Published Online: December 5, 2006 (doi:10.1001/jama.297.2.joc60179).
Author Contributions: Dr Eisenstein 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. Drs Eisenstein and Anstrom contributed equally to this work and share the lead authorship of this article.
Study concept and design: Eisenstein, Anstrom, Kong, Shaw, Califf.
Acquisition of data: Anstrom, Shaw, Califf.
Analysis and interpretation of data: Eisenstein, Anstrom, Kong, Shaw, Tuttle, Mark, Kramer, Harrington, Matchar, Kandzari, Peterson, Schulman, Califf.
Drafting of the manuscript: Eisenstein, Anstrom, Kong, Shaw, Mark, Peterson.
Critical revision of the manuscript for important intellectual content: Eisenstein, Anstrom, Kong, Shaw, Tuttle, Kramer, Harrington, Matchar, Kandzari, Peterson, Schulman, Califf.
Statistical analysis: Eisenstein, Anstrom, Shaw, Tuttle.
Obtained funding: Kong, Matchar, Schulman, Califf.
Administrative, technical, or material support: Eisenstein, Kong, Tuttle, Kramer, Harrington, Matchar, Peterson, Califf.
Study supervision: Eisenstein, Kong, Mark, Matchar, Kandzari.
Financial Disclosures: Dr Eisenstein reported receiving research grants from Medtronic Vascular. Dr Anstrom reported receiving research support from National Institutes of Health/National Heart, Lung, and Blood Institute (NHLBI), the Agency for Healthcare Research and Quality, Procter & Gamble, Pfizer, Medtronic, Alexion Pharmaceuticals, Medicure, Medtronic Vascular, Bristol-Myers Squibb, and Novartis Pharmaceuticals. Dr Mark reported receiving research grants from the National Institutes of Health/NHLBI, the Agency for Healthcare Research and Quality, Procter & Gamble, Pfizer, Medtronic, Alexion Pharmaceuticals, and Medicure; and being a consultant for Aventis, AstraZeneca, Medtronic, and Norvartis. Dr Harrington reported receiving research grants from Boston Scientific, Cordis Corporation, Medtronic, Conor Medsystems Inc, Bristol-Myers Squibb, and Sanofi-Aventis; and performing consulting work for Bristol-Myers Squibb and Sanofi-Aventis. Dr Kandzari accepted employment with Cordis Corporation, a Johnson & Johnson company, following the drafting and submission of this manuscript. Dr Peterson reported receiving research funding from Bristol-Myers Squibb and Sanofi-Aventis. Dr Schulman reported research support from Bristol-Myers Squibb and Johnson & Johnson; and has served as a consultant for Sanofi-Aventis US LLC and Boston Scientific Corporation. Dr Califf reported receiving grants or contracts from Abbott Vascular Devices, Advanced Cardiovascular Systems, Advanced Stent Technologies, Boston Scientific, Bristol-Myers Squibb, Conor Medsystems Inc, Cordis Corporation, Guidant Corporation, Medtronic, Sanofi-Aventis, and Terumo Medical Corporation. None of the other authors reported financial disclosures.
Funding/Support: This study was funded under contract 290-05-0032 from the Agency for Healthcare Research and Quality (AHRQ), US Department of Health and Human Services, as part of the Developing Evidence to Inform Decisions About Effectiveness (DECIDE) program.
Role of the Sponsors: The sponsors did not participate in the design or conduct of this study, in the collection, management, analysis, or interpretation of data, in the writing of the manuscript, or in the preparation, review, approval, or decision to submit this manuscript for publication.
Disclaimer: Statements in this article should not be construed as endorsement by the AHRQ or the US Department of Health and Human Services. Based on the AHRQ DECIDE report titled, “Treatment of In-Stent Restenosis” (AHRQ publication, under review). The authors of this study are responsible for its content.
Acknowledgment: We thank the faculty and staff of the cardiac catheterization laboratories at Duke Hospital for collecting the data. We thank Judith A. Stafford, MS, Duke Clinical Research Institute, for her programming in support of this project; Charles B. McCants, Jr, BS, Duke Clinical Research Institute, for updating the Duke Databank for Cardiovascular Disease follow-up files so that the results from these analyses would be current; and Maqui Ortiz, Duke Clinical Research Institute, for the editing and review of these materials and for her administrative support. All were compensated by the Duke Clinical Research Institute for their work. We also thank Elise Berliner, PhD, Agency for Healthcare Research and Quality, for her consistent work as an advocate for and supporter of this project, and her invaluable feedback during the course of the Treatment of In-Stent Restenosis project. Ms Berliner was compensated by the AHRQ.