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Acute outcome of stent therapy for coarctation of the aorta: Results of the coarctation of the aorta stent trial
Author(s) -
Ringel Richard E.,
Vincent Julie,
Jenkins Kathy J.,
Gauvreau Kimberlee,
Moses Heidi,
Lofgren Kimberly,
Usmani Kudret
Publication year - 2013
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.24949
Subject(s) - medicine , coarctation of the aorta , stent , aorta , cardiology , descending aorta , ascending aorta , blood pressure , surgery
Objectives The coarctation of the aorta stent trial (COAST) is a pivotal trial of the NuMED Cheatham Platinum Stent ® for treatment of coarctation of the aorta (CoA). Background CoA is a congenital obstruction to flow through the aorta. Stents have been used since the 1990s to treat CoA; none have been approved by the Food and Drug Administration for this indication. Methods In a prospective, multicenter study 105 patients received stents for treatment of CoA. Data was collected in the catheterization laboratory, on discharge and at 1‐month postprocedure. Results Of 105 patients, 69% were male; 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 29 ± 17 mm Hg. At catheterization, baseline ratio of minimum CoA diameter to diameter of descending aorta (CoA:DAo) was 0.46 ± 0.16. Implants (104/105) were successful with one stent migration. There were no deaths or serious complications. Paradoxical hypertension occurred in 6%. Four percent of patients experienced somewhat serious adverse events related to the procedure. All patients achieved relief of ascending aorta to Dao pressure gradient: mean = 2.0 ± 4.0 mm Hg ( P < 0.001). 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. Ninety‐nine percent of patients had UE to LE SBP difference <20 mm Hg. Conclusions Stenting of CoA, using the NuMED Cheatham Platinum Stent, is acutely safe and effective for treatment of CoA. © 2013 Wiley Periodicals, Inc.