Kulik Alexander, Abreu Amy M, Boronat Viviana, Ruel Marc
Lynn Heart and Vascular Institute, Boca Raton Regional Hospital, and Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, United States.
Lynn Heart and Vascular Institute, Boca Raton Regional Hospital, and Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, United States.
Contemp Clin Trials. 2017 Aug;59:98-104. doi: 10.1016/j.cct.2017.06.006. Epub 2017 Jun 10.
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.
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.
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).
隐静脉移植物病变仍然是冠状动脉旁路移植术（CABG）的主要限制因素。他汀类药物治疗可抑制静脉移植物病变的发展，并改善冠状动脉旁路移植术后的预后。然而，与传统的中等剂量相比，高剂量他汀类药物治疗是否会进一步减缓静脉移植物病变的进程并提高移植物通畅率尚不清楚。因此，本研究的目的是评估高剂量他汀类药物治疗与中等剂量他汀类药物治疗在预防冠状动脉旁路移植术后隐静脉移植物闭塞方面的疗效。
积极胆固醇治疗抑制静脉移植物事件（ACTIVE）试验是一项多中心双盲随机对照试验，纳入接受多支血管冠状动脉旁路移植术且至少有一支隐静脉移植物的患者。患者将被随机分配，术后5天内开始接受每日80mg阿托伐他汀或每日10mg阿托伐他汀治疗，为期一年。每组目标入组100例患者（共200例患者）。每3个月评估一次血脂水平。一年后，患者将接受计算机断层扫描（CT）冠状动脉造影，以评估静脉移植物闭塞和狭窄的发生率。
本试验是第一项评估术后早期高剂量他汀类药物治疗对冠状动脉旁路移植术后移植物通畅率影响的前瞻性研究。如果高剂量他汀类药物治疗能降低术后移植物闭塞的发生率，结果将进一步证明高强度他汀类药物在冠状动脉外科血管重建术后现代血脂管理中的作用（ClinicalTrials.govNCT01528709）。
