Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry
Background Transcatheter aortic valve replacement (TAVR) requires large‐bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2020-11-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.120.018042 |
| _version_ | 1828872781818757120 |
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| author | Sergio Berti Francesco Bedogni Arturo Giordano Anna S. Petronio Alessandro Iadanza Antonio L. Bartorelli Bernard Reimers Carmen Spaccarotella Carlo Trani Tiziana Attisano Angela Marella Cenname Gennaro Sardella Roberto Bonmassari Massimo Medda Fabrizio Tomai Giuseppe Tarantini Eliano P. Navarese |
| author_facet | Sergio Berti Francesco Bedogni Arturo Giordano Anna S. Petronio Alessandro Iadanza Antonio L. Bartorelli Bernard Reimers Carmen Spaccarotella Carlo Trani Tiziana Attisano Angela Marella Cenname Gennaro Sardella Roberto Bonmassari Massimo Medda Fabrizio Tomai Giuseppe Tarantini Eliano P. Navarese |
| author_sort | Sergio Berti |
| collection | DOAJ |
| description | Background Transcatheter aortic valve replacement (TAVR) requires large‐bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR. Methods and Results This large‐scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30 days and 1‐year follow‐up. At 30 days, there was a significantly greater reduction of the primary end point with ProGlide versus Prostar XL (13.8% versus 20.5%, respectively; multivariate adjusted odds ratio, 0.80 [95% CI, 0.65–0.99]; P=0.043), driven by a reduction of bleeding complications (9.1% versus 11.7%, respectively; multivariate adjusted odds ratio, 0.76 [95% CI, 0.58–0.98]; P=0.046). Propensity score analysis confirmed the significant reduction of major adverse cardiovascular events and bleeding risk with ProGlide. No significant differences in the primary end point were found between the 2 vascular closure devices at 1 year of follow‐up (multivariate adjusted hazard ratio, 0.88 [95% CI, 0.72–1.10]; P=0.902). Comparable results were obtained by propensity score analysis. During the procedure, compared with Prostar XL, ProGlide yielded significant higher device success (99.2% versus 97.5%, respectively; P=0.001). Conclusions ProGlide has superior efficacy as compared with Prostar XL in TAVR procedures and is associated with a greater reduction of composite adverse events at short‐term, driven by lower bleeding complications. Registration Information URL: clinicaltrials.gov; Unique identifier: NCT02713932. |
| first_indexed | 2024-12-13T07:02:37Z |
| format | Article |
| id | doaj.art-268a69bc2ec44d808a2b1c1731d7ae7f |
| institution | Directory Open Access Journal |
| issn | 2047-9980 |
| language | English |
| last_indexed | 2024-12-13T07:02:37Z |
| publishDate | 2020-11-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj.art-268a69bc2ec44d808a2b1c1731d7ae7f2022-12-21T23:55:54ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802020-11-0192110.1161/JAHA.120.018042Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA RegistrySergio Berti0Francesco Bedogni1Arturo Giordano2Anna S. Petronio3Alessandro Iadanza4Antonio L. Bartorelli5Bernard Reimers6Carmen Spaccarotella7Carlo Trani8Tiziana Attisano9Angela Marella Cenname10Gennaro Sardella11Roberto Bonmassari12Massimo Medda13Fabrizio Tomai14Giuseppe Tarantini15Eliano P. Navarese16Department of Diagnostic and Interventional Cardiology Gabriele Monasterio Tuscany Foundation, G. Pasquinucci Heart Hospital Massa ItalyDepartment of Clinical and Interventional Cardiology IRCCS Policlinico San Donato Milan ItalyUnità Operativa di Interventistica Cardiovascolare Pineta Grande Hospital Castel Volturno ItalyDepartment of Cardiology Azienda Ospedaliero‐Universitaria Pisana Pisa ItalyAzienda Ospedaliera Universitaria Senese, Policlinico Le Scotte Siena ItalyCentro Monzino IRCCS and Department of Biomedical and Clinical Sciences “Luigi Sacco” University of Milan ItalyCardio Center Humanitas Research Hospital IRCCS Rozzano‐Milan ItalyDivision of Cardiology CCU and Interventional Cardiology Cardiovascular Research Center University Magna Graecia Catanzaro ItalyInstitute of Cardiology Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore Rome ItalyCardiologia Interventistica Dipartimento Cardio Toraco Vascolare AOU S. Giovanni di Dio e Ruggi D’Aragona Salerno ItaltFondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore Rome ItalyDepartment of Cardiology Policlinico "Umberto I" Sapienza University of Rome ItalyDepartment of Cardiology S. Chiara Hospital Trento ItalyIstituto Clinico Sant’Ambrogio, Gruppo San Donato Milano ItalyDivision of Cardiology European Hospital Rome ItalyA.O. Policlinico Universitario di Padova, Centro Gallucci Padova ItalyDepartment of Cardiology and Internal Medicine Interventional Cardiology and Cardiovascular Medicine Research Nicolaus Copernicus University Bydgoszcz PolandBackground Transcatheter aortic valve replacement (TAVR) requires large‐bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR. Methods and Results This large‐scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30 days and 1‐year follow‐up. At 30 days, there was a significantly greater reduction of the primary end point with ProGlide versus Prostar XL (13.8% versus 20.5%, respectively; multivariate adjusted odds ratio, 0.80 [95% CI, 0.65–0.99]; P=0.043), driven by a reduction of bleeding complications (9.1% versus 11.7%, respectively; multivariate adjusted odds ratio, 0.76 [95% CI, 0.58–0.98]; P=0.046). Propensity score analysis confirmed the significant reduction of major adverse cardiovascular events and bleeding risk with ProGlide. No significant differences in the primary end point were found between the 2 vascular closure devices at 1 year of follow‐up (multivariate adjusted hazard ratio, 0.88 [95% CI, 0.72–1.10]; P=0.902). Comparable results were obtained by propensity score analysis. During the procedure, compared with Prostar XL, ProGlide yielded significant higher device success (99.2% versus 97.5%, respectively; P=0.001). Conclusions ProGlide has superior efficacy as compared with Prostar XL in TAVR procedures and is associated with a greater reduction of composite adverse events at short‐term, driven by lower bleeding complications. Registration Information URL: clinicaltrials.gov; Unique identifier: NCT02713932.https://www.ahajournals.org/doi/10.1161/JAHA.120.018042ProGlideProstartranscatheter aortic valve replacementvascular closure devices |
| spellingShingle | Sergio Berti Francesco Bedogni Arturo Giordano Anna S. Petronio Alessandro Iadanza Antonio L. Bartorelli Bernard Reimers Carmen Spaccarotella Carlo Trani Tiziana Attisano Angela Marella Cenname Gennaro Sardella Roberto Bonmassari Massimo Medda Fabrizio Tomai Giuseppe Tarantini Eliano P. Navarese Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease ProGlide Prostar transcatheter aortic valve replacement vascular closure devices |
| title | Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry |
| title_full | Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry |
| title_fullStr | Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry |
| title_full_unstemmed | Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry |
| title_short | Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry |
| title_sort | efficacy and safety of proglide versus prostar xl vascular closure devices in transcatheter aortic valve replacement the rispeva registry |
| topic | ProGlide Prostar transcatheter aortic valve replacement vascular closure devices |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.120.018042 |
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