Effect of HELP-LDL-apheresis on outcomes in patients with advanced coronary atherosclerosis and severe hypercholesterolemia.

In the secondary prevention of coronary artery disease (CAD) the beneficial effect of lipid lowering is no longer controversial. LDL-apheresis is a feasible therapy for effective lipid lowering in patients refractory to diet and cholesterol lowering drugs. To assess the impact of the HELP-therapy (heparin-induced, extracorporeal LDL precipitation) on patients' clinical outcome and coronary angiography, we set up a prospective trial, in which patients with advanced coronary atherosclerosis and severe hypercholesterolemia resistant to diet and drug therapy were treated with LDL-apheresis. A total of 44 patients were treated with adjunctive weekly HELP-therapy for 15.5 +/- 9.5 months. The mean levels of total cholesterol (Chol), LDL-cholesterol (LDL-C), Lp(a), and fibrinogen at baseline were 308.0 +/- 69.7, 231.8 +/- 72.7, 82.2 +/- 54.1, and 356.1 +/- 94.1 mg/dl, respectively. LDL-apheresis caused a mean per treatment reduction of 44.8 +/- 8.7, 55.5 +/- 8.6, 60.8 +/- 10.2, and 53.8 +/- 6.5% of Chol, LDL-C, Lp(a), and fibrinogen, resulting in mean treatment interval values of 190.4 +/- 33.7, 116.3 +/- 28.9, 51.9 +/- 33.1, and 213.7 +/- 148.9 mg/dl, respectively. Improvement of the clinical status (exercise tolerance, anti-anginal drug use, angina pectoris) was found in 73%, no change in 11%, and deterioration in 16% of the cases. Four patients died cardiac death. The maximal bicycle exercise work load of the patients increased significantly from 101 +/- 41 to 119 +/- 46 W (P < 0.001). Ten (40%) out of 25 patients who underwent follow-up angiography revealed CAD progression, whereas two (8%) patients had CAD regression. Despite angiographic deterioration eight out of ten progressors (80%) improved clinically. In patients with advanced coronary atherosclerosis and severe hypercholesterolemia HELP-therapy can safely and effectively lower LDL-C, Lp(a), and fibrinogen. The chronic weekly HELP-treatment results in clinical improvement in the majority of patients, even in those patients with angiographically shown CAD progression.