Rationale and design of the clinical evaluation of the Resolute Zotarolimus-Eluting Coronary Stent System in the treatment of de novo lesions in native coronary arteries (the RESOLUTE US clinical trial)

American Heart Journal

Volumn 161, Issue 5, 2011, Pages 807-814

  Mauri, Laura ^a,b   Leon, Martin B ^c   Yeung, Alan C ^d   Negoita, Manuela ^e   Keyes, Michelle J ^f   Massaro, Joseph M ^f  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c Och Spine at New York Presbyterian Hospitals   (United States)

^d STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e MEDTRONIC INC   (United States)

^f HARVARD CLINICAL RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANTITHROMBOCYTIC AGENT; CLOPIDOGREL; GLYCERYL TRINITRATE; HEPARIN; HIRULOG; POLYMER; ZOTAROLIMUS;

ARTERY DIAMETER; ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; CLINICAL TRIAL; CORONARY ARTERY OBSTRUCTION; CORONARY STENT; DEVICE SAFETY; DRUG ELUTING STENT; HUMAN; ISCHEMIC HEART DISEASE; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; OBSERVATIONAL STUDY; PRIORITY JOURNAL; RESTENOSIS; STUDY DESIGN;

ANGIOPLASTY, BALLOON, CORONARY; CORONARY ANGIOGRAPHY; CORONARY ARTERY DISEASE; DRUG-ELUTING STENTS; FOLLOW-UP STUDIES; HUMANS; PROSPECTIVE STUDIES; PROSTHESIS DESIGN; SIROLIMUS; TREATMENT OUTCOME;

EID: 79955073346     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2011.03.015     Document Type: Article

References (20)

1. J.W. Moses Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery N Engl J Med 349 2003 1315 1323 (Pubitemid 37186209)
2. G.W. Stone A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease N Engl J Med 350 2004 221 231 (Pubitemid 38067635)
3. M.N. Babapulle A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents Lancet 364 2004 583 591 (Pubitemid 39094175)
4. J.M. Stolker Predicting restenosis of drug-eluting stents placed in real-world clinical practice: derivation and validation of a risk model from the EVENT registry Circ Cardiovasc Interv 3 2010 327 334
5. G.W. Stone Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents N Engl J Med 356 2007 998 1008 (Pubitemid 46376800)
6. K. Udipi Development of a novel biocompatible polymer system for extended drug release in a next-generation drug-eluting stent J Biomed Mater Res A 85 2008 1064 1071 (Pubitemid 351717975)
7. S.C. Smith Jr ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention-summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) Circulation 113 2006 156 175
8. I.T. Meredith Clinical and angiographic results with the next-generation resolute stent system: a prospective, multicenter, first-in-human trial JACC Cardiovasc Interv 2 2009 977 985
9. I.T. Meredith Long-term clinical outcomes with the next-generation Resolute Stent System: a report of the two-year follow-up from the RESOLUTE clinical trial EuroIntervention 5 2010 692 697
10. K. Thygesen Universal definition of myocardial infarction Circulation 116 2007 2634 2653 (Pubitemid 350182388)
11. D.E. Cutlip Clinical end points in coronary stent trials: a case for standardized definitions Circulation 115 2007 2344 2351 (Pubitemid 46685903)
12. J. Fajadet Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial Circulation 114 2006 798 806 (Pubitemid 44268230)
13. M.B. Leon A randomized comparison of the ENDEAVOR zotarolimus-eluting stent versus the TAXUS paclitaxel-eluting stent in de novo native coronary lesions 12-month outcomes from the ENDEAVOR IV trial J Am Coll Cardiol 55 2010 543 554
14. H.P. Schultheiss Safety of direct stenting with the Endeavor stent: results of the Endeavor II continued access registry EuroIntervention 3 2007 76 81
15. G. Koch, and I. Amar Categorical data analysis 1989 Marcel Dekker New York
16. L. Mauri Long-term clinical outcomes after drug-eluting and bare-metal stenting in Massachusetts Circulation 118 2008 1817 1827
17. P.W. Serruys Comparison of zotarolimus-eluting and everolimus-eluting coronary stents N Engl J Med 363 2010 136 146
18. P. Widimsky, J. Belardi, and F.J. Neumann TCT-282: 1 year outcomes of patients with Resolute zotarolimus-eluting stent: results of the RESOLUTE International Registry J Am Coll Cardiol. 56 2010 B65
19. L. Mauri Stent thrombosis in randomized clinical trials of drug-eluting stents N Engl J Med 356 2007 1020 1029 (Pubitemid 46376802)
20. L. Mauri Long-term clinical outcomes with zotarolimus-eluting versus bare-metal coronary stents JACC Cardiovasc Interv 3 2010 1240 1249