Direct Adsorption of Low‐Density Lipoprotein by DALI‐LDL‐Apheresis: Results of a Prospective Long‐term Multicenter Follow‐up Covering 12 291 Sessions

Abstract:  Direct adsorption of lipoproteins (DALI) is the first low density lipoprotein (LDL)‐apheresis technology by which atherogenic LDL and lipoprotein(a) (Lp(a)) can be selectively removed from whole blood without plasma separation. The present follow‐up was carried out to evaluate the clinical efficacy, selectivity and safety of long‐term DALI apheresis. The follow‐up was carried out in an open, prospective uncontrolled multicenter clinical design. Included were 158 drug‐resistant hypercholesterolemic patients from 28 apheresis centers. These patients underwent 12 291 DALI sessions between January 1997 and March 2002. The patients suffered from severe atherosclerosis and their mean LDL‐C was 188 mg/dL before the sessions. Mean follow‐up was 25 ± 16 (range 1–56) months during which 78 ± 53 sessions were carried out. In most treatments, DALI 750 (63%) or DALI 1000 (30%) adsorbers were used. On average, 7423 ± 1495 mL blood was processed at a flow rate of 84 ± 16 mL/min in 102 ± 25 min. Acute reductions by the single DALI sessions averaged 69 ± 12% for LDL‐C, 41 ± 18% for TG, 15 ± 10% for HDL‐C, 19 ± 11% for fibrinogen and 62 ± 24% for Lp(a) (in patients with Lp(a) > 30 mg/dL). Adverse events were recorded in only 3.9% of the sessions. In this 5‐year follow‐up, long‐term therapy with DALI was safe, effective and selective as LDL‐C and Lp(a) could be reduced by >60% per session in approximately 100 min treatment time while HDL‐C decrease and the incidence of AE were low.