BACKGROUND: Our objective was to compare results of two therapeutic modalities to treat congenital aortic coarctation: intraluminal aortoplasty without endoluminal stent installation (patients in group A) vs. surgical aortic resection (patients in group B). Trans-coarctation gradient pressure was evaluated prior to and immediately after treatment. Re-coarctation, aneurysm formation, in-hospital morbidity and mortality, and complications related to treatment were also evaluated. METHODS: A clinical, randomized, multicenter study was performed in pediatric patients with congenital aortic coarctation. Immediate and mid- to late therapeutic results were evaluated. With regard to statistics, we evaluated event variations by Kaplan-Meier model, nonparametric Wilcoxon test, Mann-Whitney U test, two-tailed Student t and chi-square tests, and Fisher analysis. Significance was considered relevant when p<0.05. RESULTS: There were no differences in demographic variables, procedure failure, complications, mortality, or aortic aneurysm between groups A and B, respectively. Intraluminal angioplasty and surgical aortic resection were similarly effective in reducing trans-coarctation pressure gradient, as well as arterial systemic pressure. However, differences were found between groups A and B at follow-up. Group A showed higher re-coarctation (50 vs. 21%). Absence of peripheral arterial pulses in limbs was higher in group A (50 vs. 21%), as well as persistence of arterial hypertension (49 vs. 19%); these differences were significant (p<0.05). On the other hand, complications observed after surgical aortic resection were more serious than post-angioplasty complications, but these differences were not statistically significant. CONCLUSIONS: Although re-coarctation and persistency of arterial hypertension were less frequent after surgical aortic resection, complications observed with this procedure are more serious than complications related to angioplasty, although these differences are not statistically significant.
RCT Entities:
BACKGROUND: Our objective was to compare results of two therapeutic modalities to treat congenital aortic coarctation: intraluminal aortoplasty without endoluminal stent installation (patients in group A) vs. surgical aortic resection (patients in group B). Trans-coarctation gradient pressure was evaluated prior to and immediately after treatment. Re-coarctation, aneurysm formation, in-hospital morbidity and mortality, and complications related to treatment were also evaluated. METHODS: A clinical, randomized, multicenter study was performed in pediatric patients with congenital aortic coarctation. Immediate and mid- to late therapeutic results were evaluated. With regard to statistics, we evaluated event variations by Kaplan-Meier model, nonparametric Wilcoxon test, Mann-Whitney U test, two-tailed Student t and chi-square tests, and Fisher analysis. Significance was considered relevant when p<0.05. RESULTS: There were no differences in demographic variables, procedure failure, complications, mortality, or aortic aneurysm between groups A and B, respectively. Intraluminal angioplasty and surgical aortic resection were similarly effective in reducing trans-coarctation pressure gradient, as well as arterial systemic pressure. However, differences were found between groups A and B at follow-up. Group A showed higher re-coarctation (50 vs. 21%). Absence of peripheral arterial pulses in limbs was higher in group A (50 vs. 21%), as well as persistence of arterial hypertension (49 vs. 19%); these differences were significant (p<0.05). On the other hand, complications observed after surgical aortic resection were more serious than post-angioplasty complications, but these differences were not statistically significant. CONCLUSIONS: Although re-coarctation and persistency of arterial hypertension were less frequent after surgical aortic resection, complications observed with this procedure are more serious than complications related to angioplasty, although these differences are not statistically significant.