Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent (RESOLUTE-AC)

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ClinicalTrials.gov Identifier: NCT00617084

Recruitment Status : Completed

First Posted : February 15, 2008

Results First Posted : May 17, 2011

Last Update Posted : June 6, 2014

Sponsor:

Collaborator:

Medtronic Bakken Research Center

Information provided by (Responsible Party):

Medtronic Vascular

Study Description

Brief Summary:

The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm, international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The study is a "real world, all comers" study.

Primary objective: to compare the Medtronic Endeavor-Resolute (Zotarolimus-Eluting stent) system with the Abbott XIENCE V (Everolimus-Eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion Revascularization at 1 year in a "real world" patient population.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Device: Medtronic Endeavor Resolute Device: Abbott Xience V	Phase 4

Detailed Description:

Study hypothesis: To determine whether the Zotarolimus-Eluting stent (Medtronic Endeavor-Resolute) is non-inferior to the Everolimus-eluting stent (Abbott XIENCE V) in terms of the primary endpoint at 12 months after stent implantation.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2292 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	RESOLUTE-III All-comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention
Study Start Date :	April 2008
Actual Primary Completion Date :	May 2010
Actual Study Completion Date :	February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1. Resolute Medtronic Endeavor Resolute	Device: Medtronic Endeavor Resolute Medtronic Endeavor Resolute Other Name: Endeavor Resolute Zotarolimus-Eluting Coronary Stent System
Active Comparator: 2. XIENCE V Abbott Xience V	Device: Abbott Xience V Abbott Xience V Other Name: XIENCE V Everolimus Eluting Coronary Stent System

Outcome Measures

Primary Outcome Measures :

Target Lesion Failure [ Time Frame: 12 months ]
Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year. MI: Q MI if new pathological Q waves and chest pain, non Q MI if CK elevated more than two times normal, troponin elevated more than normal, according to ARC definitions. TLR, clinically indicated if associated with ischemic symptoms and angiographic min lumen diameter bigger than fifty percent by QCA or without symptoms and min lumen diameter bigger than seventy percent. Measure average.

Secondary Outcome Measures :

In-Stent Percent Diameter Stenosis [ Time Frame: 13 Months ]
In Stent Percent Diameter Stenosis at thirteen months. In Stent Percent Diameter Stenosis: measured percent of diameter stenosis at the region of the stent (calculated as 100x(RVD-MLD)/RVD using the mean values from 2 orthogonal views by QCA. RVD (Reference Vessel Diameter): average of normal segments within 10mm proximal and distal to target lesion from 2 orthogonal views using QCA. MLD (Minimal Lumen Diameter): average of 2 orthogonal views of the narrowest point wihtin the area of assessment. MLD measured during QCA by the angiographic core laboratory.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Minimal age 18 years
Symptomatic coronary artery disease
Patient acceptable candidate for treatment with drug eluting stent in accordance with applicable guidelines
Presence of one or more coronary artery stenosis >50% with reference diameter 2.25-4.0mm which can be covered by one or multiple stents
Patient indication, lesion length and vessel diameter according to 'Instructions for Use' of study stents
Patient is willing and able to cooperate with study procedures and required follow up visits and patient or legal representative has been informed and agrees by signing EC approved written informed consent.

Exclusion Criteria:

Women of childbearing potential who do not have a negative pregnancy test within 7 days before procedure and women who are lactating
Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, cobalt, nickel, chromium, molybdenum, polymer coatings, Zotarolimus, Everolimus, or contrast material
Participating in other trial before reaching primary endpoint
Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617084

Locations

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Switzerland
Stiftung Inselspital, Department of Cardiology
Bern, Switzerland, CH-3010

Sponsors and Collaborators

Medtronic Vascular

Medtronic Bakken Research Center

Investigators

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Principal Investigator:	Patrick Serruys, MD	Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands
Principal Investigator:	Sigmund Silber, MD	Kardiologische Praxis und Praxisklinik, Munich, Germany
Principal Investigator:	Stephan Windecker, MD	University Hospital Bern, Bern, Switzerland

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Koskinas KC, Siontis GC, Piccolo R, Franzone A, Haynes A, Rat-Wirtzler J, Silber S, Serruys PW, Pilgrim T, Räber L, Heg D, Jüni P, Windecker S. Impact of Diabetic Status on Outcomes After Revascularization With Drug-Eluting Stents in Relation to Coronary Artery Disease Complexity: Patient-Level Pooled Analysis of 6081 Patients. Circ Cardiovasc Interv. 2016 Feb;9(2):e003255. doi: 10.1161/CIRCINTERVENTIONS.115.003255.

