External stenting and disease progression in saphenous vein grafts two years after coronary artery bypass grafting: A multicenter randomized trial

Taggart, David P.; Gavrilov, Yulia; Krasopoulos, George; Rajakaruna, Cha; Zacharias, Joseph; Silva, Ravi De; Channon, Keith M.; Gehrig, Thomas; Donovan, Terrence J.; Friedrich, Ivar; Benedetto, Umberto; Vohra, Hunaid A.; Bittar, Mohamad; Bose, Amal; Berman, Marius; Kharbanda, Rajesh; Paraforos, Alexandros; Ladyshenskij, Leonid; Bonaros, Nikolaos; Schachner, Thomas; Sandner, Sigrid; Angleitner, Philipp; Bolotin, Gil; Jacobs, Stephan; Thielmann, Matthias; Wendt, Daniel; Choi, Yeong‐Hoon; Liakopoulos, Oliver J.; Ohri, Sunil K.; Lipey, Alexander

doi:10.1016/j.jtcvs.2021.03.120

Cited by 31 publications

(20 citation statements)

References 29 publications

(31 reference statements)

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“…The rationale for this intervention is manifold and includes mitigation of the wall stretch induced by abrupt conduit arterialization when transposing it from a low-pressure venous system to a high-pressure arterial circuit, enhancement of lumen uniformity and conduit-to-target size matching, and induction of adventitial neovascularization . Early trials of this technology have yielded promising results …”

Section: Discussionmentioning

confidence: 99%

“…Although this external support device would not be expected to reduce the risk of short-term SVG occlusion caused by intraoperative technical factors, it may increase SVG intermediate to long-term patency by limiting graft IH. Recent small trials of this device using intravascular ultrasound (IVUS) have demonstrated a reduction in IH and graft irregularity, markers of early graft disease . Based on this preliminary evidence, we conducted a randomized clinical trial to assess the effect of the device in reducing IH and SVG irregularity in patients undergoing CABG for multivessel coronary artery disease.…”

Section: Introductionmentioning

confidence: 99%

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External Support for Saphenous Vein Grafts in Coronary Artery Bypass Surgery

Goldstein

Puskas²,

Alexander

et al. 2022

JAMA Cardiol

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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 MEASURESThe 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 (Ն50% 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) mm 2 in supported grafts and 5.79 (0.20) mm 2 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) mm 2 and 5.12 (0.23) mm 2 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.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

External Support for Saphenous Vein Grafts in Coronary Artery Bypass Surgery

Goldstein

Puskas²,

Alexander

et al. 2022

JAMA Cardiol

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“…The development of external stents emerges as an approach to limit the hyperdistention of venous grafts, therefore minimizing the pathologic changes resulting from “venous remodeling.” 1 , 2 Taggart and colleagues, 1 in their relevant multicenter and randomized study, presented similar patency between SV grafts with or without application of external stents, illustrating a reduced degree of parietal irregularities and intimal hyperplasia in venous grafts in which an external stent was used, in 2 years of follow-up.…”

mentioning

confidence: 91%

“…In summary, we congratulate Taggart and colleagues 1 for the valuable article, and for the effort to improve the results obtained with the venous grafts. We emphasize, however, that the adoption of other technical approaches, such as composite grafts, might be more economically feasible and considerably more physiological to improve CABG results.…”

mentioning

confidence: 91%

Composite graft and remodeling of the saphenous vein in coronary artery bypass graft

2022

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“…In a recent randomized trial reporting on the effect of external stenting on saphenous vein grafts (SVG) disease, Taggart and colleagues 1 demonstrated that this technique improved Fitzgibbon patency scales and significantly reduced intimal hyperplasia area and thickness after a 2-year follow-up, although no difference in overall patency rates was observed between the stented and nonstented SVG (78.3% vs 82.2%, P = .43). 1 …”

mentioning

confidence: 99%