Acknowledgements
The authors thank the following Boston Scientific employees for their contribution: Peggy Pereda for assistance with statistical design; Alan Yu for contribution to the Bayesian study design; Kristin L. Hood for medical writing and editorial support; Tim Mickley, Doug Thesingh, and Dennis Boismier for stent bench testing and manuscript review; and Barbara Huibregste and the Boston Scientific Preclinical department for preclinical data. In addition, the authors thank Professor Ming-Hui Chen (University of Connecticut) for contribution to Bayesian study design. The authors also thank the PERSEUS study clinical staff, committees, and investigational sites for their support of the PERSEUS program (see below). The PERSEUS studies are sponsored and funded by Boston Scientific Corporation, Natick, MA, USA and were designed in a collaborative effort between the principal and co-principal investigators and the sponsor. Conception, drafting, and decision to submit the manuscript for publication were undertaken in a collaborative effort between the authors and contributors.
PERSEUS study organization
Data Monitoring Committee (DMC): W. Douglas Weaver, MD (DMC Chairperson, Henry Ford Heart and Vascular Institute, Detroit, MI); David P. Faxon, MD (Brigham and Women's Hospital, Boston, MA); Kirk N. Garratt, MD (Lenox Hill Hospital, New York, NY), until August 2008; Steven R. Bailey, MD (University of Texas, San Antonio, TX) December 2008 - Present; David J. Moliterno, MD (University of Kentucky Medical Center, Lexington KY); Jan G. P. Tijssen, PhD (DMC Statistician, University of Amsterdam, Amsterdam, The Netherlands; Adam Greenbaum, MD (DMC Medical Liaison, Henry Ford Hospital, Detroit, MI)
Clinical Events Committee (CEC): Donald Cutlip, MD (CEC Chairperson, Harvard Cardiovascular Research Institute Boston, MA); Julian Aroesty, MD (Beth Israel Deaconess, Boston, MA); Manish Chauhan, MD (Texas Cardiovascular Consultants, Austin, TX); Germano DiSciascio, MD (University of Rome, Rome, Italy); Kalon K. L. Ho, MD, MSc (Beth Israel Deaconess, Boston, MA); Joseph P. Kannam, MD (Beth Israel Deaconess, Boston, MA), Michel Vandormael, MD (Tampa Bay Heart Institute, Tampa, FL)
Angiographic Core Laboratory: Jeffrey Popma, MD, Beth Israel Deaconess Medical Center, Boston, MA.
Clinical Project Management: Boston Scientific (Amy Britt, Program Manager; Andrey Nersesov, Project Manager; Eileen Rose, Director)
Data Management: Boston Scientific (Aruna Jayashankar, Clinical Data Manager; Vanessa de Medeiros, Sr. Clinical Data Manager; Sally Huebner, Senior Clinical Data Manager; Cathy Muza, Director)
Biostatistical Analysis: Boston Scientific (Scott Wehrenberg, Senior Biostatistician; Alan Yu, Principal Biostatistician; Peggy Pereda, Senior Manager; Biostatistics, Peter Lam, Director)
Safety Monitoring: Boston Scientific (Erik Sperry, Safety Trial Manager; Stephanie Copithorne, Safety Trial Manager; Laura Giannini, Director)
Study Sites and Principal Investigators
Site Enrolling Patients in both PERSEUS SV and PERSEUS WH: United States: Medical Center East, Birmingham, AL (Foster, Robert E.); Bakersfield Memorial Hospital, Bakersfield, CA (Lee, Tommy C.); Scripps Clinic, La Jolla, CA (Teirstein, Paul); Christiana Hospital, Newark, DE (Hopkins, James); Mediquest Research at Munroe Medical Center, Ocala, FL (Feldman, Robert L.); Sarasota Memorial Hospital, Sarasota, FL (Yaryura, Ricardo); St John's Hospital, Springfield, IL (Mishkel, Gregory); Northern Indiana Research Alliance/Lutheran Hosp, Fort Wayne, IN (Orlow, Steven); Maine Medical Center, Portland, ME (Kellett, Mirle); Northern Michigan Hospital, Petoskey, MI (Cannon, Louis); Abbott Northwestern Hospital, Minneapolis, MN (Mooney, Michael); Carolinas Medical Center, Charlotte, NC (Wilson, B. Hadley); LeBauer Cardiovascular Research Foundation, Greensboro, NC (Stuckey, Thomas); Wake Medical Center, Raleigh, NC (Mann, J. Tift); Wake Forest University School of Medicine, Winston-Salem, NC (Kutcher, Michael); Nebraska Heart Hospital, Lincoln, NE (Martin, Steven); St. Joseph's Hospital Health Center, Liverpool, NY (Caputo, Ronald); Columbia University Medical Center, New York, NY (Moses, Jeffrey); Lenox Hill Hospital, New York, NY (Cohen, Howard); The Christ Hospital, Cincinnati, OH (Kereiakes, Dean); Riverside Methodist Hospital, Columbus, OH (Yakubov, Steven); Oklahoma Cardiovascular Research Group, Oklahoma City, OK (McGarry, Thomas); Main Line Health Heart Center, Bryn Mawr, PA (Pratsos, Antonis); Methodist DeBakey Heart Center, Houston, TX (Raizner, Albert); TexSan Heart Hospital, San Antonio, TX (Rabinowitz, Abram C.); Swedish Medical Center, Seattle, WA (Desai, Amish); Providence Medical Research Center, Spokane, WA (Ring, Michael); St. Mary's Medical Center, Huntington, WV (Studeny, Mark).
