Center of Nephrology Göttingen GbR, Göttingen, Germany.
akquinet tech@spree GmbH, Rostock Division, Rostock, Germany.
Atherosclerosis. 2024 Nov;398:118601. doi: 10.1016/j.atherosclerosis.2024.118601. Epub 2024 Sep 19.
In 2012, the German Lipoprotein Apheresis Registry (GLAR) was launched. Real-world data on lipoprotein apheresis (LA) treatment are now available for a time period of 11 years. All patients received the maximally tolerated lipid-lowering therapy, which included statins, ezetimibe, bempedoic acid, and either proprotein convertase subtilisin/kexin type 9 (PCSK9) antibodies or antisense therapy.
During the time period from 2012 to 2022, 92 German apheresis centers collected retrospective and prospective observational data of a total of 2,301 patients undergoing regular lipoprotein apheresis (LA) treatment of hypercholesterolemia or/and Lp(a)-hyperlipoproteinemia suffering from progressive atherosclerotic cardiovascular disease (ASCVD), with complete data sets of 1.125 patients, who were the subject of this analysis. More than 61,500 LA sessions are documented in the database. In 2022, all patients treated with LA demonstrated a significant immediate median reduction rate of LDL-C (68.8 %) and Lp(a) (72.9 %). Patient data were analyzed for the incidence rate of major coronary events (MACE) 1 and 2 years before the beginning of LA treatment (y-2 and y-1) and prospectively up to eleven years on LA treatment (y+1 to y+11). During the first two years of LA treatment (y+1 and y+2), a MACE reduction of 73 % was observed and continued to be low during y+3 to y+11, when all LA patients were analyzed. LA patients with only increased Lp(a) levels (Lp(a) ≥ 60 mg/dl (≥120 nmol/l) and an LDL-C < 100 mg/dl (<2.6 mmol/l)) had a higher MACE reduction (85 %; n = 443) in the first two years of LA treatment compared to LA patients with only increased LDL-C-levels (LDL-C ≥ 100 mg/dl (≥2.6 mmol/l); Lp(a) < 60 mg/dl (<120 nmol/l)) (53 %; n = 171). Adverse events of LA remained low (about 5 %) over the eleven years and mainly represented puncture problems (1.0 %). No side effects resulted in termination of LA therapy.
The current analysis of GLAR data indicates that regular LA leads to very low incidence rates of cardiovascular events in patients with high LDL-C and/or high Lp(a) levels, progressive ASCVD, and maximally tolerated lipid-lowering medication, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition. Additionally, LA was safe with a low rate of adverse effects over an 11-year period. The number of enrolled patients and the duration of observation establish GLAR as the largest LA registry worldwide.
2012 年，德国脂蛋白吸附疗法注册中心（GLAR）成立。现在，我们拥有了为期 11 年的脂蛋白吸附（LA）治疗的真实世界数据。所有患者均接受了最大限度耐受的降脂治疗，包括他汀类药物、依折麦布、贝匹莫德、前蛋白转化酶枯草溶菌素 9（PCSK9）抗体或反义疗法。
在 2012 年至 2022 年期间，92 家德国吸附中心收集了 2301 名接受常规脂蛋白吸附（LA）治疗高胆固醇血症或/和脂蛋白（a）-高脂血症的患者的回顾性和前瞻性观察数据，这些患者患有进展性动脉粥样硬化性心血管疾病（ASCVD），共有 1125 名患者的数据完整，是本次分析的对象。数据库中记录了超过 61500 次 LA 治疗。2022 年，所有接受 LA 治疗的患者的 LDL-C（68.8%）和 Lp(a)（72.9%）中位数即刻降低率均显著。对 LA 治疗前 2 年（y-2 和 y-1）和前瞻性至 11 年 LA 治疗期间（y+1 至 y+11）的主要心血管事件（MACE）发生率数据进行了分析。在 LA 治疗的前两年（y+1 和 y+2），观察到 MACE 降低了 73%，在 y+3 至 y+11 期间持续保持较低水平，此时所有 LA 患者均进行了分析。仅 Lp(a)水平升高（Lp(a)≥60mg/dl（≥120nmol/l）和 LDL-C＜100mg/dl（＜2.6mmol/l）的 LA 患者，在 LA 治疗的前两年，MACE 降低率更高（85%；n=443），与仅 LDL-C 水平升高（LDL-C≥100mg/dl（≥2.6mmol/l）；Lp(a)＜60mg/dl（＜120nmol/l）的 LA 患者相比（53%；n=171）。LA 的不良事件在 11 年期间一直保持较低水平（约 5%），主要为穿刺问题（1.0%）。没有不良反应导致 LA 治疗终止。
GLAR 数据的当前分析表明，对于接受最大限度耐受降脂治疗、包括前蛋白转化酶枯草溶菌素 9（PCSK9）抑制的高 LDL-C 和/或高 Lp(a)水平、进展性 ASCVD 的患者，常规 LA 可导致心血管事件的发生率非常低。此外，LA 在 11 年期间安全性良好，不良事件发生率低。纳入患者的数量和观察时间使 GLAR 成为全球最大的 LA 注册中心。
