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

Journal of the American College of Cardiology

Volumn 55, Issue 6, 2010, Pages 543-554

  Leon, Martin B ^a   Mauri, Laura ^c   Popma, Jeffrey J ^d   Cutlip, Donald E ^e   Nikolsky, Eugenia ^a   O'Shaughnessy, Charles ^f   Overlie, Paul A ^g   McLaurin, Brent T ^j   Solomon, Stuart L ^h   Douglas Jr , John S ^k   Ball, Michael W ^l   Caputo, Ronald P ^b   Jain, Ash ^m   Tolleson, Thaddeus R ⁱ   Reen III, Bernard M ^q   Kirtane, Ajay J ^a   Fitzgerald, Peter J ⁿ   Thompson, Kweli ^o   Kandzari, David E ^p  

^a NewYork Presbyterian Hospital   (United States)

^b St Joseph's Hospital   (United States)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

^d ST ELIZABETH'S MEDICAL CENTER   (United States)

^e BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^f Elyria Memorial Hospital   (United States)

^g Lubbock Heart Hospital   (United States)

^h HOUSTON METHODIST HOSPITAL   (United States)

ⁱ Trinity Mother Frances Health System   (United States)

^j Anderson Medical Center   (United States)

^k EMORY UNIVERSITY   (United States)

^l Indiana Heart Physicians   (United States)

^m Washington Hospital   (United States)

ⁿ STANFORD UNIVERSITY   (United States)

^o MEDTRONIC INC   (United States)

^p SCRIPPS CLINIC   (United States)

^q PRESBYTERIAN HOSPITAL   (United States)

more..

Author keywords

drug eluting stents; target lesion revascularization; zotarolimus eluting stent

Indexed keywords

PACLITAXEL; ZOTAROLIMUS;

ADULT; ANGIOCARDIOGRAPHY; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY DISEASE; CORONARY STENT; DRUG EFFICACY; DRUG ELUTING STENT; DRUG SAFETY; DRUG TREATMENT FAILURE; FEMALE; FOLLOW UP; HEART DEATH; HEART INFARCTION; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RESTENOSIS; REVASCULARIZATION; SINGLE BLIND PROCEDURE; STENT THROMBOSIS; TARGET ORGAN;

AGED; CORONARY ARTERY DISEASE; DRUG-ELUTING STENTS; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; PACLITAXEL; SINGLE-BLIND METHOD; SIROLIMUS; TREATMENT OUTCOME;

EID: 75249100540     PISSN: 07351097     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jacc.2009.08.067     Document Type: Article

References (32)

