Intermediate Outcomes in the Prospective, Multicenter Coarctation of the Aorta Stent Trial (COAST)
Background—The Coarctation of the Aorta Stent Trial (COAST) was designed to assess the safety and efficacy of the Cheatham Platinum stent when used in children and adults with native or recurrent coarctation. Acute outcomes have been reported. We report here follow-up to 2 years.
Methods and Results—105 patients underwent attempted implantation, with 104 successes. There were no procedural deaths, serious adverse events or surgical intervention. 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, 5 were successfully treated with cover stent placement, 1 resolved without intervention. Stent fractures were noted in 2 patients at 1 year, and 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 after 2 years.
Conclusions—The Cheatham Platinum stent is safe and associated with persistent relief of aortic obstruction. Stent fracture and progression of fracture occurs but have not resulted in clinically important sequelae. Reintervention is common and related to early and late aortic wall injury and need for reexpansion of small diameter stents.
Clinical Trial Registration Information—ClinicalTrials.gov. Identifier: NCT00552812.
- Received October 30, 2014.
- Revision received February 11, 2015.
- Accepted March 5, 2015.