Author Contributions: Dr Morice had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Morice, Colombo.
Acquisition of data: Morice, Colombo, Tamburino, Guagliumi, Sousa.
Analysis and interpretation of data: Morice, Colombo, Meier, Serruys, Stoll.
Drafting of the manuscript: Morice, Colombo, Stoll.
Critical revision of the manuscript for important intellectual content: Morice, Colombo, Meier, Serruys, Tamburino, Guagliumi, Sousa, Stoll.
Study supervision: Morice, Stoll.
Financial Disclosures: Dr Meier has received research support from both Cordis and Boston Scientific.
Funding/Support: This study was sponsored by Cordis Corporation (a Johnson & Johnson Company) Clinical Research Europe, Waterloo, Belgium.
Role of the Sponsor: The sponsor designed and monitored the study and assisted in the preparation of the manuscript. Approval of the sponsor was not required prior to manuscript submission. Data management was performed independently from the sponsor by Cardialysis, an external clinical research organization.
Gerrit-Anne Van Es, PhD, director of Research and Development for Cardialysis, Rotterdam, the Netherlands, an independent clinical research and data management organization, and Eric van Remortel, an employee of Cardialysis, maintained the entire trial database, completed an independent statistical review of every data point, and provided reports to the sponsor. Cardialysis received compensation for data management and statistical analysis, but Dr Van Es did not receive personal compensation for his role in this trial.
Independent Statistical Review: Christophe E. Minder, PhD, professor of Medical Statistics at the University of Bern, Switzerland, and Peter Jüni, MD, senior lecturer in Clinical Epidemiology at the University of Bern, received a complete copy of the raw data from Cordis Corporation and performed an independent statistical analysis. They received no compensation for this work and had no conflicts of interest, not receiving any type of payment, equity, or reimbursement from either of the companies manufacturing the stents compared in the trial. They confirmed that they were able to replicate the analyses of the primary angiographic and secondary clinical outcomes reported in the manuscript and that they consider the analyses to be appropriate.
The REALITY Trial Investigators: steering committee: Antonio Colombo, MD, Bernhard Meier, MD, Patrick Serruys, MD, PhD; clinical events committee: Aad van den Bos, MD, Jeroen Vos, MD, Claude Hanet, MD, Eelko Ronner, MD. Peter de Jaegere, MD; data and safety monitoring board chairman: Jan G. P. Tijssen, PhD, Freek W. A. Verheugt, MD, PhD, William Wijns, MD, PhD; participating investigators and institutions: principal investigator: Marie-Claude Morice, MD, Institut Cardiovasculaire Paris Sud, Massy, France; coinvestigators: Belgium: Luc Janssens, MD, Imelda Hospital, Bonheiden; Frank Van Den Branden, MD, University Hospital Middelheim, Antwerp; Victor Legrand, MD, CHU Sart Tilman, Liège; Walter Desmet, MD, K. U. Leuven, Leuven; the Netherlands: Patrick W. Serruys, MD, Erasmus Medical Center Rotterdam, Rotterdam; Hans Bonnier, MD, Catharina Hospital, Eindhoven; Maarten Jan Suttorp, MD, Sint Antonius Hospital, Nieuwegein; Felix Zijlstra, MD, University Hospital Groningen, Groningen; France: Jean Fajadet, MD, Clinique Pasteur, Toulouse; Khalifé Khalife, MD, CHR Bon Secours, Metz; Emmanuel Teiger, MD, Hôpital Henri Mondor, Creteil; Henri Escojido, MD, Centre Hospitalier Prive Clairval, Marseille; Hélène Eltchaninoff, MD, and Alain Cribier, MD, CHRU Rouen Hôpital Charles-Nicolle, Rouen; Gabriel Steg, MD, CHU Bichat-Claude Bernard, Paris; Philippe Guyon, MD, Centre Cardiologique Du Nord, Saint Denis; Didier Carrié, MD, Hopital Rangueil, Toulouse; Paul Barragan, MD, Centre Hospitalier Privé Beauregard, Marseille; Jean-Pierre Bassand, MD, Centre Hospitalier Universitaire Jean Minjoz, Besançon; Philippe Commeau, MD, Centre Hospitalier Privé Beauregard, Marseille; Christian Spaulding, MD, Hôpital Cochin, Paris; Philippe Garot, MD, Centre Hospitalier Privé Claude Galien, Quincy Sous Senart; Olivier Varenne, MD, Hôpital Cochin, Paris; Germany: Wolfgang Rutsch, MD, Univ. Klin. Charité Der Humboldt University, Berlin; Joachim Schofer, MD, Kardiologische Gemeinschaftspraxis, Hamburg; Christoph Nienaber, MD, Universitatsklinikum Rostock, Rostock; Christof Bode, MD, Albert-Ludwigs Universität Freiburg, Freiburg; Hans