Caliskan, Etem, Sandner, Sigrid, Misfeld, Martin, Aramendi, Jose, Salzberg, Sacha P., Choi, Yeong-Hoon, Satishchandran, Vilas, Iyer, Geeta, Perrault, Louis P., Boening, Andreas and Emmert, Maximilian Y. (2019). A novel endothelial damage inhibitor for the treatment of vascular conduits in coronary artery bypass grafting: protocol and rationale for the European, multicentre, prospective, observational DuraGraft registry. J. Cardiothorac. Surg., 14 (1). LONDON: BMC. ISSN 1749-8090

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Abstract

Background Vein graft disease (VGD) impairs graft patency rates and long-term outcomes after coronary artery bypass grafting (CABG). DuraGraft is a novel endothelial-damage inhibitor developed to efficiently protect the structural and functional integrity of the vascular endothelium. The DuraGraft registry will evaluate the long-term clinical outcomes of DuraGraft in patients undergoing CABG procedures. Methods This ongoing multicentre, prospective observational registry will enrol 3000 patients undergoing an isolated CABG procedure or a combined procedure (ie, CABG plus valve surgery or other surgery) with at least one saphenous vein grafts or one free arterial graft (ie, radial artery or mammary artery). If a patient is enrolled, all free grafts (SVG and arterial will be treated with DuraGraft. Data on baseline, clinical, and angiographic characteristics as well as procedural and clinical events will be collected. The primary outcome measure is the occurrence of a major adverse cardiac event (MACE; defined as death, non-fatal myocardial-infarction, or need for repeat-revascularisation). Secondary outcome measures are the occurrence of major adverse cardiac and cerebrovascular events (MACCE; defined as death, non-fatal myocardial-infarction, repeat-revascularisation, or stroke), patient-reported quality of life, and health-economic data. Patient assessments will be performed during hospitalisation, at 1-month, 1-year, and annually thereafter to 5 years post-CABG. Events will be adjudicated by an independent clinical events committee. This European, multi-institutional registry will provide detailed insights into clinical outcome associated with DuraGraft. Discussion This European, multi-institutional registry will provide detailed insights into clinical outcome associated with the use of DuraGraft. Beyond that, and given the comprehensive data sets comprising of patient, procedural, and graft parameters that are being collected, the registry will enable for multiple subgroup analyses targeting focus groups or specific clinical questions. These may include analysis of subpopulations such as patients with diabetes or multimorbid high-risk patients (patient level), evaluation of relevance of harvesting technique including endoscopic versus open conduit harvesting (procedural level), or particular graft-specific aspects (conduit level). Ethics and dissemination The regional ethics committees have approved the registry. Results will be submitted for publication.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Caliskan, EtemUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sandner, SigridUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Misfeld, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Aramendi, JoseUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Salzberg, Sacha P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Choi, Yeong-HoonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Satishchandran, VilasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Iyer, GeetaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Perrault, Louis P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boening, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Emmert, Maximilian Y.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-130898
DOI: 10.1186/s13019-019-1010-z
Journal or Publication Title: J. Cardiothorac. Surg.
Volume: 14
Number: 1
Date: 2019
Publisher: BMC
Place of Publication: LONDON
ISSN: 1749-8090
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
SAPHENOUS-VEIN GRAFTS; RADIAL ARTERY; PREVENT IV; LONG-TERM; FOLLOW-UP; PRESERVATION; SURGERY; OUTCOMES; FAILURE; STORAGEMultiple languages
Cardiac & Cardiovascular Systems; SurgeryMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/13089

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