Published Online: March 25, 2012. doi:10.1001/jama.2012.421
Author Contributions: Dr Stone had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Studyconcept and design: Stone, Maehara, Parise, Ochala, Carlton, Wolff, El-Omar, Metzger, Karwoski, Gibson.
Acquisition of data: Witzenbichler, Godlewski, Dambrink, Cristea, Wolff, Brener, Chowdhary, El-Omar, Neunteufl, Metzger, Mehran, Gibson.
Analysis and interpretation of data: Stone, Maehara, Parise, Ochala, Cristea, Wolff, Brener, Neunteufl, Dizon, Mehran, Gibson.
Drafting of the manuscript: Stone, Ochala, El-Omar, Neunteufl, Gibson.
Critical revision of the manuscript for important intellectual content: Maehara, Witzenbichler, Godlewski, Parise, Dambrink, Carlton, Cristea, Wolff, Brener, Chowdhary, El-Omar, Neunteufl, Metzger, Karwoski, Dizon, Mehran, Gibson.
Statistical analysis: Parise, Ochala.
Obtained funding: Carlton, Karwoski.
Administrative, technical, or material support: Maehara, Witzenbichler, Godlewski, Dambrink, Carlton, Cristea, Brener, Chowdhary, Karwoski, Dizon, Gibson.
Study supervision: Stone, Ochala, Carlton, Wolff, Chowdhary, El-Omar, Neunteufl, Metzger, Karwoski, Mehran, Gibson.
Financial Disclosures: Dr Stone reports having served as a consultant for Medtronic, Osprey, Reva, Merck, Abbott Vascular, Boston Scientific, Evalve, AstraZeneca, Eli Lilly-Daiichi Sankyo partnership, Bristol-Meyers Squibb-Sanofi partnership, Otsuka, The Medicines Company, Ortho-McNeil, Atrium, Gilead, InspireMD, TherOx, Volcano, InfraReDx, Genentech, GlaxoSmithKline, Miracor, MPP Group, and Lutonix; having received honoraria from Edwards and Vascular Solutions; and holding stock or options from CoreValve, Savacor, Biostar I and II funds, MedFocus I, II, and Accelerator funds, Caliber, Flowcardia, Mediguide, Guided Delivery Systems, Ovalum, Arstasis, Micardia, Access Closure, Embrella and VNT. Dr Witzenbichler reports having served on advisory boards for Boston Scientific and Biotronik and receiving lecture honoraria from Boston Scientific, Biotronik, Medtronic, and The Medicines Company. Mr Carlton and Mr Karwoski report being employed by Atrium Medical. Dr Wolff reports receiving honoraria and royalties from GE Healthcare and is the founder of NeoSoft and NeoCoil. Dr Brener reports having served as a consultant for Medtronic and receiving lecture honoraria for Eli Lilly. Dr Neunteufl reports having served on advisory boards for AstraZeneca, Bayer, Biotronik, Boston Scientific, Eli Lilly-Daiichi Sankyo, and St Jude and having received lecture fees from Abbott Vascular, AstraZeneca, Atrium, Boston Scientific, Edwards Life Sciences, Eli Lilly-Daiichi Sankyo and BMS/sanofi-aventis. Dr Metzger reports serving as a consultant for Abbott Vascular, Medtronic, Lutonix, IDEV, Cook Medical, and Cordis Endovascular and has received lecture fees from IDEV, Pathway, and Alpha Medical. Dr Mehran reports serving as a consultant for Abbott Vascular, AstraZeneca, Ortho McNeil, and Regado Biosciences and receiving grants from BMS/sanofi-aventis and The Medicines Company. Dr Gibson reports having served as a consultant for Biogen IDEC, Bristol Meyer Squibb, Daiichi-Sankyo, CSL Behring, Cytori Therapeutics, Eli Lilly, GlaxoSmithKline, Genentech, Ischemix, Bayer, Johnson and Johnson, Ortho McNeil, Merck, Portola Pharmaceuticals, Regado Biosciences, sanofi-aventis, St Jude, The Medicines Company, Medicure, Archemix, and Boeringer Ingelheim; having received lecture fees from Daiichi Sankyo, Eli Lilly, and The Medicines Company; receiving royalties from UpToDate in CV Medicine; and having received payments for development of educational presentations from Daiichi Sankyo and Eli Lilly. The other authors report no disclosures.
