This Article Full Text Full Text (PDF) Data Supplement All Versions of this Article: 114/8/798    most recent CIRCULATIONAHA.105.591206v1 Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Fajadet, J. Search for Related Content PubMed PubMed Citation Articles by Fajadet, J. Pubmed/NCBI databases Compound via MeSH Substance via MeSH Medline Plus Health Information Antibiotics Related Collections Restenosis Catheter-based coronary interventions: stents Acute coronary syndromes Chronic ischemic heart disease Related Article

(Circulation. 2006;114:798-806.)
© 2006 American Heart Association, Inc.

Interventional Cardiology

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

Jean Fajadet, MD; William Wijns, MD, PhD; Gert-Jan Laarman, MD; Karl-Heinz Kuck, MD; John Ormiston, MD; Thomas Münzel, MD, PhD; Jeffrey J. Popma, MD; Peter J. Fitzgerald, MD; Raoul Bonan, MD; Richard E. Kuntz, MD, MSc, for the ENDEAVOR II Investigators

From the Clinique Pasteur, Toulouse, France (J.F.); Cardiovascular Center, Aalst, Belgium (W.W.); OLV Gasthuis, Amsterdam, the Netherlands (G.-J.L.); Krankenhaus Sankt Georg, Hamburg, Germany (K.-H.K.); Mercy Hospital, Auckland, New Zealand (J.O.); Universitätsklinikum, Hamburg-Eppendorf, Germany (T.M.); Brigham and Women’s Hospital, Boston, Mass (J.J.P); Stanford University, Stanford, Calif (P.F); Medtronic Vascular, Santa Rosa, Calif (R.B.); and Harvard Medical School, Boston, Mass (R.E.K).

Correspondence to William Wijns, MD, PhD, Cardiovascular Center, OLV Hospital, Moorselbaan 164, B-9300 Aalst, Belgium. E-mail william.wijns{at}olvz-aalst.be

Received November 7, 2005; revision received June 5, 2006; accepted June 14, 2006.

Background— The use of the Endeavor stent might reduce restenosis and stent thrombosis at 9 months.

Methods and Results— Patients (n=1197) treated for single coronary artery stenosis were enrolled in a prospective, randomized, double-blind study and randomly assigned to receive the Endeavor zotarolimus-eluting phosphorylcholine polymer–coated stent (n=598) or the same bare metal stent but without the drug or the polymer coating (n=599). The 2 groups were well matched in baseline characteristics. Diabetes was present in 20.1% of patients; the mean reference vessel diameter was 2.75 mm; and the mean lesion length was 14.2 mm. The primary end point of target vessel failure at 9 months was reduced from 15.1% with the bare metal stent to 7.9% with the Endeavor (P=0.0001), and the rate of major adverse cardiac events was reduced from 14.4% with the bare metal stent to 7.3% with the Endeavor (P=0.0001). Target lesion revascularization was 4.6% with Endeavor compared with 11.8% with the bare metal stent (P=0.0001). The rate of stent thrombosis was 0.5% with the Endeavor, which was not significantly different from 1.2% with the bare metal stent. In 531 patients submitted to angiographic follow-up, late loss was reduced from 1.03±0.58 to 0.61±0.46 (P<0.001) in stent and from 0.72±0.61 to 0.36±0.46 (P<0.001) in segment. The rate of in-segment restenosis was reduced from 35.0% to 13.2% with Endeavor (P<0.0001). There was no excessive edge stenosis, aneurysm formation, or late acquired malapposition by intravascular ultrasound imaging. Differences in clinical outcome were maintained at 12 and 24 months (P<0.0001).

Conclusions— Compared with bare metal stents, the Endeavor stent is safe and reduces the rates of clinical and angiographic restenosis at 9, 12, and 24 months.

---

 

CLINICAL PERSPECTIVE

Related Article:

Issue Highlights
Circulation 2006 114: 753. [Extract] [Full Text]

This article has been cited by other articles:

				R. Chacko, M. Mulhearn, V. Novack, L. Novack, L. Mauri, S. A. Cohen, J. Moses, M. B. Leon, and D. E. Cutlip Impact of Target Lesion and Nontarget Lesion Cardiac Events on 5-Year Clinical Outcomes After Sirolimus-Eluting or Bare-Metal Stenting J. Am. Coll. Cardiol. Intv., June 1, 2009; 2(6): 498 - 503. [Abstract] [Full Text] [PDF]

				M. B. Leon, D. J. Allocco, K. D. Dawkins, and D. S. Baim Late Clinical Events After Drug-Eluting Stents: The Interplay Between Stent-Related and Natural History-Driven Events J. Am. Coll. Cardiol. Intv., June 1, 2009; 2(6): 504 - 512. [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 Intervent, June 1, 2009; 2(3): 188 - 195. [Abstract] [Full Text] [PDF]

				D. E. Forman, D. A. Cox, S. G. Ellis, J. M. Lasala, J. A. Ormiston, G. W. Stone, M. A. Turco, J. Y. Wei, A. A. Joshi, K. D. Dawkins, et al. Long-Term Paclitaxel-Eluting Stent Outcomes in Elderly Patients Circ Cardiovasc Intervent, June 1, 2009; 2(3): 178 - 187. [Abstract] [Full Text] [PDF]

