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
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 Du...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2019-10-01
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| Series: | Journal of Cardiothoracic Surgery |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13019-019-1010-z |
| _version_ | 1818348564838875136 |
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| author | Etem Caliskan Sigrid Sandner Martin Misfeld Jose Aramendi Sacha P. Salzberg Yeong-Hoon Choi Vilas Satishchandran Geeta Iyer Louis P. Perrault Andreas Böning Maximilian Y. Emmert |
| author_facet | Etem Caliskan Sigrid Sandner Martin Misfeld Jose Aramendi Sacha P. Salzberg Yeong-Hoon Choi Vilas Satishchandran Geeta Iyer Louis P. Perrault Andreas Böning Maximilian Y. Emmert |
| author_sort | Etem Caliskan |
| collection | DOAJ |
| description | 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). Trial registration ClinicalTrials.gov NCT02922088. Registered October 3, 2016. Ethics and dissemination The regional ethics committees have approved the registry. Results will be submitted for publication. |
| first_indexed | 2024-12-13T17:52:04Z |
| format | Article |
| id | doaj.art-2fa6e6dcc1634138b57e227747b430a8 |
| institution | Directory Open Access Journal |
| issn | 1749-8090 |
| language | English |
| last_indexed | 2024-12-13T17:52:04Z |
| publishDate | 2019-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Cardiothoracic Surgery |
| spelling | doaj.art-2fa6e6dcc1634138b57e227747b430a82022-12-21T23:36:28ZengBMCJournal of Cardiothoracic Surgery1749-80902019-10-011411710.1186/s13019-019-1010-zA 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 registryEtem Caliskan0Sigrid Sandner1Martin Misfeld2Jose Aramendi3Sacha P. Salzberg4Yeong-Hoon Choi5Vilas Satishchandran6Geeta Iyer7Louis P. Perrault8Andreas Böning9Maximilian Y. Emmert10Department of Cardiovascular Surgery, Charité Universitätsmedizin BerlinDepartment of Cardiac Surgery, Vienna General Hospital, Medical University of ViennaUniversity Clinic of Cardiac Surgery, Heart Center LeipzigDivision of Cardiac Surgery, Hospital de CrucesHeart Clinic, HirslandenDepartment of Cardiothoracic Surgery, Heart Center of the University Hospital of CologneSomahlutionSomahlutionDepartment of Surgery, Montreal Heart Institute, Université de MontréalDepartment of Cardiovascular Surgery, Justus-Liebig University GießenDepartment of Cardiovascular Surgery, Charité Universitätsmedizin BerlinAbstract 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). Trial registration ClinicalTrials.gov NCT02922088. Registered October 3, 2016. Ethics and dissemination The regional ethics committees have approved the registry. Results will be submitted for publication.http://link.springer.com/article/10.1186/s13019-019-1010-zSaphenous vein graftVein graft failureMyocardial infarctionCoronary artery bypass graftingPatencyEndothelial damage inhibitor |
| spellingShingle | Etem Caliskan Sigrid Sandner Martin Misfeld Jose Aramendi Sacha P. Salzberg Yeong-Hoon Choi Vilas Satishchandran Geeta Iyer Louis P. Perrault Andreas Böning Maximilian Y. Emmert 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 Journal of Cardiothoracic Surgery Saphenous vein graft Vein graft failure Myocardial infarction Coronary artery bypass grafting Patency Endothelial damage inhibitor |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Saphenous vein graft Vein graft failure Myocardial infarction Coronary artery bypass grafting Patency Endothelial damage inhibitor |
| url | http://link.springer.com/article/10.1186/s13019-019-1010-z |
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