Funding/Support: This study was sponsored and funded by Atrium Medical. Atrium supplied the local drug delivery catheter. Aspiration catheters were provided at a discount by Medtronic. Bivalirudin was provided at no charge by The Medicines Company. All other study devices and drugs were commercially purchased.
Role of the Sponsor: Atrium Medical was involved in the design and conduct of the study and site selection and had the right to a nonbinding review of the manuscript. The sponsor provided standard funding to the clinical sites for patient enrollment and fees to the Cardiovascular Research Foundation for core laboratory analyses, clinical events adjudication, and database management and biostatistical analysis. Atrium Medical had no role in the collection, management, analysis, and interpretation of the data or in the preparation or approval of the manuscript. Medtronic had the right to a nonbinding review of the manuscript but had no role in the design and conduct of the study; in the collection, management, analysis, and interpretation of the data; or in the preparation or approval of the manuscript. The Medicines Company had no role in the study other than supplying bivalirudin for the study participants and did not review the manuscript prior to its submission. No agreements exist regarding data confidentiality.
Independent Statistical Analysis: Helen Parise, from the Cardiovascular Research Foundation and Columbia University College of Physicians and Surgeons, was responsible for all data analyses. Ms Parise controlled database management, created all table shells, and performed all data analyses reported in the article.
INFUSE-AMI Trial (A 2 × 2 Factorial, Randomized, Multicenter, Single-Blind Evaluation of Intracoronary Abciximab Infusion and Aspiration Thrombectomy in Patients Undergoing Percutaneous Coronary Intervention for Anterior ST-Segment Elevation Myocardial Infarction) Organization and Participating Investigators:Executive Committee: Gregg W. Stone (Principal Investigator), Columbia University Medical Center, New York Presbyterian Hospital, and the Cardiovascular Research Foundation, New York, NY; C. Michael Gibson (Co-Principal Investigator), Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, MA; David A. Cox, Lehigh Valley Hospital, Allentown, PA; Rajesh Dave, Holy Spirit Cardiovascular Institute, Holy Spirit Hospital, Camp Hill, PA; Dariusz Dudek, Samodzielna Pracownia Hemodynamiki i Angiokardiografii, Kraków, Poland; Cindy L. Grines, William Beaumont Hospital, Royal Oak, MI; Alexandra J. Lansky, Yale University, New Haven, CT; Gabriel Steg, Hopital Bichat-Claude Bernad Service de Cardiologie, Paris, France; Thomas Stuckey, LeBauer Cardiovascular Research Foundation, Moses Cone Hospital, Greensboro, NC; Jochen Wöhrle, University of Ulm, Ulm, Germany. European Country Leaders: Thomas Neunteufl, Austria; Jochen Wöhrle, Germany; Jacques Koolen, the Netherlands; Dariusz Dudek, Poland; Anthony Gershlick, United Kingdom. Data Monitoring: Genae Associates (Antwerp, Belgium), Krakow Cardiovascular Research Institute (Krakow, Poland), Bailer Research (San Ramon, California). Clinical Events Committee: Cardiovascular Research Foundation; Shing Chiu Wong (Chair), Cornell-Weill Medical Center; Steven Marx, Columbia University Medical Center; Ozgen Dogan, Columbia University Medical Center; Kevin Dunsky, Mount Sinai Hospital, New York, NY. Data Management and Analysis: Cardiovascular Research Foundation; Roxana Mehran (Director), Helen Parise (Biostatistics). Data and Safety Monitoring Board: Bernard J. Gersh (Chair), Mayo Clinic, Rochester, MN; David Faxon, Brigham and Women's Hospital, Boston; Tim Collier, London School of Hygiene and Tropical Medicine, London, UK. Coronary Angiographic Core Laboratory Analysis: Cardiovascular Research Foundation, Ecaterina Cristea (Director), Sorin J. Brener. Cardiac MRI Core Laboratory Analysis: Cardiovascular Research Foundation, Steven D. Wolff (Director), Akiko Maehara (Co-Director). Electrocardiographic Core Laboratory Analysis: Cardiovascular Research Foundation, Jose Dizon (Director), Ecaterina Cristea.
