Published Online: August 30, 2010. doi:10.1001 /jama.2010.1322
Author Contributions: Dr Bhatt 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: Bhatt, Ohman, Hirsch, Wilson, Liau, Röther, Steg.
Acquisition of data: Bhatt, Goto, Wilson, Liau, Röther, Steg.
Analysis and interpretation of data: Bhatt, Eagle, Hirsch, Mahoney, Alberts, D’Agostino, Liau, Mas, Röther, Smith Jr, Salette, Contant, Massaro, Steg.
Drafting of the manuscript: Bhatt.
Critical revision of the manuscript for important intellectual content: Bhatt, Eagle, Ohman, Hirsch, Goto, Mahoney, Wilson, Alberts, D’Agostino, Liau, Mas, Röther, Smith Jr, Salette, Contant, Massaro, Steg.
Statistical analysis: D’Agostino, Salette, Contant, Massaro.
Obtained funding: Goto, Röther, Steg.
Administrative, technical, or material support: Bhatt, Ohman, Wilson.
Study supervision: Hirsch, Mas, Röther, Contant, Steg.
Financial Disclosures: Dr Bhatt reported having received institutional research support from AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Heartscape, Sanofi-Aventis, and The Medicines Company. Dr Eagle reported having received grant/research support from Bristol-Myers Squibb, Blue Cross Blue Shield of Michigan, the National Institutes of Health (NIH), Sanofi-Aventis, the Mardigian Foundation Varbedian Fund, GORE, and the Hewlett Foundation and being a consultant for the NIH National Heart, Lung, and Blood Institute, Sanofi-Aventis, and the Robert Wood Johnson Foundation. Dr Ohman reported receiving research grants from Bristol-Myers Squibb, CV Therapeutics, Daiichi Sankyo, Datascope, Eli Lilly, Marquet, Sanofi-Aventis, Schering-Plough, and The Medicines Company and providing consulting or other services for Abiomed, AstraZeneca, CV Therapeutics, Datascope, Gilead Sciences, Liposcience, Marquet, Northpoint Domain, Pozen, Response Biomedical, Sanofi-Aventis, The Medicines Company, and WebMD (theheart.org). Dr Hirsch reported having received research grants from Bristol-Myers Squibb, Sanofi-Aventis, and Abbott Vascular and served as a consultant to Roche, Cytokinetics, ev3, and Talecris. Dr Goto reported having received research grants from Pfizer, Sanofi-Aventis, Ono, Eisai, Otsuka, Sankyo, Daiichi, Takeda, Asteras, Kowa, and AstraZeneca and honoraria from Sanofi-Aventis, Eisai, Otsuka, Daiichi-Sankyo, and Schering-Plough. Dr Mahoney reported having received grant support from Sanofi-Aventis, Bristol-Myers Squibb, Daiichi-Sankyo, and Eli Lilly and honoraria from Sanofi-Aventis and Bristol-Myers Squibb. Dr Wilson reported having received research grants from Sanofi-Aventis. Dr Alberts reported having received research support from AGA Medical, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, EKR, Sanofi-Aventis, and Schering-Plough; having participated in speakers' bureaus for Bristol-Myers Squibb, Boehringer Ingelheim, DiaDexus, Genentech, MedScape, and Sanofi-Aventis; having received honoraria from Bristol-Myers Squibb, Boehringer Ingelheim, DiaDexus, Genentech, MedScape, and Sanofi-Aventis; and having acted as a consultant or advisory board member for Bristol-Myers Squibb, Boehringer Ingelheim, EKR, Genentech, Merck, Pfizer, and Sanofi-Aventis. Dr D’Agostino reported having received honoraria from Sanofi-Aventis. Dr Liau reported no disclosures. Dr Mas reported having received research grants, honoraria, and consulting fees from Sanofi-Aventis, Bristol-Myers Squibb, and Servier and honoraria and consulting fees from Boehringer Ingelheim. Dr Röther reported having participated in speakers' bureaus for Boehringer-Ingelheim, Bristol-Myers Squibb, Sanofi-Aventis, and Lundbeck and having acted as a consultant or advisory board member for Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Sanofi-Aventis, and Lundbeck. Dr Smith Jr reported no disclosures. Dr Salette reported being an employee of Sanofi-Aventis. Dr Contant reported no disclosures. Dr Massaro reported having received honoraria from Sanofi-Aventis. Dr Steg reported having received research grants (to his institution) from Servier; participating in consultancy or advisory boards for Astellas, AstraZeneca, Bayer, Boehringer-Ingelheim, BMS, Daiichi-Sankyo-Lilly, GlaxoSmithKline, Medtronic, Otsuka, Pfizer, Roche, Sanofi-Aventis, Servier, and The Medicines Company; and being a stockholder in Aterovax.
