Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, Canada.
Heart of the Matter CV Consulting, Austin, USA.
J Cardiothorac Surg. 2021 Nov 3;16(1):323. doi: 10.1186/s13019-021-01632-6.
The PROSE trial purpose is to investigate whether the incidence of thromboembolic-related complications is reduced with a current generation mechanical prosthesis (On-X Life Technologies/CryoLife Inc.-On-X) compared with a previous generation mechanical prosthesis (St Jude Medical-SJM). The primary purpose of the initial report is to document the preoperative demographics, and the preoperative and operative risk factors by individual prosthesis and by Western and Developing populations.
The PROSE study was conducted in 28 worldwide centres and incorporated 855 subjects randomized between 2003 and 2016. The study enrollment was discontinued on August 31, 2016. The preoperative demographics incorporated age, gender, functional class, etiology, prosthetic degeneration, primary rhythm, primary valve lesion, weight, height, BSA and BMI. The preoperative and operative evaluation incorporated 24 risk factors.
The total patient population (855) incorporated On-X population (462) and the St Jude Medical population (393). There was no significant difference of any of the preoperative demographics between the On-X and SJM groups. The preoperative and operative risk factors evaluation showed there was no significant difference between the On-X and St Jude Medical populations. The preoperative and operative risk factors by valve position (aortic and mitral) also documented no differentiation. The dominant preoperative demographics of the Western world population were older age, male gender, sinus rhythm, aortic stenosis, congenital aortic lesion, and mitral regurgitation. The dominant demographics of the Developing world population were rheumatic etiology, atrial fibrillation, aortic regurgitation, mixed aortic lesions, mitral stenosis and mixed mitral lesions. The Developing world group had only one significant risk factor, congestive heart failure. The majority of the preoperative and operative risk factors were significant in the Western world population.
The preoperative demographics do not differentiate the prostheses but do differentiate the Western and Developing world populations. The preoperative and operative risk factors do not differentiate the prostheses BUT do differentiate the Western and Developing world populations.
PROSE 试验旨在研究与前代机械瓣膜（St Jude Medical-SJM）相比，当前一代机械瓣膜（On-X Life Technologies/CryoLife Inc.-On-X）是否能降低血栓栓塞相关并发症的发生率。初步报告的主要目的是记录术前人口统计学数据，以及按个体瓣膜和按西方和发展中国家人群分类的术前和手术风险因素。
PROSE 研究在全球 28 个中心进行，纳入了 2003 年至 2016 年期间随机分组的 855 名受试者。该研究的入组于 2016 年 8 月 31 日截止。术前人口统计学数据包括年龄、性别、功能分级、病因、瓣膜退变、窦性节律、原发性瓣膜病变、体重、身高、BSA 和 BMI。术前和手术评估包括 24 个风险因素。
总患者人群（855 名）包括 On-X 人群（462 名）和 St Jude Medical 人群（393 名）。On-X 组和 SJM 组之间的任何术前人口统计学数据均无显著差异。On-X 和 St Jude Medical 人群的术前和手术风险因素评估也无显著差异。按瓣膜位置（主动脉瓣和二尖瓣）评估的术前和手术风险因素也没有差异。西方世界人群的主要术前人口统计学特征是年龄较大、男性、窦性节律、主动脉瓣狭窄、先天性主动脉病变和二尖瓣反流。发展中国家人群的主要人口统计学特征是风湿病因、房颤、主动脉瓣反流、混合性主动脉病变、二尖瓣狭窄和混合性二尖瓣病变。发展中国家组仅有一个显著的风险因素，即充血性心力衰竭。大多数术前和手术风险因素在西方世界人群中均有显著意义。
术前人口统计学数据不能区分瓣膜，但能区分西方和发展中国家人群。术前和手术风险因素不能区分瓣膜，但能区分西方和发展中国家人群。
