Randomized comparison of HARVesting the Left Internal Thoracic Artery in a skeletonized versus pedicled technique: the HARVITA trial-study protocol
Latest research has indicated a potential adverse effect on graft patency rates and clinical outcomes with skeletonizing the left internal thoracic artery. We aim to provide a prospective, randomized, multicentre trial to compare skeletonized versus pedicled harvesting technique of left internal tho...
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Published in | Interdisciplinary cardiovascular and thoracic surgery Vol. 38; no. 4 |
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Main Authors | , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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Oxford University Press
29.03.2024
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Abstract | Latest research has indicated a potential adverse effect on graft patency rates and clinical outcomes with skeletonizing the left internal thoracic artery. We aim to provide a prospective, randomized, multicentre trial to compare skeletonized versus pedicled harvesting technique of left internal thoracic artery concerning graft patency rates and patient survival. A total of 1350 patients will be randomized to either skeletonized or pedicled harvesting technique and undergo surgical revascularization. Follow-up will be performed at 30 days, 1 year, 2 years and 5 years after surgery. The primary outcome will be death or left internal thoracic artery graft occlusion in coronary computed tomography angiography or invasive angiography within 2 years (+/- 3 months) after surgery. The secondary outcome will be major adverse cardiac events (composite outcome of all-cause death, myocardial infarction and repeated revascularization) within 1 year, 2 years and 5 years after surgery. The primary end point will be compared in the modified intention-to-treat population between the two treatment groups using Kaplan-Meier graphs, together with log-rank testing. Hereby, we present the study protocol of the first adequately powered prospective, randomized, multicentre trial which compares skeletonized and pedicled harvesting technique of left internal thoracic artery regarding graft patency rates and patient survival. |
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AbstractList | Abstract
Latest research has indicated a potential adverse effect on graft patency rates and clinical outcomes with skeletonizing the left internal thoracic artery. We aim to provide a prospective, randomized, multicentre trial to compare skeletonized versus pedicled harvesting technique of left internal thoracic artery concerning graft patency rates and patient survival. A total of 1350 patients will be randomized to either skeletonized or pedicled harvesting technique and undergo surgical revascularization. Follow-up will be performed at 30 days, 1 year, 2 years and 5 years after surgery. The primary outcome will be death or left internal thoracic artery graft occlusion in coronary computed tomography angiography or invasive angiography within 2 years (+/- 3 months) after surgery. The secondary outcome will be major adverse cardiac events (composite outcome of all-cause death, myocardial infarction and repeated revascularization) within 1 year, 2 years and 5 years after surgery. The primary end point will be compared in the modified intention-to-treat population between the two treatment groups using Kaplan–Meier graphs, together with log-rank testing. Hereby, we present the study protocol of the first adequately powered prospective, randomized, multicentre trial which compares skeletonized and pedicled harvesting technique of left internal thoracic artery regarding graft patency rates and patient survival. Latest research has indicated a potential adverse effect on graft patency rates and clinical outcomes with skeletonizing the left internal thoracic artery. We aim to provide a prospective, randomized, multicentre trial to compare skeletonized versus pedicled harvesting technique of left internal thoracic artery concerning graft patency rates and patient survival. A total of 1350 patients will be randomized to either skeletonized or pedicled harvesting technique and undergo surgical revascularization. Follow-up will be performed at 30 days, 1 year, 2 years and 5 years after surgery. The primary outcome will be death or left internal thoracic artery graft occlusion in coronary computed tomography angiography or invasive angiography within 2 years (+/- 3 months) after surgery. The secondary outcome will be major adverse cardiac events (composite outcome of all-cause death, myocardial infarction and repeated revascularization) within 1 year, 2 years and 5 years after surgery. The primary end point will be compared in the modified intention-to-treat population between the two treatment groups using Kaplan-Meier graphs, together with log-rank testing. Hereby, we present the study protocol of the first adequately powered prospective, randomized, multicentre trial which compares skeletonized and pedicled harvesting technique of left internal thoracic artery regarding graft patency rates and patient survival. |
