Intensive versus moderate atorvastatin therapy and one-year graft patency after CABG: Rationale and design of the ACTIVE (Aggressive Cholesterol Therapy to Inhibit Vein Graft Events) randomized controlled trial (NCT01528709)

Contemp Clin Trials. 2017 Aug;59:98-104. doi: 10.1016/j.cct.2017.06.006. Epub 2017 Jun 10.

Abstract

Rationale: Saphenous vein graft disease remains a major limitation of coronary artery bypass graft surgery (CABG). Statin therapy inhibits the development of vein graft disease and improves outcomes after CABG. However, it is unclear whether treatment with high-dose statins will further slow the process of vein graft disease and improve graft patency, as compared to conventional moderate doses. Therefore, the goal of this study will be to evaluate the efficacy of high-dose statin therapy versus moderate-dose statin therapy for the prevention of saphenous vein graft occlusion following CABG.

Study design: The Aggressive Cholesterol Therapy to Inhibit Vein Graft Events (ACTIVE) trial is a multi-center double-blind randomized controlled trial enrolling patients who have undergone multi-vessel CABG with at least one saphenous vein graft. Patients will be randomized to receive either atorvastatin 80mg daily or atorvastatin 10mg daily for one year starting within 5days after surgery. The target enrollment is 100 patients in each arm (200 patients total). Lipid levels will be assessed every 3months. After one year, patients will undergo computed tomography (CT) coronary angiography to assess the incidence of vein graft occlusion and stenosis.

Conclusion: This trial is the first prospective study to evaluate the impact of early postoperative high-dose statin therapy on graft patency after CABG. Should high-dose statin therapy reduce the incidence of postoperative graft occlusion, the results will add to the growing evidence supporting the role of high-intensity statins for modern lipid management after coronary surgical revascularization (ClinicalTrials.govNCT01528709).

Keywords: Cholesterol; Coronary artery bypass graft surgery; Graft patency; Low-density lipoprotein; Statin; Vein graft disease.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Atorvastatin / administration & dosage*
  • Cholesterol / analysis
  • Computed Tomography Angiography / methods
  • Coronary Angiography / methods
  • Coronary Artery Bypass* / adverse effects
  • Coronary Artery Bypass* / methods
  • Coronary Artery Disease / surgery*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Graft Occlusion, Vascular* / diagnostic imaging
  • Graft Occlusion, Vascular* / etiology
  • Graft Occlusion, Vascular* / prevention & control
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage
  • Male
  • Middle Aged
  • Saphenous Vein / transplantation
  • Treatment Outcome
  • Vascular Patency / drug effects

Substances

  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Cholesterol
  • Atorvastatin

Associated data

  • ClinicalTrials.gov/NCT01528709