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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DES | Experimental | drug-eluting stents |
|
| BMS | Active Comparator | bare metal stents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sirolimus-eluting stent | Device | due to randomization Cypher stent will be implanted |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary end point of the study is composite of death, myocardial infarction and target lesion revascularization at one year after stent implantation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infarction rate | 12 months | |
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julinda Mehilli, MD | Deutsches Herzzentrum Muenchen | Principal Investigator |
| Adnan Kastrati, MD | Deutsches Herzzentrum Muenchen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herzzentrum Bad Krozingen | Bad Krozingen | Germany | ||||
| Bad Segeberger Kliniken |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29724350 | Derived | 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. | |
| 21872918 |
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| paclitaxel-eluting stent | Device | due to randomization Taxus stent will be implanted |
|
|
| biodegradable-polymer-based sirolimus-eluting stent | Device | due to randomization a rapamycin-eluting stent with biodegradable polymer will be implanted |
|
|
| bare metal stents | Device | Due to randomization one bare-metal stent will be implanted. The decision about the stent type will be up to the interventionalist |
|
|
| All cause death | 12 months |
| Stent thrombosis | 12 months |
| Bad Segeberg |
| Germany |
| Deutsches Herzzentrum Muenchen | Munich | 80636 | Germany |
| Medizinische Klinik, Klinikum rechts der Isar | München | 81675 | Germany |
| Derived |
| 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. |