Design and rationale of a prospective, collaborative meta-analysis of all randomized controlled trials of angiotensin receptor antagonists in Marfan syndrome, based on individual patient data: A report from the Marfan Treatment Trialists' Collaboration - 09/05/15

Doi : 10.1016/j.ahj.2015.01.011

Alex Pitcher, BMBCh ^a,^{^⁎} , Jonathan Emberson, PhD ^b, Ronald V. Lacro, MD ^c, Lynn A. Sleeper, Sc.D ^d, Mario Stylianou, PhD ^e, Lynn Mahony, MD ^f, Gail D. Pearson, MD, ScD ^e, Maarten Groenink, MD, PhD ^g, Barbara J. Mulder, MD, PhD ^g, Aeilko H. Zwinderman, PhD ^g, Julie De Backer, MD, PhD ^h, Anne M. De Paepe, MD, PhD ⁱ, Eloisa Arbustini, MD ^j, Guliz Erdem, MD ^k, Xu Yu Jin, MD ^l, Marcus D. Flather, MBBS ^m, Michael J. Mullen, MD ⁿ, Anne H. Child, MD, FRCP ^o, Alberto Forteza, MD, PhD ^p, Arturo Evangelista, MD ^q, Hsin-Hui Chiu, MD ^r, Mei-Hwan Wu, MD, PhD ^s, George Sandor, MD, FRCPC ^t, Ami B. Bhatt, MD ^u, Mark A. Creager, MD ^v, Richard B. Devereux, MD ^w, Bart Loeys, MD, PhD ^x, J. Colin Forfar, MD, PhD ^l, Stefan Neubauer, MD ^y, Hugh Watkins, MD, PhD ^z, Catherine Boileau, PharmD, PhD ^aa, Guillaume Jondeau, MD, PhD ^ab, Harry C. Dietz, MD ^ac, Colin Baigent, BM, BCh ^b
^a Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK
^b Clinical Trial Service Unit & Epidemiological Studies Unit, University of Oxford, Oxford, UK
^c Children's Hospital Boston and Harvard Medical School, Boston, MA
^d New England Research Institutes, Watertown, MA
^e National Heart, Lung, and Blood Institute, NIH, Bethesda, MD
^f University of Texas Southwestern Medical Center, Dallas, TX
^g Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
^h Center for Medical Genetics and Department of Cardiology, University Hospital Ghent, Ghent, Belgium
ⁱ Center for Medical Genetics, University Hospital Ghent, Ghent, Belgium
^j Centre for Inherited Cardiovascular Diseases, IRCCS Foundation, San Matteo Hospital, Pavia, Italy
^k Clinical Trials and Evaluation Unit, Royal Brompton & Harefield NHS Trust, London, UK
^l John Radcliffe Hospital, Oxford, UK
^m Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK
ⁿ UCL Institute of Cardiovascular Science, The Heart Hospital, London, UK
^o Department of Cardiac and Vascular Sciences, St George's Hospital, University of London, London, UK
^p Hospital Universitario 12 de Octubre, Madrid, Spain
^q Marfan Sydrome Unit, Department of Cardiology, Hospital Vall d'Hebron, Barcelona, Spain
^r Department of Pediatrics and Adult Congenital Heart Center, Taipei Medical University Hospital, Taipei, Taiwan
^s Department of Pediatrics and Adult Congenital Heart Center, National Taiwan University Hospital, Taipei, Taiwan
^t Children's Heart Centre, British Columbia's Children's Hospital, Vancouver, British Columbia, Canada
^u Massachusetts General Hospital, Boston, MA
^v Brigham and Women's Hospital and Harvard Medical School, Boston, MA
^w Weill Cornell Medical College and New York-Presbyterian Hospital, New York, NY
^x Center for Medical Genetics, Faculty of Medicine and Health Sciences, University of Antwerp and Antwerp University Hospital, Antwerp, Belgium
^y Oxford Centre for Clinical Magnetic Resonance Research, Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK
^z Radcliffe Department of Medicine, University of Oxford, Oxford, UK
^aa Inserm LVTS U1148, Departement de Génétique, Hôpital Xavier Bichat-Claude Bernard, Paris, France
^ab Centre National de Référence pour le syndrome de Marfan et apparentés, INSERM LVTS U1148, Service de Cardiologie, AP-HP Hôpital Bichat, Paris, France
^ac McKusick-Nathans Institute of Genetic Medicine, Johns Hopkins University School of Medicine, and the Howard Hughes Medical Institute, Baltimore, MD

^⁎Reprint requests: Alex Pitcher, BMBCh, Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, John Radcliffe Hospital, Headington, Oxford, OX3 9DU, UK.

Résumé

Rationale

A number of randomized trials are underway, which will address the effects of angiotensin receptor blockers (ARBs) on aortic root enlargement and a range of other end points in patients with Marfan syndrome. If individual participant data from these trials were to be combined, a meta-analysis of the resulting data, totaling approximately 2,300 patients, would allow estimation across a number of trials of the treatment effects both of ARB therapy and of β-blockade.

Such an analysis would also allow estimation of treatment effects in particular subgroups of patients on a range of end points of interest and would allow a more powerful estimate of the effects of these treatments on a composite end point of several clinical outcomes than would be available from any individual trial.

Design

A prospective, collaborative meta-analysis based on individual patient data from all randomized trials in Marfan syndrome of (i) ARBs versus placebo (or open-label control) and (ii) ARBs versus β-blockers will be performed.

A prospective study design, in which the principal hypotheses, trial eligibility criteria, analyses, and methods are specified in advance of the unblinding of the component trials, will help to limit bias owing to data-dependent emphasis on the results of particular trials. The use of individual patient data will allow for analysis of the effects of ARBs in particular patient subgroups and for time-to-event analysis for clinical outcomes.

The meta-analysis protocol summarized in this report was written on behalf of the Marfan Treatment Trialists' Collaboration and finalized in late 2012, without foreknowledge of the results of any component trial, and will be made available online (meta-trials).

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Plan

Background

Rationale for a meta-analysis of ARB trials in Marfan syndrome

Study eligibility and identification

Collaborative group structure, organization, and management

Protocol preparation and publication policy

Disclosures

Declaration

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Vol 169 - N° 5

P. 605-612 - mai 2015 Retour au numéro

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Design and rationale of a prospective, collaborative meta-analysis of all randomized controlled trials of angiotensin receptor antagonists in Marfan syndrome, based on individual patient data: A report from the Marfan Treatment Trialists' Collaboration - 09/05/15

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