Published Online: March 12, 2006 (doi:10.1001/jama.295.11.1253).
Author Contributions: Dr Stone 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: Stone, Ellis, Popma, Russell.
Acquisition of data: O’Shaughnessy, Martin, Satler, McGarry, Turco, Kereiakes, Kelley, Popma, Russell.
Analysis and interpretation of data: Stone, Ellis, Kereiakes, Kelley, Popma, Russell.
Drafting of the manuscript: Stone, Turco, Popma.
Critical revision of the manuscript for important intellectual content: Ellis, O’Shaughnessy, Martin, Satler, McGarry, Kereiakes, Kelley, Popma, Russell.
Statistical analysis: Ellis, Russell.
Obtained funding: Russell.
Administrative, technical, or material support: Ellis, O’Shaughnessy, McGarry, Kereiakes, Kelley, Popma, Russell.
Study supervision: Stone, Ellis, Satler, Kereiakes, Russell.
Financial Disclosures: Dr Stone is a consultant for Boston Scientific and Guidant. Dr Turco is a consultant and on the speaker's bureau for Boston Scientific. Dr Kelley is an employee of Boston Scientific. Dr Popma has received research grants from Boston Scientific. Dr Russell is a full-time employee and stockholder of Boston Scientific. No other authors reported financial disclosures.
Funding/Support: This study was sponsored and funded by Boston Scientific Corp, Natick, Mass.
Role of the Sponsor: The sponsor was involved in the design and conduct of the study, collection, management, initial analysis, and interpretation of the data, and had the right to a nonbinding review of the manuscript. Approval of the sponsor was not required prior to submission.
Independent Statistical Analysis: The accuracy of the data analysis was independently verified by Yingbo Na, MSc, and Martin Fahy, MSc, both from the Cardiovascular Research Foundation, an affiliate of Columbia University, who received the entire raw database and replicated all the analyses that were reported in the accepted manuscript. No discrepancies were discovered. Neither Dr Na or Fahy nor the Cardiovascular Research Foundation received any funding for this independent analysis.
TAXUS V ISR Study Organization
Executive Committee: G. Stone (principal investigator), Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY; S. Ellis (co-principal investigator), Cleveland Clinic Foundation, Cleveland, Ohio; M. Russell, Boston Scientific Corp, Natick, Mass.
Data Monitoring: Bailer Research, San Ramon, Calif.
Data Management: Medidata Solutions Inc, New York, NY, Stan Bouton (project manager); Boston Scientific Corp, Natick, Mass, Liza Wang (lead clinical data specialist).
Biostatistical Analysis: Boston Scientific Corp, Natick, Mass, Peggy Pereda (manager); PAREXEL International, Waltham, Mass, Rodney Sleith (manager).
Clinical Events Adjudication Committee: Donald Cutlip (chair), Harvard Cardiovascular Research Institute, Boston, Mass; Julian Aroesty, Beth Israel Deaconess, Boston, Mass; Manish Chauhan, Texas Cardiovascular Consultants, Austin; Germano Di Sciascio, University of Rome, Rome, Italy; Kalon K. L. Ho, Beth Israel Deaconess, Boston, Mass; Joseph P. Kannam, Beth Israel Deaconess, Boston, Mass; Michel Vandormael, Virginia Medical Center, Bay Pines, Fla.
Data and Safety Monitoring Committee: E. Magnus Ohman, Duke University Medical Center, Durham, NC; Daniel I. Simon, Brigham and Women's Hospital, Boston, Mass; Michael S. Lauer, Cleveland Clinic Foundation, Cleveland, Ohio; Julie M. Miller, Johns Hopkins Hospital, Baltimore, Md; James Zidar, Duke Cardiology, Raleigh, NC; Victor Hasselblad, Duke Clinical Research Institute, Durham, NC.
Angiographic Core Laboratory: Brigham and Women's Hospital, Boston, Mass, Jeffrey J. Popma (director).
Intravascular Ultrasound Imaging Core Laboratory: Cardiovascular Core Analysis Laboratory, Stanford University School of Medicine, Palo Alto, Calif, Peter Fitzgerald (director).
Study Sites and Principal Investigators
Alabama: Baptist Medical Center (V. Goli). California: Mercy General Hospital (M. Chang). Colorado: Colorado Heart Institute (B. Molk). District of Columbia: Washington Hospital Center (L. Satler and K. Kent). Florida: Florida Heart Institute (J. Greenberg). Georgia: Fuqua Heart Center (W. Jacobs and C. Brown). Louisiana: Ochsner Foundation Hospital (J. Reily). Maine: Maine Medical Center (M. Kellett). Maryland: Washington Adventist Hospital (M. Turco). Massachusetts: University of Massachusetts Memorial Medical Center (M. Furman); Tufts New England Medical Center (C. Kimmelstiel); Lahey Clinical Hospital (R. Nesto). Michigan: St Mary's Medical Center (L. Cannon); Spectrum Health Hospital (K. Wolschleger). Minnesota: Abbott Northwestern Hospital (M. Mooney and T. Henry). Missouri: Mid America Heart Institute (B. Rutherford and W. Johnson); Barnes Jewish Hospital (M. Taniuchi). Nebraska: Nebraska Heart Institute (S. Martin). New York: Lenox Hill (S. Iyer); Buffalo General Hospital (Z. Masud). North Carolina: Mid-Carolina Cardiology (D. Cox); Wake Forest University Heath Sciences (M. Kutcher); Forsyth Memorial Hospital (J. Patterson); LeBauer Cardiovascular Research Foundation (T. Stuckey). Ohio: Lindner Clinical Trial Center (D. Kereiakes); Elyria Memorial Hospital (C. O’Shaughnessy); Cleveland Clinic Foundation (R. Raymond and S. Ellis). Oklahoma: Oklahoma Heart Hospital (T. McGarry). Ontario: Sunnybrook and Women's College Health Sciences Center (E. Cohen); Toronto General Hospital (P. Seidelin). Pennsylvania: St Mary's Medical Center (G. Heyrich). Rhode Island: Miriam Hospital (P. Gordon). South Carolina: South Carolina Heart Center (M. Foster). Tennessee: St Thomas Hospital (R. Wheatley). Texas: South Austin Hospital (S. DeMaio); Institute for Research in Cardiovascular Interventions (A. Raizner). Virginia: University of Virginia Cardiology (E. Powers).
Disclaimer: Michael S. Lauer, MD, who is a JAMA Contributing Editor and who served on the Data and Safety Monitoring Committee for this study, was not involved in the editorial evaluation or decision making regarding publication of this article.