients received either CAS (n = 1,084) or carotid endarterectomy (CEA; n = 1,118).

All procedures were performed by a surgical group that had completed a training phase of 195 CAS procedures before being included in the study (earlier stenting procedures were excluded). In addition, operators used strict patient selection criteria in treating those with either greater than 60% symptomatic or greater than 70% asymptomatic carotid stenosis. For instance, patients were usually excluded from CAS if they had:

• Unfavorable aortic arch anatomy
• Severe peripheral vascular disease precluding femoral access
• Extremely tortuous carotid anatomy
• Allergies to aspirin, clopidogrel, or contrast media
• Renal insufficiency

Likewise, contraindications for CEA included: high-neck carotid bifurcations, long carotid lesions, obesity, and ongoing dual antiplatelet therapy.

At 30 days, the rates of stroke or death (primary endpoint) were low and equivalent between the 2 groups, as were the rates of disabling stroke, nondisabling stroke, MI, and MACE (table 1).

Table 1. Thirty-Day Outcomes

^a Primary endpoint.
^b Stroke, death, or MI.

There were 6 deaths and 3 fatal strokes in the CEA group but none in the CAS group at 30 days. Also during this time period, CAS produced higher rates of TIA (3.6% vs. 1.1%; P < 0.001) and nonfatal stroke (2.8% vs. 1.5%; P = 0.04), while CEA increased cranial nerve injuries (4.4% vs. 0%; P < 0.001) and length of hospital stay (4.34 ± 2.3 days vs. 2.9 ± 1.5 days; P < 0.001).

On Kaplan-Meier analysis, 5-year rates of the major composite endpoint (periprocedural stroke/death and ipsilateral stroke at 5 years) and recurrent stenosis were equivalent between CAS and CEA, with a borderline statistically significant increase in mortality with CAS (table 2).

Table 2. Five-Year Event Rates

Treatments Equal Across Subgroups

In the overall population, the 30-day stroke or death rate was lower in asymptomatic patients (n = 1,518) than in symptomatic patients (n = 684) at 2.0% vs. 3.5%, respectively (P = 0.04). Although CAS produced more events than CEA in the symptomatic and asymptomatic populations, respectively, the differences between the 2 treatments did not achieve statistical significance. In symptomatic patients, 30-day stroke or death was 4.5% with CAS vs. 2.9% with CEA (P = 0.29), and in asymptomatic patients, the rate was 2.3% with CAS vs. 1.6% with CEA (P = 0.36). On Kaplan-Meier analysis, there were no significant differences in rates of the major composite endpoint between CAS and CEA for any subgroup measured: symptomatic, asymptomatic, female, male, older, or younger patients.

After adjustment for propensity scoring, associations with the composite outcome remained unchanged. Carotid stenting did not independently predict the endpoint (HR 1.4; 95% CI 0.85-2.33; P = 0.17). Meanwhile, statin use was a negative independent predictor (HR 0.49; 95% CI 0.27-0.87; P = 0.016), and symptomatic carotid disease was a positive predictor (HR 2.0; 95% CI 1.2-3.26; P = 0.003).

“When physicians use their clinical judgment to select the appropriate technique for carotid revascularization, CAS can offer efficacy and durability comparable to CEA with benefits persisting at 5 years,” the researchers concluded.

Better Than CREST

“I’m extraordinarily impressed with the size of the study, the intensity of the training, and the decision making to approve a carotid stent,” Michael R. Jaff, DO, of Massachusetts General Hospital (Boston, MA), told TCTMD in a telephone interview. He noted that the rate of carotid stenting at the Italian center amounted to over 120 a year. “That’s as much as anybody I know,” Dr. Jaff commented, adding that “their stroke and death rates are dramatically lower than the best series every published, meaning CREST.”

In CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial), the 30-day rate of stroke, MI, and death was 5.2% with stenting and 4.5% with surgery (P = 0.38).

According to Dr. Jaff, the study shows that “if your institution and practitioners are dedicated to very high standards for training and expertise and close rigorous follow-up, and appropriate patient selection with clearly defined anatomic and clinical criteria, then you can get equivalent results with stenting and endarterectomy. I think that’s a powerful statement.”

Can the Results Be Replicated?

However, there are some obstacles to implementing a program such as the one utilized by Dr. De Rango and colleagues. “First of all, I don’t think a community hospital is going to have a volume like this,” Dr. Jaff said. “But this also requires a real institutional commitment to spend money.”

As examples, he noted several facets of the carotid revascularization program at Mass General, such as automatic neurologic surveillance by an independent neurologist before and 24 hours after carotid revascularization. “The only way I could afford that is to pay these people,” Dr. Jaff said. “I had to go to the institution to get the money, and it’s not a small amount.”

He also mentioned the prospective data registry that was required at his institution. “That costs IT money,” Dr. Jaff said. “If the system will support it financially, I think such a program could be replicated.”

Debating the Role of Surgeons

However, Dr. Jaff pointed out that all the patients in the study, whether they received CEA or CAS, were treated by surgeons. “So they had an advantage,” he said. “They didn’t have competition between radiology, neurology, surgery, neurosurgery, cardiology, and vascular surgery. So that’s probably a second big obstacle.”

In an e-mail communication with TCTMD, Dr. De Rango said that these challenges can be overcome. “Our experience is not unique and could be replicated in any center, also in the United States, when the main criteria (appropriate acquired training, good experience, and selection of patients best suited for CAS or CEA) are respected,” she said. “However, the practice of CAS by experienced vascular surgeons, more than by interventionalists or other specialists, can be relevant to ensure alternative options [are available] to all the patients best suited for the different procedures and to provide carotid surgery as an alternative to CAS with similar low risks. The presence of vascular surgeons can also help to manage eventual complications from stenting.”

Still, Dr. Jaff does not expect a great number of vascular surgeons in the Unites States to become greatly interested in performing CAS procedures until the regulatory and reimbursement landscape changes. However, he noted, this may have already started happening with the recent US Food and Drug Administration (FDA) advisory panel recommendation to extend the indication for CAS.

“When there’s approval to expand indications by the FDA and then reimbursement associated with that approval, then I think the surgeons will have no choice from a pure financial standpoint but to step in with both feet,” he said. “But for now, their results with CEA are good, and they do a big volume of it. I don’t think they’re going to give too much of that up.”

Regardless, according to Dr. De Rango, the study’s message is clear. “Today, CAS should not be condemned or judged superior to CEA,” she said. “We have, indeed, 2 valid alternatives for treatment of carotid stenosis.”

 

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Source:
De Rango P, Parlani G, Verzini F, et al. Long-term prevention of stroke: a modern comparison of current carotid stenting and carotid endarterectomy. J Am Coll Cardiol. 2011;57:664-671.

 

 

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