Acute outcome of stent therapy for coarctation of the aorta: results of the coarctation of the aorta stent trial.

Objective: The coarctation of the aorta stent trial (COAST) is a pivotal trial of the NuMED Cheatham Platinum Stent(®) for treatment of coarctation of the aorta (CoA).

Background: CoA is a congenital obstruction to flow through the aorta. Stents have been used since the 1990s to treat CoA; none have been approved by the Food and Drug Administration for this indication.

Methods: In a prospective, multicenter study 105 patients received stents for treatment of CoA. Data was collected in the catheterization laboratory, on discharge and at 1-month postprocedure.

Results: Of 105 patients, 69% were male; 57% had native CoA. Noninvasive, baseline systolic blood pressure (SBP) showed upper extremity (UE) SBP to be 140 ± 16 mm Hg and UE to lower extremity (LE) SBP difference 29 ± 17 mm Hg. At catheterization, baseline ratio of minimum CoA diameter to diameter of descending aorta (CoA:DAo) was 0.46 ± 0.16. Implants (104/105) were successful with one stent migration. There were no deaths or serious complications. Paradoxical hypertension occurred in 6%. Four percent of patients experienced somewhat serious adverse events related to the procedure. All patients achieved relief of ascending aorta to Dao pressure gradient: mean = 2.0 ± 4.0 mm Hg (P < 0.001). The CoA:DAo increased to 0.84 ± 0.18. At 1-month, UE SBP was 120 ± 12 mm Hg, UE to LE SBP difference = -1 ± 12 mm Hg. Ninety-nine percent of patients had UE to LE SBP difference <20 mm Hg.

Conclusions: Stenting of CoA, using the NuMED Cheatham Platinum Stent, is acutely safe and effective for treatment of CoA.