依洛尤单抗用于既往 PCI 但无心肌梗死患者：VESALIUS-CV 预设亚组分析
VESALIUS-CV 研究预设亚组分析纳入 3627 例既往接受过 PCI 但无心肌梗死或卒中的高危患者，随机接受依洛尤单抗或安慰剂，中位随访 4.6 年。结果显示依洛尤单抗显著降低 3 点 MACE、4 点 MACE、心肌梗死和紧急冠脉血运重建风险。研究支持在这类已行 PCI 但无既往 MI 的患者中强化降低 LDL-C。
要点
- 既往 PCI 但无 MI 患者中，依洛尤单抗降低 3 点 MACE 风险 30%（HR 0.70，P=0.004）。
- 依洛尤单抗使心肌梗死风险下降 50%（HR 0.50，P<0.001），6 个月即显效。
- 该亚组 48 周 LDL-C 中位数在治疗组为 41.5 mg/dL，安慰剂组为 107.0 mg/dL。
核心结论
- 依洛尤单抗可降低既往 PCI 但无 MI 的稳定患者的主要心血管事件风险。
- 研究支持即使无既往 MI，已行 PCI 的患者也应强化 LDL-C 降低治疗。
研究设计与样本
- VESALIUS-CV 为随机对照试验，纳入动脉粥样硬化或高危糖尿病、无既往 MI 或卒中且 LDL-C≥90 mg/dL 的患者，比较依洛尤单抗与安慰剂。
- 本预设亚组分析按试验入组前是否接受过 PCI 分类，纳入 3627 例既往 PCI 患者，中位随访 4.6 年。
主要发现
- 既往 PCI 亚组中，依洛尤单抗组 48 周 LDL-C 中位数为 41.5 mg/dL，安慰剂组为 107.0 mg/dL（P<0.0001）。
- 依洛尤单抗使 3 点 MACE 相对风险降低 30%（5 年 Kaplan-Meier 率为 7.0% 对 9.5%；HR 0.70，95% CI 0.56-0.89；P=0.004）。
- 依洛尤单抗使 4 点 MACE 相对风险降低 18%（17.9% 对 21.7%；HR 0.82，95% CI 0.71-0.96；P=0.012）。
- 依洛尤单抗使心肌梗死相对风险降低 50%（3.0% 对 6.1%；HR 0.50，95% CI 0.36-0.70；P<0.001），6 个月即出现效应。
- 紧急冠脉血运重建相对风险降低 39%（HR 0.61，95% CI 0.46-0.80；P<0.001）。
关键数值与推荐
- 3 点 MACE：HR 0.70，95% CI 0.56-0.89，P=0.004。
- 4 点 MACE：HR 0.82，95% CI 0.71-0.96，P=0.012。
- 心肌梗死：HR 0.50，95% CI 0.36-0.70，P<0.001。
- 紧急冠脉血运重建：HR 0.61，95% CI 0.46-0.80，P<0.001。
- 心血管死亡：名义上降低，2.6% 对 3.7%；HR 0.66，95% CI 0.45-0.96；P=0.030。
临床怎么用
- 对于既往接受 PCI 但无 MI 的动脉粥样硬化或高危糖尿病患者，可考虑依洛尤单抗强化降 LDL-C 以降低心血管事件风险。
局限性
- 本研究为该随机试验的预设亚组分析，亚组内比较的统计学效能受限于样本量。
- 心血管死亡和全因死亡的降低为名义显著性，需谨慎解释。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
BACKGROUND: The clinical benefit of intensive LDL cholesterol (LDL-C) lowering with evolocumab in patients with prior percutaneous coronary intervention (PCI) but without a prior myocardial infarction (MI) is not established. METHODS: VESALIUS-CV (The Effect of Evolocumabin Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke) randomized patients with atherosclerosis or high-risk diabetes but without prior MI or stroke and with LDL-C ≥90 mg/dL to evolocumab versus placebo. The median follow-up was 4.6 years. The dual primary end points were coronary heart disease death, MI, or ischemic stroke (3-point major adverse cardiovascular event [MACE]) and the same composite plus ischemia-driven revascularization (4-point MACE). For this prespecified subgroup analysis, patients were categorized by whether they had undergone PCI at any time before trial enrollment. RESULTS: Among 12 257 randomized patients, 3627 (29.6%) had undergone prior PCI with a median time between PCI and enrollment of 4 years. Their median age was 66 years, and 30.7% were women. The median LDL-C in a lipid substudy at 48 weeks was 41.5 (26.0-67.0) mg/dL versus 107.0 (84.0-135.0) mg/dL in the evolocumab versus placebo arms (P<0.0001). Evolocumab reduced the relative rate of 3-point MACE by 30% (5-year Kaplan-Meier rates 7.0% versus 9.5%; hazard ratio [HR], 0.70 [95% CI, 0.56-0.89]; P=0.004) and 4-point MACE by 18% (17.9% versus 21.7%; HR, 0.82 [95% CI, 0.71-0.96]; P=0.012) as well as both MI by 50% (3.0% versus 6.1%; HR, 0.50 [95% CI, 0.36-0.70]; P<0.001), with the effect apparent as soon as 6 months after randomization, and urgent coronary revascularization by 39% (HR, 0.61 [95% CI, 0.46-0.80]; P<0.001). There were nominally lower rates of cardiovascular death (2.6% versus 3.7%; HR, 0.66 [95% CI, 0.45-0.96]; P=0.030) and all-cause death (8.2% versus 10.2%; HR, 0.76 [95% CI, 0.60-0.95]; P=0.016) with evolocumab. CONCLUSIONS: Evolocumab reduced the risk of major cardiovascular events in stable patients with prior PCI but no MI. These findings support intensive LDL-C lowering in patients who have undergone PCI even in the absence of prior MI. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03872401.
引用
- Bergmark, Bohula, Marston, et al. Evolocumab in Patients With Prior Percutaneous Coronary Intervention and No Prior Myocardial Infarction: Results From the VESALIUS-CV Trial. Circulation. 2026. PMID: 42153665. doi:10.1161/CIRCULATIONAHA.126.080616
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。