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Randomized Controlled Trial
. 2022 Aug 1;7(8):808-816.
doi: 10.1001/jamacardio.2022.1437.

External Support for Saphenous Vein Grafts in Coronary Artery Bypass Surgery: A Randomized Clinical Trial

Daniel J Goldstein  1 , John D Puskas  2 , John H Alexander  3 , Helena L Chang  4 , James S Gammie  5 , Mary E Marks  4 , Alexander Iribarne  6 , Yuliya Vengrenyuk  7 , Samantha Raymond  4 , Bradley S Taylor  8 , Orit Yarden  9 , Eyal Orion  9 , François Dagenais  10 , Gorav Ailawadi  11 , Michael W A Chu  12 , J Michael DiMaio  13 , Jagat Narula  14 , Ellen G Moquete  4 , Karen O'Sullivan  4 , Judson B Williams Jr  15 , Juan A Crestanello  16 , Mariell Jessup  17 , Eric A Rose  4 , Vincent Scavo  18 , Michael A Acker  19 , Marc Gillinov  20 , Michael J Mack  13 , Annetine C Gelijns  4 , Patrick T O'Gara  21 , Alan J Moskowitz  4 , Emilia Bagiella  4 , Pierre Voisine  10
Affiliations
Randomized Controlled Trial

External Support for Saphenous Vein Grafts in Coronary Artery Bypass Surgery: A Randomized Clinical Trial

Daniel J Goldstein et al. JAMA Cardiol. .

Abstract

Importance: Intimal hyperplasia and subsequent saphenous vein graft failure may have significant adverse clinical effects in patients undergoing coronary artery bypass surgery. External support of saphenous vein grafts has the potential to prevent vein graft dilation and hence slow the rate of intimal hyperplasia and increase long-term vein patency.

Objective: To determine efficacy, as measured by intimal hyperplasia, and safety of an external saphenous vein graft support device in patients undergoing a coronary bypass graft procedure.

Design, setting, and participants: This within-patient randomized, open-label, multicenter study was conducted at 17 Cardiothoracic Surgical Trials Network centers in North America. Between January 2018 and February 2019, 224 patients with multivessel coronary artery disease undergoing isolated bypass surgery were enrolled. For each patient, 1 of 2 vein grafts was randomized to receive external support or no support.

Interventions: External vein graft support or no support.

Main outcomes and measures: The primary efficacy end point was intimal hyperplasia area assessed by intravascular ultrasound at 12 months postrandomization for each study graft. Secondary confirmatory end points were lumen diameter uniformity assessed by angiography and graft failure (≥50% stenosis) by quantitative coronary angiography. Major cardiac and cerebrovascular events were collected through month 12.

Results: Among 224 patients (mean [SD] age, 65.8 [8.3] years; 178 [79.5%] male), 203 (90.6%) were eligible for intravascular ultrasound, of which 85 (41.9%) had at least 1 study graft occluded or severely diseased at 12 months (55 supported, 56 unsupported). After imputation of data missing because of graft occlusion or severe disease, the estimated mean (SE) intimal hyperplasia area was 5.11 (0.16) mm2 in supported grafts and 5.79 (0.20) mm2 in unsupported grafts (P = .07). In a sensitivity analysis of 113 patients with both grafts imaged, the mean intimal hyperplasia area was 4.58 (0.18) mm2 and 5.12 (0.23) mm2 in supported and unsupported grafts, respectively (P = .04). By 12 months, 5 patients (2.2%) died and 16 patients (7.1%) experienced a major cardiac or cerebrovascular event.

Conclusions and relevance: The 12-month difference in intimal hyperplasia area between supported and unsupported grafts did not achieve statistical significance. Cumulative mortality and major cardiac or cerebrovascular events rates were similar to those in other randomized coronary artery bypass trials. Further investigation to assess the effect of external graft support devices on long-term graft patency and clinical outcomes is warranted.

Trial registration: ClinicalTrials.gov Identifier: NCT03209609.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Goldstein reports consultation agreements with Abbott and Abiomed outside the submitted work. Dr Puskas reports consultation agreements with Medtronic and Scanlan outside the submitted work. Dr Alexander reports institutional research support from Bayer, Bristol Myers Squibb, CryoLife, CSL Behring, Ferring, US Food and Drug Administration, GlaxoSmithKline, Humacyte, National Institutes of Health, and XaTek and reports consultant and honoraria payments from AbbVie, Akros, AtriCure, Bristol Myers Squibb, CryoLife, Ferring, GlaxoSmithKline, Janssen, Pfizer, Portola, and US Veterans Administration, all outside the submitted work. Dr Gammie reports personal fees from Edwards Lifesciences and other from Protaryx Medical outside the submitted work. Dr Taylor reports other from WL Gore outside the submitted work. Dr Yarden reports being vice president of clinical and regulatory affairs at Vascular Graft Solutions, as well as having equity/ownership at Vascular Graft Solutions. Dr Orion reports being the founder and chief executive officer of Vascular Graft Solutions and co-inventor of the VEST device and having equity/ownership interest at Vascular Graft Solutions. Dr Chu reports speakers’ honoraria from Medtronic, Edwards Lifesciences, Terumo Aortic, Abbott Vascular, and CryoLife outside the submitted work. Dr Crestanello reports other from Medtronic outside the submitted work. Dr Jessup reports employment by the American Heart Association. Dr Rose reports membership of the scientific advisory board for Broadview Ventures outside the submitted work. Dr Scavo reports personal fees from Lutheran Medical Group during the conduct of the study. Dr Gillinov reports consultancy for CryoLife, Edwards Lifesciences, Medtronic, Abbott, AtriCure, and Clearflow and a patent for devices for mitral valve repair outside the submitted work. Dr Gelijns reports grants from the National Heart, Lung, and Blood Institute (NHLBI) during the conduct of the study. Dr Moskowitz reports grants from NHLBI during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram
The 3 most common reasons for not meeting inclusion criteria were not having 2 or more vein grafts to native vessels with at least 75% stenosis and comparable runoff, having a concomitant non-CABG cardiac surgical procedure, and having documented or suspected untreated diffuse peripheral vascular disease. At 1 year, 203 patients were eligible for intravascular ultrasound (IVUS) imaging. Among the 203 saphenous vein grafts (SVGs) with external support, 143 SVGs had the intimal hyperplasia area assessed by IVUS; 55 SVGs were occluded/severely diseased, which precluded the IVUS procedure; and intimal hyperplasia area was not measurable in 5 SVGs for technical reasons. Among the 203 SVGs without external support, 142 SVGs had the intimal hyperplasia area assessed by IVUS; 56 SVGs were occluded/severely diseased, which precluded the IVUS procedure; and intimal hyperplasia area was not measurable in 5 SVGs for technical reasons. CABG indicates coronary artery bypass graft procedure.
Figure 2.
Figure 2.. Primary and Secondary Confirmatory End Points at 12 Months for Supported and Unsupported Saphenous Vein Grafts (SVGs)
Estimated mean intimal hyperplasia area and variance were based on 30 imputations with estimates combined using the Rubin rule for device-supported and unsupported grafts. Error bars indicate 95% CI. In the Fitzgibbon patency scale, class I indicates no intimal irregularity; class II, irregularity of less than 50% of estimated intimal surface; and class III, irregularity of 50% or more of estimated intimal surface.
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