<p>Angina incidence.</p>

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.研究背景 在当前指南推荐的药物治疗框架下，急性ST段抬高型心肌梗死（acute 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，单次术前联用依洛尤单抗（evolocumab）与瑞舒伐他汀（rosuvastatin）的治疗效果仍未得到充分明确。 研究方法 本前瞻性随机试验于2023至2024年在聊城市人民医院开展，共纳入80例拟行急诊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/日维持治疗；对照组：于PCI术后起始予瑞舒伐他汀10mg/日单药治疗。本试验主要终点为随访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完成注册，注册号为ChiCTR2500099498。 研究结果 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：随访6个月时，治疗组7.5% vs 对照组27.5%（P=0.037）；LDL-C降幅：治疗组在给药第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）及随访第1个月（P=0.036）均出现显著降低；ST段回落>70%比例：治疗组60% vs 对照组30%（P<0.05）；炎症标志物：治疗组白细胞介素6（IL-6，P=0.02）与白细胞介素17（IL-17，P=0.01）水平更低。 研究结论 尽管依洛尤单抗与瑞舒伐他汀联合方案未能显著降低6个月时的MACEs发生率，但该方案展现出多项具有临床意义的获益，包括心绞痛发作频率降低、低密度脂蛋白胆固醇降幅加快、心肌再灌注改善及炎症反应减轻，且安全性良好。上述研究结果支持对急性STEMI管理中的强化降脂策略开展进一步研究。