CT-angiographic Follow up of Patients That Underwent Coronary Bypass Surgery Between 1993-1997 - Full Text View

Purpose

Coronary artery surgery (CABG) is necessary to improve blood circulation in many patients with coronary artery disease. This is done by using alternative blood vessels (grafts) to bypass the stenosed coronary arteries. In CABG, vein grafts are traditionally used where surrounding tissue is removed, this may damage the vessel and influence its patency.

The "no-touch" technique was developed by Professor Domingos Souza at the Department of Cardiovascular and Thoracic Surgery, Örebro University Hospital. This technique includes taking out the vein with its surrounding tissue and by this way the vessel is less damaged. The first two follow ups have shown that no-touch grafts had better patency than conventionally extracted graft at 18 months and 8.5 years.

This long term follow up is a continuation of the randomized trial started in 1993 where the patency and incidence of stenoses in the no touch and conventional vein grafts has been studied.

Condition	Intervention
Coronary Artery Disease	Procedure: No touch technique Procedure: Conventional technique

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	CT-angiographic Follow Upp of Patients That Underwent Coronary Bypass Surgery Between 1993-1997. A Randomized Longitudinal Trial.

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by Örebro County Council:

Primary Outcome Measures:

Patency of the grafts [ Time Frame: Mean time of 15 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Stenosis in the grafts. [ Time Frame: Mean time of 15 years. ] [ Designated as safety issue: No ]

Enrollment:	52
Study Start Date:	June 2010
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: No touch vein grafts The grafts were harvested with there surrounding tissues.	Procedure: No touch technique The vein graft is harvested with its surronding tissues.
Active Comparator: Conventional vein grafts. The grafts were stripped from surrounding tissue.	Procedure: Conventional technique The vein graft is stripped from its surrounding tissues.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

First time coronary artery bypass grafting with either conventional or no touch vein grafts performed by Dr.Souza between 1993-1997.
Included in the previous follow up studies
Signed and dated consent.

Exclusion Criteria:

Allergy to contrast
Renal failure
Uncontrolled diabetes
Unable to implement the study according to protocol -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686100

Locations

Sweden
Department for Cardiovascular and Thoracic Surgery, Örebro University Hospital
Örebro, Sweden, 70185

Sponsors and Collaborators

Örebro County Council

More Information

Publications:

Souza DS, Johansson B, Bojö L, Karlsson R, Geijer H, Filbey D, Bodin L, Arbeus M, Dashwood MR. Harvesting the saphenous vein with surrounding tissue for CABG provides long-term graft patency comparable to the left internal thoracic artery: results of a randomized longitudinal trial. J Thorac Cardiovasc Surg. 2006 Aug;132(2):373-8.

Loesch A, Dashwood MR, Souza DS. Does the method of harvesting the saphenous vein for coronary artery bypass surgery affect venous smooth muscle cells? iNOS immunolabelling and ultrastructural findings. Int J Surg. 2006;4(1):20-9. Epub 2006 Jan 3.

Dashwood MR, Dooley A, Shi-Wen X, Abraham DJ, Dreifaldt M, Souza DS. Perivascular fat-derived leptin: a potential role in improved vein graft performance in coronary artery bypass surgery. Interact Cardiovasc Thorac Surg. 2011 Feb;12(2):170-3. Epub 2010 Nov 3.

Dreifaldt M, Souza DS, Loesch A, Muddle JR, Karlsson MG, Filbey D, Bodin L, Norgren L, Dashwood MR. The "no-touch" harvesting technique for vein grafts in coronary artery bypass surgery preserves an intact vasa vasorum. J Thorac Cardiovasc Surg. 2011 Jan;141(1):145-50. Epub 2010 Apr 9.

Johansson BL, Souza DS, Bodin L, Filbey D, Loesch A, Geijer H, Bojö L. Slower progression of atherosclerosis in vein grafts harvested with 'no touch' technique compared with conventional harvesting technique in coronary artery bypass grafting: an angiographic and intravascular ultrasound study. Eur J Cardiothorac Surg. 2010 Oct;38(4):414-9. Epub 2010 Apr 1.

Johansson BL, Souza DS, Bodin L, Filbey D, Bojö L. No touch vein harvesting technique for CABG improves the long-term clinical outcome. Scand Cardiovasc J. 2009 Feb;43(1):63-8.

Rueda F, Souza D, Lima Rde C, Menezes A, Johansson B, Dashwood M, Thé E, Gesteira M, Escobar M, Vasconcelos F. Novel no-touch technique of harvesting the saphenous vein for coronary artery bypass grafting. Arq Bras Cardiol. 2008 Jun;90(6):356-62. English, Portuguese.

Dashwood MR, Savage K, Dooley A, Shi-Wen X, Abraham DJ, Souza DS. Effect of vein graft harvesting on endothelial nitric oxide synthase and nitric oxide production. Ann Thorac Surg. 2005 Sep;80(3):939-44.

Dashwood M, Anand R, Loesch A, Souza D. Surgical trauma and vein graft failure: further evidence for a role of ET-1 in graft occlusion. J Cardiovasc Pharmacol. 2004 Nov;44 Suppl 1:S16-9.

Souza DS, Dashwood MR, Tsui JC, Filbey D, Bodin L, Johansson B, Borowiec J. Improved patency in vein grafts harvested with surrounding tissue: results of a randomized study using three harvesting techniques. Ann Thorac Surg. 2002 Apr;73(4):1189-95.

Tsui JC, Souza DS, Filbey D, Karlsson MG, Dashwood MR. Localization of nitric oxide synthase in saphenous vein grafts harvested with a novel "no-touch" technique: potential role of nitric oxide contribution to improved early graft patency rates. J Vasc Surg. 2002 Feb;35(2):356-62.

Tsui JC, Souza DS, Filbey D, Bomfim V, Dashwood MR. Preserved endothelial integrity and nitric oxide synthase in saphenous vein grafts harvested by a 'no-touch' technique. Br J Surg. 2001 Sep;88(9):1209-15.

Souza DS, Christofferson RH, Bomfim V, Filbey D. "No-touch" technique using saphenous vein harvested with its surrounding tissue for coronary artery bypass grafting maintains an intact endothelium. Scand Cardiovasc J. 1999;33(6):323-9.

Souza D. A new no-touch preparation technique. Technical notes. Scand J Thorac Cardiovasc Surg. 1996;30(1):41-4.

Responsible Party:	Ninos Samano M.D., Doctor, Örebro County Council
ClinicalTrials.gov Identifier:	NCT01686100 History of Changes
Other Study ID Numbers:	102841
Study First Received:	September 12, 2012
Last Updated:	September 18, 2012
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Örebro County Council:

Coronary artery bypass grafting
Saphenous vein grafts

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013