Clinical Trial
Controlled Clinical Trial
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The adult patient with native coarctation of the aorta: balloon angioplasty or primary stenting?

Heart 2003 January
OBJECTIVE: To compare results of dilatation of native coarctation of the aorta with and without stent implantation.

DESIGN: Open, observational, non-randomised study.

PATIENTS: 54 consecutive adult patients: 32 with balloon angioplasty alone (group 1) and 22 with stent placement (group 2).

INTERVENTIONS: Balloon dilatation from 1995 to 1997; dilatation with Palmaz stent placement from 1997 to 1999.

MAIN OUTCOME MEASURES: The primary end point was a composite index of failure including heart related death, a residual gradient of > 20 mm Hg, the need of reintervention, and aneurysm formation.

RESULTS: Peak systolic gradient (mean (SD)) was reduced both in group 1 (from 63.3 (22.8) to 10.7 (10.8) mm Hg, p < 0.001) and group 2 (from 63.9 (20.8) to 2.7 (4.3) mm Hg, p < 0.001), but Delta change was significantly greater in group 2. A residual gradient of > 10 mm Hg was shown to be the best cut off point to separate risk groups, representing a hazard ratio (HR) of 9.59 compared with a residual gradient of < or = 10 mm Hg (95% confidence interval (CI) 1.92 to 47.8). From multivariate Cox regression analysis, the only risk marker was the residual gradient (HR 8.9, 95% CI 1.2 to 63.0). The type of the coarctation and the use of stent were the factors associated with a residual gradient of < or = 10 mm Hg.

CONCLUSIONS: Mid term outcome in adult patients with native aortic coarctation receiving percutaneous treatment is strongly related to the immediate residual gradient. When treating these cases, efforts should be made to obtain gradients under 10 mm Hg, either by angioplasty alone or by placing a stent. Patients with discrete aortic coarctation have similar mid term results when the immediate residual gradient is < or = 10 mm Hg despite the implantation of a stent. To achieve these gradients, patients with hypoplastic isthmus or tubular coarctation should be treated with primary stenting. Further studies including exercise tests and non-invasive imaging are still needed before definitive conclusions can be drawn.

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