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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

Donald E. Cutlip, MD; Stephan Windecker, MD; Roxana Mehran, MD; Ashley Boam, MSBE; David J. Cohen, MD; Gerrit-Anne van Es, PhD, MSc; P. Gabriel Steg, MD; Marie-angèle Morel, BSc; Laura Mauri, MD, MSc; Pascal Vranckx, MD; Eugene McFadden, MD; Alexandra Lansky, MD; Martial Hamon, MD; Mitchell W. Krucoff, MD; Patrick W. Serruys, MD, on behalf of the Academic Research Consortium

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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				E. Di Lorenzo, G. De Luca, R. Sauro, A. Varricchio, M. Capasso, T. Lanzillo, F. Manganelli, C. Mariello, F. Siano, M. R. Pagliuca, et al. The PASEO (PaclitAxel or Sirolimus-Eluting Stent Versus Bare Metal Stent in Primary Angioplasty) Randomized Trial J. Am. Coll. Cardiol. Intv., June 1, 2009; 2(6): 515 - 523. [Abstract] [Full Text] [PDF]

				N. Kukreja, Y. Onuma, H. M. Garcia-Garcia, J. Daemen, R. van Domburg, P. W. Serruys, and on behalf of the Interventional cardiologists of t The Risk of Stent Thrombosis in Patients With Acute Coronary Syndromes Treated With Bare-Metal and Drug-Eluting Stents J. Am. Coll. Cardiol. Intv., June 1, 2009; 2(6): 534 - 541. [Abstract] [Full Text] [PDF]

				S. Anwaruddin, A. T. Askari, H. Saudye, L. Batizy, P. L. Houghtaling, M. Alamoudi, M. Militello, K. Muhammad, S. Kapadia, and S. G. Ellis Characterization of Post-Operative Risk Associated With Prior Drug-Eluting Stent Use J. Am. Coll. Cardiol. Intv., June 1, 2009; 2(6): 542 - 549. [Abstract] [Full Text] [PDF]

				B. Chevalier, S. Silber, S.-J. Park, E. Garcia, G. Schuler, H. Suryapranata, J. Koolen, K. E. Hauptmann, W. Wijns, M.-C. Morice, et al. Randomized Comparison of the Nobori Biolimus A9-Eluting Coronary Stent With the Taxus Liberte Paclitaxel-Eluting Coronary Stent in Patients With Stenosis in Native Coronary Arteries: The NOBORI 1 Trial--Phase 2 Circ Cardiovasc Interv, June 1, 2009; 2(3): 188 - 195. [Abstract] [Full Text] [PDF]

				J. Mehilli, A. Kastrati, R. A. Byrne, O. Bruskina, R. Iijima, S. Schulz, J. Pache, M. Seyfarth, S. Massberg, K.-L. Laugwitz, et al. Paclitaxel- Versus Sirolimus-Eluting Stents for Unprotected Left Main Coronary Artery Disease J. Am. Coll. Cardiol., May 12, 2009; 53(19): 1760 - 1768. [Abstract] [Full Text] [PDF]

				G. W. Stone, A. J. Lansky, S. J. Pocock, B. J. Gersh, G. Dangas, S. C. Wong, B. Witzenbichler, G. Guagliumi, J. Z. Peruga, B. R. Brodie, et al. Paclitaxel-Eluting Stents versus Bare-Metal Stents in Acute Myocardial Infarction N. Engl. J. Med., May 7, 2009; 360(19): 1946 - 1959. [Abstract] [Full Text] [PDF]

				B. Vaquerizo, T. Lefevre, O. Darremont, M. Silvestri, Y. Louvard, J. L. Leymarie, P. Garot, H. Routledge, F. de Marco, T. Unterseeh, et al. Unprotected Left Main Stenting in the Real World: Two-Year Outcomes of the French Left Main Taxus Registry Circulation, May 5, 2009; 119(17): 2349 - 2356. [Abstract] [Full Text] [PDF]

				J. W. van Werkum, A. A. Heestermans, A. C. Zomer, J. C. Kelder, M.-J. Suttorp, B. J. Rensing, J. J. Koolen, B.R. G. Brueren, J.-H. E. Dambrink, R. W. Hautvast, et al. Predictors of Coronary Stent Thrombosis: The Dutch Stent Thrombosis Registry J. Am. Coll. Cardiol., April 21, 2009; 53(16): 1399 - 1409. [Abstract] [Full Text] [PDF]

				D. Sibbing, J. Stegherr, W. Latz, W. Koch, J. Mehilli, K. Dorrler, T. Morath, A. Schomig, A. Kastrati, and N. von Beckerath Cytochrome P450 2C19 loss-of-function polymorphism and stent thrombosis following percutaneous coronary intervention Eur. Heart J., April 2, 2009; 30(8): 916 - 922. [Abstract] [Full Text] [PDF]

