Uehara Hiroki, Kajiya Takashi, Abe Masami, Nakata Marohito, Hosogi Shingo, Ueda Shinichiro
Department of Cardiology, Urasoe General Hospital, 1-56-1/Maeda Urasoe City, Okinawa 9012102, Japan.
Department of Clinical Research Education and Management, University of Ryukyus Graduate School of Medicine, 207 Uebaru Nishihara town, Okinawa 9030215, Japan.
Eur Heart J Open. 2024 Jul 23;4(4):oeae055. doi: 10.1093/ehjopen/oeae055. eCollection 2024 Jul.
Proprotein convertase anti-subtilisin-kexin type 9 inhibitors (PCSK9Is) improve plaque volume and composition and reduce major adverse coronary events in chronic coronary artery disease. We evaluated the effects of the short-term use of PCSK9Is on coronary plaque stability in patients with acute coronary syndrome (ACS) using optical coherence tomography (OCT).
This is a multicentre, open-label randomized controlled trial. The enrolled 80 subjects met the inclusion criteria. Of these, 52 patients (age 60 ± 11 years, 38 men, 14 women) with ST-elevated ACS had undergone successful primary percutaneous coronary intervention with LDL-cholesterol (LDL-C) levels > 70 mg/dL while receiving high-intensity statins. Participants were randomly assigned to the PCSK9I group (evolocumab 420 mg for 3 months, = 29) or the standard of care (SoC) group ( = 23). Optical coherence tomography was performed at baseline (BL) and 3 and 9 months after randomization to assess lipid-rich plaques in non-culprit lesions. The change in the minimum fibrous cap thickness (MFCT) from BL to 9 months was the primary endpoint. The percentage change in LDL-C levels from BL to 3 months was significantly greater in the PCSK9I group (-67.8 ± 21.5% in the PCSK9I group vs. -16.3 ± 21.8% in the SoC group; < 0.0001), and the difference between the two groups disappeared from BL to 9 months (-20.0 ± 37.8% in the PCSK9I group vs. -6.7 ± 34.2% in the SoC group; = 0.20). The changes in MFCT from BL to 9 months were significantly greater in the PCSK9I group, even after PCSK9I discontinuation {100 μm [interquartile range (IQR): 45-180 μm] vs. 50 μm [IQR: 0-110 μm]; = 0.032}.
Combination treatment with PCSK9Is and statins resulted in more marked plaque stabilization after ACS than SoC alone, and this effect persisted for 6 months after PCSK9I discontinuation.
Adage-Joto study, UMIN ID No. 26516.
前蛋白转化酶枯草溶菌素9型抑制剂（PCSK9Is）可改善斑块体积和成分，并减少慢性冠状动脉疾病中的主要不良冠状动脉事件。我们使用光学相干断层扫描（OCT）评估了短期使用PCSK9Is对急性冠状动脉综合征（ACS）患者冠状动脉斑块稳定性的影响。
这是一项多中心、开放标签的随机对照试验。纳入的80名受试者符合纳入标准。其中，52例ST段抬高型ACS患者（年龄60±11岁，男性38例，女性14例）在接受高强度他汀类药物治疗时，低密度脂蛋白胆固醇（LDL-C）水平>70mg/dL，已成功接受了直接经皮冠状动脉介入治疗。参与者被随机分配到PCSK9I组（依洛尤单抗420mg，为期3个月，n = 29）或标准治疗（SoC）组（n = 23）。在基线（BL）以及随机分组后3个月和9个月时进行光学相干断层扫描，以评估非罪犯病变中的富含脂质斑块。从BL到9个月时最小纤维帽厚度（MFCT）的变化是主要终点。从BL到3个月时，PCSK9I组LDL-C水平的百分比变化显著更大（PCSK9I组为-67.8±21.5%，SoC组为-16.3±21.8%；P<0.0001），而从BL到9个月时两组之间的差异消失（PCSK9I组为-20.0±37.8%，SoC组为-6.7±34.2%；P = 0.20）。即使在停用PCSK9I后，PCSK9I组从BL到9个月时MFCT的变化仍显著更大{100μm[四分位间距（IQR）：45 - 180μm] vs. 50μm[IQR：0 - 110μm]；P = 0.032}。
与单独的SoC相比，PCSK9Is与他汀类药物联合治疗在ACS后导致更显著的斑块稳定，并且这种效果在停用PCSK9I后持续6个月。
Adage-Joto研究，UMIN ID编号26516。
