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, Koglin,
Acquisition of data: Ellis, Cannon, Mann, Green
berg, Spriggs, O’Shaughnessy, DeMaio, Hall, Popma, K oglin, Russell.
Analysis and interpretation of data: Stone,
Ellis, Hall, Koglin, Russell.
Drafting of the manuscript: Stone.
Critical revision of the manuscript for important
intellectual content: Stone, Ellis, Cannon, Mann, Green berg, Spriggs,
O’Shaughnessy, DeMaio, Hall, Popma, Koglin, Russell.
Statistical analysis: Koglin.
Obtained funding: Koglin, Russell.
Administrative, technical, or material support:
O’Shaughnessy, Hall, Popma, Russell.
Study supervision: Stone, Ellis, Cannon, Greenberg,
Financial Disclosures: Dr Stone is a consultant
to and has received research support from Boston Scientific Corp. Drs Ellis
and DeMaio are consultants to Boston Scientific Corp. Dr Greenberg owns 2500
shares of stock in Boston Scientific Corp. Dr Popma has received research
grants to perform angiographic analysis from Boston Scientific Corp.
Independent Statistical Analysis: Martin Fahy,
MSc, and Yingbo Na, MSc, both from the Cardiovascular Research Foundation,
an affiliate of Columbia University, received the entire trial database and
completed an independent statistical review of every data point. There was
more than 99% concordance with initial analysis. For the minor differences
that were found, the results are reported based on the independent analysis.
TAXUS V 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,
Data Management: Medidata Solutions Inc, New
York, NY, I. Shafer (system manager), K. Sachse (data manager); Boston Scientific
Corp, Natick, Mass.
Biostatistical Analysis: PAREXEL International,
Waltham, Mass, R. Sleith (manager); Boston Scientific Corp, Natick, Mass,
M. Cody (director).
Clinical Events Adjudication Committee: Harvard
Cardiovascular Research Institute, Boston, Mass: D. Cutlip (chair), J. Aroesty,
M. Chauhan, G. DiSciascio, K. Ho, J. Kannam, M. Vandormael.
Data and Safety Monitoring Committee: M. Ohman
(chair), University of North Carolina, Chapel Hill; D. Simon, Brigham and
Women’s Hospital, Boston, Mass; M. Lauer, Cleveland Clinic, Cleveland,
Ohio; J. Zidar, Duke Cardiology of Raleigh, Raleigh, NC; J. Miller, Johns
Hopkins Hospital, Baltimore, Md; V. Hasselblad, Duke Clinical Research Institute,
Angiographic Core Laboratory: Brigham and Women’s
Hospital, Boston, Mass, J. Popma (director).
Intravascular Ultrasound Imaging Core Laboratory: Washington Hospital Center, Washington, DC, N. Weissman (director).
Study Sites and Principal Investigators
Alabama: Baptist Medical Center Montclair (J.
Eagen); Baptist Medical Center (V. Goli); University of Alabama Cardiology
(V. Misra). Arizona: Arizona Heart Institute (R.
Strumpf). California: Mercy General Hospital (M.
Chang); Stanford Medical Center (A. Yeung); University of California–Davis
Medical Center (R. Low). Colorado: Aurora-Denver
Cardiology Associates (B. Molk). District of Columbia:
Washington Hospital Center (L. Satler). Florida:
Morton Plant Hospital (D. Spriggs, P. Cambier); Miami Heart Institute (K.
Coy); Florida Hospital (J. Greenberg); JFK Medical Center (J. Midwall); Mediquest
Research Group (R. Feldman). Georgia: St Joseph’s
Hospital of Atlanta (W. Knapp); Emory University Hospital (J. Douglas); Fuqua
Heart Center (W. Jacobs). Illinois: Evanston Hospital
(T. Feldman); Midwest Heart Foundation (P. Kerwin). Louisiana: Oschner Foundation Hospital (J. Reilly). Kansas: Shawnee Mission Medical Center (P. Kramer). Kentucky: Central Baptist Hospital (M. Jones). Maine:
Maine Medical Center (M. Kellett). Maryland: Washington
Adventist Hospital (M. Turco). Massachusetts: Massachusetts
General Hospital (I. Palacios); Tufts New England Medical Center (C. Kimmelstiel);
Lahey Clinical Hospital (R. Nesto); University of Massachusetts Memorial Medical
Center (M. Furman). Michigan: Cardiac and Vascular
Research Center of Northern Michigan (L. Cannon); William Beaumont Hospital
(W. O’Neill); Spectrum Health Hospital (R. McNamara). Minnesota: Abbott Northwestern Hospital (M. Mooney); Mayo Clinic (G.
Barsness). Missouri: Barnes Jewish Hospital (M. Taniuchi);
St Luke’s Hospital (B. Rutherford). North Carolina: Forsyth Memorial Hospital (J. Patterson); LeBauer Cardiovascular
Research Foundation (T. Stuckey); Mid Carolina Cardiology (D. Cox); Wake Forest
University Health Sciences (M. Kutcher); WakeMed (J. Mann). New York: Albany Medical Center (A. DeLago); Buffalo General Hospital
(A. Masud); Lenox Hill Hospital (S. Iyer); Mount Sinai Medical Center (S.
Sharma); New York Presbyterian Hospital (S. Wong); Rochester General Hospital
(J. Doling); St Francis Hospital (R. Schlofmitz, R. Timmermans). New Jersey: Hackensack University Medical Center (V. Sethi); St Michael’s
Medical Center (J. DeGregorio). Ohio: Cleveland Clinic
Foundation (R. Russell); Linder Clinical Trial Center (D. Kereiakes); Midwest
Cardiology Research Foundation (S. Yakubov); North Ohio Research (C. O’Shaughnessy). Oklahoma: Oklahoma Heart Hospital (T. McGarry). Pennsylvania: St Mary’s Medical Center (G. Heyrich). Rhode Island: Miriam Hospital (P. Gordon). South
Carolina: South Carolina Heart (M. Foster). Tennessee: St Thomas Hospital (R. Wheatley). Texas:
Cardiovascular Research Institute of Dallas (T. Das); South Austin Hospital
(S. DeMaio); University of Texas Houston Health Science Center (R. Smalling). Washington: Swedish Medical Center (M. Reisman). Wisconsin: St Luke’s Medical Center (T. Vellinga). Utah: Utah Valley Regional Medical Center (R. Badger). Virginia: Sentara Norfolk General Hospital (R. Stine);
University of Virginia Cardiology (E. Powers).
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 manuscript
Disclaimer: Michael Lauer, MD, was not involved
in the editorial evaluation or decision making regarding publication of this
article or in the editing of the accepted manuscript.