Evolocumab in Patients With Prior Percutaneous Coronary Intervention and No Prior Myocardial Infarction: Results From the VESALIUS-CV Trial.

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.

VESALIUS-CV（依洛尤单抗在高心血管风险患者中的效果，既往无心肌梗死或中风）随机选取了动脉粥样硬化或高风险糖尿病患者，这些患者既往未发生过心肌梗死或中风，并且LDL-C水平≥90 mg/dL，将他们分为依洛尤单抗组和安慰剂组。

The median follow-up was 4.6 years.

随访的中位数为4.6年。

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).

双重主要终点是冠心病死亡、心肌梗死或缺血性中风（3点主要不良心血管事件[MACE]）以及相同的复合终点加上缺血驱动的血运重建（4点MACE）。

For this prespecified subgroup analysis, patients were categorized by whether they had undergone PCI at any time before trial enrollment.

在这项预先指定的亚组分析中，患者根据在试验登记前是否接受过经皮冠状动脉介入治疗（PCI）进行分类。

Results

Among 12 257 randomized patients, 3627 (29.6%) had undergone prior PCI with a median time between PCI and enrollment of 4 years.

在12257名随机患者中，有3627名（29.6%）在试验登记前接受过经皮冠状动脉介入治疗（PCI），PCI与登记之间的中位时间间隔为4年。

Their median age was 66 years, and 30.7% were women.

他们的中位年龄为66岁，其中30.7%为女性。

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).

在48周的脂质亚研究中，与安慰剂组相比，依洛尤单抗组的中位低密度脂蛋白胆固醇（LDL-C）为41.5（26.0-67.0）mg/dL，而安慰剂组为107.0（84.0-135.0）mg/dL（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).

依洛尤单抗将3点MACE的相对发生率降低了30%（5年Kaplan-Meier发生率分别为7.0%对比9.5%；风险比[HR]，0.70 [95% 置信区间，0.56-0.89]；P=0.004），将4点MACE的发生率降低了18%（17.9%对比21.7%；HR，0.82 [95% 置信区间，0.71-0.96]；P=0.012），同时将心肌梗死的发生率降低了50%（3.0%对比6.1%；HR，0.50 [95% 置信区间，0.36-0.70]；P<0.001），并且在随机分组后6个月就显示出效果，将紧急冠状动脉血运重建的发生率降低了39%（HR，0.61 [95% 置信区间，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.

使用依洛尤单抗后，心血管死亡率（2.6%对比3.7%；HR，0.66 [95% 置信区间，0.45-0.96]；P=0.030）和全因死亡率（8.2%对比10.2%；HR，0.76 [95% 置信区间，0.60-0.95]；P=0.016）都有所降低。

Conclusions

Evolocumab reduced the risk of major cardiovascular events in stable patients with prior PCI but no MI.

在既往接受过经皮冠状动脉介入治疗（PCI）但无心肌梗死（MI）的稳定患者中，依洛尤单抗降低了主要心血管事件的风险。

These findings support intensive LDL-C lowering in patients who have undergone PCI even in the absence of prior MI.

这些发现支持在既往接受过经皮冠状动脉介入治疗（PCI）但无心肌梗死（MI）的患者中进行积极的低密度脂蛋白胆固醇（LDL-C）降低治疗。

registration

URL: https://www.clinicaltrials.gov; Unique identifier: NCT03872401.

网址: https://www.clinicaltrials.gov; 唯一标识符: NCT03872401。