Effect of Evolocumab on Saphenous Vein Graft Patency Following Coronary Artery Bypass Surgery

Phase 4 Completed 782 enrolled Unity Health Toronto Applied Health Research Centre · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to determine if evolocumab added to regular statin therapy improves vein graft patency after coronary artery bypass graft (CABG) surgery.

Timeline

Start: 2019-05-30
Primary completion: 2025-01-30
Completion: 2025-01-30

Outcome

Missed primary endpoint

paper The 24-month VGDR was 21·7% (149 of 686 grafts) in the evolocumab group and 19·7% (127 of 644 grafts) in the placebo group PMID 40907505 ↗

paper difference 2·0% [95% CI -3·1 to 7·1]; p=0·44). PMID 40907505 ↗

paper Among patients who underwent CABG, evolocumab did not reduce SVG disease at 24 months following the index surgery despite substantial LDL-C lowering. PMID 40907505 ↗

Publications

Verma S, Leiter LA, Teoh H, Mancini GBJ, Quan A, Elituv R, Verma M, Misner E, Szarek M, Thorpe KE, Saha T, Whitlock RP, Yanagawa B, Merkely B, Juni P, Koren MJ, Nicholls SJ, Bhatt DL, Mazer CD. Effect of evolocumab on saphenous vein graft patency after coronary artery bypass surgery (NEWTON-CABG CardioLink-5): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2025 Sep 20;406(10509):1223-1234. doi: 10.1016/S0140-6736(25)01633-2. Epub 2025 Sep 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evolocumab	Monoclonal antibody	140 mg	Subcutaneous