Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry.
Aged
Aged, 80 and over
Aortic Valve Stenosis
/ complications
Cohort Studies
Female
Hemostatic Techniques
/ instrumentation
Humans
Length of Stay
Male
Postoperative Hemorrhage
/ epidemiology
Registries
Transcatheter Aortic Valve Replacement
/ adverse effects
Treatment Outcome
Vascular Closure Devices
ProGlide
Prostar
transcatheter aortic valve replacement
vascular closure devices
Journal
Journal of the American Heart Association
ISSN: 2047-9980
Titre abrégé: J Am Heart Assoc
Pays: England
ID NLM: 101580524
Informations de publication
Date de publication:
03 11 2020
03 11 2020
Historique:
pubmed:
27
10
2020
medline:
27
3
2021
entrez:
26
10
2020
Statut:
ppublish
Résumé
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];
Identifiants
pubmed: 33103545
doi: 10.1161/JAHA.120.018042
pmc: PMC7763424
doi:
Banques de données
ClinicalTrials.gov
['NCT02713932']
Types de publication
Comparative Study
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
e018042Références
Pharm Stat. 2011 Mar-Apr;10(2):150-61
pubmed: 20925139
EuroIntervention. 2016 Nov 20;12(10):1298-1304
pubmed: 27866140
Catheter Cardiovasc Interv. 2019 Jun 1;93(7):1374-1381
pubmed: 31116908
J Am Heart Assoc. 2020 Nov 3;9(21):e018042
pubmed: 33103545
Minerva Cardioangiol. 2019 Dec;67(6):443-449
pubmed: 31670491
J Am Coll Cardiol. 2019 Jan 29;73(3):340-374
pubmed: 30031107
EuroIntervention. 2015 Oct;11(6):690-7
pubmed: 26499222
Vasc Med. 2017 Jun;22(3):234-244
pubmed: 28494713
Biom J. 2018 May;60(3):431-449
pubmed: 29292533
EuroIntervention. 2019 Feb 08;14(15):e1558-e1565
pubmed: 30295293
JACC Cardiovasc Interv. 2017 Jul 24;10(14):1436-1446
pubmed: 28728657
Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60
pubmed: 23026738
Heart. 2013 Jun;99(12):860-5
pubmed: 23236027
JACC Cardiovasc Interv. 2019 Sep 9;12(17):1730-1736
pubmed: 31488301
Int J Cardiol. 2016 Nov 15;223:564-567
pubmed: 27561160
J Am Coll Cardiol. 2017 Jul 4;70(1):29-41
pubmed: 28662805
J Cardiovasc Med (Hagerstown). 2017 Feb;18(2):96-102
pubmed: 27898500
Eur Heart J. 2015 Dec 14;36(47):3370-9
pubmed: 26314688
Am J Cardiol. 2002 Mar 15;89(6):777-9
pubmed: 11897227
Multivariate Behav Res. 2011 May;46(3):399-424
pubmed: 21818162
J Am Coll Cardiol. 2012 Jun 19;59(25):2317-26
pubmed: 22503058
JACC Cardiovasc Interv. 2013 Aug;6(8):767-76
pubmed: 23968697
Int J Cardiol. 2018 Jul 15;263:29-31
pubmed: 29681408
CVIR Endovasc. 2018;1(1):20
pubmed: 30652151
Mayo Clin Proc. 2019 Aug;94(8):1457-1466
pubmed: 30824280