THE HELP-LDL-APHERESIS MULTICENTER STUDY, AN ANGIOGRAPHICALLY ASSESSED TRIAL ON THE ROLE OF LDL-APHERESIS IN THE SECONDARY PREVENTION OF CORONARY HEART-DISEASE .2. FINAL EVALUATION OF THE EFFECT OF REGULAR TREATMENT ON LDL-CHOLESTEROL PLASMA-CONCENTRATIONS AND THE COURSE OF CORONARY HEART-DISEASE

The efficacy of the heparin-induced extracorporeal LDL-precipitation ( HELP)-apheresis procedure has been studied in an open prospective mult icentre trial. After 2 years of regular weekly HELP-treatment the data from 39 of 51 patients could be evaluated according to the study crit eria. Twelve of the initially recruited study patients were omitted fr om the evaluation either because of premature termination of the treat ment or because they did not fulfil the exact guidelines of the study protocol. A mean of 2.831 plasma was regularly treated on average ever y 7.85 days. The mean pre-/post-apheresis LDL-cholesterol levels decre ased from 286/121 mg dl(-1) at the first HELP treatment to 203/77 mg d l(-1) after 1 year and to 205/77 mg dl(-1) after 2 years of regular ap heresis; the corresponding values for fibrinogen were 314/144, 246/98 and 250/105 mg dl(-1), respectively. In contrast, the mean pre-/post-a pheresis HDL-cholesterol levels rose from 41/38 through 51/44 mg dl(-1 ) after 1 year to 52/43 mg dl(-1) after 2 years of treatment. The over all result was a normalization of the atherogenic index (LDL-/HDL-chol esterol ratio) from 6.9/3.2 to 4.0/1.9. The angiographies from 33 pati ents obtained before and after 2 years of regular treatment could be e valuated blindly using the cardiovascular angiography analysis system. The mean degree of stenosis of all segments decreased from 32.5% (SD = 16) to 30.6% (SD = 16.8) over the 2 years. A regression > 8% was obs erved in 50/187 (26.7%) segments, whereas 29/187 (15.5%) segments show ed progression. In 108/187 (57.8%) segments the lesions were stable (< 8% deviation) over 2 years. We conclude that regular treatment with H ELP-LDL-apheresis is able to stabilize progressive atherosclerotic dis ease and to induce almost twice as much regression as progression of a therosclerotic lesions.