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A pilot randomized controlled trial comparing CABG surgery performed with total arterial grafts or without
OBJECTIVE: To date only a few randomized controlled studies have compared grafting strategies in patients with multi-vessel coronary disease. This study represents a pilot RCT designed to test the feasibility of a trial comparing conventional CABG performed with a LIMA-LAD plus saphenous vein grafts...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4299408/ https://www.ncbi.nlm.nih.gov/pubmed/25567131 http://dx.doi.org/10.1186/s13019-014-0203-8 |
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author | Le, Jeffrey Baskett, Roger JF Buth, Karen J Hirsch, Gregory M Brydie, Allan Gayner, Ryan Legare, Jean-Francois |
author_facet | Le, Jeffrey Baskett, Roger JF Buth, Karen J Hirsch, Gregory M Brydie, Allan Gayner, Ryan Legare, Jean-Francois |
author_sort | Le, Jeffrey |
collection | PubMed |
description | OBJECTIVE: To date only a few randomized controlled studies have compared grafting strategies in patients with multi-vessel coronary disease. This study represents a pilot RCT designed to test the feasibility of a trial comparing conventional CABG performed with a LIMA-LAD plus saphenous vein grafts (LIMA+SVG) and CABG performed with total arterial grafting (TAG). METHODS: Consenting patients undergoing non-redo isolated CABG surgery at a single institution were randomized to TAG or LIMA+SVG groups. Exclusion criteria included prior CABG, emergent procedure, concomitant procedure, varicose veins and renal dysfunction. The primary endpoints were: enrolment >20% and completion of CT coronary angiography at 6 months >80%. Statistical investigation was performed on an intention to treat analysis. RESULTS: Of 421 eligible patients, 60 were enrolled and 2 withdrew (n = 30 in TAG, n = 28 LIMA+SVG) for 14% enrolment rate. Patient characteristics were similar in each group. No patients died in hospital and adverse events such as MI, stroke and deep sternal wound infection were not significantly different between groups. Clinical follow-up was complete in 100% of patients, with 44/58 (76%) undergoing CT coronary angio at 6 months. Graft occlusion occurred in 2 patients in each group for patency rates of 89% (TAG) and 91% (LIMA+SVG). CONCLUSIONS: We provide evidence that an RCT comparing grafting strategy is possible but also show that achieving recruitment or follow-up CT may be difficult. Given the excellent patency results and little difference between groups, our findings suggest that the sample size required may make it infeasible to compare graft patency at 6 months as a study end-point. TRIAL REGISTRATION: Randomized Controlled Trial number: ISRCTN80270323. ULTRA-MINI ABSTRACT: Few RCT’s exist comparing conventional CABG performed with a LIMA-LAD plus saphenous vein grafts (LIMA+SVG) compared to CABG performed with total arterial grafting (TAG). This study is a pilot RCT designed to test the feasibility of such a trial and identify pitfalls. |
format | Online Article Text |
id | pubmed-4299408 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-42994082015-01-21 A pilot randomized controlled trial comparing CABG surgery performed with total arterial grafts or without Le, Jeffrey Baskett, Roger JF Buth, Karen J Hirsch, Gregory M Brydie, Allan Gayner, Ryan Legare, Jean-Francois J Cardiothorac Surg Research Article OBJECTIVE: To date only a few randomized controlled studies have compared grafting strategies in patients with multi-vessel coronary disease. This study represents a pilot RCT designed to test the feasibility of a trial comparing conventional CABG performed with a LIMA-LAD plus saphenous vein grafts (LIMA+SVG) and CABG performed with total arterial grafting (TAG). METHODS: Consenting patients undergoing non-redo isolated CABG surgery at a single institution were randomized to TAG or LIMA+SVG groups. Exclusion criteria included prior CABG, emergent procedure, concomitant procedure, varicose veins and renal dysfunction. The primary endpoints were: enrolment >20% and completion of CT coronary angiography at 6 months >80%. Statistical investigation was performed on an intention to treat analysis. RESULTS: Of 421 eligible patients, 60 were enrolled and 2 withdrew (n = 30 in TAG, n = 28 LIMA+SVG) for 14% enrolment rate. Patient characteristics were similar in each group. No patients died in hospital and adverse events such as MI, stroke and deep sternal wound infection were not significantly different between groups. Clinical follow-up was complete in 100% of patients, with 44/58 (76%) undergoing CT coronary angio at 6 months. Graft occlusion occurred in 2 patients in each group for patency rates of 89% (TAG) and 91% (LIMA+SVG). CONCLUSIONS: We provide evidence that an RCT comparing grafting strategy is possible but also show that achieving recruitment or follow-up CT may be difficult. Given the excellent patency results and little difference between groups, our findings suggest that the sample size required may make it infeasible to compare graft patency at 6 months as a study end-point. TRIAL REGISTRATION: Randomized Controlled Trial number: ISRCTN80270323. ULTRA-MINI ABSTRACT: Few RCT’s exist comparing conventional CABG performed with a LIMA-LAD plus saphenous vein grafts (LIMA+SVG) compared to CABG performed with total arterial grafting (TAG). This study is a pilot RCT designed to test the feasibility of such a trial and identify pitfalls. BioMed Central 2015-01-08 /pmc/articles/PMC4299408/ /pubmed/25567131 http://dx.doi.org/10.1186/s13019-014-0203-8 Text en © Le et al.; licensee BioMed Central. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Article Le, Jeffrey Baskett, Roger JF Buth, Karen J Hirsch, Gregory M Brydie, Allan Gayner, Ryan Legare, Jean-Francois A pilot randomized controlled trial comparing CABG surgery performed with total arterial grafts or without |
title | A pilot randomized controlled trial comparing CABG surgery performed with total arterial grafts or without |
title_full | A pilot randomized controlled trial comparing CABG surgery performed with total arterial grafts or without |
title_fullStr | A pilot randomized controlled trial comparing CABG surgery performed with total arterial grafts or without |
title_full_unstemmed | A pilot randomized controlled trial comparing CABG surgery performed with total arterial grafts or without |
title_short | A pilot randomized controlled trial comparing CABG surgery performed with total arterial grafts or without |
title_sort | pilot randomized controlled trial comparing cabg surgery performed with total arterial grafts or without |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4299408/ https://www.ncbi.nlm.nih.gov/pubmed/25567131 http://dx.doi.org/10.1186/s13019-014-0203-8 |
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