Störger, MD, Rotes Kreuz Krankenhaus; Frankfurt; Gerhard Schuler, MD, Herzzentrum Leipzig, Leipzig; Eberhard Grube, MD, Krankenhaus Siegburg Gmbh, Siegburg; Johannes Brachmann, MD, Klinikum Coburg Gmbh, Coburg; Dieter Horstkotte, MD, Herz-und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen; Karl-Heinz Kuck, MD, Allgemeines Krankenhaus St. Georg II, Hamburg; Harald Mudra, MD, Städtisches Krankenhaus, Neuperlach, Munich; Andreas Mügge, MD, Ruhr Universität Bochum St. Josef Krankenhaus, Bochum; Andreas M. Zeiher, MD, Klin. Der J. W. Goethe Universität, Frankfurt; Italy: Antonio Colombo, MD, Fondazione S. Raffaele/Centro Cuore, Milan; Bernhard Reimers, MD, Ospedale Di Mirano, Mirano; Ezio Bramucci, MD, Policlinico San Matteo, Pavia; Imad Sheiban, MD, Azienda Ospedaliera San Giovanni Battista Di Torino University, Turin; Antonio Bartorelli, MD, Centro Cardiologico “Ford. Monzino,” Milan; Giulio Guagliumi, MD, Ospedale Riuniti Di Bergamo, Bergamo; Corrado Tamburino, MD, Azienda Ospedaliera Vittorio Emanuele, Catania; United Kingdom: Keith D. Dawkins, MD, Southampton University Hospital Wessex, Southampton; Carlo Di Mario, MD, Royal Brompton Hospital, London; Keith G. Oldroyd, MD, Western Infirmary, Glasgow; Mark A. De Belder, MD, James Cook University Hospital, Middlesborough; David Thomas, MD, King's College Hospital, London; Rodney Stables, MD, Cardiothoracic Centre–Liverpool; Richard David Levy, MD, South Manchester University Hospital, Manchester; Peter Crean, MD, St James's Hospital, Dublin; David P. Foley, MD, Beaumont Hospital, Dublin; Declan Sugrue, MD, Mater Misericordiae Hospital Public, Dublin; Farzin-Fath Ordoubadi, MD, Manchester Heart Centre, Manchester; Stephen Holmberg, MD, Royal Sussex County Hospital, Brighton; Austria: Dietmar Glogar, MD, Allgemeines Krankenhaus Der Stadt Wien, Vienna; Sweden: Göran Olivecrona, MD, Lunds University Sjukhus, Lund; Denmark: Leif Thuesen, MD, Skejby Sygehus, Aarhus; Henning Kelbaek, MD, Heart Center, Rigshospitalet, Copenhagen; Jan Ravkilde, MD, Aalborg University Hospital, Aalborg; Per Thayssen, MD, Odense University Hospital, Odense; Ulrik Abildgaard, MD, Gentofte University Hospital, Hellerup; Norway: Jan Erik Nordrehaug, MD, Haukeland Sykehus, Bergen; Poland: Robert Gil, MD, Woloska MSWA Warszawa, Warsaw; Janusz Rzezniczak, MD, Instytut Kardiologii, Poznan; Dariusz Dudek, MD, Jagiellonian University, Krakow; Portugal: Ricardo Seabra-Gomes, MD, Hospital De La Santa Cruz, Linda-A-Velha; Jorge Quininha, MD, Hospital Santa Marta, Lisbon; José Baptista, MD, Unidade De Intervencao Cardiovascular (UIC), Portimao-Alvor; Serbia and Montenegro: Miodrag Ostojic, MD, Serbian Clinical Centre University, Belgrade; Switzerland: Stephan Windecker, MD, University Hospital, Bern; Spain: Carlos Macaya, MD, Hospital Clínico San Carlos, Madrid; Amadeo Betriu, MD, Hospital Clínico y Provincial, Barcelona; Thierry Colman, MD, Hospital Marqués De Valdecilla, Santander; Argentina: Jorge A. Belardi, MD, Instituto Cardiovascular De Buenos Aires, Buenos Aires; Liliana Grinfeld, MD, Hospital Italiano De Buenos Aires, Buenos Aires; Oscar Mendiz, MD, Institute of Cardiology & Cardiovascular Surgery, Buenos Aires; Czech Republic: Michail Zelizko, MD, Institute for Clinical & Experimental Medicine, Prague; Ladislav Groch, MD, Fakultni Nemocnice U Svate Anny, Brno; Greece: Vassilis Voudris, MD, Onassis Cardiac Surgery Center, Athens/Kalithea; Colombia: Juan Jose Arango, MD, Fundacion Valle De Lili, Cali; Brazil: Marco Perin, MD, Instituto Albert Einstein, Sao Paulo; J. Eduardo Sousa, MD, Instituto Dante Pazzanese, Sao Paulo; Mexico: Jorge Gaspar, MD, Instituto Nacional De Cardiologia “Ignacio Chavez,” Mexico City; Singapore: Philip Wong, MD, Singapore General Hospital; Tan Huay Cheem, MD, National University Hospital, Singapore; Hong Kong: Steven Li, MD, Queen Elizabeth Hospital, Hong Kong; Shu Kin Li, MD, Pamela Youde Nethersole Hospital, Hong Kong; India: Ashwinb Mehta, MD, Jaslok Hospital, Mumbai; K. Samuel Mathews, MD, Leelavati Hospital, Mumbai.
Acknowledgment: We thank Ingrid Pansar, MS, for her major contributions in managing this project, Dennis Donohoe, MD, for his critical review of the manuscript, and Gerrit-Anne Van Es, PhD, for providing an independent statistical analysis of the data. Ms Pansar and Dr Donohoe are employees of the sponsor and did not receive any compensation for their roles in this trial in particular.