				R. A. Byrne, J. Mehilli, R. Iijima, S. Schulz, J. Pache, M. Seyfarth, A. Schomig, A. Kastrati, and for the Intracoronary Stenting and Angiographic Re A polymer-free dual drug-eluting stent in patients with coronary artery disease: a randomized trial vs. polymer-based drug-eluting stents Eur. Heart J., April 2, 2009; 30(8): 923 - 931. [Abstract] [Full Text] [PDF]

				J. M. Ruiz-Nodar, F. Marin, J. Sanchez-Paya, J. A. Hurtado, J. Valencia-Martin, S. Manzano-Fernandez, V. Roldan, V. Perez-Andreu, F. Sogorb, M. Valdes, et al. Efficacy and safety of drug-eluting stent use in patients with atrial fibrillation Eur. Heart J., April 2, 2009; 30(8): 932 - 939. [Abstract] [Full Text] [PDF]

				R. A. Byrne, R. Iijima, J. Mehilli, S. Pinieck, O. Bruskina, A. Schomig, and A. Kastrati Durability of Antirestenotic Efficacy in Drug-Eluting Stents With and Without Permanent Polymer J. Am. Coll. Cardiol. Intv., April 1, 2009; 2(4): 291 - 299. [Abstract] [Full Text] [PDF]

				Y. Han, Q. Jing, B. Xu, L. Yang, H. Liu, X. Shang, T. Jiang, Z. Li, H. Zhang, H. Li, et al. Safety and Efficacy of Biodegradable Polymer-Coated Sirolimus-Eluting Stents in "Real-World" Practice: 18-Month Clinical and 9-Month Angiographic Outcomes J. Am. Coll. Cardiol. Intv., April 1, 2009; 2(4): 303 - 309. [Abstract] [Full Text] [PDF]

				M. J. Eisenberg, P. R. Richard, D. Libersan, and K. B. Filion Safety of Short-Term Discontinuation of Antiplatelet Therapy in Patients With Drug-Eluting Stents Circulation, March 31, 2009; 119(12): 1634 - 1642. [Abstract] [Full Text] [PDF]

				S. Verheye, P. Agostoni, C. L. Dubois, J. Dens, J. Ormiston, S. Worthley, B. Trauthen, T. Hasegawa, B.-K. Koo, P. J. Fitzgerald, et al. 9-Month Clinical, Angiographic, and Intravascular Ultrasound Results of a Prospective Evaluation of the Axxess Self-Expanding Biolimus A9-Eluting Stent in Coronary Bifurcation Lesions: The DIVERGE (Drug-Eluting Stent Intervention for Treating Side Branches Effectively) Study J. Am. Coll. Cardiol., March 24, 2009; 53(12): 1031 - 1039. [Abstract] [Full Text] [PDF]

				E. S. Brilakis, C. Lichtenwalter, J. A. de Lemos, M. Roesle, O. Obel, D. Haagen, B. Saeed, C. Gadiparthi, J. K. Bissett, R. Sachdeva, et al. A Randomized Controlled Trial of a Paclitaxel-Eluting Stent Versus a Similar Bare-Metal Stent in Saphenous Vein Graft Lesions: The SOS (Stenting Of Saphenous Vein Grafts) Trial J. Am. Coll. Cardiol., March 17, 2009; 53(11): 919 - 928. [Abstract] [Full Text] [PDF]

				D. Sibbing, S. Braun, T. Morath, J. Mehilli, W. Vogt, A. Schomig, A. Kastrati, and N. von Beckerath Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J. Am. Coll. Cardiol., March 10, 2009; 53(10): 849 - 856. [Abstract] [Full Text] [PDF]

				A. R. Galassi, S. D. Tomasello, D. Capodanno, G. Barrano, G. P. Ussia, and C. Tamburino Mini-Crush Versus T-Provisional Techniques in Bifurcation Lesions: Clinical and Angiographic Long-Term Outcome After Implantation of Drug-Eluting Stents J. Am. Coll. Cardiol. Intv., March 1, 2009; 2(3): 185 - 194. [Abstract] [Full Text] [PDF]

				C. Tamburino, A. La Manna, M. E. Di Salvo, G. Sacchetta, D. Capodanno, R. Mehran, G. Dangas, T. Corcos, and F. Prati First-in-Man 1-Year Clinical Outcomes of the Catania Coronary Stent System With Nanothin Polyzene-F in De Novo Native Coronary Artery Lesions: The ATLANTA (Assessment of The LAtest Non-Thrombogenic Angioplasty stent) Trial J. Am. Coll. Cardiol. Intv., March 1, 2009; 2(3): 197 - 204. [Abstract] [Full Text] [PDF]

				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]

				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]

				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]

				S. Windecker and P. Juni The Drug-Eluting Stent Saga Circulation, February 10, 2009; 119(5): 653 - 656. [Full Text] [PDF]

				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]

				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]

				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]