Two-Year COAST Outcomes Support Cheatham Platinum Stent for Coarctation in Children and Adults

April 20, 2015—Two-year outcomes from COAST, the Coarctation of the Aorta Stent Trial, were published by Jeffery Meadows, MD, et al online ahead of print in Circulation. COAST was designed to assess the safety and efficacy of the Cheatham Platinum stent (the CP Stent, NuMed, Inc.) when used in children and adults with native or recurrent coarctation.

The COAST investigators concluded that the Cheatham Platinum stent is safe and associated with persistent relief of aortic obstruction. They found that stent fracture and progression of fracture occurs but have not resulted in clinically important sequelae. Also, reintervention is common and related to early and late aortic wall injury and need for re-expansion of small-diameter stents.

The investigators reported in Circulation that 105 patients underwent attempted implantation, with 104 successes. There were no procedural deaths, serious adverse events, or surgical interventions. All patients experienced immediate reduction in upper to lower extremity blood pressure difference with sustained improvement to 2 years. Rates of hypertension and medication use decreased from baseline to 12 months and remained largely unchanged at 2 years. Six aortic aneurysms have been identified, of which five were successfully treated with cover stent placement and one resolved without intervention. Stent fractures were noted in two patients at 1 year and in 11 patients at 2 years, with evidence of fracture progression. 

To date, only larger stent diameter was associated with stent fracture. 12 additional fractures have occurred after 2 years. No fracture has resulted in loss of stent integrity, stent embolization, aortic wall injury, or reobstruction. Nine reinterventions occurred in the first 2 years for stent redilation and address of aneurysms, and 10 additional reinterventions took place after 2 years, stated the investigators in Circulation.