Iqbal J, Serruys PW, Silber S, Kelbaek H, Richardt G, Morel MA, Negoita M, Buszman PE, Windecker S. Comparison of zotarolimus- and everolimus-eluting coronary stents: final 5-year report of the RESOLUTE all-comers trial. Circ Cardiovasc Interv. 2015 Jun;8(6):e002230. doi: 10.1161/CIRCINTERVENTIONS.114.002230.

Taniwaki M, Windecker S, Zaugg S, Stefanini GG, Baumgartner S, Zanchin T, Wenaweser P, Meier B, Jüni P, Räber L. The association between in-stent neoatherosclerosis and native coronary artery disease progression: a long-term angiographic and optical coherence tomography cohort study. Eur Heart J. 2015 Aug 21;36(32):2167-76. doi: 10.1093/eurheartj/ehv227. Epub 2015 Jun 3.

Campos CM, Costa F, Garcia-Garcia HM, Bourantas C, Suwannasom P, Valgimigli M, Morel MA, Windecker S, Serruys PW. Anatomic characteristics and clinical implications of angiographic coronary thrombus: insights from a patient-level pooled analysis of SYNTAX, RESOLUTE, and LEADERS Trials. Circ Cardiovasc Interv. 2015 Apr;8(4). pii: e002279. doi: 10.1161/CIRCINTERVENTIONS.114.002279.

Taniwaki M, Radu MD, Garcia-Garcia HM, Heg D, Kelbæk H, Holmvang L, Moschovitis A, Noble S, Pedrazzini G, Saunamäki K, Dijkstra J, Landmesser U, Wenaweser P, Meier B, Stefanini GG, Roffi M, Lüscher TF, Windecker S, Räber L. Long-term safety and feasibility of three-vessel multimodality intravascular imaging in patients with ST-elevation myocardial infarction: the IBIS-4 (integrated biomarker and imaging study) substudy. Int J Cardiovasc Imaging. 2015 Jun;31(5):915-26. doi: 10.1007/s10554-015-0631-0. Epub 2015 Feb 28.

Taniwaki M, Stefanini GG, Silber S, Richardt G, Vranckx P, Serruys PW, Buszman PE, Kelbaek H, Windecker S; RESOLUTE All-Comers Investigators. 4-year clinical outcomes and predictors of repeat revascularization in patients treated with new-generation drug-eluting stents: a report from the RESOLUTE All-Comers trial (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention). J Am Coll Cardiol. 2014 Apr 29;63(16):1617-25. doi: 10.1016/j.jacc.2013.12.036. Epub 2014 Feb 13.

Silber S, Kirtane AJ, Belardi JA, Liu M, Brar S, Rothman M, Windecker S. Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation. Eur Heart J. 2014 Aug 1;35(29):1949-56. doi: 10.1093/eurheartj/ehu026. Epub 2014 Feb 7.

Richardt G, Leschke M, Abdel-Wahab M, Toelg R, El-Mawardy M, Serruys PW, Silber S, Windecker S, Belardi JA, Neumann FJ, Widimsky P; RESOLUTE All Comers; RESOLUTE International Investigators. Clinical outcomes of the Resolute zotarolimus-eluting stent in patients with in-stent restenosis: 2-year results from a pooled analysis. JACC Cardiovasc Interv. 2013 Sep;6(9):905-13. doi: 10.1016/j.jcin.2013.04.017. Epub 2013 Aug 14.

Gutiérrez-Chico JL, Räber L, Regar E, Okamura T, di Mario C, van Es GA, Windecker S, Serruys PW. Tissue coverage and neointimal hyperplasia in overlap versus nonoverlap segments of drug-eluting stents 9 to 13 months after implantation: in vivo assessment with optical coherence tomography. Am Heart J. 2013 Jul;166(1):83-94. doi: 10.1016/j.ahj.2013.04.001. Epub 2013 May 3.

Silber S, Serruys PW, Leon MB, Meredith IT, Windecker S, Neumann FJ, Belardi J, Widimsky P, Massaro J, Novack V, Yeung AC, Saito S, Mauri L. Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program. JACC Cardiovasc Interv. 2013 Apr;6(4):357-68. doi: 10.1016/j.jcin.2012.11.006. Epub 2013 Mar 20.

Farooq V, Vranckx P, Mauri L, Cutlip DE, Belardi J, Silber S, Widimsky P, Leon M, Windecker S, Meredith I, Negoita M, van Leeuwen F, Neumann FJ, Yeung AC, Garcia-Garcia HM, Serruys PW. Impact of overlapping newer generation drug-eluting stents on clinical and angiographic outcomes: pooled analysis of five trials from the international Global RESOLUTE Program. Heart. 2013 May;99(9):626-33. doi: 10.1136/heartjnl-2012-303368. Epub 2013 Mar 6.

