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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S. Verheye, P. Agostoni, K. D. Dawkins, J. Dens, W. Rutsch, D. Carrie, J. Schofer, C. Lotan, C. L. Dubois, S. A. Cohen, et al. The GENESIS (Randomized, Multicenter Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System in Patients with De Novo Lesions of the Native Coronary Arteries) Trial J. Am. Coll. Cardiol. Intv., March 1, 2009; 2(3): 205 - 214. [Abstract] [Full Text] [PDF]
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E. Mahmud, J. A. Ormiston, M. A. Turco, J. J. Popma, N. J. Weissman, C. D. O'Shaughnessy, T. Mann, J. J. Hall, T. F. McGarry, L. A. Cannon, et al. TAXUS Liberte Attenuates the Risk of Restenosis in Patients With Medically Treated Diabetes Mellitus: Results From the TAXUS ATLAS Program J. Am. Coll. Cardiol. Intv., March 1, 2009; 2(3): 240 - 252. [Abstract] [Full Text] [PDF]
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J. W. van Werkum, A. A.C.M. Heestermans, F. I. de Korte, J. C. Kelder, M.-J. Suttorp, B. J.W.M. Rensing, B. Zwart, B. R. G. Brueren, J. J. Koolen, J.-H. E. Dambrink, et al. Long-Term Clinical Outcome After a First Angiographically Confirmed Coronary Stent Thrombosis: An Analysis of 431 Cases Circulation, February 17, 2009; 119(6): 828 - 834. [Abstract] [Full Text] [PDF]
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S. Windecker and P. Juni The Drug-Eluting Stent Saga Circulation, February 10, 2009; 119(5): 653 - 656. [Full Text] [PDF]
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G. W. Stone, M. Midei, W. Newman, M. Sanz, J. B. Hermiller, J. Williams, N. Farhat, R. Caputo, N. Xenopoulos, R. Applegate, et al. Randomized Comparison of Everolimus-Eluting and Paclitaxel-Eluting Stents: Two-Year Clinical Follow-Up From the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SPIRIT) III Trial Circulation, February 10, 2009; 119(5): 680 - 686. [Abstract] [Full Text] [PDF]
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N. Piazza, Y. Onuma, P. de Jaegere, and P. W. Serruys Guidelines for reporting mortality and morbidity after cardiac valve interventions--need for a reappraisal? Ann. Thorac. Surg., February 1, 2009; 87(2): 357 - 358. [Full Text] [PDF]
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D. E. Kandzari, S. V. Rao, J. W. Moses, V. Dzavik, B. H. Strauss, M. J. Kutryk, C. A. Simonton, J. Garg, Y. Lokhnygina, G.B. J. Mancini, et al. Clinical and Angiographic Outcomes With Sirolimus-Eluting Stents in Total Coronary Occlusions: The ACROSS/TOSCA-4 (Approaches to Chronic Occlusions With Sirolimus-Eluting Stents/Total Occlusion Study of Coronary Arteries-4) Trial J. Am. Coll. Cardiol. Intv., February 1, 2009; 2(2): 97 - 106. [Abstract] [Full Text] [PDF]
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A. K.M. Hassan, S. C. Bergheanu, T. Stijnen, B. L. van der Hoeven, J. D. Snoep, J. W.M. Plevier, M. J. Schalij, and J. W. Jukema Late stent malapposition risk is higher after drug-eluting stent compared with bare-metal stent implantation and associates with late stent thrombosis Eur. Heart J., January 21, 2009; (2009) ehn553v1. [Abstract] [Full Text] [PDF]
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A. Colombo, E. Bramucci, S. Sacca, R. Violini, C. Lettieri, R. Zanini, I. Sheiban, L. Paloscia, E. Grube, J. Schofer, et al. Randomized Study of the Crush Technique Versus Provisional Side-Branch Stenting in True Coronary Bifurcations: The CACTUS (Coronary Bifurcations: Application of the Crushing Technique Using Sirolimus-Eluting Stents) Study Circulation, January 6, 2009; 119(1): 71 - 78. [Abstract] [Full Text] [PDF]
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Authors/writing members:, J. Daemen, M. L. Simoons, W. Wijns, A. Bagust, G. Bos, J. M. Bowen, E. Braunwald, E. Camenzind, B. Chevalier, et al. Meeting Report: ESC Forum on Drug Eluting Stents European Heart House, Nice, 27-28 September 2007 Eur. Heart J., January 2, 2009; 30(2): 152 - 161. [Full Text] [PDF]
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M. Pfisterer, H. P. Brunner-La Rocca, P. Rickenbacher, P. Hunziker, C. Mueller, F. Nietlispach, G. Leibundgut, F. Bader, C. Kaiser, and for the BASKET Investigators Long-term benefit-risk balance of drug-eluting vs. bare-metal stents in daily practice: does stent diameter matter? Three-year follow-up of BASKET Eur. Heart J., January 1, 2009; 30(1): 16 - 24. [Abstract] [Full Text] [PDF]
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S.-J. Park and Y.-H. Kim Current Status of Percutaneous Coronary Intervention With Drug-Eluting Stents in Asia Circulation, December 16, 2008; 118(25): 2730 - 2737. [Full Text] [PDF]
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J. Daemen, K. H. Kuck, C. Macaya, V. LeGrand, M. Vrolix, D. Carrie, I. Sheiban, M. J. Suttorp, P. Vranckx, T. Rademaker, et al. Multivessel Coronary Revascularization in Patients With and Without Diabetes Mellitus: 3-Year Follow-Up of the ARTS-II (Arterial Revascularization Therapies Study-Part II) Trial J. Am. Coll. Cardiol., December 9, 2008; 52(24): 1957 - 1967. [Abstract] [Full Text] [PDF]
