AI Article Synopsis
- The PROSE trial aimed to compare the On-X mechanical prosthesis with the St Jude Medical mechanical prosthesis for thromboembolic complications.
- The study involved 855 subjects across 28 centers from 2003 to 2016 and found no significant differences in thromboembolism or mortality rates between the two prostheses at the 5-year mark.
- Notable differences were observed in valve thrombosis occurrences based on valve position and between Western and Developing populations, with Developing populations experiencing more complications, particularly in the mitral valve position.
Article Abstract
Objectives: 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.
Methods: 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.
Results: 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 ( = .007) and Western < Developing ( = .005). In the mitral position there were no cases in Western populations, whereas there were 8 in Developing populations ( = .217).
Conclusions: 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.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9801238 | PMC |
| http://dx.doi.org/10.1016/j.xjon.2022.07.011 | DOI Listing |
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