COAST Results Support NuMED's Cheatham Platinum Stent to Treat Coarctation of the Aorta

October 16, 2013—Richard E. Ringel, MD, et al published acute outcomes of stent therapy from the pivotal COAST (Coarctation of the Aorta Stent Trial) study of the Cheatham Platinum stent (NuMed, Inc., Hopkinton, NY) for the treatment of coarctation of the aorta (CoA) in Catheterization and Cardiovascular Interventions (CCI) (2013;82:503–510).

The COAST investigators noted that stents have been used since the 1990s to treat CoA, a congenital obstruction to flow through the aorta; however, no stents have been approved by the US Food and Drug Administration for this indication.

As summarized in CCI, the COAST prospective, multicenter study enrolled 105 patients who received stents for treatment of CoA. Data were collected in the catheterization laboratory, on discharge, and at 1-month postprocedure. Of the 105 patients, 69% were male and 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 to be 29 ± 17 mm Hg.

At catheterization, the baseline ratio of minimum CoA diameter to diameter of the descending aorta (CoA:DAo) was 0.46 ± 0.16. Implantations (104/105) were successful with one stent migration. There were no deaths or serious complications. Paradoxical hypertension occurred in 6% of patients, and 4% of patients experienced somewhat serious adverse events related to the procedure.

All patients achieved relief of ascending aorta to DAo pressure gradient (mean, 2 ± 4 mm Hg [P < .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); 99% of patients had a UE to LE SBP difference < 20 mm Hg.

These findings demonstrate that stenting of CoA with the NuMED Cheatham Platinum stent is acutely safe and effective for treatment of CoA, concluded the COAST investigators in CCI.