2022 台灣版高血脂治療指引-針對心血管疾病高風險族群 5 PAD-New PCSK9 inhibitor data

2025-12-09 14:10

2022 focused update of the 2017 Taiwanlipid guidelines for high risk patients:Coronary artery disease, peripheral arterydisease and ischemic stroke

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PCSK9抑制劑新數據

在使用依洛尤單抗治療 ASCVD 的 FOURIER 試驗中，入組時有 3642 名受試者（佔總參與者的 13.2%）患有 PAD，其中包括有既往外周血管重建史、因血管原因截肢史和/或踝臂指數 <0.85 且有間歇性跛行症狀的患者。 10 48 週時，接受依洛尤單抗合併他汀類藥物治療的 PAD 組患者的 LDL-C 中位數為 31 mg/dL（四分位數間距為 19-49 mg/dL）。 FOURIER試驗中周邊動脈疾病（PAD）患者的結局分析顯示，在2.5年的追蹤期內，依洛尤單抗合併他汀類藥物治療可顯著降低主要終點事件的發生率，此主要終點事件包括心血管死亡、心肌梗塞、中風、不穩定型心絞痛住院或冠狀動脈血運重建，降低幅度達21%（ 0.66-0.94）。 ¹⁰ 此外，依洛尤單抗合併他汀類藥物治療的PAD患者發生主要肢體不良事件的風險也顯著降低，此主要不良肢體事件包括急性肢體缺血、截肢或緊急血管重建（HR 0.58，95% CI 0.38-0.88）。此分析結果為積極降低PAD患者的低密度脂蛋白膽固醇（LDL-C）水平提供了臨床效益的證據。

推薦

對於有症狀的外周動脈疾病（PAD）患者，低密度脂蛋白膽固醇（LDL-C）目標值為<70 mg/dL，包括：(1)既往有外周動脈血運重建史；(2)既往因動脈粥樣硬化性疾病導致肢體缺血而截肢；(3)臨床表現為PAD，且影像學檢查證實外周動脈狹窄>50%（證據I，等級。對於合併冠狀動脈疾病（CAD）或頸動脈狹窄的有症狀PAD患者，可考慮將LDL-C目標值設定為<55 mg/dL（證據等級IIa，證據等級B）。

New PCSK9 inhibitor data

In the FOURIER trial using evolocumab for ASCVD, there were 3642 subjects (13.2% of total participants) had PAD at enrollment, including those with a history of prior peripheral revascularization, a history of amputation for vascular cause, and/or had an ankle brachial index <0.85 with symptoms of claudication.10 At 48 weeks, the median LDL-C level among the PAD group was 31 mg/dL (interquartile range, 19e49 mg/dL) with evolocumab plus statin therapy. The outcome analysis of PAD patients in the FOURIER trial showed that add-on evolocumab to statin significantly reduced the incidence of primary endpoint which was a composite of cardiovascular death, MI, stroke, hospitalization for unstable angina or coronary revascularization by 21% (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.66e0.94) in a follow-up of 2.5 years.10 Moreover, PAD patients with evolocumab plus statin had significantly lower risk of major adverse limb events which was a composite of acute limb ischemia, major amputation or urgent revascularization (HR 0.58, 95% CI 0.38e0.88). The results of the analysis provided evidence supporting the clinical benefit of aggressive LDLC reduction in patients with PAD.

Recommendation

The LDL-C target is < 70 mg/dL in patients with symptomatic PAD including (1) history of peripheral artery revascularization, (2) history of amputation for ischemic limb due to atherosclerotic disease and (3) clinical symptoms of PAD with > 50% stenosis of peripheral arteries confirmed by imaging studies (COR I, LOE B). In symptomatic PAD with CAD or carotid stenosis, a lower target of LDL-C < 55 mg/dL may be considered (COR IIa, LOE B).