Department of Cardiothoracic Surgery, The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, Republic of Korea.
Department of Cardiology, The Catholic University of Korea Eunpyeong St. Mary's Hospital, Seoul, Republic of Korea.
Trials. 2022 May 23;23(1):430. doi: 10.1186/s13063-022-06398-3.
Despite advances in surgical and postoperative care, myocardial injury or infarction (MI) is still a common complication in patients undergoing coronary artery bypass surgery (CABG). Several studies that aimed to reduce postoperative myocardial injury, including those investigating statin loading, have been conducted but did not indicate any clear benefits. Evolocumab, a PCSK9 inhibitor, has been reported to lower lipids and prevent ischemic events in various medical conditions. However, the effect of evolocumab in cardiovascular surgery has not been evaluated. The objective of this trial is to evaluate the cardioprotective effects of evolocumab in elective CABG patients with multivessel coronary artery disease.
EVOCABG is a prospective, randomized, open, controlled, multicenter, superiority, phase III clinical trial. Patients with multivessel coronary artery disease without initial cardiac enzyme elevation will be recruited (n=100). Participants will be randomly allocated into two groups: a test group (evolocumab (140mg) administration once within 72 h before CABG) and a control group (no administration). The primary outcome is the change in peak levels of serum cardiac marker (troponin-I) within 3 days of CABG surgery compared to the baseline. Secondary outcomes include post-operative clinical events including death, myocardial infarction, heart failure, stroke, and atrial fibrillation.
This trial is the first prospective randomized controlled trial to demonstrate the efficacy of evolocumab in reducing ischemic-reperfusion injury in patients undergoing CABG. This trial will provide the first high-quality evidence for preoperative use of evolocumab in mitigating or preventing ischemic-reperfusion-related myocardial injury during the surgery.
Clinical Research Information Service (CRIS) of the Republic of Korea KCT0005577 . Registered on 4 November 2020.
尽管外科和术后护理技术取得了进步，但心肌损伤或梗死（MI）仍然是冠状动脉旁路移植术（CABG）患者的常见并发症。已经进行了几项旨在减少术后心肌损伤的研究，包括研究他汀类药物负荷，但并没有表明有任何明确的益处。依洛尤单抗是一种 PCSK9 抑制剂，已被报道可降低血脂并预防各种疾病中的缺血事件。然而，依洛尤单抗在心血管手术中的作用尚未得到评估。本试验的目的是评估依洛尤单抗在多支冠状动脉疾病的择期 CABG 患者中的心脏保护作用。
EVOCABG 是一项前瞻性、随机、开放、对照、多中心、优效性、III 期临床试验。将招募多支冠状动脉疾病且初始心肌酶不升高的患者（n=100）。参与者将被随机分为两组：试验组（CABG 术前 72 小时内给予依洛尤单抗（140mg）一次）和对照组（不给予）。主要结局是与基线相比，CABG 术后 3 天内血清心脏标志物（肌钙蛋白 I）峰值水平的变化。次要结局包括术后临床事件，包括死亡、心肌梗死、心力衰竭、卒中和心房颤动。
本试验是首个前瞻性随机对照试验，旨在证明依洛尤单抗在降低 CABG 患者缺血再灌注损伤中的疗效。该试验将为依洛尤单抗在减轻或预防手术中与缺血再灌注相关的心肌损伤的术前应用提供首个高质量证据。
韩国临床试验注册中心（KCT0005577）。于 2020 年 11 月 4 日注册。
