Intensive versus moderate statin therapy and early graft occlusion after coronary bypass surgery: The Aggressive Cholesterol Therapy to Inhibit Vein Graft Events randomized clinical trial

Abstract

Objective: Statins prevent saphenous vein graft (SVG) disease and improve outcomes after coronary artery bypass graft surgery. However, the optimal postoperative statin dose remains unclear. The Aggressive Cholesterol Therapy to Inhibit Vein Graft Events trial was undertaken to evaluate whether early postoperative high‐dose statin therapy reduces SVG occlusion compared with conventional moderate‐dose therapy. Methods: In this pilot, multicenter, double‐blind randomized trial, 173 patients who had coronary artery bypass graft surgery with SVG were randomized to receive 10 mg or 80 mg atorvastatin daily for 1 year. The primary outcome was SVG occlusion at 1 year. Secondary outcomes were SVG stenosis and major adverse cardiovascular events. Results: During trial enrollment, patients randomized to 80 mg atorvastatin achieved significantly lower low‐density lipoprotein cholesterol levels (P < .00001). One‐year graft assessment was performed in 145 patients (83.8%). The primary outcome, SVG occlusion at 1 year, did not significantly differ between the 2 groups (12.9% vs 11.4% for 10 mg atorvastatin vs 80 mg atorvastatin; P = .85). The incidence of vein graft stenosis also did not significantly differ between the groups (P = .54). However, there was a trend toward fewer patients developing vein graft disease (either occlusion or stenosis) in the 80 mg atorvastatin group (29.2% vs 19.2%, 10 mg atorvastatin vs 80 mg atorvastatin; P = .18). Freedom from major adverse cardiovascular events at 1 year was similar between the groups (P = .27). Conclusions: Compared with 10 mg atorvastatin, 80 mg atorvastatin did not significantly reduce vein graft occlusion 1 year after coronary artery bypass graft surgery in this pilot trial.