Centers adding transcarotid artery revascularization
(TCAR) to their treatment options had improved perioperative outcomes
for patients with carotid artery stenosis, according to the Vascular
Quality Initiative (VQI) registry.
Major adverse cardiovascular event (MACE) rates -- counting
in-hospital stroke, MI, and death at 30 days -- were similar between
patients undergoing TCAR and those getting surgical carotid
endarterectomy (CEA; 2.3% vs 2.4%, P=0.91), reported a group led by Jesse Columbo, MD, MS, of Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.
Despite
such similar results, VQI centers had 10% less MACE in their overall
carotid revascularization programs in the year after adopting TCAR than
if they had stuck with the surgical option alone (OR 0.90, 95% CI
0.81-0.99), according to a difference-in-difference analysis by
Columbo's group, published online in JAMA Open Network.
"This finding suggests that this new technology may have allowed
proceduralists to select patients for whom TCAR may be superior to CEA,
while still performing CEA on patients for whom that procedure was
appropriate," study authors said.
"Overall, while observational in nature, these data imply that both
TCAR and CEA may be reasonable treatment choices for patients undergoing
carotid revascularization and providers may be able to choose the
modality they feel best aligns with the patient's clinical presentation and anatomy," they concluded.
Moreover, the observed 10% MACE reduction, already "impressive," may
in fact be an underestimation of the benefits of TCAR adoption, because
the study included only VQI hospitals, which record only 10% of the CEAs
performed in the U.S., commented Peter Groeneveld, MD, of the
University of Pennsylvania in Philadelphia, in an invited commentary.
In contrast, device sales records indicate that the registry captures more than 95% of TCAR procedures.
TCAR was introduced to the U.S. market with the 2015 FDA approval of the Enroute stent system from Silk Road Medical.
The carotid procedure is designed to be a lower-risk alternative to
surgery for patients at high risk due to anatomic or medical challenges.
It is also designed with no need to traverse the aortic arch and
carotid lesion prior to embolic protection, unlike transfemoral carotid stenting.
Whether TCAR is truly noninferior to CEA has not been proven in a
randomized controlled trial. Transfemoral carotid stenting has been
linked to more periprocedural events but no difference in outcomes at 10 years compared with surgery.
"An ongoing challenge for cardiovascular surgeons and
interventionalists is to ascertain whether new therapeutic options for
patients with a severe cardiovascular disease improve clinical outcomes
across the full spectrum
of patients with the disease. There are no guarantees that new
therapies will produce net benefits across broad populations,"
Groeneveld cautioned.
He
cited the examples of percutaneous coronary intervention, which may
have "inappropriately shifted numerous patients away from the better
treatment option" of coronary artery bypass grafting, and transcatheter
aortic valve replacement, which conversely increased the accessibility
of treatment while "potentially improving outcomes across the full
spectrum of patients with aortic valve disease."
In general, better clinical outcomes for heart procedure recipients
will require a "collective learning process" that harnesses data
collection and judicious interpretation of statistical analyses,
according to Groeneveld.
The study was a retrospective analysis of a national quality
improvement registry maintained by the Society for Vascular Surgery.
Included were people who underwent carotid procedures in 2015-2019.
Those who got transfemoral carotid stenting were excluded.
A total of 86,027 patients at 469 participating VQI centers
constituted the study cohort. Although only 8.9% got TCAR, TCAR
procedures had jumped from 0.7% of all carotid procedures in 2015 to
17.0% in 2019. Accordingly, adoption of TCAR rose from 15 VQI centers in
2015 to 247 in 2019.
The TCAR group was significantly older on average (73.1 vs 70.6 years) and included fewer women (36.4% vs 39.5%) than the CEA group.
Unobserved confounding was a major potential limitation to the study.
"The primary threat to this study's validity is whether TCAR adoption
by a hospital was associated with other concurrent quality-of-care
initiatives that were the actual effectors of lower MACE rates. For
example, it would not be surprising if TCAR-adopting hospitals were on a
different trajectory for surgical quality than hospitals that did not
adopt TCAR or did so slowly," according to Groeneveld.
A randomized trial "is likely the only way to dispel any lingering
doubts regarding TCAR's comparative effectiveness" against surgery, but
the "preponderance of existing observational data and evidence from
single-group trials certainly supports TCAR's noninferiority to CEA,"
the editorialist acknowledged.
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Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow
Disclosures
Columbo and Groeneveld had no disclosures.
Study coauthors reported ties to the NIH, the Patient-Centered Outcomes Research Institute, and Silk Road Medical.