Circulation. 2007;115:2344-2351
doi: 10.1161/CIRCULATIONAHA.106.685313
doi: 10.1161/CIRCULATIONAHA.106.685313
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(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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B. Chevalier, C. Di Mario, F.-J. Neumann, F. Ribichini, P. Urban, J. J. Popma, P. J. Fitzgerald, D. E. Cutlip, D. O. Williams, J. Ormiston, et al. A Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Zotarolimus- Versus Paclitaxel-Eluting Stents in De Novo Occlusive Lesions in Coronary Arteries: The ZoMaxx I Trial J. Am. Coll. Cardiol. Intv., October 1, 2008; 1(5): 524 - 532. [Abstract] [Full Text] [PDF]
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N. Kukreja, Y. Onuma, H. Garcia-Garcia, J. Daemen, R. van Domburg, and P. W. Serruys Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction: Long-Term Outcome After Bare Metal and Drug-Eluting Stent Implantation Circ Cardiovasc Intervent, October 1, 2008; 1(2): 103 - 110. [Abstract] [Full Text] [PDF]
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P. Wenaweser, J. Daemen, M. Zwahlen, R. van Domburg, P. Juni, S. Vaina, G. Hellige, K. Tsuchida, C. Morger, E. Boersma, et al. Incidence and Correlates of Drug-Eluting Stent Thrombosis in Routine Clinical Practice: 4-Year Results From a Large 2-Institutional Cohort Study J. Am. Coll. Cardiol., September 30, 2008; 52(14): 1134 - 1140. [Abstract] [Full Text] [PDF]
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M. E. Pfisterer Late Stent Thrombosis After Drug-Eluting Stent Implantation for Acute Myocardial Infarction: A New Red Flag Is Raised Circulation, September 9, 2008; 118(11): 1117 - 1119. [Full Text] [PDF]
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H. Kelbaek, L. Thuesen, S. Helqvist, P. Clemmensen, L. Klovgaard, A. Kaltoft, B. Andersen, H. Thuesen, T. Engstrom, H. E. Botker, et al. Drug-Eluting Versus Bare Metal Stents in Patients With ST-Segment-Elevation Myocardial Infarction: Eight-Month Follow-Up in the Drug Elution and Distal Protection in Acute Myocardial Infarction (DEDICATION) Trial Circulation, September 9, 2008; 118(11): 1155 - 1162. [Abstract] [Full Text] [PDF]
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J. Mehilli, R. A. Byrne, A. Wieczorek, R. Iijima, S. Schulz, O. Bruskina, J. Pache, R. Wessely, A. Schomig, A. Kastrati, et al. Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis Eur. Heart J., August 2, 2008; 29(16): 1975 - 1982. [Abstract] [Full Text] [PDF]
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H. C. Routledge, M.-C. Morice, T. Lefevre, P. Garot, F. De Marco, B. Vaquerizo, and Y. Louvard 2-Year Outcome of Patients Treated for Bifurcation Coronary Disease With Provisional Side Branch T-Stenting Using Drug-Eluting Stents J. Am. Coll. Cardiol. Intv., August 1, 2008; 1(4): 358 - 365. [Abstract] [Full Text] [PDF]
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S. G. Ellis, C. D. O'Shaughnessy, S. L. Martin, K. Kent, T. McGarry, M. A. Turco, D. J. Kereiakes, J. J. Popma, M. Friedman, J. Koglin, et al. Two-year clinical outcomes after paclitaxel-eluting stent or brachytherapy treatment for bare metal stent restenosis: the TAXUS V ISR trial Eur. Heart J., July 1, 2008; 29(13): 1625 - 1634. [Abstract] [Full Text] [PDF]
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E. Mahmud, G. Bromberg-Marin, V. Palakodeti, L. Ang, D. Creanga, and A. N. DeMaria Clinical efficacy of drug-eluting stents in diabetic patients: a meta-analysis. J. Am. Coll. Cardiol., June 24, 2008; 51(25): 2385 - 2395. [Abstract] [Full Text] [PDF]
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T. Chechi, S. Vecchio, G. Vittori, G. Giuliani, A. Lilli, G. Spaziani, L. Consoli, G. Baldereschi, G. G.L. Biondi-Zoccai, I. Sheiban, et al. ST-segment elevation myocardial infarction due to early and late stent thrombosis a new group of high-risk patients. J. Am. Coll. Cardiol., June 24, 2008; 51(25): 2396 - 2402. [Abstract] [Full Text] [PDF]
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E. Meliga, H. M. Garcia-Garcia, M. Valgimigli, A. Chieffo, G. Biondi-Zoccai, A. O. Maree, S. Cook, L. Reardon, C. Moretti, S. De Servi, et al. Longest available clinical outcomes after drug-eluting stent implantation for unprotected left main coronary artery disease: the DELFT (Drug Eluting stent for LeFT main) Registry. J. Am. Coll. Cardiol., June 10, 2008; 51(23): 2212 - 2219. [Abstract] [Full Text] [PDF]
