1st Medical Clinic, General Hospital, Passau, Germany (J.L.); Center for Nephrology, Hypertension, and Metabolic Diseases, Hannover, Germany (E.R.); 3rd Medical Clinic, University Hospital, Dresden, Germany (U.J.); MVZ Kempten-Allgaeu, Kempten, Germany (F.H.); Dialysis- and Lipid Center North Rhine, Essen, Germany (R.S.); Clinic for Nephrology and Dialysis, Tangermuende, Germany (D.H.); KfH-Kidney Center, Germering, Germany (P.B.); Institute of Public Health and Preventive Medicine, University Heidelberg, Mannheim, and Synlab Academy, Mannheim, and Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Graz, Austria (W.M.); Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Cologne, Germany (W.L.); and Apheresis Research Institute, Cologne, Germany (A.H., R.K.).
Circulation. 2013 Dec 17;128(24):2567-76. doi: 10.1161/CIRCULATIONAHA.113.002432. Epub 2013 Sep 20.
BACKGROUND: Lipoprotein(a) (Lp(a)) hyperlipoproteinemia is a major risk factor for cardiovascular disease, which is not affected by treatment of other cardiovascular risk factors. This study sought to assess the effect of chronic lipoprotein apheresis (LA) on the incidence of cardiovascular events in patients with progressive cardiovascular disease receiving maximally tolerated lipid-lowering treatment. METHODS AND RESULTS: In a prospective observational multicenter study, 170 patients were investigated who commenced LA because of Lp(a)-hyperlipoproteinemia and progressive cardiovascular disease. Patients were characterized regarding plasma lipid status, lipid-lowering drug treatment, and variants at the LPA gene locus. The incidence rates of cardiovascular events 2 years before (y-2 and y-1) and prospectively 2 years during LA treatment (y+1, y+2) were compared. The mean age of patients was 51 years at the first cardiovascular event and 57 years at the first LA. Before LA, mean low-density lipoprotein cholesterol and Lp(a) were 2.56±1.04 mmol·L(-1) (99.0±40.1 mg·dL(-1)) and Lp(a) 3.74±1.63 µmol·L(-1) (104.9±45.7 mg·dL(-1)), respectively. Mean annual rates for major adverse coronary events declined from 0.41 for 2 years before LA to 0.09 for 2 years during LA (P<0.0001). Event rates including all vascular beds declined from 0.61 to 0.16 (P<0.0001). Analysis of single years revealed increasing major adverse coronary event rates from 0.30 to 0.54 (P=0.001) for y-2 to y-1 before LA, decline to 0.14 from y-1 to y+1 (P<0.0001) and to 0.05 from y+1 to y+2 (P=0.014). CONCLUSIONS: In patients with Lp(a)-hyperlipoproteinemia, progressive cardiovascular disease, and maximally tolerated lipid-lowering medication, LA effectively lowered the incidence rate of cardiovascular events. CLINICAL TRIAL REGISTRATION URL: https://drks-neu.uniklinik-freiburg.de. Unique identifier: DRKS00003119.
背景：脂蛋白(a)[Lp(a)]血症是心血管疾病的主要危险因素，且不受其他心血管危险因素治疗的影响。本研究旨在评估慢性脂蛋白吸附（LA）治疗对接受最大耐受降脂治疗的进展性心血管疾病患者心血管事件发生的影响。
方法和结果：在一项前瞻性观察性多中心研究中，我们对 170 名因 Lp(a) 血症和进展性心血管疾病而开始 LA 治疗的患者进行了调查。我们对患者的血浆脂质状态、降脂药物治疗以及 LPA 基因座的变异进行了特征描述。比较了 LA 治疗前 2 年（y-2 和 y-1）和前瞻性 2 年（y+1、y+2）的心血管事件发生率。患者首次心血管事件的平均年龄为 51 岁，首次 LA 的平均年龄为 57 岁。LA 前，平均低密度脂蛋白胆固醇和 Lp(a)分别为 2.56±1.04mmol·L(-1)（99.0±40.1mg·dL(-1)）和 3.74±1.63μmol·L(-1)（104.9±45.7mg·dL(-1)）。主要不良冠状动脉事件的年平均发生率从 LA 前 2 年的 0.41 降至 LA 期间 2 年的 0.09（P<0.0001）。包括所有血管床在内的事件发生率从 0.61 降至 0.16（P<0.0001）。单一年份分析显示，LA 前从 y-2 到 y-1 的主要不良冠状动脉事件发生率从 0.30 增至 0.54（P=0.001），从 y-1 到 y+1 下降至 0.14（P<0.0001），从 y+1 到 y+2 下降至 0.05（P=0.014）。
结论：在接受 Lp(a)血症、进展性心血管疾病和最大耐受降脂药物治疗的患者中，LA 可有效降低心血管事件的发生率。
临床试验注册网址：https://drks-neu.uniklinik-freiburg.de。唯一标识符：DRKS00003119。
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