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European Heart Journal 1996 17(10):1538-1545;
Copyright © 1996 by the European Society of Cardiology.
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© 1996 The European Society of Cardiology

Porous balloon delivery of low molecular weight heparin in the dog coronary artery

A. Baumbach, M. Oberhoff, K. Rübsamen*, K. Jochims*, C. Herdeg, A. Kranzhöfer, A. Safer and K. R. Karsch

Division of Cardiology, Department of Medicine, University of Tübingen; Ludwigshafen. Germany
*Research & Development, Knoll AG. Ludwigshafen. Germany

revised 19 January 1996; accepted 15 February 1996.

Karl R. Karsch. MD, Medizinische Klinik III, Otfried-Müller-Str. 10, 72076 Tübingen, Germany.

Abstract

The aim of this experimental study was to assess the safety of local delivery of low molecular weight hepann via a porous balloon in the canine coronary artery.

In 16 mongrel dogs, percutaneous transluminal coronary angioplasty was performed. In addition, eight of the dogs were given 4 ml Clivarin (1500 IU) delivered locally into the coronary artery immediately after dilatation. The animals were killed after 3 or 14 days. In the animals with local administration, the results of histopathology after 3 days showed the findings to be heterogeneous with marked disruption of the internal elastic lamina in all animals, and varying degrees of medial haemorrhage, medial necrosis, perivascular haemorrhage and signs of myocardial necrosis. Similar changes, but of lesser severity, were present in the animals treated with balloon dilatation only. After 14 days, the severity of vascular and perivascular alterations (medial haemorrhage, perivascular haemorrhage, thrombus formation) was significantly lower in the local delivery group (P<0·05), but disruption of the internal elastic lamina, as a marker of the initial trauma, was present in all the animals. The presence of residual intracoronary thrombus was only seen in the PTCA group without local delivery.

CONCLUSIONS: In this safety study, both groups showed pronounced alterations in the vessel wall 3 days following percutaneous transluminal coronary angioplasty. This changed 14 days following percutaneous transluminal coronary angioplasty when intramural injection of Clivarin resulted in a marked decrease of residual thrombus and medial as well as perivascular haemorrhage. Although the additional vessel trauma by the drug delivery technique did not result in increased complications, a careful approach with this potentially harmful procedure is essential.

(Eur Heart J 1996; 17: 1538–1545)

Key Words: Local delivery • low molecular weight heparin • restenosis • PTCA


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