Patient Age Affects Carotid Treatment Results

The primary adverse-event measure in CREST was the composite rate of any stroke, myocardial infarction, or death during the 30 days following treatment plus the rate of any ipsilateral stroke during long-term follow-up of up to 4 years. This rate was 7.2% for stenting and 6.8% for endarterectomy, with similar rates of ipsilateral strokes occurring from 31 days to 4 years (2.0% vs. 2.4%).

In contrast to younger patients, at age 75, the rate of adverse outcomes after stenting rose by about 35% compared with surgery; at age 80, the adverse outcome rate was more than 50% higher with stenting than with surgery; and at age 85, the adverse event rate was roughly doubled by stenting. In patients who were 70 years old, the adverse event rates were essentially identical regardless of which procedure was used.

No Data on Asymptomatic Patients

The CREST results reported so far gave no details on how endarterectomy and stenting fared in asymptomatic patients, compared with patients who already had symptoms of carotid disease. In the absence of these data, several experts cautioned that the findings should not be taken as an endorsement of aggressive carotid interventions for asymptomatic patients, especially now that medical therapy has become so effective.

“It's worth revisiting the role of interventions in asymptomatic patients. Even low [adverse event] rates do not mean that everyone with an asymptomatic lesion needs to have endarterectomy or a stent,” Dr. Grotta said.

“We need to look carefully at the asymptomatic data. Asymptomatic patients walk a fine line. There is not much room for any additional morbidity and mortality,” Dr. Gorelick said.

“We think that a reasonable question to ask today, after a couple of decades of advancement in medical therapy, is whether in asymptomatic patients best medical therapy is the equal of carotid revascularization. That's something to investigate,” Dr. Brott said.

In contrast to CREST, the results from ICSS showed a clear benefit from endarterectomy over stenting. Experts offered several possible explanations for this difference.

Dr. Ralph L. Sacco, professor and chairman of neurology at the University of Miami, cited differences between the two studies: CREST enrolled both asymptomatic and symptomatic patients, while ICSS involved only symptomatic patients; CREST used a single stent and embolic protection device, while ICSS allowed participating physicians to use whichever device they wanted; and CREST had results during follow-up of as long as 4 years, while the ICSS report focused on outcomes within the first 120 days of treatment.

But perhaps the most important difference was that CREST included a lead-in phase for participating operators to hone their stenting skills, something that ICSS lacked.

“We had in CREST a very detailed credentialing process, including about 1,600 lead-in cases that were not included in the randomized trial,” noted Dr. Clark, a CREST participant and professor of medicine and director of the Oregon Stroke Center at the Oregon Health and Science University in Portland.

But the careful training phase of stent operators in CREST raised issues on the generalizability of the results.

“The results of this trial are not generalizable to the medical community as a whole,” said Dr. Mary E. Jensen, a professor of radiology at the University of Virginia in Charlottesville. “They should not be interpreted to mean that carotid stenting is ready to be rapidly adopted as a standard practice at every hospital. Other studies have shown that carotid stenting can be more dangerous than carotid endarterectomy if the operators lack the technical expertise and experience required to maintain a low complication rate. I hope that if the Centers for Medicare and Medicaid Services uses the CREST data to expand coverage [of carotid stenting], it will include a credentialing/training/competency requirement that matches CREST in addition to insisting that all patients are seen before and after by neurologists so that independent observation of complications occurs.”

“This is another reason we need comprehensive stroke centers,” Dr. Grotta said. “Part of the licensing of stroke centers is having acceptable complication rates for carotid surgery and stenting.”

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Source Elsevier Global Medical News