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Limus Eluted From A Durable Versus ERodable Stent Coating (LEADERS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00389220
First Posted: October 18, 2006
Last Update Posted: September 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biosensors Europe SA
  Purpose
The purpose of this study is to compare the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a non-inferiority trial.

Condition Intervention Phase
Coronary Disease Coronary Stenosis Device: Coronary stent placement Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of a Biolimus-Eluting Stent With a Sirolimus-Eluting Stent for Percutaneous Coronary Intervention

Further study details as provided by Biosensors Europe SA:

Primary Outcome Measures:
  • Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 9 month ]
    Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)


Secondary Outcome Measures:
  • Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 30 days ]
    Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)

  • Cardiac death [ Time Frame: 30 days ]
    Cardiac death

  • All deaths [ Time Frame: 30 days ]
    All deaths (cardiac and non-cardiac)

  • Myocardial infarction [ Time Frame: 30 days ]
    Myocardial infarction (Q-wave and NQWMI)

  • Angiographic and clinical stent thrombosis. [ Time Frame: 30 days ]
    Angiographic and clinical stent thrombosis

  • In-stent and in-segment binary restenosis rate as assessed by QCA. [ Time Frame: 9 month ]
    In-stent and in-segment binary restenosis rate as assessed by QCA.

  • In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA. [ Time Frame: 9 month ]
    In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA

  • In-segment percent diameter stenosis (%DS). [ Time Frame: 9 month ]
    In-segment percent diameter stenosis (%DS) as assessed by QCA

  • In-stent and in-segment late luminal loss [ Time Frame: 9 month ]
    In-stent and in-segment late luminal loss as assessed by QCA

  • Device success, lesion success and procedural success. [ Time Frame: at implant ]
  • Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 6 month ]
    Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)

  • Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 1 year ]
    Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)

  • Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 2 years ]
    Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)

  • Cardiac death [ Time Frame: 6 month ]
    Cardiac death

  • Cardiac death [ Time Frame: 9 month ]
    Cardiac death

  • Cardiac death [ Time Frame: 1 year ]
    Cardiac death

  • Cardiac death [ Time Frame: 2 year ]
    Cardiac death

  • Cardiac death [ Time Frame: 3 year ]
    Cardiac death

  • Cardiac death [ Time Frame: 4 year ]
    Cardiac death

  • Cardiac death [ Time Frame: 5 year ]
    Cardiac death

  • Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 3 year ]
    Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)

  • Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 4 year ]
    Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)

  • Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 5 year ]
    Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)

  • All deaths [ Time Frame: 6 month ]
    All deaths (cardiac and non-cardiac)

  • All deaths [ Time Frame: 9 month ]
    All deaths (cardiac and non-cardiac)

  • All deaths [ Time Frame: 1 year ]
    All deaths (cardiac and non-cardiac)

  • All deaths [ Time Frame: 2 years ]
    All deaths (cardiac and non-cardiac)

  • All deaths [ Time Frame: 3 years ]
    All deaths (cardiac and non-cardiac)

  • All deaths [ Time Frame: 4 years ]
    All deaths (cardiac and non-cardiac)

  • All deaths [ Time Frame: 5 years ]
    All deaths (cardiac and non-cardiac)

  • Myocardial infarction [ Time Frame: 6 month ]
    Myocardial infarction (Q-wave and NQWMI)

  • Myocardial infarction [ Time Frame: 9 month ]
    Myocardial infarction (Q-wave and NQWMI)

  • Myocardial infarction [ Time Frame: 1 year ]
    Myocardial infarction (Q-wave and NQWMI)

  • Myocardial infarction [ Time Frame: 2 years ]
    Myocardial infarction (Q-wave and NQWMI)

  • Myocardial infarction [ Time Frame: 3 years ]
    Myocardial infarction (Q-wave and NQWMI)

  • Myocardial infarction [ Time Frame: 4 years ]
    Myocardial infarction (Q-wave and NQWMI)

  • Myocardial infarction [ Time Frame: 5 years ]
    Myocardial infarction (Q-wave and NQWMI)

  • Angiographic and clinical stent thrombosis. [ Time Frame: 6 month ]
    Angiographic and clinical stent thrombosis

  • Angiographic and clinical stent thrombosis. [ Time Frame: 9 month ]
    Angiographic and clinical stent thrombosis

  • Angiographic and clinical stent thrombosis. [ Time Frame: 1 year ]
    Angiographic and clinical stent thrombosis

  • Angiographic and clinical stent thrombosis. [ Time Frame: 2 years ]
    Angiographic and clinical stent thrombosis

