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Choice of vein-harvest technique for coronary artery bypass grafting: rationale and design of the REGROUP trial.

Abstract：

:The Randomized Endo-vein Graft Prospective (REGROUP) trial (ClinicalTrials.gov NCT01850082) is a randomized, intent-to-treat, 2-arm, parallel-design, multicenter study funded by the Cooperative Studies Program (CSP No. 588) of the US Department of Veterans Affairs. Cardiac surgeons at 16 Veterans Affairs (VA) medical centers with technical expertise in performing both endoscopic vein harvesting (EVH) and open vein harvesting (OVH) were recruited as the REGROUP surgeon participants. Subjects requiring elective or urgent coronary artery bypass grafting using cardiopulmonary bypass with use of ≥1 saphenous vein graft will be screened for enrollment using pre-established inclusion/exclusion criteria. Enrolled subjects (planned N = 1150) will be randomized to 1 of the 2 arms (EVH or OVH) after an experienced vein harvester has been assigned. The primary outcomes measure is the rate of major adverse cardiac events (MACE), including death, myocardial infarction, or revascularization. Subject assessments will be performed at multiple times, including at baseline, intraoperatively, postoperatively, and at discharge (or 30 days after surgery, if still hospitalized). Assessment of leg-wound complications will be completed at 6 weeks after surgery. Telephone follow-ups will occur at 3-month intervals after surgery until the participating sites are decommissioned after the trial's completion (approximately 4.5 years after the full study startup). To assess long-term outcomes, centralized follow-up of MACE for 2 additional years will be centrally performed using VA and non-VA clinical and administrative databases. The primary MACE outcome will be compared between the 2 arms, EVH and OVH, at the end of the trial duration.

journal_name

Clin Cardiol

journal_title

Clinical cardiology

authors

Zenati MA,Gaziano JM,Collins JF,Biswas K,Gabany JM,Quin JA,Bitondo JM,Bakaeen FG,Kelly RF,Shroyer AL,Bhatt DL

doi

10.1002/clc.22267

subject

Has Abstract

pub_date

2014-06-01 00:00:00

pages

325-30

issue

eissn

0160-9289

issn

1932-8737

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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Choice of vein-harvest technique for coronary artery bypass grafting: rationale and design of the REGROUP trial.