Department of Cardiothoracic Surgery, University Hospital Cologne, Kerpener Str. 62, 50937 Cologne, Germany.
Department of Cardiac Surgery, Kerckhoff-Clinic, Campus Kerckhoff, Justus-Liebig-University of Giessen, Benekestr. 2-8, 61231 Bad Nauheim, Germany.
Eur Heart J. 2023 Jul 1;44(25):2322-2331. doi: 10.1093/eurheartj/ehad238.
Evidence suggests that a high-dose statin loading before a percutaneous coronary revascularization improves outcomes in patients receiving long-term statins. This study aimed to analyse the effects of such an additional statin therapy before surgical revascularization.
This investigator-initiated, randomized, double-blind, and placebo-controlled trial was conducted from November 2012 to April 2019 at 14 centres in Germany. Adult patients (n = 2635) with a long-term statin treatment (≥30 days) who were scheduled for isolated coronary artery bypass grafting (CABG) were randomly assigned to receive a statin-loading therapy or placebo at 12 and 2 h prior to surgery using a web-based system. The primary outcome of major adverse cardiac and cerebrovascular events (MACCE) was a composite consisting of all-cause mortality, myocardial infarction (MI), and a cerebrovascular event occuring within 30 days after surgery. Key secondary endpoints included a composite of cardiac death and MI, myocardial injury, and death within 12 months. Non-statistically relevant differences were found in the modified intention-to-treat analysis (2406 patients; 1203 per group) between the statin (13.9%) and placebo groups (14.9%) for the primary outcome [odds ratio (OR) 0.93, 95% confidence interval (CI) 0.74-1.18; P = 0.562] or any of its individual components. Secondary endpoints including cardiac death and MI (12.1% vs. 13.5%; OR 0.88, 95% CI 0.69-1.12; P = 0.300), the area under the troponin T-release curve (median 0.398 vs. 0.394 ng/ml, P = 0.333), and death at 12 months (3.1% vs. 2.9%; P = 0.825) were comparable between treatment arms.
Additional statin loading before CABG failed to reduce the rate of MACCE occuring within 30 days of surgery.
有证据表明,经皮冠状动脉血运重建前给予高剂量他汀类药物负荷剂量可改善长期接受他汀类药物治疗的患者的预后。本研究旨在分析在外科血运重建前进行这种额外他汀类药物治疗的效果。
这是一项由研究者发起的、随机的、双盲的、安慰剂对照的临床试验,于 2012 年 11 月至 2019 年 4 月在德国的 14 个中心进行。长期接受他汀类药物治疗(≥30 天)并计划接受单纯冠状动脉旁路移植术(CABG)的成年患者(n=2635)被随机分配在手术前 12 小时和 2 小时使用基于网络的系统接受他汀类药物负荷治疗或安慰剂。主要心脏不良事件和脑血管事件(MACCE)的主要结局是手术后 30 天内全因死亡率、心肌梗死(MI)和脑血管事件的复合结果。次要关键终点包括心脏死亡和 MI、心肌损伤以及 12 个月内死亡的复合结果。在修改后的意向治疗分析中(2406 例患者;每组 1203 例),他汀类药物组(13.9%)和安慰剂组(14.9%)在主要结局(比值比[OR]0.93,95%置信区间[CI]0.74-1.18;P=0.562)或其任何单个成分方面均无统计学显著差异。次要终点包括心脏死亡和 MI(12.1% vs. 13.5%;OR 0.88,95%CI 0.69-1.12;P=0.300)、肌钙蛋白 T 释放曲线下面积(中位数 0.398 vs. 0.394ng/ml,P=0.333)和 12 个月时的死亡率(3.1% vs. 2.9%;P=0.825)在治疗组之间也相似。
CABG 术前额外给予他汀类药物负荷剂量未能降低术后 30 天内 MACCE 的发生率。