Participating countries (with total enrollment), hospitals, and principal investigators: Austria (total enrollment = 47): Landeskrankenhaus Braunau/Simbach, Braunau, Johann Auer; Landeskrankenhaus Bruck/Mur, Bruck/Mur, Gerald Zenker; Landeskrankenhaus Graz West, Graz, Herwig Schuchlenz; Medizinische Universität Wien, Univ. Klinik für Innere Medizin II, Vienna, Thomas Neunteufl; Univ. Klinik für Innere Medizin III, Innsbruck, Guy Friedrich; Germany (total enrollment = 81): Charité Campus Benjamin Franklin Universitätsmedizin Berlin, Berlin, Bernhard Witzenbichler; Klinikum der Stadt Ludwigshafen am Rhein, Ludwigshafen, Uwe Zeymer; Klinikum der Universität Regensburg, Regensburg, Andreas Luchner; Klinikum Villingen Kardiologie Darmstadt, Darmstadt, Gerald Werner; Universitätsmedizin Mannheim, Mannheim, Tim Süselbeck; University of Ulm, Ulm, Germany, Jochen Wöhrle; Netherlands (total enrollment = 50): Catharina Hospital, Eindhoven, Jacques Koolen; Hospital Isala Klinieken, Zwolle, Jan-Henk Dambrink; Ziekenhuis Rijnstate, Arnhem, Wim Aengevaeren; Poland (total enrollment = 99): Centrum Kardiologii Inwazyjnej, Oświecim, Stanislaw Bartus; Instytut Kardiologii im. Prymasa Tysiaclecia, Warsaw, Adam Witkowski; Krakowskie Centrum Kardiologii Inwazyjnej, Kraków, Roman Wojdyla; Krakowski Szpital Specjalistyczny im. Jana Pawła II, Kraków, Jacek Godlewski; Oddział Kardiologii Inwazyjnej, Warsaw, Janusz Kochman; Polsko-Amerykańskie Kliniki Serca, Bielsko-Biala, Andrzej Ochala;Samodzielna Pracownia Hemodynamiki i Angiokardiografii, Kraków, Dariusz Dudek; United Kingdom (total enrollment = 122): Bristol Heart Institute, Bristol, Andreas Baumbach; Freeman Hospital, Newcastle, Afzar Zaman; Golden Jubilee Hospital, Glasgow, Keith Oldroyd; King's College Hospital, London, Jonathan Hill; Manchester Royal Infirmary, Heart Center, Manchester, Magdi El-Omar; Royal Victoria Hospital, Belfast, Mark Spence; Southampton University Hospital, Southampton, Nick Curzen; University Hospitals of Leicester, Glenfield Hospital, Leicester, Anthony Gershlick; Wythenshawe Hospital, Manchester, Saqib Chowdary; United States (total enrollment = 53): Carolina Medical Center, Charlotte, NC, Michael Rinaldi; Geisinger Medical Center, Danville, PA, Thomas Scott; Holy Spirit Cardiovascular Institute, Holy Spirit Hospital, Camp Hill, PA, Rajesh Dave; LeBauer Cardiovascular Research Foundation, Moses Cone Hospital, Greensboro, NC, Thomas Stuckey; Sentara Virginia Beach General Hospital, Virginia Beach, VA, John Griffin; Wellmont CVA Heart Institute, Kingsport, TN, Christopher Metzger; Washington Adventist Hospital, Takoma Park, MD, Mark Turco, David Brill.
See video of procedural coronary angiograms.