  • Angiographic and clinical stent thrombosis. [ Time Frame: 3 years ]
    Angiographic and clinical stent thrombosis

  • Angiographic and clinical stent thrombosis. [ Time Frame: 4 years ]
    Angiographic and clinical stent thrombosis

  • Angiographic and clinical stent thrombosis. [ Time Frame: 5 years ]
    Angiographic and clinical stent thrombosis


Enrollment: 1707
Study Start Date: November 2006
Study Completion Date: June 2012
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BioMatrix Flex stent
Coronary stent placement with Biolimus A9 coated stent with biodegradable polymer
Device: Coronary stent placement
Coronary stent placement
Active Comparator: Cypher Select stent
Coronary stent placement with Sirolimus coated stent with durable polymer
Device: Coronary stent placement
Coronary stent placement

Detailed Description:
Compare the safety and efficacy of the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a prospective, multi-center, randomized, controlled, non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Age >= 18 years;
  • Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction and ST-elevation myocardial infarction;
  • Presence of one or more coronary artery stenoses >50% in a native coronary artery or a saphenous bypass graft from 2.25 to 3.5 mm in diameter that can be covered with one or multiple stents;
  • No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion Criteria:

  • Pregnancy;
  • Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Biolimus or contrast material;
  • Inability to provide informed consent;
  • Currently participating in another trial before reaching first endpoint;
  • Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the perisurgical 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): NCT00389220


Locations
Belgium
Onze Lieve Vrouw Ziekenhuis, Cardiologisch Centrum, Moorselbaan 164
Aalst, Belgium, B-9300
France
L'Institut Cardiovasculaire Paris Sud, Institut Hospitalier Jacques Cartier, Service de Coronarographie, 6, Avenue du Noyer Lambert
Massy, France, 91300
Germany
Herzzentrum Leipzig, Innere Medizin/Kardiologie, Struimpellstrasse 39
Leipzig, Germany, D-04289
Universitatsklinikum Munchen, Medizinische Klinik Kardiologie, Ziemssenstrasse 1
Munich, Germany, 80336
Klinikum Bogenhausen der Stad München, Abteilung für Kardiologie und Pnemlogie, Englschalkstrasse 77
Munich, Germany, D-8000
Netherlands
University Medical Center Rotterdam Erasmus, Thoraxcentrum
Rotterdam, Netherlands, 3015 GD
Poland
American Heart of Poland Sp. z o.o.
Dąbrowa Górnicza, Poland, 43100
Switzerland
Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern, Inselspital
Bern, Switzerland, CH-3010
University Hospital Zürich, Director of Invasive Cardiology, Rämistrasse 100
Zurich, Switzerland, 8091
United Kingdom
Royal Brompton Hospital, Sydney Street
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Biosensors Europe SA
Investigators
Principal Investigator: Stephan Windecker, Prof. Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern
  More Information

Publications:
Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008 Sep 27;372(9644):1163-73. doi: 10.1016/S0140-6736(08)61244-1. Epub 2008 Aug 31.
Garg S, Sarno G, Serruys PW, de Vries T, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, Di Mario C, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P, Windecker S. The twelve-month outcomes of a biolimus eluting stent with a biodegradable polymer compared with a sirolimus eluting stent with a durable polymer. EuroIntervention. 2010 Jun;6(2):233-9. doi: 10.4244/.
Sarno G, Garg S, Onuma Y, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, van Geuns RJ, Eerdmans P, Garcia-Garcia HM, van Es GA, Goedhart D, de Vries T, Jüni P, Meier B, Windecker S, Serruys P. The impact of body mass index on the one year outcomes of patients treated by percutaneous coronary intervention with Biolimus- and Sirolimus-eluting stents (from the LEADERS Trial). Am J Cardiol. 2010 Feb 15;105(4):475-9. doi: 10.1016/j.amjcard.2009.09.055. Epub 2010 Jan 5.
Wykrzykowska JJ, Serruys PW, Onuma Y, de Vries T, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S. Impact of vessel size on angiographic and clinical outcomes of revascularization with biolimus-eluting stent with biodegradable polymer and sirolimus-eluting stent with durable polymer the LEADERS trial substudy. JACC Cardiovasc Interv. 2009 Sep;2(9):861-70. doi: 10.1016/j.jcin.2009.05.024.
Wykrzykowska JJ, Räber L, de Vries T, Bressers M, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Regar E, Jüni P, Windecker S, Serruys PW. Biolimus-eluting biodegradable polymer versus sirolimus-eluting permanent polymer stent performance in long lesions: results from the LEADERS multicentre trial substudy. EuroIntervention. 2009 Aug;5(3):310-7.