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D. Austin, J. P. Pell, K. G. Oldroyd, P. Agostoni, P. Vermeersch, O. C. Marroquin, S. R. Mulukutla, and K. E. Kip Bare-Metal versus Drug-Eluting Coronary Stents N. Engl. J. Med., June 5, 2008; 358(23): 2516 - 2518. [Full Text] [PDF]
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H. Kelbaek, L. Klovgaard, S. Helqvist, J. F. Lassen, L. R. Krusell, T. Engstrom, H. E. Botker, E. Jorgensen, K. Saunamaki, S. Aljabbari, et al. Long-Term Outcome in Patients Treated With Sirolimus-Eluting Stents in Complex Coronary Artery Lesions: 3-Year Results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) Trial J. Am. Coll. Cardiol., May 27, 2008; 51(21): 2011 - 2016. [Abstract] [Full Text] [PDF]
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G. W. Stone, B. Witzenbichler, G. Guagliumi, J. Z. Peruga, B. R. Brodie, D. Dudek, R. Kornowski, F. Hartmann, B. J. Gersh, S. J. Pocock, et al. Bivalirudin during Primary PCI in Acute Myocardial Infarction N. Engl. J. Med., May 22, 2008; 358(21): 2218 - 2230. [Abstract] [Full Text] [PDF]
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P. Garg, D. J. Cohen, T. Gaziano, and L. Mauri Balancing the Risks of Restenosis and Stent Thrombosis in Bare-Metal Versus Drug-Eluting Stents: Results of a Decision Analytic Model J. Am. Coll. Cardiol., May 13, 2008; 51(19): 1844 - 1853. [Abstract] [Full Text] [PDF]
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G. W. Stone, M. Midei, W. Newman, M. Sanz, J. B. Hermiller, J. Williams, N. Farhat, K. W. Mahaffey, D. E. Cutlip, P. J. Fitzgerald, et al. Comparison of an Everolimus-Eluting Stent and a Paclitaxel-Eluting Stent in Patients With Coronary Artery Disease: A Randomized Trial JAMA, April 23, 2008; 299(16): 1903 - 1913. [Abstract] [Full Text] [PDF]
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M. R. Patel and D. R. Holmes Jr Next-Generation Drug-Eluting Stents: A Spirited Step Forward or More of the Same JAMA, April 23, 2008; 299(16): 1952 - 1953. [Full Text] [PDF]
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M. W. Krucoff, D. J. Kereiakes, J. L. Petersen, R. Mehran, V. Hasselblad, A. J. Lansky, P. J. Fitzgerald, J. Garg, M. A. Turco, C. A. Simonton III, et al. A novel bioresorbable polymer paclitaxel-eluting stent for the treatment of single and multivessel coronary disease: primary results of the COSTAR (Cobalt Chromium Stent With Antiproliferative for Restenosis) II study. J. Am. Coll. Cardiol., April 22, 2008; 51(16): 1543 - 1552. [Abstract] [Full Text] [PDF]
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M. Valgimigli, G. Campo, G. Percoco, L. Bolognese, C. Vassanelli, S. Colangelo, N. de Cesare, A. E. Rodriguez, M. Ferrario, R. Moreno, et al. Comparison of Angioplasty With Infusion of Tirofiban or Abciximab and With Implantation of Sirolimus-Eluting or Uncoated Stents for Acute Myocardial Infarction: The MULTISTRATEGY Randomized Trial JAMA, April 16, 2008; 299(15): 1788 - 1799. [Abstract] [Full Text] [PDF]
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M. Pfisterer, H. P. Brunner-La Rocca, and C. Kaiser The balance of risks and benefits of drug-eluting versus bare-metal stents. J. Am. Coll. Cardiol., March 4, 2008; 51(9): 972 - 972. [Full Text] [PDF]
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H. L. Dauerman Percutaneous Coronary Intervention Pharmacology From a Triangle to a Square. J. Am. Coll. Cardiol., February 19, 2008; 51(7): 698 - 700. [Full Text] [PDF]
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K. E. Kip, K. Hollabaugh, O. C. Marroquin, and D. O. Williams The Problem With Composite End Points in Cardiovascular Studies The Story of Major Adverse Cardiac Events and Percutaneous Coronary Intervention. J. Am. Coll. Cardiol., February 19, 2008; 51(7): 701 - 707. [Abstract] [Full Text] [PDF]
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A. J. Kirtane, S. G. Ellis, K. D. Dawkins, A. Colombo, E. Grube, J. J. Popma, M. Fahy, M. B. Leon, J. W. Moses, R. Mehran, et al. Paclitaxel-Eluting Coronary Stents in Patients With Diabetes Mellitus Pooled Analysis From 5 Randomized Trials. J. Am. Coll. Cardiol., February 19, 2008; 51(7): 708 - 715. [Abstract] [Full Text] [PDF]
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