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Background The impact of single-dose preoperative evolocumab combined with rosuvastatin therapy prior to emergency percutaneous coronary intervention (PCI) in patients with acute ST-elevation myocardial infarction (STEMI) remains insufficiently characterized within current guideline-directed medical therapy. Methods In this prospective randomized trial conducted at Liaocheng People’s Hospital (2023–2024), 80 STEMI patients undergoing emergency PCI were randomized to: Treatment group: Single subcutaneous evolocumab 140 mg plus oral rosuvastatin 10 mg administered pre-PCI, followed by rosuvastatin 10 mg/day; Control group: Rosuvastatin 10 mg/day alone initiated post-PCI. Primary endpoint was major adverse cardiovascular events (MACEs) at 6 months. Secondary endpoints included angina incidence, low-density lipoprotein cholesterol (LDL-C) levels, interleukins, and ST-segment resolution rate (STR). The trial was registered at the Chinese Clinical Trial Registry (ChiCTR2500099498). Results Primary endpoint (MACEs): 5.0% (treatment group) vs. 12.5% (control group)(P = 0.228) at 6-month follow-up. Secondary endpoints: Angina incidence: 7.5% vs 27.5% (P = 0.037) at 6-month follow-up; LDL-C reduction: Significant in treatment group at day 1 (2.97 ± 0.63 vs 3.33 ± 0.78 mmol/L; P = 0.029), day 7 (1.66 ± 0.89 vs 2.25 ± 0.77 mmol/L, P = 0.003), and month 1 (P = 0.036); ST-segment resolution >70%: 60% vs 30% (P < 0.05); Inflammatory markers: Lower IL-6 (P = 0.02) and IL-17 (P = 0.01) in treatment group. Conclusions While the evolocumab-rosuvastatin combination did not significantly reduce 6-month MACEs, it demonstrated clinically important benefits including reduced angina frequency, accelerated LDL-C lowering, improved myocardial reperfusion, and attenuated inflammatory response, with a favorable safety profile. These findings support further investigation of intensive lipid-lowering strategies in acute STEMI management.
## 背景 目前在指南指导的药物治疗框架下,急性ST段抬高型心肌梗死(ST-elevation myocardial infarction, STEMI)患者接受急诊经皮冠状动脉介入治疗(percutaneous coronary intervention, PCI)前,单次术前剂量的依洛尤单抗(evolocumab)联合瑞舒伐他汀(rosuvastatin)治疗的相关临床特征仍未被充分阐明。 ## 方法 本研究为2023—2024年于聊城市人民医院开展的前瞻性随机对照试验,共纳入80例行急诊PCI的STEMI患者,按随机原则分为两组:治疗组于PCI术前予皮下注射单次剂量依洛尤单抗140mg联合口服瑞舒伐他汀10mg,后续予瑞舒伐他汀10mg/天维持治疗;对照组于PCI术后起始予瑞舒伐他汀10mg/天单药治疗。本试验的主要终点为随访6个月时的主要不良心血管事件(major adverse cardiovascular events, MACEs);次要终点包括心绞痛发生率、低密度脂蛋白胆固醇(low-density lipoprotein cholesterol, LDL-C)水平、白细胞介素水平及ST段回落率(ST-segment resolution rate, STR)。本试验已在中国临床试验注册中心(Chinese Clinical Trial Registry)完成注册,注册号为ChiCTR2500099498。 ## 结果 主要终点(MACEs):随访6个月时,治疗组发生率为5.0%,对照组为12.5%(P=0.228)。 次要终点:心绞痛发生率方面,随访6个月时治疗组为7.5%,对照组为27.5%(P=0.037);LDL-C降幅方面,治疗组在术后第1天[2.97±0.63 vs 3.33±0.78 mmol/L,P=0.029]、第7天[1.66±0.89 vs 2.25±0.77 mmol/L,P=0.003]及第1个月(P=0.036)均出现显著降低;ST段回落幅度超过70%的比例:治疗组为60%,对照组为30%(P<0.05);炎症标志物方面,治疗组白细胞介素6(IL-6)及白细胞介素17(IL-17)水平均显著降低(P分别为0.02和0.01)。 ## 结论 尽管依洛尤单抗联合瑞舒伐他汀方案未显著降低6个月随访期内的MACEs发生率,但该方案展现出多项具有临床意义的获益:包括减少心绞痛发作频率、加速LDL-C降幅、改善心肌再灌注及减轻炎症反应,且安全性良好。本研究结果支持进一步探索急性STEMI管理中的强化降脂策略。




