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European Heart Journal 1995 16(Supplement L):56-62; doi:10.1093/eurheartj/16.suppl_L.56
Copyright © 1995 by the European Society of Cardiology.
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© 1995 The European Scociety of Cardiology

Evaluation of recombinant hirudin (CGP 39 393/TM REVASC) in the prevention of restenosis after percutaneous transluminal coronary angioplasty

Rationale and design of the HELVETICA trial, a multicentre randomized double blind heparin controlled study

J.-P. R. Herrman*, R. Simon{dagger}, V. A. W. M. Umans*, P. F. Peerboom{ddagger}, D. Keane*, J. J. M. M. Rijnierse§, D. Bach||, P. Kobi||, R. Kerry||, P. Close||, J. W. Deckers, P. W. Serruys*, On Behalf of The Helvetica Study Group

* Thorax centre, Erasmus University, Rotterdam the Netherlands
{dagger} Medizinsche Universitätsklinilk Kiel, Germany
{ddagger} Cardialysis BV, Rotterdam The Netherlands
§ Ciba-Geigy Ltd, Arnhem The Netherlands
|| Ciba-Geigy Ltd Basle Switzerland

Correspondence: Patrick W. Serruys MD, PhD, FESC, FACC, Thoraxcentre Erasmus University Room Ee 2332, P.O. Box 1738, 3000 DR Rotterdam, The Netherlands

One of the main areas of interest in interventional cardiology is the understanding, and ultimate prevention of restenosis after an initially successful percutaneous transluminal coronary angioplasty. Restenosis is the recurrence of luminal narrowing following angioplasty, and still frustrates the late results in the treatment of angina pectoris Experimental, pathological and clinical studies suggest that restenosis may occur via activation of the coagulation cascade, platelet activation and thrombus formation. Thrombin itself is identified as the most potent platelet activator, and has a pivotal role in the coagulation system. Furthermore, thrombin directly mediates smooth muscle cell proliferation by stimulating thrombin receptors at the smooth muscle cell surface. Thrombus indirectly induces excessive intimal smooth muscle cell proliferation by means of released mitogens (growth factors), which may contribute to late restenosis. Therefore direct and irreversible thrombin blockade by hirudin is deemed to be effective in the prevention of restenosis following angioplasty.

The HELVETICA trial is a multicentre, randomized, double-blind heparin-controlled study, designed to compare the effects of two dose regimens of recombinant-hirudin (CGP 39 393/TMRevasc) with those of heparin on event-free survival, safely, tolerability and luminal renarrowing using quantitative coronary angiography no later than 26 weeks after the coronary angioplasty procedure.

Key Words: Angioplasty • clinical trials phase IV • CGP 39 393 • coronary disease • heparin • hirudin • neointima proliferation • restenosis

HELVETICA: Hirudin in an European restenosis prevention trial versus heparin treatment in PTCA patients.


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