Vranckx P, Farooq V, Garg S, Van Es GA, Silber S, Windecker S, Stone GW, Serruys PW. Different cardiac biomarkers to detect peri-procedural myocardial infarction in contemporary coronary stent trials: impact on outcome reporting. Heart. 2012 Oct;98(19):1424-30. doi: 10.1136/heartjnl-2012-302267. Epub 2012 Jul 21.

Stefanini GG, Kalesan B, Pilgrim T, Räber L, Onuma Y, Silber S, Serruys PW, Meier B, Jüni P, Windecker S. Impact of sex on clinical and angiographic outcomes among patients undergoing revascularization with drug-eluting stents. JACC Cardiovasc Interv. 2012 Mar;5(3):301-10. doi: 10.1016/j.jcin.2011.11.011.

Gutiérrez-Chico JL, Wykrzykowska J, Nüesch E, van Geuns RJ, Koch KT, Koolen JJ, di Mario C, Windecker S, van Es GA, Gobbens P, Jüni P, Regar E, Serruys PW. Vascular tissue reaction to acute malapposition in human coronary arteries: sequential assessment with optical coherence tomography. Circ Cardiovasc Interv. 2012 Feb 1;5(1):20-9, S1-8. doi: 10.1161/CIRCINTERVENTIONS.111.965301. Epub 2012 Feb 7.

Gomez-Lara J, Heo JH, Brugaletta S, Garg S, Garcia-Garcia HM, van Geuns RJ, Silber S, Windecker S, Serruys PW. Risk of target lesion failure in relationship to vessel angiographic geometry and stent conformability using the second generation of drug-eluting stents. Am Heart J. 2011 Dec;162(6):1069-1079.e2. doi: 10.1016/j.ahj.2011.09.010. Epub 2011 Nov 8.

Gutiérrez-Chico JL, Regar E, Nüesch E, Okamura T, Wykrzykowska J, di Mario C, Windecker S, van Es GA, Gobbens P, Jüni P, Serruys PW. Delayed coverage in malapposed and side-branch struts with respect to well-apposed struts in drug-eluting stents: in vivo assessment with optical coherence tomography. Circulation. 2011 Aug 2;124(5):612-23. doi: 10.1161/CIRCULATIONAHA.110.014514. Epub 2011 Jul 18.

Gutiérrez-Chico JL, van Geuns RJ, Regar E, van der Giessen WJ, Kelbæk H, Saunamäki K, Escaned J, Gonzalo N, di Mario C, Borgia F, Nüesch E, García-García HM, Silber S, Windecker S, Serruys PW. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All Comers trial. Eur Heart J. 2011 Oct;32(19):2454-63. doi: 10.1093/eurheartj/ehr182. Epub 2011 Jun 9.

Stefanini GG, Serruys PW, Silber S, Khattab AA, van Geuns RJ, Richardt G, Buszman PE, Kelbæk H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, Di Mario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli AL, Gobbens P, Windecker S. The impact of patient and lesion complexity on clinical and angiographic outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial (a randomized comparison of a zotarolimus-eluting stent with an everolimus-eluting stent for percutaneous coronary intervention). J Am Coll Cardiol. 2011 May 31;57(22):2221-32. doi: 10.1016/j.jacc.2011.01.036.

Garg S, Serruys PW, Silber S, Wykrzykowska J, van Geuns RJ, Richardt G, Buszman PE, Kelbæk H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, DiMario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Van Remortel E, Ronden J, Windecker S. The prognostic utility of the SYNTAX score on 1-year outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial. JACC Cardiovasc Interv. 2011 Apr;4(4):432-41. doi: 10.1016/j.jcin.2011.01.008.

Silber S, Windecker S, Vranckx P, Serruys PW; RESOLUTE All Comers investigators. Unrestricted randomised use of two new generation drug-eluting coronary stents: 2-year patient-related versus stent-related outcomes from the RESOLUTE All Comers trial. Lancet. 2011 Apr 9;377(9773):1241-7. doi: 10.1016/S0140-6736(11)60395-4. Epub 2011 Apr 1.

Serruys PW, Silber S, Garg S, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, DiMario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Ronden J, Bressers M, Gobbens P, Negoita M, van Leeuwen F, Windecker S. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010 Jul 8;363(2):136-46. doi: 10.1056/NEJMoa1004130. Epub 2010 Jun 16.

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Responsible Party:	Medtronic Vascular
ClinicalTrials.gov Identifier:	NCT00617084
Other Study ID Numbers:	Version 1.2 - IP090
First Posted:	February 15, 2008 Key Record Dates
Results First Posted:	May 17, 2011
Last Update Posted:	June 6, 2014
Last Verified:	May 2014

Keywords provided by Medtronic Vascular:


Drug Eluting Stents Interventional Cardiology

Additional relevant MeSH terms:

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Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases	Vascular Diseases Everolimus Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs

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