Direct adsorption of low-density lipoprotein by DALI-LDL-apheresis: results of a prospective long-term multicenter follow-up covering 12,291 sessions.
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.
Bosch
Thomas
T
Nephrology Division, Department I of Internal Medicine, University Hospital Munich-Grosshadern, Munich, Germany.
Gahr
Simon
S
Belschner
Ulrike
U
Schaefer
Claudia
C
Lennertz
Andrea
A
Rammo
Jörg
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D050197:Atherosclerosis / Q000517:prevention & control; D001781:Blood Component Removal / Q000009:adverse effects / Q000379:methods*; D002648:Child; D005260:Female; D005500:Follow-Up Studies; D006464:Hemoperfusion / Q000009:adverse effects / Q000379:methods*; D006579:Heterozygote; D006720:Homozygote; D006801:Humans; D006938:Hyperlipoproteinemia Type II / Q000628:therapy*; D017270:Lipoprotein(a) / Q000097:blood*; D008077:Lipoproteins, LDL / Q000097:blood* / Q000302:isolation & purification; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
D017270:Lipoprotein(a); D008077:Lipoproteins, LDL