PERIPHERAL MATTERS
FDA Approves Covered
Stent for Treatment of
Aortic Wall Injury
T
he U.S. Food and Drug Administration
(FDA) recently approved the NuMED
Cheatham Platinum (CP) Stent System
for the prevention and/or treatment of aortic wall
injury (AWI) in patients with coarctation of the
aorta involving a compliant aortic isthmus or first
segment of the descending aorta where there is
adequate size and patency of at least one femoral
artery and balloon angioplasty is contraindicated
or predicted to be ineffective.
Stent therapy for coarctation of the aorta offers a
non-surgical alternative to traditional operative repair
of the aortic obstruction with similar results and
complication rates. Stent treatment also has a lower
rate of recurrence and aortic wall injury compared to
balloon dilation alone.
Covered stent therapy provides similar outcomes
and allows for simultaneous treatment of aortic wall
injuries, such as aneurysm and pseudo-aneurysm
that might be present, related to previous surgical or
catheter based therapy of the coarctation.
In the COAST II clinical trial, published in
JACC: Cardiovascular Interventions, the average
ascending-to-descending aorta systolic gradient
improved from 27 ± 20 mm Hg to 4 ± 6 mm
Hg. Complete coverage of pre-existing AWI was
achieved in 66 of 71 patients (93%) with AWI
who received the stent. No patients have required
Stent therapy for
coarctation of the
aorta offers a nonsurgical alternative
to traditional
operative repair
of the aortic
obstruction.
additional or subsequent surgical therapy. Approximately 15% of patients require further dilation of
the stent after a few years, mostly to keep up with
patient growth. Only two patients experienced
clinically apparent access artery injury, requiring repair. Subclinical femoral artery injury was
suspected in nine patients and borderline femoral
artery injury occurred in ten additional patients.
“FDA approval of the NuMED CP and Covered CP
stents marks important milestones in the catheter
mediated therapy of children and adults with congenital heart disease,” states Richard E. Ringel, MD,
a professor of pediatrics in the division of pediatric
cardiology at Johns Hopkins School of Medicine.
“These are the first large diameter, balloon expandable stents to be approved by the FDA for usage in
the aorta. The Covered CP stent increases the safety
of therapy for coarctation of the aorta.”
He adds that, “for years, coarctation of the aorta
therapy has been conducted safely by catheter
techniques in the catheteri zation laboratory. However, the risk of serious, life
threatening complication has
To see more about
now been further reduced
the FDA announcement, visit accessby giving physicians the
data.fda.gov/scripts/
ability to immediately repair
cdrh/cfdocs/cfpma/
an unexpected aortic tear.
pma.cfm?id=P150028
or scan the QR code.
Furthermore, physicians
can hopefully make aortic
tears even rarer, by using the
Covered CP stent prophylactically when treating coarctation of the aorta in high risk
patients.” ■
A Closer Look at the COAST II Trial
The COAST II (Covered Cheatham-Platinum Stents for Prevention or Treatment
of Aortic Wall Injury Associated With Coarctation of the Aorta Trial) is a multicenter, single-arm trial using the CCPS for the treatment and/or prevention of
AWI in patients with CoA and pre-existing AWI or increased risk of AWI. Patients
were enrolled if they had a history of CoA with pre-existing AWI (Treatment
group) or with increased risk of AWI (Prevention group). Pre/post-implant hemodynamics and angiography were reported. A core lab performed a standardized review of all angiograms. One-month follow-up was reported.
A total of 158 patients (65% male; median age, 19 years) underwent placement of CCPS. Eighty-three patients had pre-existing AWI. The average
ascending-to-descending aorta systolic gradient improved from 27 ± 20 mm
34
CardioSource WorldNews: Interventions
Hg to 4 ± 6 mm Hg. Complete coverage of pre-existing AWI was achieved in
66/71 patients (93%) with AWI who received a single CCPS. Ultimately, complete
coverage of AWI was achieved in 76/83 patients (92%); seven patients had
minor endoleaks that did not require repeat intervention. Four patients experienced important access site vascular injury. There were no acute AWIs, repeat
interventions, or deaths.
The authors concluded that CCPS can effectively treat and potentially prevent aortic wall injury associated with CoA. ■
REFERENCE
Taggart NW, Minahan M, Cabalka AK, et al. JACC Intv. 2016;9(5):484-93.
July/August 2016