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

Emilia Bagiella, John D. Puskas, Alan J. Moskowitz, Annetine C. Gelijns, John H. Alexander, Jagat Narula, Peter K. Smith, Kelley Hutcheson, Helena L. Chang, James S. Gammie, Alexander Iribarne, Mary E. Marks, Yuliya Vengrenyuk, Keisuke Yasumura, Samantha Raymond, Bradley S. Taylor, Orit Yarden, Eyal Orion, François Dagenais, Gorav AilawadiMichael W.A. Chu, Lopa Gupta, Ronald G. Levitan, Judson B. Williams, Juan A. Crestanello, Mariell Jessup, Eric A. Rose, Vincent Scavo, Michael A. Acker, Marc Gillinov, Patrick T. O'Gara, Pierre Voisine, Michael J. Mack, Daniel J. Goldstein

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)12-20
Number of pages9
JournalAmerican heart journal
Volume246
DOIs
StatePublished - Apr 2022

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Fingerprint

Dive into the research topics of 'Rationale and design of a randomized trial evaluating an external support device for saphenous vein coronary grafts'. Together they form a unique fingerprint.

Cite this