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Transcatheter aortic valve implantation with the Edwards SAPIEN versus the Medtronic CoreValve Revalving system devices: a multicenter collaborative study: the PRAGMATIC Plus Initiative (Pooled-RotterdAm-Milano-Toulouse In Collaboration).
J Am Coll Cardiol ; 61(8): 830-6, 2013 Feb 26.
Article em En | MEDLINE | ID: mdl-23333140
ABSTRACT

OBJECTIVES:

The aim of this study was to compare outcomes after transfemoral transcatheter aortic valve implantation with the Medtronic CoreValve (MCV) versus the Edwards SAPIEN/SAPIEN XT transcatheter heart valve (ESV) for severe aortic stenosis.

BACKGROUND:

No large matched comparison study has been conducted so far evaluating both commercially available devices.

METHODS:

The data from databases of 4 experienced European centers were pooled and analyzed. Due to differences in baseline clinical characteristics, propensity score matching was performed. Study objectives were Valve Academic Research Consortium outcomes at 30 days and 1 year.

RESULTS:

In total, 793 patients were included 453 (57.1%) treated with the MCV and 340 (42.9%) with the ESV. After propensity matching, 204 patients were identified in each group. At 30 days, there were no differences in all-cause mortality (MCV, 8.8% vs. ESV, 6.4%; hazard ratio [HR] 1.422; 95% confidence interval [CI] 0.677 to 2.984; p = 0.352), cardiovascular mortality (MCV, 6.9% vs. ESV, 6.4%; HR 1.083; 95% CI 0.496 to 2.364; p = 0.842), myocardial infarction (MCV, 0.5% vs. ESV, 1.5%; HR 0.330; 95% CI 0.034 to 3.200; p = 0.339), stroke (MCV, 2.9% vs. ESV, 1.0%; HR 3.061; 95% CI 0.610 to 15.346; p = 0.174), or device success (MCV, 95.6% vs. ESV, 96.6%; HR 0.770; 95% CI 0.281 to 2.108; p = 0.611). Additionally, there were no differences in major vascular complications (MCV, 9.3% vs. ESV, 12.3%; HR 0.735; 95% CI 0.391 to 1.382; p = 0.340) or life-threatening bleeding (MCV, 13.7% vs. ESV, 8.8%; HR 1.644; 95% CI 0.878 to 3.077; p = 0.120). MCV was associated with more permanent pacemakers (22.5% vs. 5.9%; HR 4.634; 95% CI 2.373 to 9.050; p < 0.001). At 1 year, there were no differences in all-cause (MCV, 16.2% vs. ESV, 12.3%; HR 1.374; 95% CI 0.785 to 2.407; p = 0.266) or cardiovascular (MCV, 8.3% vs. ESV, 7.4%; HR 1.145; 95% CI 0.556 to 12.361; p = 0.713) mortality.

CONCLUSIONS:

No differences between the 2 commercially available transfemoral transcatheter aortic valve implantation devices were observed at the adjusted analysis in Valve Academic Research Consortium outcomes except for the need for permanent pacemakers with the MCV.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Estenose da Valva Aórtica / Complicações Pós-Operatórias / Desenho de Prótese / Doenças Vasculares / Próteses Valvulares Cardíacas / Cateterismo Cardíaco / Implante de Prótese de Valva Cardíaca Tipo de estudo: Diagnostic_studies / Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Aged / Aged80 / Female / Humans / Male Idioma: En Ano de publicação: 2013 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Estenose da Valva Aórtica / Complicações Pós-Operatórias / Desenho de Prótese / Doenças Vasculares / Próteses Valvulares Cardíacas / Cateterismo Cardíaco / Implante de Prótese de Valva Cardíaca Tipo de estudo: Diagnostic_studies / Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Aged / Aged80 / Female / Humans / Male Idioma: En Ano de publicação: 2013 Tipo de documento: Article