Prospective randomised cross-over comparison of three LDL-apheresis systems in statin pretreated patients with familial hypercholesterolaemia

Various LDL-apheresis systems have gained wider clinical acceptance in rece nt years to treat patients with severe familial hypercholesterolaemia, in p articular in patients with coronary artery disease. For each single device data on efficacy have been provided, but up to now no comparative analysis including the novel direct adsorption of lipoproteins from whole blood has been reported. This prospectively designed cross-over comparison of three c ommercially available LDL-apheresis systems (immunoadsorption, IMAL; dextra n sulphate adsorption, DSA; direct adsorption of lipoproteins, DALI) was pe rformed in eight patients with homozygous (n = 3) and heterozygous (n = 5) familial hypercholesterolaemia. Removal of atherogenic lipoproteins was hig hly effective in all systems, for LDL-cholesterol in particular: DSA: - 84. 3 +/- 6.2%; IMAL: - 82.1 +/- 8.3%; DALI: - 76.6 +/- 7.2% (P < 0.05 as compa red DALI versus IMAL and DSA). A reduction in Lp(a) of about 63% was achiev ed by each device. Loss in HDL-cholesterol was highest with IMAL (- 21.3 +/ - 4.9%, P < 0.05) as compared to the other two treatment modalities. DSA de creased HDL-cholesterol by - 10.4 +/- 6.1% and the DALI system by - 12.7 +/ - 5.0%. Remarkable differences were found for the removal of fibrinogen (DS A: - 29.8 +/- 14.7%, (P < 0.05 versus DALI/IMAL); IMAL: - 21.4 +/- 10.1% (P < 0.05 versus DALI); DALI: - 14.8 +/- 8.0%). The shortest duration for tre atment was achieved by the DALI system (135 +/- 20 min, P < 0.05 Versus IMA L (195 +/- 20 min) and DSA (187 +/- 29 min)). No side effects were recorded in the total of 96 treatments performed during the study. Long-term observ ations have yet to prove whether these differences in efficacy may be of cl inical relevance. (C) 2000 Elsevier Science Ireland Ltd. All rights reserve d.