American Society of Hirudotherapy

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

Randomized controlled trial published in European heart journal (1995)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Randomized controlled trialClinical TrialsDrug DevelopmentHerrman JP · European heart journal, 1995

Abstract

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, safety, tolerability and luminal renarrowing using quantitative coronary angiography no later than 26 weeks after the coronary angioplasty procedure.

Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.

Publication typeClinical TrialJournal ArticleMulticenter StudyRandomized Controlled TrialReview
Indexed MeSH termsAdultAgedAngioplasty, Balloon, CoronaryCoronary DiseaseDouble-Blind MethodFemaleHeparinHirudin TherapyHumansMaleMiddle AgedPostoperative Period

Summary

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.

Why This Matters for Hirudotherapy

This article outlines the design of the HELVETICA trial, described in the abstract as a multicentre, randomized, double-blind heparin-controlled study comparing two dose regimens of recombinant hirudin (CGP 39,393/TMRevasc) with heparin on event-free survival, safety, tolerability, and luminal renarrowing after coronary angioplasty. The abstract presents the pharmacological rationale that direct and irreversible thrombin blockade by hirudin may prevent restenosis by inhibiting thrombin-mediated coagulation and smooth muscle cell proliferation. The abstract does not mention leeches, leech saliva, or hirudotherapy, characterizing hirudin only as a recombinant thrombin inhibitor. No connection to ASH's domain of live leech therapy is established by the abstract.

Citation

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

Herrman JP · European heart journal, 1995

Added to ASH library: May 27, 2026 · Site last updated: June 18, 2026

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