Author + information
- Received September 1, 2015
- Revision received November 4, 2015
- Accepted November 19, 2015
- Published online March 14, 2016.
- Nathaniel W. Taggart, MDa,∗ (, )
- Matthew Minahan, BSb,
- Allison K. Cabalka, MDa,
- Frank Cetta, MDa,
- Kudret Usmani, BA, BScb,
- Richard E. Ringel, MDc,
- COAST II Investigators
- aDivision of Pediatric Cardiology, Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, Minnesota
- bDepartment of Cardiology, Boston Children’s Hospital, Boston, Massachusetts
- cDivision of Pediatric Cardiology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland
- ↵∗Reprint requests and correspondence:
Dr. Nathaniel W. Taggart, Mayo Clinic, Division of Pediatric Cardiology, Department of Pediatric and Adolescent Medicine, 200 1st Street SW, Rochester, Minnesota 55905.
Objectives This study aimed to describe the safety and short-term efficacy of the Covered Cheatham-Platinum stent (CCPS) in treating or preventing aortic wall injury (AWI) in patients with coarctation of the aorta (CoA).
Background The COAST II trial (Covered Cheatham-Platinum Stents for Prevention or Treatment of Aortic Wall Injury Associated with Coarctation of the Aorta Trial) is a multicenter, single-arm trial using the CCPS for the treatment and/or prevention of AWI in patients with CoA and pre-existing AWI or increased risk of AWI.
Methods Patients were enrolled if they had a history of CoA with pre-existing AWI (Treatment group) or with increased risk of AWI (Prevention group). Pre/post-implant hemodynamics and angiography were reported. A core laboratory performed standardized review of all angiograms. One-month follow-up was reported.
Results A total of 158 patients (male = 65%; median age 19 years) underwent placement of CCPS. Eighty-three patients had pre-existing AWI. The average ascending-to-descending aorta systolic gradient improved from 27 ± 20 mm Hg to 4 ± 6 mm Hg. Complete coverage of pre-existing AWI was achieved in 66 of 71 patients (93%) with AWI who received a single CCPS. Ultimately, complete coverage of AWI was achieved in 76 of 83 patients (92%); 7 patients had minor endoleaks that did not require repeat intervention. Four patients experienced important access site vascular injury. There were no acute AWI, repeat interventions, or deaths.
Conclusions The CCPS can effectively treat and potentially prevent AWI associated with CoA. Access site arterial injury is the most common important complication. Longer-term follow-up is necessary to define mid- and late-term outcomes.
Support for the COAST II study is provided by a grant from the FDA Office of Orphan Product Development, grant number: 1R01FD003898-01. The NuMED Corp., maker of the Covered CP stent and Balloon-in-Balloon catheters, provided funding for this trial, including salary and administrative support for Mr. Minahan, Ms. Usmani, and Dr. Ringel. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 1, 2015.
- Revision received November 4, 2015.
- Accepted November 19, 2015.
- American College of Cardiology Foundation