Additional Sites Enrolling Patients in PERSEUS WH: Australia: Royal Adelaide Hospital, Adelaide, SA (Worthley, Matthew); Monash Medical Centre, Clayton, Victoria (Meredith, Ian); St. Vincent's Public Hospital, Fitzroy, Victoria (Whitbourn, Robert). New Zealand: Auckland City Hospital, Auckland, (Ormiston, John); Christchurch Hospital, Christchurch (McClean, Dougal); Waikato Hospital, Hamilton (Devlin, Gerry); Wellington Hospital, Wellington (Matsis, Phillip). Singapore: National Heart Centre, Singapore (Lim, Soo-Teik). United States: Baptist Medical Center Princeton, Birmingham, AL (Bouchard, Alain); Scripps Memorial Hospital, La Jolla, CA (Fortuna, Richard); Alvarado Hospital, La Jolla, CA (Buchbinder, Maurice); Mercy General Hospital, Sacramento, CA (Kozina, Joseph); University of California, Davis, Medical Center, Sacramento, CA (Low, Reginald); South Denver Cardiology Associates, PC, Englewood, CO (Dauber, Ira); Florida Hospital, Orlando, FL (Taussig, Andrew); Tallahassee Memorial Hospital, Tallahassee, FL (Batchelor, Wayne); Piedmont Hospital, Atlanta, GA (Brown, Charles); St. Joseph's Research Institute, Atlanta, GA (Heller, Louis); Medical Center of Central Georgia, Macon, GA (Dorogy, Mark); Kaiser Foundation Hospitals, Honolulu, HI (Ho, Paul); Midwest Cardiovascular Research Foundation, Davenport, IA (Dippel, Eric); Iowa Heart Center, Des Moines, IA (Ghali, Magdi G.H.); Evanston Hospital, Evanston, IL (Feldman, Ted); St. Anthony's Medical Center, Rockford, IL (Skowronski, Jan); St. Vincent's Hospital, The Care Group, LLC, Indianapolis, IN (Ball, Michael); Krannert Institute of Cardiology, Indianapolis, IN (Breall, Jeffrey); Beth Israel Deaconess Medical Center, Boston, MA (Pinto, Duane); Tufts Medical Center, Boston, MA (Kimmelstiel, Carey); Cape Cod Research Institute, Hyannis, MA (Zelman, Richard); Union Memorial Hospital, Baltimore, MD (Wang, John Chung-Yee); Washington Adventist Hospital The Center for Cardiac and Vascular Research, Takoma Park, MD (Turco, Mark); Genesys Regional Medical Center, Grand Blanc, MI (Dobies, David); Lakeland Hospitals at St. Joseph, St. Joseph, MI (Pow, Thomas); St. Mary's Duluth Clinic Regional Heart Center, Duluth, MN (Diebele, Albert); Mercy Hospital Metropolitan Cardiology Consultants, Minneapolis, MN (Stark, Randall); St. Anthony's Medical Center, St. Louis, MO (Morton, David); Cardiology Associates of North Mississippi, Tupelo, MS (Bertolet, Barry); Forsyth Medical Center, Winston-Salem, NC (Patterson, John); Dartmouth Hitchcock Medical Center, Lebanon, NH (Kaplan, Aaron); New Mexico Heart Institute, Albuquerque, NM (Federici, Robert); Ohio State University Medical Center, Columbus, OH (Magorien, Raymond); St. Vincent Mercy Medical Center, Toledo, OH (Kabour, Ameer); Providence St. Vincent Medical Center, Portland, OR (Caulfield, Todd); Lehigh Valley Hospital, Allentown, PA (Cox, David); Lancaster General Hospital, Lancaster, PA (Casale, Paul); St. Mary Medical Center, Langhorne, PA (Heyrich, George); University of Pennsylvania Medical Center, Philadelphia, PA (Herrmann, Howard); Sisters of Charity Providence Hospital, Columbia, SC (Foster, Michael); St. Francis Physician Services Upstate Cardiology, Greenville, SC (Smith, Christopher); Wellmont Holston Valley Medical Center, Kingsport, TN (Ladley, Herbert); Vanderbilt University Medical Center, Nashville, TN (McPherson, John); Baylor Heart and Vascular Hospital, Dallas, TX (Stoler, Robert); Tyler Cardiovascular Consultants, Tyler, TX (Carney, Robert); Inova Fairfax Hospital, Falls Church, VA (Raybuck, Bryan); Lynchburg General Hospital, Lynchburg, VA (Nygaard, Thomas); Sentara Norfolk General Hospital Sentara Cardiovascular Research Institute, Norfolk, VA (Mahoney, Paul); Fletcher Allen Health Care, Burlington, VT (Dauerman, Harold); Deaconess Medical Center, Spokane, WA (Huber, Philip); Washington Hospital Center, Washington DC (Waksman, Ron); University of Wisconsin, Madison, WI (Gimelli, Giorgio); Aurora St. Luke's Medical Center, Milwaukee, WI (Bajwa, Tanvir); CaRE Foundation, Inc., Wausau, WI (Grady, Timothy).