PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis EvaluationCentral MessagePerspective
W. R. Eric Jamieson, MD,
John L. Ely, MS,
Johan Brink, MBChB, PhD,
Timothy Pennel, MBChB, MMED,
Paul Bannon, MB, BS, PhD,
Jashvant Patel, MS, MCh,
Rajiv Kumar Gupta, MBBS, MS, MCh,
Prasanna Simha Mohan Rao, MS, MCh,
Damyanti Agrawal, MS, MCh,
Lars Wiklund, MD, PhD,
A. Pieter Kappetein, MD, PhD,
Rune Haaverstad, MD, PhD,
Thomas Geisner, MD,
Torsten Doenst, MD, PhD,
Christian Schlensak, MD, PhD,
Salgunan Nair, MBBS, MS, MCh,
Craig Brown, MD,
Matthias Siepe, MD,
Ralph J. Damiano, MD,
Yves Langlois, MD,
Kotturathu M. Cherian, MBBS, MS,
Hormoz Azar, MD,
John C. Chen, MD,
Joseph E. Bavaria, MD,
Lynn M. Fedoruk, MD,
Nabil A. Munfakh, MD,
V. Sridhar, MBBS, MS, MCh,
Peter M. Scholz, MD,
Thomas A. Pfeffer, MD,
Jian Ye, MSc, MD
Affiliations
W. R. Eric Jamieson, MD
Vancouver Coastal Health Research Institute, Vancouver General Hospital and St. Paul's Hospital, University of British Columbia, Vancouver, British Colombia, Canada; Address for reprints: W. R. Eric Jamieson, MD, Vancouver Coastal Health Research Institute, University of British Columbia, 272 Waterleigh Dr, Vancouver, British Columbia V5X 4T2, Canada.
John L. Ely, MS
Heart of the Matter Clinical Consultants, Austin, Tex
Johan Brink, MBChB, PhD
Division of Cardiothoracic Surgery, University of Cape Town, Cape Town, South Africa
Timothy Pennel, MBChB, MMED
Division of Cardiothoracic Surgery, University of Cape Town, Cape Town, South Africa
Paul Bannon, MB, BS, PhD
Department of Cardiovascular Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
Jashvant Patel, MS, MCh
Department of Cardiac Surgery, B. D. Mehta Mahavir Heart Institute, Surat, India
Rajiv Kumar Gupta, MBBS, MS, MCh
Department of Cardiovascular and Thoracic Surgery, Dayanand Medical College, Ludhiana, India
Prasanna Simha Mohan Rao, MS, MCh
Department of Cardiothoracic Surgery, Shri Jaya Deva Institute of Cardiovascular Sciences, Bangalore, India
Damyanti Agrawal, MS, MCh
Department of Cardiovascular Surgery, Banaras Hindu University, Varanasi, India
Lars Wiklund, MD, PhD
Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenberg, Sweden
A. Pieter Kappetein, MD, PhD
Thorax Center, Erasmus Medical College, Rotterdam, the Netherlands
Rune Haaverstad, MD, PhD
Department of Cardiothoracic Surgery, Haukeland University Hospital, Bergen, Norway
Thomas Geisner, MD
Department of Cardiothoracic Surgery, Universitats Klinik Jena, Jena, Germany
Torsten Doenst, MD, PhD
Department of Cardiovascular and Thoracic Surgery, Universitats Klinik Tuebingen, Tuebingen, Germany
Christian Schlensak, MD, PhD
Department of Cardiothoracic Surgery, Apollo Multispecialty Hospital, Chennai, India
Salgunan Nair, MBBS, MS, MCh
Department of Cardiovascular Surgery, Horizon New Brunswick Heart Center, Saint John, New Brunswich, Canada
Craig Brown, MD
Department of Cardiovascular Surgery, Universitats Herzzentrum, Freiburg, Germany
Matthias Siepe, MD
Department of Surgery, Washington University School of Medicine, St Louis, Mo
Ralph J. Damiano, MD
Division of Cardiac Surgery, Jewish General Hospital, Montreal, Québec, Canada
Yves Langlois, MD
Department of Cardiovascular Surgery, Frontier Lifeline Hospital, Chennai, India
Kotturathu M. Cherian, MBBS, MS
Department of Cardiovascular Surgery, Sentara Norfolk General Hospital, Norfolk, Va
Hormoz Azar, MD
Department of Thoracic Surgery, Kaiser-Permanente Hospital, Honolulu, Hawaii
John C. Chen, MD
Department of Surgery, Christian Hospital Northeast, St Louis, Mo
Joseph E. Bavaria, MD
Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pa
Lynn M. Fedoruk, MD
Division of Cardiac Surgery, Victoria Heart Institute, Victoria, British Columbia, Canada
Nabil A. Munfakh, MD
Department of Cardiothoracic and Vascular Surgery, Apollo Multispecialty Hospital, Madurai, India
V. Sridhar, MBBS, MS, MCh
Department of Surgery, Robert Wood Johnson Medical School, New Brunswick, NJ
Peter M. Scholz, MD
Department of Surgery, Robert Wood Johnson Medical School, New Brunswick, NJ
Thomas A. Pfeffer, MD
Department of Thoracic Surgery, Kaiser-Permanente Hospital, Los Angeles, Calif
Jian Ye, MSc, MD
Division of Cardiovascular Surgery, St Paul's Hospital, Vancouver, British Columbia, Canada
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.
