LOS ANGELES -- If stents are as safe and durable as surgery at 5 years, will that equipoise still be evident at 10 years? Yes, and what's more, at 10 years patients who underwent stenting or endarterectomy to treat severe carotid stenosis were no more likely to have a stroke than same age healthy patients.
Those findings emerged from the long term follow-up of study of CREST, initial results of which were reported in 2010 and which paved the way for FDA approval of Abbott Vascular's Acculink carotid stent. Thomas G. Brott, MD, of the Mayo Clinic, Jacksonville reported the 10-year results at the International Stroke Conference here; the results were simultaneously published in The New England Journal of Medicine.
The results followed by a day the findings from ACT-1, which found that stenting was as good as surgery for asymptomatic patients and those results were durable for 5 years.
But ACT-1 enrolled only asymptomatic patients with stenosis of at least 70% and CREST included both symptomatic and asymptomatic patients, Brott said.Yet the CREST results face the same issue as ACT-1: relevancy. Both studies began recruiting patients during an era when medical management of patients was not terribly effective. Medical management was based on data from the 1980s, when "there would have been ash trays in this room," Brott noted at a press conference. Since that time medical management has kicked into high gear with "systolic blood pressure targets of less than 140 mmHg, LDL less than 70 mg/dL, A1C targets are lower, and there is aggressive use of statins," he added. Lifestyle interventions -- smoking cessation, diet, and exercise programs -- are now standard practice.
Although the overall findings from CREST solidly confirmed the non-inferiority of stenting, the results also found an increase in early events, mostly minor stokes, among the stent patients. This mirrored the results from ACT-1. Indeed the advances in medical management were noted in an accompany NEJM editorial by British stroke researchers J. David Spence, MD, and A. Ross Naylor, MD. They wrote that the benefit of modern medical therapy "is certainly a highly topical and controversial issue in the current era, because data from both randomized trials [ACT-1 and CREST] and nonrandomized studies suggest that the annual rate of stroke among medically treated asymptomatic patients has declined over the past two decades, regardless of the severity of stenosis at baseline."
Brott told MedPage Today that the answer to that conundrum -- medical management, stenting, or endarterectomy -- should be forthcoming from the CREST 2 study, of which he is also the principal clinical investigator.
That trial, which has about 70 participating centers thus far and an enrollment of roughly 200 patients, "is a COURAGE trial for stroke," Brott said, citing the landmark study that compared optimal medical therapy to stenting -- mostly with bare metal stents -- in patients with stable angina. The results, which found no benefit for stenting over medical management, set off a firestorm in the cardiology world pitting medical cardiologists against interventionalists. And the "final" answer turned out to be less than final as the results continue to be challenged.
Mark Alberts, MD, of UT Southwestern Medical Center in Dallas, who is a spokesperson for the American Stroke Association, said that taken together CREST and ACT-1 provide confirmation that stenting is a viable option, but he agreed that medical management needs to be investigated. Asked if he would be comfortable recommending only medical management for an asymptomatic patient, he replied, "I would be comfortable recommending that patient for the CREST-2 trial."
The original CREST study recruited 2,502 patients, of whom 47.2% were asymptomatic, and 1,607 of them (52.5% asymptomatic) agreed to the full 10-year follow-up.
There was no significant difference in the 10-year rates of the primary composite endpoint -- stroke, MI, or death during the periprocedural period or ipsilateral stroke during follow-up. In the stent group, 11.8% reached the composite endpoint (95% CI 9.1%-14.8%) versus 9.9% in the surgery group (95% CI 7.9%-12.2%). The 10-year primary long-term endpoint was postprocedural ipsilateral stroke, which occurred in 6.9% of the stent group (95% CI 4.4%-9.7%) and 5.6% of surgery patients (95% CI 3.7%-7.6%).