PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation: Part 2: Study results-prostheses, positions, and economic development.
BMI, body mass index
CHF, congestive heart failure
INR, international normalized ratio
NYHA, New York Heart Association
PROSE, Prospective Randomized On-X Mechanical Prosthesis Versus St Jude Medical Mechanical Prosthesis Evaluation
TE, thromboembolism
VT, valve thrombosis
economic development
position
prosthesis
Journal
JTCVS open
ISSN: 2666-2736
Titre abrégé: JTCVS Open
Pays: Netherlands
ID NLM: 101768541
Informations de publication
Date de publication:
Dec 2022
Dec 2022
Historique:
received:
19
03
2022
revised:
04
06
2022
accepted:
23
06
2022
entrez:
2
1
2023
pubmed:
3
1
2023
medline:
3
1
2023
Statut:
epublish
Résumé
The Prospective Randomized On-X Mechanical Prosthesis Versus St Jude Medical Mechanical Prosthesis Evaluation (PROSE) trial purpose was to investigate whether a current-generation mechanical prosthesis (On-X; On-X Life Technologies/Artivion Inc) reduced the incidence of thromboembolic-related complications compared with a previous-generation mechanical prosthesis (St Jude Medical Mechanical Prosthesis; Abbott/St Jude Medical). This second report documents the valve-related complications by individual prostheses and by Western and Developing populations. The PROSE trial study was conducted in 28 worldwide centers and incorporated 855 subjects randomized between 2003 and 2016. The study enrollment was discontinued on August 31, 2016. The study protocol, and analyses of 10 demographic variables and 24 risk factors were published in detail in 2021. The total patient population (N = 855) included patients receiving an On-X valve (n = 462) and a St Jude Medical valve (n = 393). The overall freedom evaluation showed no differences at 5 years between the prostheses for thromboembolism or for valve thrombosis. There were also no differences in mortality. There were several differences between Developing and Western populations. The freedom relations at 5 years for mortality favored Western over Developing populations. Valve thrombosis was differentiated by position and site: aortic < mitral ( The On-X valve and St Jude Medical valve performed equally well in the study with no differences found. The only differentiation occurred with valve thrombosis in the mitral position more than the aortic position and occurring in Developing more than Western populations. The occurrence of valve thrombosis was also related to a younger population possibly due to anticoagulation compliance based on record review.
Identifiants
pubmed: 36590733
doi: 10.1016/j.xjon.2022.07.011
pii: S2666-2736(22)00308-4
pmc: PMC9801238
doi:
Types de publication
Journal Article
Langues
eng
Pagination
51-70Informations de copyright
© 2022 The Author(s).
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