Rationale and design of the SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial).

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Citation: American Heart Journal. 243:92-102, 2022 01.PMID: 34587510Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Aortic Valve Stenosis | *Heart Valve Prosthesis | *Transcatheter Aortic Valve Replacement | Aortic Valve/dg [Diagnostic Imaging] | Aortic Valve/su [Surgery] | Female | Humans | Prospective Studies | Prosthesis Design | Risk Factors | Severity of Illness Index | Transcatheter Aortic Valve Replacement/mt [Methods] | Treatment OutcomeYear: 2022Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006ISSN:
  • 0002-8703
Name of journal: American heart journalAbstract: BACKGROUND: The SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial was designed to compare the performance of the two most widely available commercial transcatheter aortic valve replacement (TAVR) devices in patients with symptomatic severe native aortic stenosis with a small aortic valve annulus undergoing transfemoral TAVR. Patients with small aortic valve annuli are typically female and are often underrepresented in clinical trials.CLINICAL TRIAL REGISTRATION: URL: www.clinicaltrials.gov, Unique identifier: NCT04722250. Copyright (c) 2021 Elsevier Inc. All rights reserved.CONCLUSIONS: The SMART trial will be the largest head-to-head comparative trial of transfemoral TAVR using the two most widely available contemporary TAVR devices in the setting of small aortic annuli and the largest trial to enroll primarily women.METHODS: The SMART Trial is an international, prospective, multi-center, randomized controlled, post-market trial. The trial will be conducted in approximately 700 subjects at approximately 90 sites globally. Inclusion criteria include severe aortic stenosis, aortic valve annulus area of <=430 mm2 based on multi-detector computed tomography, and appropriate anatomy for both the Medtronic Evolut PRO/PRO+ self-expanding and Edwards SAPIEN 3/3 Ultra balloon-expandable devices. The primary clinical outcome composite endpoint is defined as mortality, disabling stroke or heart failure rehospitalization at 12 months. The co-primary valve function composite endpoint is defined as bioprosthetic valve dysfunction at 12 months which includes hemodynamic structural valve dysfunction, defined as a mean gradient >=20 mmHg, non-structural valve dysfunction, defined as severe prothesis-patient mismatch or >=moderate aortic regurgitation, thrombosis, endocarditis, and aortic valve re-intervention. Powered secondary endpoints will be assessed hierarchically.All authors: Abdel-Wahab M, Attizzani GF, Batchelor W, Bleiziffer S, Chang Y, Gada H, Gillam L, Guerrero M, Herrmann HC, Mahoney PD, Mehran R, Petronio AS, Rogers T, Rovin J, Szerlip M, Tchetche D, Verdoliva S, Whisenant BOriginally published: American Heart Journal. 243:92-102, 2022 Jan.Fiscal year: FY2022Digital Object Identifier: Date added to catalog: 2021-11-01
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Journal Article MedStar Authors Catalog Article 34587510 Available 34587510

Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006

BACKGROUND: The SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial was designed to compare the performance of the two most widely available commercial transcatheter aortic valve replacement (TAVR) devices in patients with symptomatic severe native aortic stenosis with a small aortic valve annulus undergoing transfemoral TAVR. Patients with small aortic valve annuli are typically female and are often underrepresented in clinical trials.

CLINICAL TRIAL REGISTRATION: URL: www.clinicaltrials.gov, Unique identifier: NCT04722250. Copyright (c) 2021 Elsevier Inc. All rights reserved.

CONCLUSIONS: The SMART trial will be the largest head-to-head comparative trial of transfemoral TAVR using the two most widely available contemporary TAVR devices in the setting of small aortic annuli and the largest trial to enroll primarily women.

METHODS: The SMART Trial is an international, prospective, multi-center, randomized controlled, post-market trial. The trial will be conducted in approximately 700 subjects at approximately 90 sites globally. Inclusion criteria include severe aortic stenosis, aortic valve annulus area of <=430 mm2 based on multi-detector computed tomography, and appropriate anatomy for both the Medtronic Evolut PRO/PRO+ self-expanding and Edwards SAPIEN 3/3 Ultra balloon-expandable devices. The primary clinical outcome composite endpoint is defined as mortality, disabling stroke or heart failure rehospitalization at 12 months. The co-primary valve function composite endpoint is defined as bioprosthetic valve dysfunction at 12 months which includes hemodynamic structural valve dysfunction, defined as a mean gradient >=20 mmHg, non-structural valve dysfunction, defined as severe prothesis-patient mismatch or >=moderate aortic regurgitation, thrombosis, endocarditis, and aortic valve re-intervention. Powered secondary endpoints will be assessed hierarchically.

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