Circulation. 2007;115:2344-2351
doi: 10.1161/CIRCULATIONAHA.106.685313
doi: 10.1161/CIRCULATIONAHA.106.685313
(Circulation. 2007;115:2344-2351.)
© 2007 American Heart Association, Inc.
Special Reports |
Clinical End Points in Coronary Stent Trials
A Case for Standardized Definitions
From Harvard Clinical Research Institute (D.E.C., D.J.C., L.M.), Harvard Medical School, Boston, Mass; University Hospital (S.W.), Bern, Switzerland; Cardiovascular Research Foundation (R.M., A.L.), Columbia University, New York, NY; The US Food and Drug Administration (A.B.), Rockville, Md; Cardialysis (G.v.-E., M.M.), Rotterdam, the Netherlands; CHU Bichat (P.G.S.), Paris, France; Hospital Virga Jesse (P.V.), Hasselt, Belgium; University Hospital (E.M.), Cork, Ireland; CHU Caen (M.H.), Normandy, France; Duke Clinical Research Institute (M.W.K.), Duke University, Durham, NC; Erasmus Medical Center (P.W.S.), Thoraxcenter, Rotterdam, the Netherlands.
Correspondence to Donald E. Cutlip, MD, Harvard Clinical Research Institute, 930 Commonwealth Avenue, Boston, MA 02215. E-mail dcutlip{at}bidmc.harvard.edu
Background— Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation.
Methods and Results— The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in Washington, DC, in January 2006 and in Dublin, Ireland, in June 2006, sponsored by the Academic Research Consortium and including representatives of the US Food and Drug Administration and all device manufacturers who were working with the Food and Drug Administration on drug-eluting stent clinical trial programs, were focused on consensus end point definitions for drug-eluting stent evaluations. The effort was pursued with the objective to establish consistency among end point definitions and provide consensus recommendations. On the basis of considerations from historical legacy to key pathophysiological mechanisms and relevance to clinical interpretability, criteria for assessment of death, myocardial infarction, repeat revascularization, and stent thrombosis were developed. The broadly based consensus end point definitions in this document may be usefully applied or recognized for regulatory and clinical trial purposes.
Conclusion— Although consensus criteria will inevitably include certain arbitrary features, consensus criteria for clinical end points provide consistency across studies that can facilitate the evaluation of safety and effectiveness of these devices.
Key Words: restenosis • stents • thrombosis • clinical trials
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