Sirolimus-eluting Stents With Biodegradable Polymer Versus an Everolimus-eluting Stents

NCT01443104 | Completed DMC

• 1 other identifier: 065/11
• Study Type: interventional
• Target: 2,119
• Locations: 1 country
• Sites: 9

Brief Summary

Coronary artery stents have improved the safety and efficacy of percutaneous coronary intervention for coronary artery disease. Drug-eluting stents have been shown to decrease neointimal hyperplasia and to reduce the rate of restenosis and target-lesion revascularization as compared to bare-metal stents. Drug-eluting stents consist of a metallic platform and a therapeutic substance that is usually released from a polymer matrix. A previous study utilizing a bioresorbable polymer has demonstrated a favorable safety and efficacy profile in a large-scale clinical trial as compared to a first-generation druf-eluting stent (LEADERS trial). The objective of the study is to compare the safety and efficacy of a sirolimus-eluting stent with a biodegradable polymer with an everolimus-eluting stent with a durable polymer in a prospective multicenter randomized controlled non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Infarction

Keywords

coronary artery disease; drug-eluting stents; polymers

Outcome Measures

Primary Outcomes (1)

• Target lesion failure (TLF), defined as the composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) and emergent coronary artery bypass grafting (CABG)

  12 months

Secondary Outcomes (25)

• Number of patients with target lesion revascularization (TLR)

  30 days

• Number of patients with target lesion revascularization (TLR)

  1 year

• Number of patients with target lesion revascularization (TLR)

  2 years

• Number of patients with target lesion revascularization (TLR)

  5 years

• Clinically indicated and not clinically indicated target vessel revascularization (TVR)

  30 days

Study Arms (2)

Orsiro Stent

ACTIVE COMPARATOR

Sirolimus-eluting Stent with a Biodegradable Polymer

Device: Sirolimus-eluting stent with a bioresorbable polymer (Orsiro)

Xience Prime Stent

ACTIVE COMPARATOR

Everolimus-eluting Stent with a Durable Polymer

Device: Everolimus-eluting stent with a durable polymer

Interventions

Sirolimus-eluting stent with a bioresorbable polymer (Orsiro) DEVICE

Percutaneous coronary intervention with implantation of a sirolimus-eluting stent with a bioresorbable polymer for coronary artery disease

Orsiro Stent

Everolimus-eluting stent with a durable polymer DEVICE

Percutaneous coronary intervention with implantation of an everolimus-eluting stent with a durable polymer for coronary artery disease

Xience Prime Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including NSTE-ACS and STE-ACS
• Presence of one or more coronary artery stenoses \>50% in a native coronary artery or a saphenous bypass graft which can be treated with a stent ranging in diameter from 2.25 to 4.0 mm and can be covered with one or multiple stents
• No limitation on the number of treated lesions, and vessels, and lesion length

You may not qualify if:

• Pregnancy
• Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Everolimus 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 peri-surgical period

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Biotronik AG: collaborator
• University of Bern: collaborator

Study Sites (9)

Kantonsspital Aarau

Aarau, 5000, Switzerland

Location

Universitätsklinik Basel

Basel, 4031, Switzerland

Location

Department of Cardiology, Bern University Hospital

Bern, 3010, Switzerland

Location

HFR Freiburg

Fribourg, 1708, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, 1211, Switzerland

Location

Service de cardiologie CHUV

Lausanne, 1010, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6004, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Stadtspital Triemli

Zurich, 8055, Switzerland

Location

Related Publications (13)

• Zbinden R, Piccolo R, Heg D, Roffi M, Kurz DJ, Muller O, Vuilliomenet A, Cook S, Weilenmann D, Kaiser C, Jamshidi P, Franzone A, Eberli F, Juni P, Windecker S, Pilgrim T. Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable-Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularization: 2-Year Results of the BIOSCIENCE Trial. J Am Heart Assoc. 2016 Mar 15;5(3):e003255. doi: 10.1161/JAHA.116.003255.

  PMID: 26979080 RESULT

• Franzone A, Pilgrim T, Heg D, Roffi M, Tuller D, Vuilliomenet A, Muller O, Cook S, Weilenmann D, Kaiser C, Jamshidi P, Raber L, Stortecky S, Wenaweser P, Juni P, Windecker S. Clinical outcomes according to diabetic status in patients treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents: prespecified subgroup analysis of the BIOSCIENCE trial. Circ Cardiovasc Interv. 2015 Jun;8(6):e002319. doi: 10.1161/CIRCINTERVENTIONS.114.002319.

  PMID: 26043895 RESULT

• Pilgrim T, Piccolo R, Heg D, Roffi M, Tuller D, Vuilliomenet A, Muller O, Cook S, Weilenmann D, Kaiser C, Jamshidi P, Khattab AA, Taniwaki M, Rigamonti F, Nietlispach F, Blochlinger S, Wenaweser P, Juni P, Windecker S. Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for primary percutaneous coronary revascularisation of acute myocardial infarction. EuroIntervention. 2016 Dec 10;12(11):e1343-e1354. doi: 10.4244/EIJY15M12_09.

