Department of Medicine, Division of Cardiology, Loyola University Medical Center, 2160 S. 1st Avenue, Maywood, IL 60153, USA.
Department of Medicine, Division of Cardiology, Edward Hines Jr. VA Hospital, 5000 South 5th Avenue, Hines, IL, USA.
Eur Heart J Cardiovasc Imaging. 2023 Jun 21;24(7):866-873. doi: 10.1093/ehjci/jead063.
Icosapent ethyl (IPE) significantly reduced ischaemic events in statin-treated patients with atherosclerosis or diabetes and elevated triglycerides in REDUCE-IT, including large reductions in myocardial infarction and elective, urgent, and emergent coronary revascularization. However, the mechanisms driving this clinical benefit are not fully known. The EVAPORATE trial demonstrated that IPE significantly reduced plaque burden. No study to date has assessed the impact of IPE on coronary physiology. Fractional flow reserve (FFR) derived from coronary computed tomography angiography (CTA) data sets (FFRCT) applies computational fluid dynamics to calculate FFR values in epicardial coronary arteries. Our objective was to assess the impact of IPE on coronary physiology assessed by FFRCT using imaging data from EVAPORATE.
A total of 47 patients and of 507 coronary lesions at baseline, 9 months, and 18 months with coronary CTA and FFRCT were studied in a blinded core lab. The pre-specified primary endpoint was the FFRCT value in the distal coronary segment from baseline to follow-up in the most diseased vessel per patient using IPE compared with placebo. The pre-specified secondary endpoint was the change in translesional FFRCT (ΔFFRCT) across the most severe (minimum 30% diameter stenosis) coronary lesion per vessel. Baseline FFRCT was similar for IPE compared with placebo (0.83 ± 0.08 vs. 0.84 ± 0.08, P = 0.55). There was significant improvement in the primary endpoint, as IPE improved mean distal segment FFRCT at 9- and 18-month follow-up compared with placebo (0.01 ± 0.05 vs. -0.05 ± 0.09, P = 0.02, and -0.01 ± 0.09 vs. -0.09 ± 0.12, P = 0.03, respectively). ΔFFRCT in 140 coronary lesions was improved, although not statistically significant, with IPE compared with placebo (-0.06 ± 0.08 vs. -0.09 ± 0.1, P = 0.054).
Icosapent ethyl demonstrated significant benefits in coronary physiology compared with placebo. This early and sustained improvement in FFRCT at 9- and 18-month follow-up provides mechanistic insight into the clinical benefit observed in the REDUCE-IT trial. Furthermore, this is the first assessment of FFRCT to determine drug effect.
在 REDUCE-IT 研究中，依泽替米贝（IPE）显著降低了接受他汀类药物治疗的动脉粥样硬化或糖尿病伴高甘油三酯血症患者的缺血性事件，包括心肌梗死和择期、紧急和紧急冠状动脉血运重建的大幅减少。然而，驱动这种临床获益的机制尚不完全清楚。EVAPORATE 试验表明，IPE 显著降低了斑块负担。迄今为止，尚无研究评估 IPE 对冠状动脉生理学的影响。基于冠状动脉计算机断层血管造影（CTA）数据集的血流储备分数（FFRCT）应用计算流体动力学来计算心外膜冠状动脉的 FFR 值。我们的目的是使用来自 EVAPORATE 的成像数据评估 IPE 对通过 FFRCT 评估的冠状动脉生理学的影响。
共有 47 名患者和 507 处冠状动脉病变在基线、9 个月和 18 个月时接受了冠状动脉 CTA 和 FFRCT 检查，并在一个盲法核心实验室进行了研究。主要终点是在患者的最严重血管中，与安慰剂相比，使用 IPE 治疗时从基线到随访时远端冠状动脉节段的 FFRCT 值。次要终点是每支血管中最严重（最小 30%直径狭窄）冠状动脉病变的跨病变 FFRCT（ΔFFRCT）的变化。与安慰剂相比，IPE 组的基线 FFRCT 相似（0.83±0.08 对 0.84±0.08，P=0.55）。主要终点有显著改善，因为与安慰剂相比，IPE 在 9 个月和 18 个月随访时改善了平均远端节段 FFRCT（0.01±0.05 对-0.05±0.09，P=0.02，和 0.01±0.09 对-0.09±0.12，P=0.03）。与安慰剂相比，IPE 组的 140 处冠状动脉病变的 ΔFFRCT 虽然没有统计学意义，但也有所改善（-0.06±0.08 对-0.09±0.1，P=0.054）。
与安慰剂相比，依泽替米贝在冠状动脉生理学方面显示出显著益处。在 9 个月和 18 个月的随访中，FFRCT 的早期和持续改善为 REDUCE-IT 试验中观察到的临床益处提供了机制上的见解。此外，这是首次评估 FFRCT 以确定药物效果。
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