During 10 years of follow-up, patients with carotid artery stenosis who underwent carotid stenting or endarterectomy in the CREST trial had similar rates of stroke, MI and mortality, according to long-term data presented at the International Stroke Conference.
From 2000 to 2008, 2,502 patients underwent randomization to carotid stenting or carotid endarterectomy in the CREST trial. Previously reported data on outcomes after 2.5 years of follow-up demonstrated no significant difference between stenting (RX Acculink or RX Accumet, Abbott Vascular Solutions) or endarterectomy for the composite primary endpoint of periprocedural stroke, MI or death, and subsequent ipsilateral stroke.
“The life expectancy for Medicare-age women is 20 years and 18 years for men,” Thomas G. Brott, MD, professor of neurology and director for research at the Mayo Clinic in Jacksonville, Florida, said during a press conference. “Whether 2.5 years of follow-up is sufficient for our patients could certainly [be] debate[d]. So we extended the results out to 10 years.”
The original trial protocol was amended and patients re-consented for follow-up for up to 10 years. Of the 2,502 patients, 1,607 patients consented to long term follow-up. The median follow-up was 7.4 years.
The researchers assessed the primary composite endpoint, but well as the long-term extension primary endpoint of ipsilateral stroke after the periprocedural period.
According to data reported at ISC, the rate of the primary composite endpoint was 11.8% in the stenting group vs. 9.9% in the endarterectomy group during 10 years of follow-up (HR = 1.1; 95% CI, 0.83-1.44).
Postprocedural ipsilateral stroke occurred in 6.9% of the stenting group vs. 5.6% of the endarterectomy group over 10 years (HR = 0.99; 95% CI, 0.64-1.52).
There was no difference in either endpoint when the researchers analyzed symptomatic vs. asymptomatic patients (P = .59 for interaction).
“Postprocedural rates of stroke for stenting or surgery are similar and less than 0.7% annually for symptomatic and asymptomatic patients,” Brott said. “In contrast to previous trials, symptomatic status was not a predictor of postprocedural outcomes.”
The rate of a composite of stroke and death during 10 years was 11% in the stenting group vs. 7.9% in the endarterectomy group (HR = 1.37; 95% CI, 1.01-1.86).
“All of the action is in the first few days. The separation in these procedures with regard to stroke and death happens within several days, during the time when the procedure is being done and complications are most likely to occur,” he said.
Rates of restenosis and revascularization were also similar between the two groups during follow-up (12.2% in stenting group vs. 9.7% in endarterectomy group; HR = 1.24; 95% CI, 0.91-1.7).
In other results, risk factor control improved overall, but those assigned stenting had greater improvements in glucose control at 72 months and smoking cessation.
“We also found that our patients are living longer. Men in CREST are only living 2 years shorter and women in CREST 1 year shorter in comparison with the general population,” Brott said.
In a related editorial published in NEJM, J. David Spence, MD, and A. Ross Naylor, MD, emphasized that while these findings confirm the durability of carotid stenting and endarterectomy, there are still questions about the generalizability of randomized trial findings into routine clinical practice [and] how best to treat the asymptomatic patient.
“It is hopes that the CREST-2 [trial], which includes a medical group will help settle this [latter] issue,” Spence, of the Stroke Prevention and Atherosclerosis Research Center, Robarts Research Institute and Western University, Canada, and Naylor, of the vascular surgery group, division of cardiovascular sciences, Leicester Royal Infirmary, United Kingdom, wrote. – by Tracey Romero
Brott T. LB 10. Presented at: International Stroke Conference; Feb. 16-19, 2016; Los Angeles.
Brott T, et al. New Engl J Med. 2016;doi:10.1056/NEJMoa1505215.
Spence JD, Naylor AR. New Engl J Med. 2016;doi:10.1056/NEJMe1600123.
isclosures: The trial was funded by the NIH and Abbott Vascular Solutions. Brott reports receiving grant support from the National Institute of Neurological Disorders and Stroke during the conduct of the study and consulting for 3D Communications and Boston Scientific. Naylor reports no relevant financial disclosures. Spence reports receiving grant support from the Canadian Institutes for Health Research, the Heart & Stroke Foundation of Canada, and the NIH/National Institute of Neurological Disorders and Stroke; personal fees from the American Heart Association, Canadian Journal of Cardiology, European Stroke Organization, McGraw-Hill Medical Publishers and Vanderbilt University Press; and personal fees/other support from Bayer, Bristol-Myers Squibb and Vascularis Inc.