PROSE：On-X机械瓣膜与圣犹达医疗机械瓣膜的前瞻性随机试验评估：第2部分：研究结果——瓣膜、位置与经济发展

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.

作者信息

Jamieson W R Eric, Ely John L, Brink Johan, Pennel Timothy, Bannon Paul, Patel Jashvant, Gupta Rajiv Kumar, Mohan Rao Prasanna Simha, Agrawal Damyanti, Wiklund Lars, Kappetein A Pieter, Haaverstad Rune, Geisner Thomas, Doenst Torsten, Schlensak Christian, Nair Salgunan, Brown Craig, Siepe Matthias, Damiano Ralph J, Langlois Yves, Cherian Kotturathu M, Azar Hormoz, Chen John C, Bavaria Joseph E, Fedoruk Lynn M, Munfakh Nabil A, Sridhar V, Scholz Peter M, Pfeffer Thomas A, Ye Jian

机构信息

Vancouver Coastal Health Research Institute, Vancouver General Hospital and St. Paul's Hospital, University of British Columbia, Vancouver, British Colombia, Canada.

Heart of the Matter Clinical Consultants, Austin, Tex.

出版信息

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

DOI:10.1016/j.xjon.2022.07.011

PMID:36590733

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9801238/

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.

摘要

目的

前瞻性随机On-X机械瓣膜与圣犹达医疗机械瓣膜评估（PROSE）试验的目的是研究与上一代机械瓣膜（圣犹达医疗机械瓣膜；雅培/圣犹达医疗）相比，新一代机械瓣膜（On-X；On-X生命技术公司/Artivion公司）是否能降低血栓栓塞相关并发症的发生率。本第二篇报告按个体假体以及西方和发展中人群记录了瓣膜相关并发症。

方法

PROSE试验研究在全球28个中心进行，纳入了2003年至2016年间随机分组的855名受试者。研究招募于2016年8月31日停止。研究方案以及对10个人口统计学变量和24个风险因素的分析于2021年详细发表。

结果

患者总数（N = 855）包括接受On-X瓣膜（n = 462）和圣犹达医疗瓣膜（n = 393）的患者。总体自由度评估显示，在5年时，两种假体在血栓栓塞或瓣膜血栓形成方面无差异。死亡率也无差异。发展中人群和西方人群之间存在一些差异。5年时死亡率的自由度关系显示西方人群优于发展中人群。瓣膜血栓形成按位置和部位区分：主动脉瓣＜二尖瓣（P = 0.007），西方人群＜发展中人群（P = 0.005）。在二尖瓣位置，西方人群无病例，而发展中人群有8例（P = 0.217）。