				O. Frobert, B. Lagerqvist, J. Carlsson, J. Lindback, U. Stenestrand, and S. K. James Differences in restenosis rate with different drug-eluting stents in patients with and without diabetes mellitus: a report from the SCAAR (Swedish Angiography and Angioplasty Registry). J. Am. Coll. Cardiol., May 5, 2009; 53(18): 1660 - 1667. [Abstract] [Full Text] [PDF]

				U Kaul and V Bhatia Choice of DES: is there a difference? Heart Asia, March 6, 2009; 2009(2): 11 - 15. [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]

				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]

				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]

				J. P. Chen, L. V. Crisco, R. Jabara, and S. B. King III Late Angiographic Stent Thrombosis: The LAST Straw for Drug-Eluting Stents? Angiology, January 1, 2009; 59(6): 667 - 675. [Abstract] [PDF]

				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]

				D. Aradi, A. Konyi, L. Palinkas, T. Berki, T. Pinter, T. Tahin, I. Horvath, L. Papp, and A. Komocsi Thienopyridine Therapy Influences Late Outcome After Coronary Stent Implantation Angiology, May 1, 2008; 59(2): 172 - 178. [Abstract] [PDF]

				T. L. Pinto Slottow and R. Waksman Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel Meeting on the Endeavor Zotarolimus-Eluting Coronary Stent Circulation, March 25, 2008; 117(12): 1603 - 1608. [Full Text] [PDF]

				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]

				B. L. van der Hoeven, S.-S. Liem, J. W. Jukema, N. Suraphakdee, H. Putter, J. Dijkstra, D. E. Atsma, M. Bootsma, K. Zeppenfeld, P. V. Oemrawsingh, et al. Sirolimus-eluting stents versus bare-metal stents in patients with ST-segment elevation myocardial infarction: 9-month angiographic and intravascular ultrasound results and 12-month clinical outcome results from the MISSION! Intervention Study. J. Am. Coll. Cardiol., February 12, 2008; 51(6): 618 - 626. [Abstract] [Full Text] [PDF]

				F. Saia, A. Marzocchi, and A. Branzi Review: The safety of drug-eluting stents Therapeutic Advances in Cardiovascular Disease, February 1, 2008; 2(1): 43 - 52. [Abstract] [PDF]

				S. J. Pocock, A. J. Lansky, R. Mehran, J. J. Popma, M. P. Fahy, Y. Na, G. Dangas, J. W. Moses, T. Pucelikova, D. E. Kandzari, et al. Angiographic surrogate end points in drug-eluting stent trials: a systematic evaluation based on individual patient data from 11 randomized, controlled trials. J. Am. Coll. Cardiol., January 1, 2008; 51(1): 23 - 32. [Abstract] [Full Text] [PDF]

				S. Windecker and B. Meier Late Coronary Stent Thrombosis Circulation, October 23, 2007; 116(17): 1952 - 1965. [Full Text] [PDF]

				M.-C. Morice, P. W. Serruys, P. Barragan, C. Bode, G.-A. Van Es, H.-P. Stoll, D. Snead, L. Mauri, D. E. Cutlip, and E. Sousa Long-Term Clinical Outcomes With Sirolimus-Eluting Coronary Stents: Five-Year Results of the RAVEL Trial J. Am. Coll. Cardiol., October 2, 2007; 50(14): 1299 - 1304. [Abstract] [Full Text] [PDF]

				C. Bode and M. Zehender The use of antiplatelet agents following percutaneous coronary intervention: focus on late stent thrombosis Eur. Heart J. Suppl., August 1, 2007; 9(suppl_D): D10 - D19. [Abstract] [Full Text] [PDF]

				S. R. Dixon, C. L. Grines, and W. W. O'Neill The Year in Interventional Cardiology J. Am. Coll. Cardiol., July 17, 2007; 50(3): 270 - 285. [Full Text] [PDF]

				J. Daemen and P. W. Serruys Drug-Eluting Stent Update 2007: Part I: A Survey of Current and Future Generation Drug-Eluting Stents: Meaningful Advances or More of the Same? Circulation, July 17, 2007; 116(3): 316 - 328. [Full Text] [PDF]

				R. Moreno, C. Fernandez, A. Sanchez-Recalde, G. Galeote, L. Calvo, F. Alfonso, R. Hernandez, R. Sanchez-Aquino, D. J. Angiolillo, S. Villarreal, et al. Clinical impact of in-stent late loss after drug-eluting coronary stent implantation Eur. Heart J., July 1, 2007; 28(13): 1583 - 1591. [Abstract] [Full Text] [PDF]

				Authors/Task Force Members, J.-P. Bassand, C. W. Hamm, D. Ardissino, E. Boersma, A. Budaj, F. Fernandez-Aviles, K. A.A. Fox, D. Hasdai, E. M. Ohman, et al. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes: The Task Force for the Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of the European Society of Cardiology Eur. Heart J., July 1, 2007; 28(13): 1598 - 1660. [Full Text] [PDF]

				T. Adriaenssens, J. Mehilli, R. Wessely, G. Ndrepepa, M. Seyfarth, A. Wieczorek, B. Blaich, R. Iijima, J. Pache, A. Kastrati, et al. Does Addition of Estradiol Improve the Efficacy of a Rapamycin-Eluting Stent?: Results of the ISAR-PEACE Randomized Trial J. Am. Coll. Cardiol., March 27, 2007; 49(12): 1265 - 1271. [Abstract] [Full Text] [PDF]