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Rationale and design of a randomized trial evaluating an external support device for saphenous vein coronary grafts.

ABSTRACT:

Background

Coronary artery bypass grafting (CABG) is the most common revascularization approach for the treatment of multi-vessel coronary artery disease. While the internal mammary artery is nearly universally used to bypass the left anterior descending coronary artery, autologous saphenous vein grafts (SVGs) are still the most frequently used conduits to grafts the remaining coronary artery targets. Long-term failure of these grafts, however, continues to limit the benefits of surgery.

Methods

The Cardiothoracic Surgical Trials Network trial of the safety and effectiveness of a Venous External Support (VEST) device is a randomized, multicenter, within-patient trial comparing VEST-supported versus unsupported saphenous vein grafts in patients undergoing CABG. Key inclusion criteria are the need for CABG with a planned internal mammary artery to the left anterior descending and two or more saphenous vein grafts to other coronary arteries. The primary efficacy endpoint of the trial is SVG intimal hyperplasia (plaque + media) area assessed by intravascular ultrasound at 12 months post randomization. Occluded grafts are accounted for in the analysis of the primary endpoint. Secondary confirmatory endpoints are lumen diameter uniformity and graft failure (>50% stenosis) assessed by coronary angiography at 12 months. The safety endpoints are the occurrence of major adverse cardiac and cerebrovascular events and hospitalization within 5 years from randomization.

Conclusions

The results of the VEST trial will determine whether the VEST device can safely limit SVG intimal hyperplasia in patients undergoing CABG as treatment for coronary atherosclerotic disease.

SUBMITTER: Bagiella E

PROVIDER: S-EPMC9857318 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

Rationale and design of a randomized trial evaluating an external support device for saphenous vein coronary grafts.

Bagiella Emilia E Puskas John D JD Moskowitz Alan J AJ Gelijns Annetine C AC Alexander John H JH Narula Jagat J Smith Peter K PK Hutcheson Kelley K Chang Helena L HL Gammie James S JS Iribarne Alexander A Marks Mary E ME Vengrenyuk Yuliya Y Yasumura Keisuke K Raymond Samantha S Taylor Bradley S BS Yarden Orit O Orion Eyal E Dagenais François F Ailawadi Gorav G Chu Michael W A MWA Gupta Lopa L Levitan Ronald G RG Williams Judson B JB Crestanello Juan A JA Jessup Mariell M Rose Eric A EA Scavo Vincent V Acker Michael A MA Gillinov Marc M O'Gara Patrick T PT Voisine Pierre P Mack Michael J MJ Goldstein Daniel J DJ

American heart journal 20211220

<h4>Background</h4>Coronary artery bypass grafting (CABG) is the most common revascularization approach for the treatment of multi-vessel coronary artery disease. While the internal mammary artery is nearly universally used to bypass the left anterior descending coronary artery, autologous saphenous vein grafts (SVGs) are still the most frequently used conduits to grafts the remaining coronary artery targets. Long-term failure of these grafts, however, continues to limit the benefits of surgery. ...[more]

PMID: 34936861

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Project description:ImportanceIntimal 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.ObjectiveTo 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 participantsThis 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.InterventionsExternal 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 (≥50% stenosis) by quantitative coronary angiography. Major cardiac and cerebrovascular events were collected through month 12.ResultsAmong 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 relevanceThe 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 registrationClinicalTrials.gov Identifier: NCT03209609.

Dataset Information

Rationale and design of a randomized trial evaluating an external support device for saphenous vein coronary grafts.

Background

Methods

Conclusions

Publications

Rationale and design of a randomized trial evaluating an external support device for saphenous vein coronary grafts.

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