Original title: Acute outcome of stent therapy for coarctation of the aorta: results of the coarctation of the aorta stent trial (COAST). Reference: Ringel RE et al. CatheterCardiovascInterv. 2013 Oct 1;82(4):503-10.
The COAST trial (the Coarctation of the Aorta Stent Trial) is a pivotal trial of the NuMED Cheatham Platinum Stent to treat coarctation of the aorta.
Coarctation of the aorta is a congenital cardiopathy that may be associated to other birth conditions. It is an obstruction to flow through the aorta that typically occurs after the left subclavian artery. Even though since the 90s stenting has been the regular course of action to treat CoA, the FDA has not yet approved any of these devices to this indication.
This prospective, multicenter study included 105 patients receiving the new device to treat coarctation, followed up in hospital and at 30 days.
57% of the population presented native coarctations, the rest being re coarctations after previous procedures. Mean gradient at coarctation level was 29 ± 17 mm Hg and baseline ratio of minimum CoA diameter to diameter of descending aorta was 0.46 ± 0.16.
All implants were successful except for one stent migration, with not peri procedural deaths or other serious complications.
All patients achieved relief of ascending aorta to descending aorta mean gradient (2.0 ± 4.0 mm Hg; p < 0.001) and 99% of patients had upper extremity to lower extremity systolic blood pressure difference of
Coarctation of the aorta stenting with NuMED Cheatham Platinum Stent is acutely safe and effective.
Selected population was adults and adolescents over 35Kg in order to evaluate long term outcomes without risking growth challenges. Most critical coarctations were excluded from this study, probably because they would benefit more from a covered stent.