  PMID: 26690319 RESULT

• Pilgrim T, Heg D, Roffi M, Tuller D, Muller O, Vuilliomenet A, Cook S, Weilenmann D, Kaiser C, Jamshidi P, Fahrni T, Moschovitis A, Noble S, Eberli FR, Wenaweser P, Juni P, Windecker S. Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): a randomised, single-blind, non-inferiority trial. Lancet. 2014 Dec 13;384(9960):2111-22. doi: 10.1016/S0140-6736(14)61038-2. Epub 2014 Sep 1.

  PMID: 25189359 RESULT

• Pilgrim T, Piccolo R, Heg D, Roffi M, Tuller D, Muller O, Moarof I, Siontis GCM, Cook S, Weilenmann D, Kaiser C, Cuculi F, Hunziker L, Eberli FR, Juni P, Windecker S. Ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents versus thin-strut, durable-polymer, everolimus-eluting stents for percutaneous coronary revascularisation: 5-year outcomes of the BIOSCIENCE randomised trial. Lancet. 2018 Sep 1;392(10149):737-746. doi: 10.1016/S0140-6736(18)31715-X. Epub 2018 Aug 28.

  PMID: 30170848 RESULT

• Haner JD, Rohla M, Losdat S, Iglesias JF, Muller O, Eeckhout E, Kurz D, Weilenmann D, Kaiser C, Tapponnier M, Roffi M, Heg D, Windecker S, Pilgrim T. Ultrathin-strut vs thin-strut drug-eluting stents for multi and single-stent lesions: A lesion-level subgroup analysis of 2 randomized trials. Am Heart J. 2023 Sep;263:73-84. doi: 10.1016/j.ahj.2023.05.004. Epub 2023 May 14.

  PMID: 37192697 DERIVED

• Iglesias JF, Muller O, Losdat S, Roffi M, Kurz DJ, Weilenmann D, Kaiser C, Heg D, Windecker S, Pilgrim T. Complex primary percutaneous coronary intervention with ultrathin-strut biodegradable versus thin-strut durable polymer drug-eluting stents in patients with ST-segment elevation myocardial infarction: A subgroup analysis from the BIOSTEMI randomized trial. Catheter Cardiovasc Interv. 2023 Mar;101(4):687-700. doi: 10.1002/ccd.30600. Epub 2023 Feb 19.

  PMID: 36807456 DERIVED

• Iglesias JF, Heg D, Roffi M, Degrauwe S, Tuller D, Muller O, Brinkert M, Cook S, Weilenmann D, Kaiser C, Cuculi F, Valgimigli M, Juni P, Windecker S, Pilgrim T. Five-Year Outcomes With Biodegradable-Polymer Sirolimus-Eluting Stents Versus Durable-Polymer Everolimus-Eluting Stents in Patients With Acute Coronary Syndrome: A Subgroup Analysis of the BIOSCIENCE Trial. Cardiovasc Revasc Med. 2022 Jan;34:3-10. doi: 10.1016/j.carrev.2021.02.008. Epub 2021 Feb 25.

  PMID: 33653633 DERIVED

• Iglesias JF, Heg D, Roffi M, Tuller D, Lanz J, Rigamonti F, Muller O, Moarof I, Cook S, Weilenmann D, Kaiser C, Cuculi F, Valgimigli M, Juni P, Windecker S, Pilgrim T. Five-Year Outcomes in Patients With Diabetes Mellitus Treated With Biodegradable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents. J Am Heart Assoc. 2019 Nov 19;8(22):e013607. doi: 10.1161/JAHA.119.013607. Epub 2019 Nov 7.

  PMID: 31696762 DERIVED

• Iglesias JF, Heg D, Roffi M, Tuller D, Noble S, Muller O, Moarof I, Cook S, Weilenmann D, Kaiser C, Cuculi F, Haner J, Juni P, Windecker S, Pilgrim T. Long-Term Effect of Ultrathin-Strut Versus Thin-Strut Drug-Eluting Stents in Patients With Small Vessel Coronary Artery Disease Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the BIOSCIENCE Randomized Trial. Circ Cardiovasc Interv. 2019 Aug;12(8):e008024. doi: 10.1161/CIRCINTERVENTIONS.119.008024. Epub 2019 Aug 6.

  PMID: 31525083 DERIVED

• Koskinas KC, Siontis GC, Piccolo R, Franzone A, Haynes A, Rat-Wirtzler J, Silber S, Serruys PW, Pilgrim T, Raber L, Heg D, Juni 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.

  PMID: 26823484 DERIVED

• 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):e002279. doi: 10.1161/CIRCINTERVENTIONS.114.002279.

  PMID: 25825008 DERIVED

• Pilgrim T, Roffi M, Tuller D, Muller O, Vuilliomenet A, Cook S, Weilenmann D, Kaiser C, Jamshidi P, Heg D, Juni P, Windecker S. Randomized comparison of biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for percutaneous coronary revascularization: rationale and design of the BIOSCIENCE trial. Am Heart J. 2014 Sep;168(3):256-61. doi: 10.1016/j.ahj.2014.06.004. Epub 2014 Jun 6.

  PMID: 25173535 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Stephan Windecker

  Department of Cardiology, Bern University Hospital, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 29, 2011
• Study Start: February 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

CH (9)