1. Moses J.W., Leon M.B., Popma J.J., et al., SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 349 (2003) 1315-1323
2. Stone G.W., Ellis S.G., Cox D.A., et al., TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 350 (2004) 221-231
3. Stone G.W., Ellis S.G., Cannon L., et al., TAXUS V Investigators. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA 294 (2005) 1215-1223
4. Stone G.W., Midei M., Newman W., et al., SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease. A randomized trial. JAMA 299 (2008) 1903-1913
5. Marroquin O.C., Selzer F., Mulukutla S.R., et al. A comparison of bare-metal and drug-eluting stents for off-label indications. N Engl J Med 358 (2008) 342-352
6. Camenzind E., Steg P.G., and Wijns W. Stent thrombosis late after implantation of first-generation drug-eluting stents: a cause for concern. Circulation 115 (2007) 1440-1445
7. Daemen J., Wenaweser P., Tsuchida K., et al. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet 369 (2007) 667-668
8. Lagerqvist B., James S.K., Stenestrand U., Lindback J., Nilsson T., and Wallentin L. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med 356 (2007) 1009-1019
9. Grines C.L., Bonow R.O., Casey Jr. D.E., et al. Prevention of premature discontinuation of dual antiplatelet therapy in patients with coronary artery stents: a science advisory from the American Heart Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American College of Surgeons, and American Dental. J Am Coll Cardiol 49 (2007) 734-739
10. Hodgson J.M., Stone G.W., Lincoff A.M., et al., Society for Cardiovascular Angiography and Interventions. Late stent thrombosis: considerations and practical advice for the use of drug-eluting stents: a report from the Society for Cardiovascular Angiography and Interventions Drug-eluting Stent Task Force. Catheter Cardiovasc Interv 69 (2007) 327-333
11. Joner M., Finn A.V., Farb A., et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 48 (2006) 193-202
12. Joner M., Nakazawa G., Finn A.V., et al. Endothelial cell recovery between comparator polymer-based drug-eluting stents. J Am Coll Cardiol 52 (2008) 333-342
13. Meredith I.T., Ormiston J., Whitbourn R., et al. First-in-human study of the Endeavor ABT-578-eluting phosphorylcholine-encapsulated stent system in de novo native coronary artery lesions: Endeavor I trial. EuroIntervention 1 (2005) 157-164
14. Meredith I.T., Ormiston J., Whitbourn R., et al., ENDEAVOR I Investigators. Four-year clinical follow-up after implantation of the endeavor zotarolimus-eluting stent: ENDEAVOR I, the first-in-human study. Am J Cardiol 100 (2007) 56M-61M
15. Fajadet J., Wijns W., Laarman G.J., et al., ENDEAVOR II Investigators. 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
16. Kandzari D.E., Leon M.B., Popma J.J., et al., ENDEAVOR III Investigators. Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: a randomized controlled trial. J Am Coll Cardiol 48 (2006) 2440-2447
17. Burke S.E., Kuntz R.E., and Schwartz L.B. Zotarolimus (ABT-578) eluting stents. Adv Drug Deliv Rev 58 (2006) 437-446
18. Hayward J.A., and Chapman D. Biomembrane surfaces as models for polymer design: the potential for haemocompatibility. Biomaterials 5 (1984) 135-142
19. Baldo P., Cecco S., Giacomin E., et al. mTOR pathway and mTOR inhibitors as agents for cancer therapy. Curr Cancer Drug Targets 8 (2008) 647-665
20. Whelan D.M., van der Giessen W.J., Krabbendam S.C., et al. Biocompatibility of phosphorylcholine coated stents in normal porcine coronary arteries. Heart 83 (2000) 338-345
21. Garcia-Touchard A., Burke S.E., Toner J.L., Cromack K., and Schwartz R.S. Zotarolimus-eluting stents reduce experimental coronary artery neointimal hyperplasia after 4 weeks. Eur Heart J 27 (2006) 988-993
22. Cutlip D.E., Windecker S., Mehran R., et al., Academic Research Consortium. Clinical endpoints in coronary stent trials: a case for standardized definitions. Circulation 115 (2007) 2344-2351
23. Farrington C.P., and Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med 9 (1990) 1447-1454
24. Popma J.J., Mauri L., Kirtane A., Cutlip D., Almonacid A., and Leon M.B. Frequency and clinical consequences associated with sidebranch occlusion during stent implantation using zotarolimus-eluting and paclitaxel-eluting coronary stents. Circ Cardiovasc Intervent 2 (2009) 133-139
25. Cutlip D.E., Baim D.S., Ho K.K., et al. Stent thrombosis in the modern era: a pooled analysis of multicenter coronary stent clinical trials. Circulation 103 (2001) 1967-1971
26. Gershlick A., Kandzari D.E., Leon M.B., et al., ENDEAVOR Investigators. Zotarolimus-eluting stents in patients with native coronary artery disease: clinical and angiographic outcomes in 1,317 patients. Am J Cardiol 100 (2007) 45M-55M
27. Mauri L., Cutlip D.E., Leon M.B., et al. Long term safety results from the Endeavor program: four-year follow-up (abstr). Am J Cardiol 102 Suppl 8 (2008) 124i
28. Laskey W.K., Yancy C.W., and Maisel W.H. Thrombosis in coronary drug-eluting stents: report from the meeting of the Circulatory System Medical Devices Advisory Panel of the Food and Drug Administration Center for Devices and Radiologic Health, December 7-8, 2006. Circulation 115 (2007) 2352-2357
29. Galløe A.M., Thuesen L., Kelbaek H., et al., SORT OUT II Investigators. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA 299 (2008) 409-416
30. Lassen J.F., Rasmussen K., Galløe A., et al. SORT-OUT III: A Prospective, Randomized Comparison of Zotarolimus-eluting and Sirolimus-eluting Stents in Patients with Coronary Artery Disease. Paper presented at: Transcatheter Therapeutics. Washington, DC (October 16, 2008)
31. Brugaletta S., Burzotta F., and Sabaté M. Zotarolimus for the treatment of coronary artery disease: pathophysiology, DES design, clinical evaluation and future perspective. Expert Opin Pharmacother 10 (2009) 1047-1058
32. Topol E.J., and Nissen S.E. Our preoccupation with coronary luminology: the dissociation between clinical and angiographic findings in ischemic heart disease. Circulation 92 (1995) 2333-2342