David P Taggart1, Yanai Ben Gal2, Belinda Lees3, Niket Patel4, Carolyn Webb5, Syed M Rehman6, Anthony Desouza7, Rashmi Yadav7, Fabio De Robertis8, Miles Dalby9, Adrian Banning4, Keith M Channon4, Carlo Di Mario5, Eyal Orion10. 1. Nuffield Department of Surgery, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom. Electronic address: david.taggart@ouh.nhs.uk. 2. Department of Cardiothoracic Surgery, Tal Aviv Sourasky Medical Center, Tel Aviv University, Tel Aviv, Israel. 3. Clinical Trials and Evaluation Unit, Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom. 4. Department of Cardiovascular Medicine, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom. 5. Department of Cardiology, Royal Brompton Hospital, London, United Kingdom. 6. Nuffield Department of Surgery, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom. 7. Department of Cardiothoracic Surgery, Royal Brompton Hospital, London, United Kingdom. 8. Department of Cardiothoracic Surgery, Harefield Hospital, Middlesex, London, United Kingdom. 9. Department of Cardiology, Harefield Hospital, Middlesex, London, United Kingdom. 10. Vascular Graft Solutions Ltd, Tel Aviv, Israel.
Abstract
BACKGROUND:External stents inhibit saphenous vein graft (SVG) intimal hyperplasia in animal studies. We investigated whether external stenting inhibits SVGdiffuse intimal hyperplasia 1 year after coronary artery bypass graft surgery. METHODS:Thirty patients with multivessel disease undergoing coronary artery bypass graft surgery were enrolled. In addition to an internal mammary artery graft, each patient received one external stent to a single SVG randomly allocated to either the right or left coronary territories; and one or more nonstented SVG served as the control. Graft patency was confirmed at the end of surgery in all patients. The primary endpoint was SVG intimal hyperplasia (mean area) assessed by intravascular ultrasonography at 1 year. Secondary endpoints were SVG failure, ectasia (>50% initial diameter), and overall uniformity as judged by Fitzgibbon classification. RESULTS: One-year follow-up angiography was completed in 29 patients (96.6%). All internal mammary artery grafts were patent. Overall SVG failure rates did not differ significantly between the two groups (30% stented versus 28.2% nonstented SVG, p = 0.55). The SVG mean intimal hyperplasia area, assessed in 43 SVGs, was significantly reduced in the stented group (4.37 ± 1.40 mm(2)) versus nonstented group (5.12 ± 1.35 mm(2), p = 0.04). In addition, stented SVGs demonstrated marginally significant improvement in lumen uniformity (p = 0.08) and less ectasia (6.7% versus 28.2%, p = 0.05). There was some evidence that ligation of side branches with metallic clips increased SVG failure in the stented group. CONCLUSIONS:External stenting has the potential to improve SVG lumen uniformity and reduce diffuse intimal hyperplasia 1 year after coronary artery bypass graft surgery.
RCT Entities:
BACKGROUND: External stents inhibit saphenous vein graft (SVG) intimal hyperplasia in animal studies. We investigated whether external stenting inhibits SVG diffuse intimal hyperplasia 1 year after coronary artery bypass graft surgery. METHODS: Thirty patients with multivessel disease undergoing coronary artery bypass graft surgery were enrolled. In addition to an internal mammary artery graft, each patient received one external stent to a single SVG randomly allocated to either the right or left coronary territories; and one or more nonstented SVG served as the control. Graft patency was confirmed at the end of surgery in all patients. The primary endpoint was SVG intimal hyperplasia (mean area) assessed by intravascular ultrasonography at 1 year. Secondary endpoints were SVG failure, ectasia (>50% initial diameter), and overall uniformity as judged by Fitzgibbon classification. RESULTS: One-year follow-up angiography was completed in 29 patients (96.6%). All internal mammary artery grafts were patent. Overall SVG failure rates did not differ significantly between the two groups (30% stented versus 28.2% nonstented SVG, p = 0.55). The SVG mean intimal hyperplasia area, assessed in 43 SVGs, was significantly reduced in the stented group (4.37 ± 1.40 mm(2)) versus nonstented group (5.12 ± 1.35 mm(2), p = 0.04). In addition, stented SVGs demonstrated marginally significant improvement in lumen uniformity (p = 0.08) and less ectasia (6.7% versus 28.2%, p = 0.05). There was some evidence that ligation of side branches with metallic clips increased SVG failure in the stented group. CONCLUSIONS: External stenting has the potential to improve SVG lumen uniformity and reduce diffuse intimal hyperplasia 1 year after coronary artery bypass graft surgery.
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