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COAST II: Covered stent effective for treatment of patients with coarctation of aorta
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In patients with coarctation of the aorta, a covered platinum stent appears to be an effective approach for treating and possibly preventing associated aortic wall injury, according to findings from the COAST II trial.
In the multicenter, single-arm trial, researchers evaluated 158 patients (65% men; median age, 19 years) with a history of native or recurrent coarctation of the aorta who underwent placement of a balloon-expandable Covered Cheatham-Platinum stent (CCPS; NuMED) for treatment or prevention of aortic wall injury. Patients were divided into a treatment group (n = 83; 53%), consisting of those with pre-existing acute wall injury, or a prevention group (n = 75; 47%), consisting of those at increased risk for acute wall injury. The researchers evaluated pre- and post-implant hemodynamics and angiography for both groups, with all angiograms evaluated by a core laboratory reviewer.
Researchers interviewed and examined patients before hospital discharge and 1 month post-CCPS placement, and measured and recorded their upper and lower extremity BPs.
Complete coverage
The researchers found an improvement in the average ascending-to-descending aorta systolic gradient, from 27 ± 20 mm Hg to 4 ± 6 mm Hg.
In the prevention group, which had more significant baseline coarctation of the aorta, there was an improvement in peak ascending-descending aorta gradient, from 36 mm Hg to 4 mm Hg.
Ninety-three percent of patients in the treatment group who received a single stent achieved complete coverage of acute wall injury.
Ultimately, 92% attained complete coverage; the remaining five patients had minor residual endoleak that did not necessitate further intervention.
Twelve patients in the treatment group received multiple stents: seven for coverage of a persistent moderate (n = 6) or large (n = 1) endoleak. Multiple stents in the remaining five patients were indicated for other reasons, such as residual coarctation or a non-study stent fraction. Of the seven patients treated with multiple stents for persistent endoleak, complete coverage was ultimately attained in five patients.
Few adverse events
Four patients experienced significant access-site vascular injuries, including dissection of the iliac artery in two patients, femoral artery pseudoaneurysm in one patient, and femoral artery occlusion related to suture-mediated vascular disease in one patient. These adverse events occurred before hospital discharge, although in the case of the patient with iliac artery dissection, the degree of site injury was not known until after discharge. No new acute wall injuries were seen as a result of stent implantation, nor were there any strokes, deaths or episodes of bacteremia/endocarditis. No repeat interventions, coarctation of the aorta-associated surgeries or deaths occurred within 30 days of index stent implantation.
“This large, prospective study shows excellent short-term safety and efficacy of the [CCPS] in managing patients with existing [aortic wall injury] and avoiding [aortic wall injury] in high-risk patients,” the researchers wrote. “Longer-term data are necessary and are forthcoming to describe the durability of the CCPS and incidence of aneurysm formation after stent implantation.” – by Jennifer Byrne
Disclosure: The NuMED Corp. provided funding for the trial, including salary and administrative support for three of the researchers.
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