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ACT 1: Carotid stenting beneficial in women, heavy atherosclerotic burden
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LAS VEGAS — Two subanalyses of the ACT 1 trial found carotid artery stenting benefited women and patients with the worst atherosclerotic burden vs. carotid endarterectomy.
Initial results of the ACT 1 trial demonstrated that carotid artery stenting (CAS) with embolic protection (Xact, Abbott Vascular) was noninferior to carotid endarterectomy in patients aged younger than 80 years with asymptomatic but significant carotid stenosis at standard risk for surgery.
Gary M. Ansel, MD, FACC, system medical chief for vascular at OhioHealth in Columbus and Cardiology Today’s Intervention Editorial Board Member, presented two subanalyses at VIVA 17 based on 5-year data.
Men vs. women
The researchers performed a prespecified analysis of men vs. women because a subanalysis from the CREST trial suggested women did not benefit with CAS vs. surgery; however, that finding was not consistent with what many investigators saw in their practices, Ansel said during a presentation.
“We wanted to look at this with highly trained interventionalists and a large group,” he said.
Ansel and colleagues compared 212 women vs. 278 men with 5-year follow-up from the ACT 1 study. The overall study included 1,453 patients. The sexes did not differ in baseline characteristics.
From 31 days to 5 years, the rate of freedom from ipsilateral stroke was 99.2% among women assigned CAS compared with 96.5% among women assigned carotid endarterectomy (P = .02), Ansel said.
The difference was not observed in men (CAS group, 96.9%; surgery group, 97.9%; P = .54), according to the researchers.
Atherosclerotic burden
Ansel and colleagues also compared outcomes among 161 patients with carotid atherosclerosis only, 141 with carotid disease and CAD, 65 with carotid disease and peripheral artery disease and 109 with carotid disease, CAD and PAD who completed 5-year follow-up. There were no differences in risk factors between those assigned CAS and those assigned surgery. The subanalysis was not prespecified, he said.
In the group with the highest atherosclerotic burden — carotid disease, CAD and PAD — patients assigned CAS had a higher rate of freedom from death, stroke or MI at 30 days and ipsilateral stroke between 31 days and 5 years vs. those assigned surgery (CAS group, 93.9%; surgery group, 85.6%; P = .04), as well as a higher rate of freedom from ipsilateral stroke between 31 days and 5 years (CAS group, 97.8%; surgery group, 91.8%; P = .04), Ansel said.
However, he noted that patients from the other three disease-burden groups did not differ in outcomes by CAS vs. surgery.
In patients with the highest atherosclerotic burden, “the long-term clinical outcomes appear to be better with carotid artery stenting than [surgery], which is concordant with CAPTURE 2. This is the largest randomized asymptomatic dataset with experienced operators,” he said.
“I hate to look at these two things as competitive. I like to do personalized medicine, which is what is best for a particular patient subgroup. We’re getting smarter as we go along, looking at really large datasets, to try to ink this out. It appears that patients with a heavy atherosclerotic burden are doing better with a less-invasive approach,” he said during a panel session. – by Erik Swain
Disclosures: The study was funded by Abbott Vascular. Ansel reports he receives honoraria from Bard Peripheral Vascular, Cook Medical, Cordis and Medtronic and consults for 480 Biomedical, Abbott Vascular, Bard Peripheral Vascular, Best Doctors, Boston Scientific, Cardinal Health, Cook Medical, Cordis, Ostial Corp., Philips, Reflow Medical, Shockwave Medical, Surmodics, Veryan/Novate and W.L. Gore and Associates.
Perspective
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John H. Rundback, MD, FAHA, FSVM, FSIR
While this study was of a selected group of individuals from a trial with a high operator skillset, it proves that in the asymptomatic population — and 80% of patients with carotid disease who undergo treatment are asymptomatic — stenting is extraordinarily effective, regardless of sex.
I’m not sure why there was a high rate of delayed events in endarterectomy. Perhaps endarterectomy needs to be revisited in this population if there is a predisposition toward late embolic events.
The take-home message is that carotid stenting is a therapy that is ready for prime time. We need to find a way to be able to use it.
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