Author | Czerny, Martin Grimm, Michael Thielmann, Matthias Zimpfer, Daniel Feuchtner, Gudrun Ulmer, Hanno Sandner, Sigrid Doenst, Torsten Bonaros, Nikolaos Ruttmann-Ulmer, Elfriede Böning, Andreas Siepe, Matthias Maier, Sarah Abfalterer, Hannes Gaudino, Mario |
Author_xml | – sequence: 1 givenname: Hannes orcidid: 0000-0002-1470-6026 surname: Abfalterer fullname: Abfalterer, Hannes organization: Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria – sequence: 2 givenname: Elfriede surname: Ruttmann-Ulmer fullname: Ruttmann-Ulmer, Elfriede organization: Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria – sequence: 3 givenname: Michael surname: Grimm fullname: Grimm, Michael organization: Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria – sequence: 4 givenname: Gudrun orcidid: 0000-0001-6755-4399 surname: Feuchtner fullname: Feuchtner, Gudrun organization: Department of Radiology, Medical University of Innsbruck, Innsbruck, Austria – sequence: 5 givenname: Sarah surname: Maier fullname: Maier, Sarah organization: Institute of Medical Statistics and Informatics, Medical University of Innsbruck, Innsbruck, Austria – sequence: 6 givenname: Hanno orcidid: 0000-0001-5911-1002 surname: Ulmer fullname: Ulmer, Hanno organization: Institute of Medical Statistics and Informatics, Medical University of Innsbruck, Innsbruck, Austria – sequence: 7 givenname: Sigrid orcidid: 0000-0003-4669-9841 surname: Sandner fullname: Sandner, Sigrid organization: Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria – sequence: 8 givenname: Daniel surname: Zimpfer fullname: Zimpfer, Daniel organization: Department of Surgery, Division of Cardiac Surgery, Medical University of Graz, Graz, Austria – sequence: 9 givenname: Torsten surname: Doenst fullname: Doenst, Torsten organization: Department of Cardiac Surgery, University of Jena, Jena, Germany – sequence: 10 givenname: Martin orcidid: 0000-0003-4766-9775 surname: Czerny fullname: Czerny, Martin organization: Department of Cardiovascular Surgery, University of Freiburg, Freiburg, Germany – sequence: 11 givenname: Matthias surname: Thielmann fullname: Thielmann, Matthias organization: Department of Thoracic and Cardiovascular Surgery, West-German Heart & Vascular Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany – sequence: 12 givenname: Andreas orcidid: 0000-0002-4404-510X surname: Böning fullname: Böning, Andreas organization: Department of Cardiovascular Surgery, University Hospital Giessen, Giessen, Germany – sequence: 13 givenname: Mario orcidid: 0000-0003-4680-0815 surname: Gaudino fullname: Gaudino, Mario organization: Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York City, NY, USA – sequence: 14 givenname: Matthias orcidid: 0000-0003-3305-9343 surname: Siepe fullname: Siepe, Matthias organization: Department of Cardiac Surgery, University Hospital Bern, University of Bern, Switzerland – sequence: 15 givenname: Nikolaos orcidid: 0000-0002-7656-5812 surname: Bonaros fullname: Bonaros, Nikolaos organization: Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria |
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Keywords | Harvesting technique Skeletonized versus pedicled Graft patency rate Left internal thoracic artery |
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Snippet | Latest research has indicated a potential adverse effect on graft patency rates and clinical outcomes with skeletonizing the left internal thoracic artery. We... Abstract Latest research has indicated a potential adverse effect on graft patency rates and clinical outcomes with skeletonizing the left internal thoracic... |
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SubjectTerms | Coronary Disease |
Title | Randomized comparison of HARVesting the Left Internal Thoracic Artery in a skeletonized versus pedicled technique: the HARVITA trial-study protocol |
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