Funding/Support: The REACH Registry is sponsored by Sanofi-Aventis, Bristol-Myers Squibb, and the Waksman Foundation (Tokyo, Japan). The REACH Registry is endorsed by the World Heart Federation.
Role of the Sponsors: The design and conduct of the study were done by the academic executive committee in collaboration with the sponsors; the collection and management of the data were done by the sponsors under the direction of the academic executive committee; analysis was done by the sponsors and independently verified by an academic statistician (Dr Massaro) and those are the analyses presented in the article; the interpretation of the data was done solely by the authors; and the preparation of the first draft of the manuscript was done by Dr Bhatt. All authors reviewed and commented on the manuscript, and all authors gave approval of the submitted manuscript. The sponsors had the opportunity to review but not to approve.
Independent Statistical Analysis: Dr Massaro was provided SAS data sets, the manuscript containing the statistical analytical plan and results, and a blank copy of the study annotated case report forms. Dr Massaro reviewed and regenerated the results of the statistical analysis on the end points in the tables and figures and independently verified the results and conclusions presented in the final manuscript. Those are the analyses and results presented in this article. Dr Massaro was not compensated for the independent statistical review.
REACH Registry Executive Committee: Deepak L. Bhatt, MD, MPH, VA Boston Healthcare System, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts (chair); Ph. Gabriel Steg, MD, Hôpital Bichat-Claude Bernard, Paris, France (chair); E. Magnus Ohman, MD, Duke University Medical Center, Durham, North Carolina; Joachim Röther, MD, Department of Neurology, Asklepios Klinik Altona, Hamburg, Germany; Peter W. F. Wilson, MD, Emory University School of Medicine, Atlanta, Georgia.
REACH Registry Global Publication Committee: Mark J. Alberts, MD, Northwestern University Medical School, Chicago, Illinois; Deepak L. Bhatt, MD, MPH, VA Boston Healthcare System, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts (chair); Ralph D’Agostino, PhD, Boston University, Boston; Kim A. Eagle, MD, University of Michigan, Ann Arbor; Shinya Goto, MD, PhD, Tokai University School of Medicine, Isehara, Japan; Alan T. Hirsch, MD, University of Minnesota School of Public Health, Minneapolis; Chiau-Suong Liau, MD, PhD, Taiwan University Hospital and College of Medicine, Taipei, Taiwan; Jean-Louis Mas, MD, Centre Raymond Garcin, Paris, France; E. Magnus Ohman, MD, Duke University Medical Center, Durham, North Carolina; Joachim Röther, MD, Department of Neurology, Asklepios Klinik Altona, Hamburg, Germany; Sidney C. Smith Jr, MD, University of North Carolina at Chapel Hill; Ph. Gabriel Steg, MD, Hôpital Bichat-Claude Bernard, Paris (chair); Peter W. F. Wilson, MD, Emory University School of Medicine, Atlanta, Georgia.
Additional Contributions: The REACH Registry enforces a no ghost-writing policy. The manuscript was written and edited by the authors, who take full responsibility for its content. The first draft was written by Dr Bhatt. Sophie Rushton-Smith, PhD, and Rachel Spice, PhD, assisted with coordinating revisions and provided editorial help in preparing this manuscript, including editing, checking content and language, formatting, referencing, and preparing tables and figures; they received compensation from Sanofi-Aventis. Lucie Parent, an employee of Sanofi-Aventis, provided support for statistical analyses. Milan Novakovic, MD, Sanofi-Aventis, and Nihar Bhakta, MD, Bristol-Myers Squibb, provided support for the REACH Registry. Fang Ren, MS, Brigham and Women's Hospital and the TIMI Study Group, helped with statistical analyses.
A complete list of the REACH Registry Investigators was published in JAMA. 2006;295(2):180-189.