NDLI: A pilot randomized controlled trial comparing CABG surgery performed with total arterial grafts or without

Content Provider	Springer Nature : BioMed Central
Author	Le, Jeffrey Baskett, Roger JF Buth, Karen J Hirsch, Gregory M Brydie, Allan Gayner, Ryan Legare, Jean-Francois
Abstract	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.
Related Links	https://cardiothoracicsurgery.biomedcentral.com/counter/pdf/10.1186/s13019-014-0203-8.pdf
Ending Page	8
Page Count	8
Starting Page	1
File Format	HTM / HTML
ISSN	17498090
DOI	10.1186/s13019-014-0203-8
Journal	Journal of Cardiothoracic Surgery
Issue Number	1
Volume Number	10
Language	English
Publisher	BioMed Central
Publisher Date	2015-01-08
Access Restriction	Open
Subject Keyword	Cardiac Surgery Thoracic Surgery CABG artery Arteries CABG Outcomes
Content Type	Text
Resource Type	Article
Subject	Surgery Cardiology and Cardiovascular Medicine Pulmonary and Respiratory Medicine
Journal Impact Factor	1.5/2023
5-Year Journal Impact Factor	1.6/2023

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