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, Hermiller, Sood.
Acquisition of data: Midei, Newman, Sanz, Hermiller, Williams, Farhat, Mahaffey, Sood.
Analysis and interpretation of data: Stone, Williams, Cutlip, Fitzgerald, Su, Lansky.
Drafting of the manuscript: Stone, Sood.
Critical revision of the manuscript for important intellectual content: Midei, Newman, Sanz, Hermiller, Williams, Farhat, Mahaffey, Cutlip, Fitzgerald, Su, Lansky.
Statistical analysis: Su, Lansky.
Obtained funding: Hermiller.
Administrative, technical, or material support: Newman, Sanz, Hermiller, Williams, Cutlip, Sood.
Study supervision: Stone, Sanz, Farhat.
Financial Disclosures: Dr Stone reported receiving research support from Abbott Vascular and Boston Scientific Corp and honoraria from Medtronic. Dr Hermiller reported serving as a consultant for Abbott Vascular and Boston Scientific Corp. Dr Fitzgerald reported serving as a consultant for Abbott Vascular. Dr Mahaffey reported receiving research grants, consultancy fees, and speakers honoraria from Amgen, Bayer, Daiichi, Genentech, Johnson & Johnson, Lilly, Novartis, sanofi-aventis, sanofi-synthelabo, and Scios, and receiving research grants from Abbott Vascular, AstraZeneca, Bioheart, BMS, Boehringer Ingelheim, Boston Scientific, Cardiokinetix, Cierra, Conor, Cordis, Corgentech, Edwards, GE Medical Systems, Innocoll, KCI, Medtronic, Momenta, Portola, Sicel Technologies, and The Medicines Company. No other disclosures were reported.
Funding/Support: This study was sponsored and funded by Abbott Vascular, Santa Clara, California. Abbott supplied the everolimus-eluting stents; the paclitaxel-eluting stents were commercially purchased.
Role of the Sponsor: Abbott Vascular was involved in the design and conduct of the study; the 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 Martin Fahy, MSc, from the Cardiovascular Research Foundation (CRF), an affiliate of Columbia University College of Physicians and Surgeons. (The dean of Columbia University is responsible for this collaboration with the CRF and empowers an active oversight committee to monitor this relationship and the activities of the CRF.) Mr Fahy received the entire raw database and replicated all of the analyses that were reported in the manuscript, and no discrepancies were discovered. The results reported in this article are the results based on this independent analysis. Neither Mr Fahy nor the CRF received any funding for this independent analysis.
SPIRIT III Trial Organization and Participating Investigators:Steering Committee: G. W. Stone (Principal Investigator) and A. J. Lansky, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York; G. Johnson, K. Sudhir, G. Thompson, T. Engels, R. White, J. Coe, C. Lewis, and J. Doostzadeh, Abbott Vascular, Santa Clara, California. Past member: C. Rogers (involved with protocol development and early trial initiation), formerly Brigham and Women's Hospital, Boston, Massachusetts, currently with Cordis Corp, Miami Lakes, Florida. Data Monitoring: Abbott Vascular, Santa Clara, California; Paragon Biomedical, Irvine, California. Data Management and Biostatistical Analysis: Abbott Vascular, Santa Clara, California. Clinical Events Adjudication Committees:Duke Clinical Research Institute, Durham, North Carolina (primary protocol-specified events): K. Mahaffey (Director), J. Petersen (lead physician), M. Meyer (lead coordinator), R. Mehta, A. Goyal, T. Wang, D. Montgomery, A. Wright, P. Connolly, R. Doletski; Harvard Clinical Research Institute, Boston, Massachusetts (stent thrombosis adjudication per Academic Research Consortium definitions): D. Cutlip (Director), C. Berger, L Epstein, S. Waxman, J. Markis. Data and Safety Monitoring Board: Axio Research Company, Seattle, Washington; Brigham and Women's Hospital, Boston, Massachusetts: D. Faxon (Chair); Clinimetrics Clinical Research Associates, San Jose, California: L. Pennelly; University of Kentucky, Lexington: D. Moliterno; University of Florida, Jacksonville: M. Costa; Campbell Heart Institute, Nashville, Tennessee: R. Piana. Angiographic Core Laboratory:Cardiovascular Research Foundation, New York, New York: A. J. Lansky (Director), E. Cristea. Intravascular Ultrasound Imaging Core Laboratory:Stanford Center for Research in Cardiovascular Intervention, Palo Alto, California: P. Fitzgerald (Director). Study Sites, Principal Investigators, and Primary Study Coordinators:Baptist Medical Center Princeton, Birmingham, Alabama (A. Bouchard, W. Wade); Trinity Medical Center, Birmingham, Alabama (J. Eagan, B. Williams); Arizona Heart Hospital, Phoenix (R. Strumpf, L. Grow); Scripps Memorial Hospital, La Jolla, California (R. Fortuna, S. Weaver); Good Samaritan Hospital, Los Angeles, California (R. Matthews, S. Mullin); Alta Bates Summit Medical Center, Oakland, California (R. Feldman, J. Ingram); Mercy General Hospital, Sacramento, California (M. Chang, S. Bordash); Poudre Valley Hospital, Fort Collins, Colorado (A. Doing, D. Robeson); Washington Hospital Center, Washington, DC (L. Satler, S. Pokharel); North Ridge Medical Center, Ft Lauderdale, Florida (A. Niederman, T. Kellerman); Baptist Hospital of Miami, Miami, Florida (R. Quesada, C. Hodgson); Emory Crawford Long Hospital, Atlanta, Georgia (H.A. Liberman, T. Sanders); Piedmont Hospital, Atlanta, Georgia (C. Brown, N. Flockhart); Saint Joseph's Hospital of Atlanta, Atlanta, Georgia (M. Unterman, W. Knapp, P. Patel); Rush University Medical Center, Chicago, Illinios (G. Schaer, K. Abdul-Ahad); Elmhurst Memorial Hospital, Lombard, Illinois (M. Brottman, L. Elder); St John's Hospital, Springfield, Illinois (G. Mishkel, P. Warren); The Heart Center of Indiana LLC, Indianapolis (J. Hermiller, S. Gallagher); Jewish Hospital, Louisville, Kentucky (N. Xenopoulos, B. Henehan); Ochsner Clinic Foundation, New Orleans, Lousiana (S. Ramee, B. Hirstius); Brigham and Women's Hospital, Boston, Massachusetts (L. Mauri, D. Manuelian); Johns Hopkins Hospital, Baltimore, Maryland (J. Resar, K. Citro); Barnes-Jewish Hospital, St Louis, Missouri (J. Lasala, K. Striler); Washington Adventist Hospital, Takoma Park, Maryland (M. Turco, D. Shaddinger); St Joseph Medical Center, Towson, Maryland (M. Midei, E. Yaker); St John Hospital and Medical Center, Detroit, Michigan (T. Davis, M. O’Bryan); Spectrum Health Hospital, Grand Rapids, Michigan (D. Wohns, H. Singh, K. Postema); Borgess Medical Center, Kalamazoo, Michigan (T. Fischell, J. Stauffer); Northern Michigan Hospital, Petoskey (L. Cannon, J. LaLonde); Abbott Northwestern Hospital, Minneapolis, Minnesota (M. Mooney, C. Stone); St Luke's Hospital, Kansas City, Missouri (A. Grantham, C. Rutherford); North Mississippi Medical Center, Tupelo (B. Bertolet, K. Glenn); St Patrick Hospital, Missoula, Montana (M. Sanz, H. Boehm); Presbyterian Hospital, Charlotte, North Carolina (J. Williams, A. Maganares); Duke University Medical Center, Durham, North Carolina (J. Zidar, D. Glisson); Wake Medical Center, Raleigh, North Carolina (W. Newman, S. Darden); Wake Forest University Health Sciences, Winston-Salem, North Carolina (R. Applegate, T. Young); Nebraska Heart Hospital, Lincoln (D. Netz, R. Holcomb); Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire (A.V. Kaplan, L. Martel); Hackensack Medical Center, Hackensack, New Jersey (V. Sethi, M. Reid); The Valley Hospital, Ridgewood, New Jersey (C. Hirsch, K. Sayles); Presbyterian Hospital, Albuquerque, New Mexico (N. Shadoff, P. Nail); St Joseph's Hospital Health Center, Liverpool, New York (R. Caputo, C. Lastinger); Long Island Jewish Medical Center, New Hyde Park, New York (B. Kaplan, B. Gonzales); Columbia University Medical Center, New York, New York (M. Collins, V. Laroche); The Christ Hospital, Cincinnati, Ohio (D. Kereiakes, D. White); Riverside Methodist Hospital, Columbus, Ohio (S. Yakubov, T. Edwards); EMH Regional Medical Center, Elyria, Ohio (N. Farhat, A. Giunta); Integris Baptist Medical Center Inc, Oklahoma City, Oklahoma (S. Prabhu, B. Pentrina); University of Oklahoma Health Sciences Center, Oklahoma City (J. Saucedo, D. Beard); Sacred Heart Medical Center, Eugene, Oregon (J. Chambers, D. Butler); Providence St Vincent Medical Center, Portland, Oregon (T. Caulfield, E. Johnson); Allegheny General Hospital, Pittsburgh, Pennsylvania (T. Farah, C. Harter); Pinnacle Health at Harrisburg Hospital, Wormleysburg, Pennsylvania (W. Bachinsky, A. Todd); Rhode Island Hospital, Providence (D. Williams, J. Muratori); The Miriam Hospital, Providence, Rhode Island (P. Gordon, L. DeSimone); Medical University of South Carolina, Charleston (C. Nielsen, B. Owens); Heart Hospital of Austin, Austin, Texas (R. Gammon, M. Robison); Medical City Dallas Hospital, Dallas, Texas (D. Brown, T. Goldston); The Methodist Hospital, Houston, Texas (N. Kleiman, H. Campbell); TexSan Heart Hospital, San Antonio, Texas (W. Wu, G. Carreon); Fletcher Allen Health Care, Burlington, Vermont (H. Dauerman, F. Straight); Swedish Medical Center, Seattle, Washington (M. Reisman, J. Hudacheck); St Luke's Medical Center, Milwaukee, Wisconsin (P. Berstein, S. Oxborough).