Efficacy Study of Drug-eluting and Bare Metal Stents in Bypass Graft Lesions (ISAR-CABG)

• ClinicalTrials.gov Identifier: NCT00611910
• Recruitment Status: Completed
• First Posted: February 11, 2008
• Last Update Posted: May 13, 2011
• Sponsor: Deutsches Herzzentrum Muenchen
• Information provided by: Deutsches Herzzentrum Muenchen

Study Description

Brief Summary:

The aim of this study is to compare the efficacy of drug-eluting stents and bare metal stents to reduce reblockage of bypass grafts after coronary stenting

Condition or disease	Intervention/treatment	Phase
Arteriosclerosis of Arterial Coronary Artery Bypass Graft	Device: sirolimus-eluting stent; Device: paclitaxel-eluting stent; Device: biodegradable-polymer-based sirolimus-eluting stent; Device: bare metal stents	Phase 4

Detailed Description:

A large number of studies showed that drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare metal stents. Although this applies to the vast majority of patients, intimal hyperplasia and in-stent restenosis have not been completely eliminated and remain to occur in certain high risk subgroups. While there is a plenty of data about the efficacy of DES in complex lesions or diabetics, no randomized data exist about the efficacy of DES in coronary artery bypass graft lesions.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 610 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective, Randomized Trial of Drug-eluting Stents vs. Bare Metal Stents for the Reduction of Restenosis in Bypass Grafts.
• Study Start Date: November 2007
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: March 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: DES; drug-eluting stents	Device: sirolimus-eluting stent; due to randomization Cypher stent will be implanted; Other Name: Cypher; Device: paclitaxel-eluting stent; due to randomization Taxus stent will be implanted; Other Name: Taxus; Device: biodegradable-polymer-based sirolimus-eluting stent; due to randomization a rapamycin-eluting stent with biodegradable polymer will be implanted; Other Name: ISAR-DES, Yukon PC
Active Comparator: BMS; bare metal stents	Device: bare metal stents; Due to randomization one bare-metal stent will be implanted. The decision about the stent type will be up to the interventionalist; Other Names: Multilink Vision; Driver; etc.

Outcome Measures

Primary Outcome Measures :

1. The primary end point of the study is composite of death, myocardial infarction and target lesion revascularization at one year after stent implantation [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. Myocardial infarction rate [ Time Frame: 12 months ]
2. Need of target lesion revascularization (TLR), defined as any revascularization procedure involving the target lesion due to luminal re-narrowing in the presence of symptoms or objective signs of ischemia. [ Time Frame: 12 months ]
3. All cause death [ Time Frame: 12 months ]
4. Stent thrombosis [ Time Frame: 12 months ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in CABG
• Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
• In women with childbearing potential a negative pregnancy test is mandatory

Exclusion Criteria:

• Cardiogenic shock
• Target lesion located in the native coronary vessels.
• In-stent restenosis of CABG
• Target lesion located at internal mammary artery graft or free arterial graft
• Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
• Known allergy to the study medications: clopidogrel, rapamycin, paclitaxel, stainless steel.
• Inability to take clopidogrel for at least 6 months.
• Pregnancy (present, suspected or planned) or positive pregnancy test.
• Previous enrollment in this trial.
• Patient's inability to fully cooperate with the study protocol.

Contacts and Locations

Locations

Germany

Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Bad Segeberger Kliniken

Bad Segeberg, Germany

Medizinische Klinik, Klinikum rechts der Isar

Muenchen, Germany, 81675

Deutsches Herzzentrum Muenchen

Munich, Germany, 80636

Sponsors and Collaborators

Deutsches Herzzentrum Muenchen

Investigators

• Principal Investigator: Julinda Mehilli, MD; Deutsches Herzzentrum Muenchen
• Study Chair: Adnan Kastrati, MD; Deutsches Herzzentrum Muenchen

More Information

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

Colleran R, Kufner S, Mehilli J, Rosenbeiger C, Schupke S, Hoppmann P, Joner M, Mankerious N, Fusaro M, Cassese S, Abdel-Wahab M, Neumann FJ, Richardt G, Ibrahim T, Schunkert H, Laugwitz KL, Kastrati A, Byrne RA; ISAR-CABG Investigators. Efficacy Over Time With Drug-Eluting Stents in Saphenous Vein Graft Lesions. J Am Coll Cardiol. 2018 May 8;71(18):1973-1982. doi: 10.1016/j.jacc.2018.03.456.

Mehilli J, Pache J, Abdel-Wahab M, Schulz S, Byrne RA, Tiroch K, Hausleiter J, Seyfarth M, Ott I, Ibrahim T, Fusaro M, Laugwitz KL, Massberg S, Neumann FJ, Richardt G, Schomig A, Kastrati A; Is Drug-Eluting-Stenting Associated with Improved Results in Coronary Artery Bypass Grafts? (ISAR-CABG) Investigators. Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): a randomised controlled superiority trial. Lancet. 2011 Sep 17;378(9796):1071-8. doi: 10.1016/S0140-6736(11)61255-5. Epub 2011 Aug 26. Erratum In: Lancet. 2012 Jan 14;379(9811):122.

• Responsible Party: Prof. A. Schömig, Deutsches Herzzentrum Munich
• ClinicalTrials.gov Identifier: NCT00611910
• Other Study ID Numbers: GE IDE No. S02707
• First Posted: February 11, 2008
• Last Update Posted: May 13, 2011
• Last Verified: May 2011

Additional relevant MeSH terms:

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Sirolimus; Paclitaxel; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs