@article{5f71cea4653a4143bad9a79f9221dcd5,
title = "External Support for Saphenous Vein Grafts in Coronary Artery Bypass Surgery: A Randomized Clinical Trial",
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.",
author = "Goldstein, {Daniel J.} and Puskas, {John D.} and Alexander, {John H.} and Chang, {Helena L.} and Gammie, {James S.} and Marks, {Mary E.} and Alexander Iribarne and Yuliya Vengrenyuk and Samantha Raymond and Taylor, {Bradley S.} and Orit Yarden and Eyal Orion and Fran{\c c}ois Dagenais and Gorav Ailawadi and Chu, {Michael W.A.} and Dimaio, {J. Michael} and Jagat Narula and Moquete, {Ellen G.} and Karen O'Sullivan and Williams, {Judson B.} and Crestanello, {Juan A.} and Mariell Jessup and Rose, {Eric A.} and Vincent Scavo and Acker, {Michael A.} and Marc Gillinov and Mack, {Michael J.} and Gelijns, {Annetine C.} and O'Gara, {Patrick T.} and Moskowitz, {Alan J.} and Emilia Bagiella and Pierre Voisine",
note = "Funding Information: 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{\textquoteright} 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 Publisher Copyright: {\textcopyright} 2022 American Medical Association. All rights reserved.",
year = "2022",
month = aug,
doi = "10.1001/jamacardio.2022.1437",
language = "English (US)",
volume = "7",
pages = "808--816",
journal = "JAMA Cardiology",
issn = "2380-6583",
publisher = "American Medical Association",
number = "8",
}