Experimental and early clinical experience with reviparin-sodium for prevention of restenosis after percutaneous transluminal coronary angioplasty.

Restenosis after successful percutaneous transluminal coronary angioplasty (PTCA) remains a major problem limiting the clinical efficacy of the procedure. It has been shown that smooth muscle cell proliferation plays a major role in this accelerated atherosclerotic process. In vitro and in vivo experiments with a low molecular weight heparin, reviparin-sodium suggest a pronounced inhibitory effect of this compound on smooth muscle cell proliferation. To evaluate the safety of reviparin-sodium and the incidence of angiographic restenosis in humans a study with increasing dosages was conducted in 41 patients. Repeat coronary angiography was performed 3 months after angioplasty. Restenosis occurred in five of 37 evaluative patients (14%) with initially successful PTCA. No major bleeding complications were documented for any patient in this trial. Thus, in this limited series, administration of reviparin-sodium resulted in a low incidence of restenosis following PTCA without causing major bleeding complications. A randomized, double-blind, multicentre trial is being carried out to define the real impact of this compound for reduction of restenosis in patients who underwent successful balloon angioplasty.