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. 2022 Aug 1:12:51-70.
doi: 10.1016/j.xjon.2022.07.011. eCollection 2022 Dec.

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

W R Eric Jamieson  1 , John L Ely  2 , Johan Brink  3 , Timothy Pennel  3 , Paul Bannon  4 , Jashvant Patel  5 , Rajiv Kumar Gupta  6 , Prasanna Simha Mohan Rao  7 , Damyanti Agrawal  8 , Lars Wiklund  9 , A Pieter Kappetein  10 , Rune Haaverstad  11 , Thomas Geisner  12 , Torsten Doenst  13 , Christian Schlensak  14 , Salgunan Nair  15 , Craig Brown  16 , Matthias Siepe  17 , Ralph J Damiano  18 , Yves Langlois  19 , Kotturathu M Cherian  20 , Hormoz Azar  21 , John C Chen  22 , Joseph E Bavaria  23 , Lynn M Fedoruk  24 , Nabil A Munfakh  25 , V Sridhar  26 , Peter M Scholz  26 , Thomas A Pfeffer  27 , Jian Ye  28
Affiliations

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

W R Eric Jamieson et al. JTCVS Open. .

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 (P = .007) and Western < Developing (P = .005). In the mitral position there were no cases in Western populations, whereas there were 8 in Developing populations (P = .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.

Keywords: 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.

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Figures

None
On-X Prosthetic Heart Valve (On-X Life Technologies/Artivion Inc).
Figure 1
Figure 1
On-X Prosthetic Heart Valve (On-X Life Technologies/Artivion Inc).
Figure 2
Figure 2
Freedom from thromboembolism by valve type with 95% CIs. Five-year event-free rate in percent ± SE and log rank P value. On-X Prosthetic Heart Valve (On-X Life Technologies [On-X]/Artivion Inc); St Jude Medical Mechanical Prosthesis (Abbott/St Jude Medical [SJM]). CI, Confidence Interval; SE, standard error.
Figure 3
Figure 3
Freedom from Valve Thrombosis by Valve Type with 95% CIs. Five-year event-free rate in percent ± SE, and log rank P value. On-X Prosthetic Heart Valve (On-X Life Technologies [On-X]/Artivion Inc); St Jude Medical Mechanical Prosthesis (Abbott/St Jude Medical [SJM]). CI, Confidence interval; SE, standard error.
Figure 4
Figure 4
Freedom from valve thrombosis by valve position with 95% CIs. Five-year event-free rate in percent ± SE, and log rank P value. CI, Confidence interval; SE, standard error.
Figure 5
Figure 5
Freedom from thromboembolism by site with 95% CIs. Five-year event-free rate in percent ± SE, and log rank P-value. CI, Confidence interval; SE, standard error.
Figure 6
Figure 6
Freedom from valve thrombosis by site with 95% CI. Five-year event-free rate in percent ± SE, and log rank P value. CI, Confidence interval; SE, standard error.
Figure 7
Figure 7
Thromboembolism (TE) and valve thrombosis (VT) event rates by study cohort: Summary figure for TE and VT linearized rates in percent per patient-year for all cohorts analyzed with indicators for statistically significant differences at P < .05. Bold double-ended arrows indicate significant differences in VT. SJM, St Jude Medical; On-X, On-X Life Technologies.
Figure 8
Figure 8
Prostheses used: A, On-X aortic valve (On-X Life Technologies/Artivion Inc). B, St Jude Medical aortic valve (Abbott/St Jude Medical). C, On-X mitral valve. D, St Jude Medical mitral valve.
Figure E1
Figure E1
Consolidated standards of reporting trials flow diagram for randomized groups in the Prospective Randomized On-X Prosthesis Versus St Jude Medical Mechanical Prosthesis Evaluation trial.
Figure E2
Figure E2
Thromboembolism (TE) and valve thrombosis (VT) rates for mitral patients by cohort. Summary figure for TE and VT linearized rates among mitral valve patients in percent per patient-year for all cohorts analyzed with indicators for statistically significant differences at P < .05. On-X, On-X Life Technologies; SJM, St Jude Medical.
Figure E3
Figure E3
Thromboembolism (TE) and valve thrombosis (VT) rates for aortic patients by cohort. Summary figure for TE and VT linearized rates among aortic valve patients in percent per patient-year for all cohorts analyzed with indicators for statistically significant differences at P < .05. On-X, On-X Life Technologies; SJM, St Jude Medical.
None
See this image and copyright information in PMC

References

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