ACT 1: Stenting Was Noninferior to Surgery for Asymptomatic Carotid Stenosis

ACT 1: Stenting Was Noninferior to Surgery for Asymptomatic Carotid Stenosis


(upbeat, fast-paced music) – Good afternoon, and welcome. I’m Bruce Ovbiagele, Vice Chair of the 2016 ISC Program Committee. I’m here with Doctor Larry Wechsler, professor in stroke neurology at the University of Pittsburg, and investigator of the ACT I trial. Welcome, Larry, – Thank you. – So, why did you and
your colleagues decide to do this trial? – This trial, Bruce, dates
back to the early 2000s in terms of its conception. At that time, there was much known about carotid endarterectomy
for asymptomatic stenosis. The CREST trial was
just getting under way, primarily, at that time,
entering symptomatic stenosis, and the question of the relative benefit of carotid stenting versus
carotid endarterectomy for asymptomatic stenosis was a question that needed to be answered. – What was the design of the trial? – The trial was a randomized,
non-inferiority trial that compared carotid stenting
to carotid endarterectomy in standard-risk patients,
who were asymptomatic with significant stenosis
of the carotid artery. The patients were entered if
they had at least 70% stenosis of the carotid artery,
that they had no symptoms within 180 days of their randomization, they had to be less than age 80, so we excluded octogenarians; and they had to have
less than 60% stenosis of the contralateral carotid artery. – I see; and what did you find? – What we found was that
carotid artery stenting was non-inferior to carotid endarterectomy based upon the threshold that we chose, which was less than 3% for
the 95% confidence interval of the difference between
the two approaches. In fact, the event rates for
30-day stroke, MI, and death plus ipsilateral strokes out to one year, were very similar: 3.8%
for carotid stenting, 3.4% for carotid endarterectomy. That difference is only 0.4%, but the 95% confidence interval for that difference was 2.27, which was less than the threshold of 3%, and so the p-value was
.01 for non-inferiority. – I see; and so, Larry,
what are the implications for clinical practice, and what
are the next research steps? – The implication is that carotid stenting is a reasonable alternative
to carotid endarterectomy for appropriate patients
with asymptomatic stenosis, as studied in this trial,
that is, non-octogenarians, patients who are at standard risk for carotid endarterectomy. But I think the next question
is a very important one, and that is since this
study was initiated, since it was under way, we
know that medical management has changed dramatically,
and so the next question is whether either one of these procedures, endarterectomy or stenting, are superior to medical management for
asymptomatic stenosis. And that, of course, is being addressed in the CREST II trial,
which is now under way. – Well Larry, I wanna
thank you for completing such a trial aimed at a
very important question, and I’m grateful for the
audience to listening to us. Thank you. (upbeat, fast-paced music)

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