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.
Preisack
M B
MB
Department of Cardiology, Tübingen University, Germany.
Karsch
K R
KR
D015906:Angioplasty, Balloon, Coronary; D000818:Animals; D002986:Clinical Trials as Topic; D003327:Coronary Disease / Q000453:epidemiology / Q000517:prevention & control* / Q000628:therapy; D004311:Double-Blind Method; D004353:Drug Evaluation, Preclinical; D006493:Heparin / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D015337:Multicenter Studies as Topic; D010865:Pilot Projects; D011817:Rabbits; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence
D006493:Heparin