THE HELP-LDL-APHERESIS MULTICENTER STUDY, AN ANGIOGRAPHICALLY ASSESSED TRIAL ON THE ROLE OF LDL-APHERESIS IN THE SECONDARY PREVENTION OF CORONARY HEART-DISEASE .1. EVALUATION OF SAFETY AND CHOLESTEROL-LOWERING EFFECTS DURING THE 1ST 12 MONTHS

Fifty-one patients with coronary heart disease (CHD) and LDL-cholesterol levels greater-than-or-equal-to 200 mg dl-1 despite diet and drug therapy have been recruited into an angiographically controlled, multicentre, two-year study to evaluate HELP-LDL-apheresis in the secondary prevention of CHD. There were five drop-outs in the first year and 46 patients completed one year of therapy. An average of 2.791 of plasma was treated per patient every 7.7 days. Treatment was well tolerated and the incidence of side effects was small (2.9% of treatments). Mean pre/post-apheresis LDL-cholesterol levels decreased from 283/120 mg dl-1 at baseline to 207/78 mg dl-1 and 203/76 mg dl-1 after 6 and 12 months, respectively. Mean pre-/post-apheresis HDL-cholesterol levels rose significantly over the course of therapy from 40.5/36.6 mg dl-1 to 44.8/39.7 mg dl-1 and 48.2/41.3 mg dl-1 after 0, 6 and 12 months, respectively. No major derangement of pre-apheresis haemostasis nor of haematological or clinical chemical parameters had occurred after 12 months of treatment. The data from this study support the feasibility of HELP-LDL-apheresis as an adjunctive therapy for lowering cholesterol levels in CHD patients refractory to cholesterol-lowering drugs while substantially improving the HDL/LDL ratio.