Maximilian Salcher1, Huseyin Naci2, Tyler J Law2, Titus Kuehne2, Stephan Schubert2, Marcus Kelm2. 1. From LSE Health, London School of Economics and Political Science, United Kingdom (M.S., H.N., T.J.L.); Department of Anesthesia, University of Toronto, Ontario, Canada (T.J.L.); and Department of Paediatric Cardiology and Congenital Heart Diseases, Deutsches Herzzentrum Berlin, Germany (T.K., S.S., M.K.).Lynkeus, Rome, ItalyDeutsches Herzzentrum Berlin, Berlin, GermanyFraunhofer MEVIS, Bremen, Germanygnúbila, Argonay, FranceLondon School of Economics and Political Science, London, United KingdomMedizinische Universität Graz, Graz, AustriaSiemens AG, Munich, GermanyOspedale Pediatrico Bambino Gesù, Rome, ItalyUniversity College London, London, United Kingdom m.salcher@lse.ac.uk. 2. From LSE Health, London School of Economics and Political Science, United Kingdom (M.S., H.N., T.J.L.); Department of Anesthesia, University of Toronto, Ontario, Canada (T.J.L.); and Department of Paediatric Cardiology and Congenital Heart Diseases, Deutsches Herzzentrum Berlin, Germany (T.K., S.S., M.K.).Lynkeus, Rome, ItalyDeutsches Herzzentrum Berlin, Berlin, GermanyFraunhofer MEVIS, Bremen, Germanygnúbila, Argonay, FranceLondon School of Economics and Political Science, London, United KingdomMedizinische Universität Graz, Graz, AustriaSiemens AG, Munich, GermanyOspedale Pediatrico Bambino Gesù, Rome, ItalyUniversity College London, London, United Kingdom.
Abstract
BACKGROUND: There is no systematic assessment of available evidence on effectiveness and comparative effectiveness of balloon dilatation and stenting for aortic coarctation. METHODS AND RESULTS: We systematically searched 4 online databases to identify and select relevant studies of balloon dilatation and stenting for aortic coarctation based on a priori criteria (PROSPERO 2014:CRD42014014418). We quantitatively synthesized results for each intervention from single-arm studies and obtained pooled estimates for relative effectiveness from pairwise and network meta-analysis of comparative studies. Our primary analysis included 15 stenting (423 participants) and 12 balloon dilatation studies (361 participants), including patients ≥10 years of age. Post-treatment blood pressure gradient reduction to ≤20 and ≤10 mm Hg was achieved in 89.5% (95% confidence interval, 83.7-95.3) and 66.5% (44.1-88.9%) of patients undergoing balloon dilatation, and in 99.5% (97.5-100.0%) and 93.8% (88.5-99.1%) of patients undergoing stenting, respectively. Odds of achieving ≤20 mm Hg were lower with balloon dilatation as compared with stenting (odds ratio, 0.105 [0.010-0.886]). Thirty-day survival rates were comparable. Numerically more patients undergoing balloon dilatation experienced severe complications during admission (6.4% [2.6-10.2%]) compared with stenting (2.6% [0.5-4.7%]). This was supported by meta-analysis of head-to-head studies (odds ratio, 9.617 [2.654-34.845]) and network meta-analysis (odds ratio, 16.23, 95% credible interval: 4.27-62.77) in a secondary analysis in patients ≥1 month of age, including 57 stenting (3397 participants) and 62 balloon dilatation studies (4331 participants). CONCLUSIONS: Despite the limitations of the evidence base consisting predominantly of single-arm studies, our review indicates that stenting achieves superior immediate relief of a relevant pressure gradient compared with balloon dilatation.
BACKGROUND: There is no systematic assessment of available evidence on effectiveness and comparative effectiveness of balloon dilatation and stenting for aortic coarctation. METHODS AND RESULTS: We systematically searched 4 online databases to identify and select relevant studies of balloon dilatation and stenting for aortic coarctation based on a priori criteria (PROSPERO 2014:CRD42014014418). We quantitatively synthesized results for each intervention from single-arm studies and obtained pooled estimates for relative effectiveness from pairwise and network meta-analysis of comparative studies. Our primary analysis included 15 stenting (423 participants) and 12 balloon dilatation studies (361 participants), including patients ≥10 years of age. Post-treatment blood pressure gradient reduction to ≤20 and ≤10 mm Hg was achieved in 89.5% (95% confidence interval, 83.7-95.3) and 66.5% (44.1-88.9%) of patients undergoing balloon dilatation, and in 99.5% (97.5-100.0%) and 93.8% (88.5-99.1%) of patients undergoing stenting, respectively. Odds of achieving ≤20 mm Hg were lower with balloon dilatation as compared with stenting (odds ratio, 0.105 [0.010-0.886]). Thirty-day survival rates were comparable. Numerically more patients undergoing balloon dilatation experienced severe complications during admission (6.4% [2.6-10.2%]) compared with stenting (2.6% [0.5-4.7%]). This was supported by meta-analysis of head-to-head studies (odds ratio, 9.617 [2.654-34.845]) and network meta-analysis (odds ratio, 16.23, 95% credible interval: 4.27-62.77) in a secondary analysis in patients ≥1 month of age, including 57 stenting (3397 participants) and 62 balloon dilatation studies (4331 participants). CONCLUSIONS: Despite the limitations of the evidence base consisting predominantly of single-arm studies, our review indicates that stenting achieves superior immediate relief of a relevant pressure gradient compared with balloon dilatation.
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