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F. Burzotta, A. Parma, C. Pristipino, A. Manzoli, F. Belloni, G. Sardella, S. Rigattieri, A. Danesi, P. Mazzarotto, F. Summaria, et al. Angiographic and clinical outcome of invasively managed patients with thrombosed coronary bare metal or drug-eluting stents: the OPTIMIST study Eur. Heart J., December 2, 2008; 29(24): 3011 - 3021. [Abstract] [Full Text] [PDF]
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J. Rodes-Cabau, J. DeBlois, O. F. Bertrand, S. Mohammadi, J. Courtis, E. Larose, F. Dagenais, J.-P. Dery, P. Mathieu, M. Rousseau, et al. Nonrandomized Comparison of Coronary Artery Bypass Surgery and Percutaneous Coronary Intervention for the Treatment of Unprotected Left Main Coronary Artery Disease in Octogenarians Circulation, December 2, 2008; 118(23): 2374 - 2381. [Abstract] [Full Text] [PDF]
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L. O. Jensen, M. Maeng, P. Thayssen, A. Kaltoft, H. H. Tilsted, M. Bottcher, J. F. Lassen, K. N. Hansen, L. R. Krusell, K. Rasmussen, et al. Clinical Outcome After Primary Percutaneous Coronary Intervention With Drug-Eluting and Bare Metal Stents in Patients With ST-Segment Elevation Myocardial Infarction Circ Cardiovasc Interv, December 1, 2008; 1(3): 176 - 184. [Abstract] [Full Text] [PDF]
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A. Colombo and R. T. Gerber Should dual antiplatelet therapy after drug-eluting stents be continued for more than 1 year?: Dual Antiplatelet Therapy After Drug-Eluting Stents Should Not Be Continued for More Than 1 Year and Preferably Indefinitely Circ Cardiovasc Interv, December 1, 2008; 1(3): 226 - 232. [Full Text] [PDF]
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T. Adriaenssens, R. A. Byrne, A. Dibra, R. Iijima, J. Mehilli, O. Bruskina, A. Schomig, and A. Kastrati Culotte stenting technique in coronary bifurcation disease: angiographic follow-up using dedicated quantitative coronary angiographic analysis and 12-month clinical outcomes Eur. Heart J., December 1, 2008; 29(23): 2868 - 2876. [Abstract] [Full Text] [PDF]
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M. A. Turco, J. A. Ormiston, J. J. Popma, J. J. Hall, T. Mann, L. A. Cannon, M. W.I. Webster, G. J. Mishkel, C. D. O'Shaughnessy, T. F. McGarry, et al. Reduced Risk of Restenosis in Small Vessels and Reduced Risk of Myocardial Infarction in Long Lesions With the New Thin-Strut TAXUS Liberte Stent: 1-Year Results From the TAXUS ATLAS Program J. Am. Coll. Cardiol. Intv., December 1, 2008; 1(6): 699 - 709. [Abstract] [Full Text] [PDF]
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F. Alfonso, M.-J. Perez-Vizcayno, R. Hernandez, A. Bethencourt, V. Marti, J. R. Lopez-Minguez, J. Angel, A. Iniguez, C. Moris, A. Cequier, et al. Long-Term Clinical Benefit of Sirolimus-Eluting Stents in Patients With In-Stent Restenosis: Results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) Study J. Am. Coll. Cardiol., November 11, 2008; 52(20): 1621 - 1627. [Abstract] [Full Text] [PDF]
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E. Meliga, A. O. Maree, H. M. Garcia-Garcia, and P. W. Serruys Reply J. Am. Coll. Cardiol., November 11, 2008; 52(20): 1681 - 1681. [Full Text] [PDF]
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L. O. Jensen, M. Maeng, P. Thayssen, E. H. Christiansen, K. N. Hansen, A. Galloe, H. Kelbaek, J. F. Lassen, and L. Thuesen Neointimal hyperplasia after sirolimus-eluting and paclitaxel-eluting stent implantation in diabetic patients: The Randomized Diabetes and Drug-Eluting Stent (DiabeDES) Intravascular Ultrasound Trial Eur. Heart J., November 2, 2008; 29(22): 2733 - 2741. [Abstract] [Full Text] [PDF]
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P. Barlis, K. Dimopoulos, and C. Di Mario Letter by Barlis et al Regarding Article, "Two-Year Clinical Outcomes With Drug-Eluting Stents for Diabetic Patients With De Novo Coronary Lesions: Results From a Real-World Multicenter Registry Circulation, October 28, 2008; 118(18): e679 - e679. [Full Text] [PDF]
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P. Ortolani, F. Saia, R. M.T. Cooke, A. Marzocchi, M. Balducelli, A. Maresta, P. Marzaroli, P. Guastaroba, R. Grilli, G. Piovaccari, et al. Response to Letters Regarding Article, "Two-Year Clinical Outcomes With Drug-Eluting Stents for Diabetic Patients With De Novo Coronary Lesions: Results From a Real-World Multicenter Registry" Circulation, October 28, 2008; 118(18): e681 - e681. [Full Text] [PDF]
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D.-W. Park, S.-C. Yun, S.-W. Lee, Y.-H. Kim, C. W. Lee, M.-K. Hong, S.-S. Cheong, J.-J. Kim, S.-W. Park, and S.-J. Park Stent Thrombosis, Clinical Events, and Influence of Prolonged Clopidogrel Use After Placement of Drug-Eluting Stent: Data From an Observational Cohort Study of Drug-Eluting Versus Bare-Metal Stents J. Am. Coll. Cardiol. Intv., October 1, 2008; 1(5): 494 - 503. [Abstract] [Full Text] [PDF]
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