Lawrence A Leiter, Robert P Giugliano, Nicholas A Marston, Gaetano De Ferrari, Jose C Nicolau, Ajay K Bhatia, Marcoli Cyrille, Jeong-Gun Park, Julia F Kuder, Sabina A Murphy, Lyrica Liu, Emileigh Walsh, Huei Wang, Andrej Džupina, Jorge Ferreira, Ioanna Gouni-Berthold, Henrik K Jensen, Johanna Kuusisto, Daniel Pella, Naveed Sattar, Konstantinos P Tsioufis, Dragos Vinereanu, Gabriel Paiva da Silva Lima, Marc S Sabatine, Erin A Bohula
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The dual primary end points were a composite of coronary heart disease death, MI or ischemic stroke (three-point major adverse cardiovascular event [3P-MACE]) and 3P-MACE plus ischemia-driven arterial revascularization (four-point [4P]-MACE).</p><p><strong>Results: </strong>Of the 6,002 patients with high-risk diabetes, 67% were on a high-intensity statin and 24% were on a sodium-glucose cotransporter 2 inhibitor (SGLT2i) or a glucagon-like peptide 1 receptor agonist (GLP-1RA) at baseline. The median LDL-C at 48 weeks was 47 mg/dL and 109 mg/dL in the evolocumab and placebo arms, respectively (P < 0.0001). After a median follow-up of 4.6 years, evolocumab decreased the relative rates of 3P-MACE and 4P-MACE by 29% (hazard ratio [HR] 0.71; 95% CI 0.59, 0.86; P = 0.0004) and 21% (HR 0.79; 95% CI 0.69, 0.91; P = 0.0013), respectively. These findings were consistent regardless of the presence or absence of qualifying atherosclerosis, baseline LDL-C, statin intensity, and SGLT2i or GLP-1RA use (Pint > 0.05 for each). 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引用次数: 0
摘要
目的：这项预先指定的分析Evolocumab在无心肌梗死或卒中的高危心血管患者中的作用（VESALIUS-CV）评估了PCSK9抑制剂Evolocumab预防高危糖尿病患者首次心血管事件的疗效。研究设计和方法：VESALIUS-CV将高风险糖尿病（微血管疾病、胰岛素使用或病程≥10年）或符合动脉粥样硬化条件，但既往无心肌梗死（MI）或卒中，且LDL- c≥90 mg/dL的患者随机分组，每2周给evolocumab 140 mg或匹配安慰剂。双重主要终点是冠心病死亡、心肌梗死或缺血性卒中（3点主要心血管不良事件[3P-MACE]）和3P-MACE加缺血驱动的动脉血运重化术（4点[4P]-MACE）的复合终点。结果：在6002例高危糖尿病患者中，67%在基线时使用高强度他汀类药物，24%在基线时使用钠-葡萄糖共转运蛋白2抑制剂（SGLT2i）或胰高血糖素样肽1受体激动剂（GLP-1RA）。evolocumab组和安慰剂组48周时的中位LDL-C分别为47 mg/dL和109 mg/dL （P < 0.0001）。中位随访4.6年后，evolocumab将P- mace和P- mace的相对发生率分别降低了29%（风险比[HR] 0.71; 95% CI 0.59, 0.86; P = 0.0004）和21%（风险比[HR] 0.79; 95% CI 0.69, 0.91; P = 0.0013）。无论是否存在合格的动脉粥样硬化、基线LDL-C、他汀类药物强度、SGLT2i或GLP-1RA的使用（每项0.05），这些结果都是一致的。在evolocumab组和安慰剂组中，全因死亡的患者比例分别为8.8%和11.0% （HR 0.79; 95% CI 0.67, 0.93）。结论：Evolocumab降低了高危糖尿病患者心血管事件的发生率，无论是否存在符合条件的动脉粥样硬化和其他心脏保护药物的背景使用。
Evolocumab in Patients With High-Risk Diabetes: Results From the VESALIUS-CV Trial.
Objective: This prespecified analysis of Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV) evaluated the efficacy of the PCSK9 inhibitor evolocumab for preventing first cardiovascular events in patients with high-risk diabetes.
Research design and methods: VESALIUS-CV randomized patients with high-risk diabetes (microvascular disease, insulin use, or duration ≥10 years) or qualifying atherosclerosis, but no prior myocardial infarction (MI) or stroke, and LDL cholesterol (LDL-C) ≥90 mg/dL to evolocumab 140 mg or matching placebo every 2 weeks. The dual primary end points were a composite of coronary heart disease death, MI or ischemic stroke (three-point major adverse cardiovascular event [3P-MACE]) and 3P-MACE plus ischemia-driven arterial revascularization (four-point [4P]-MACE).
Results: Of the 6,002 patients with high-risk diabetes, 67% were on a high-intensity statin and 24% were on a sodium-glucose cotransporter 2 inhibitor (SGLT2i) or a glucagon-like peptide 1 receptor agonist (GLP-1RA) at baseline. The median LDL-C at 48 weeks was 47 mg/dL and 109 mg/dL in the evolocumab and placebo arms, respectively (P < 0.0001). After a median follow-up of 4.6 years, evolocumab decreased the relative rates of 3P-MACE and 4P-MACE by 29% (hazard ratio [HR] 0.71; 95% CI 0.59, 0.86; P = 0.0004) and 21% (HR 0.79; 95% CI 0.69, 0.91; P = 0.0013), respectively. These findings were consistent regardless of the presence or absence of qualifying atherosclerosis, baseline LDL-C, statin intensity, and SGLT2i or GLP-1RA use (Pint > 0.05 for each). The porportion of patients with all-cause death was 8.8% vs. 11.0% in the evolocumab versus placebo arms (HR 0.79; 95% CI 0.67, 0.93).
Conclusions: Evolocumab reduced the rate of cardiovascular events in patients with high-risk diabetes, regardless of the presence or absence of qualifying atherosclerosis and background use of other cardioprotective agents.
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