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.
Grundeken MJ, Wykrzykowska JJ, Ishibashi Y, Garg S, de Vries T, Garcia-Garcia HM, Onuma Y, de Winter RJ, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Meier B, Jüni P, Yazdani A, Copt S, Windecker S, Serruys PW. First generation versus second generation drug-eluting stents for the treatment of bifurcations: 5-year follow-up of the LEADERS all-comers randomized trial. Catheter Cardiovasc Interv. 2016 Jun;87(7):E248-60. doi: 10.1002/ccd.26344. Epub 2015 Dec 9.
Zhang YJ, Iqbal J, Windecker S, Linke A, Antoni D, Sohn HY, Corti R, van Es GA, Copt S, Eerdmans P, Saitta R, Morice MC, Di Mario C, Juni P, Wijns W, Buszman P, Serruys PW. Biolimus-eluting stent with biodegradable polymer improves clinical outcomes in patients with acute myocardial infarction. Heart. 2015 Feb;101(4):271-8. doi: 10.1136/heartjnl-2014-306359. Epub 2014 Nov 25.
Vranckx P, Kalesan B, Stefanini GG, Farooq V, Onuma Y, Silber S, de Vries T, Jüni P, Serruys PW, Windecker S. Clinical outcome of patients with stable ischaemic heart disease as compared to those with acute coronary syndromes after percutaneous coronary intervention. EuroIntervention. 2015 Jun;11(2):171-9. doi: 10.4244/EIJV11I2A31.
Serruys PW, Farooq V, Kalesan B, de Vries T, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, Rademaker-Havinga T, van Es GA, Meier B, Jüni P, Windecker S. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. JACC Cardiovasc Interv. 2013 Aug;6(8):777-89. doi: 10.1016/j.jcin.2013.04.011.
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.
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, Jüni P, García-García HM, Regar E, Nüesch E, Borgia F, van der Giessen WJ, Davies S, van Geuns RJ, Secco GG, Meis S, Windecker S, Serruys PW, di Mario C. Long-term tissue coverage of a biodegradable polylactide polymer-coated biolimus-eluting stent: comparative sequential assessment with optical coherence tomography until complete resorption of the polymer. Am Heart J. 2011 Nov;162(5):922-31. doi: 10.1016/j.ahj.2011.09.005. Epub 2011 Oct 7.
Stefanini GG, Kalesan B, Serruys PW, Heg D, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, van Es GA, Meier B, Windecker S, Jüni P. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial. Lancet. 2011 Dec 3;378(9807):1940-8. doi: 10.1016/S0140-6736(11)61672-3. Epub 2011 Nov 8.
Klauss V, Serruys PW, Pilgrim T, Buszman P, Linke A, Ischinger T, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, van Geuns RJ, van Es GA, Kalesan B, Wenaweser P, Jüni P, Windecker S. 2-year clinical follow-up from the randomized comparison of biolimus-eluting stents with biodegradable polymer and sirolimus-eluting stents with durable polymer in routine clinical practice. JACC Cardiovasc Interv. 2011 Aug;4(8):887-95. doi: 10.1016/j.jcin.2011.03.017.
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.
Wykrzykowska JJ, Garg S, Onuma Y, de Vries T, Goedhart D, Morel MA, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S, Serruys PW. Value of age, creatinine, and ejection fraction (ACEF score) in assessing risk in patients undergoing percutaneous coronary interventions in the 'All-Comers' LEADERS trial. Circ Cardiovasc Interv. 2011 Feb 1;4(1):47-56. doi: 10.1161/CIRCINTERVENTIONS.110.958389. Epub 2011 Jan 4.
Wykrzykowska JJ, Garg S, Girasis C, de Vries T, Morel MA, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S, Serruys PW. Value of the SYNTAX score for risk assessment in the all-comers population of the randomized multicenter LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) trial. J Am Coll Cardiol. 2010 Jul 20;56(4):272-7. doi: 10.1016/j.jacc.2010.03.044.

Responsible Party: Biosensors Europe SA
ClinicalTrials.gov Identifier: NCT00389220     History of Changes
Other Study ID Numbers: 05EU01
First Submitted: October 13, 2006
First Posted: October 18, 2006
Last Update Posted: September 24, 2013
Last Verified: September 2013

Keywords provided by Biosensors Europe SA:
Coronary Disease
Coronary Stenosis
Angioplasty
Coronary Restenosis
Drug Eluting Stent

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Coronary Stenosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases


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