alexa The Appraisal-Trial: Evaluating RESTEN-MPTM in Patients with Bare Metal Stent De Novo Native Coronary Artery Lesions
ISSN: 2155-9880

Journal of Clinical & Experimental Cardiology
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Research Article

The Appraisal-Trial: Evaluating RESTEN-MPTM in Patients with Bare Metal Stent De Novo Native Coronary Artery Lesions

Sebastian Philipp1,2*, Stefan Sack2,3, Igor Kordish2, Johannes Brachmann4, Stefan Hardt5, Joseph Horn6, Raimund Erbel2 and Dirk Böse2
1Department of Cardiology, Elbe Klinikum, Stade, Germany
2Department of Cardiology, West-German Heart Center, University Duisburg-Essen, Essen, Germany
3Department of Cardiology, Klinikum München Schwabing, München, Germany
4Heart Center Coburg, Germany
Department of Cardiology, University of Heidelberg; Germany
6Global Therapeutics, a Cook medical company, Broomfield, CO, USA
Corresponding Author : Sebastian Philipp
Department of Cardiology
Elbe Klinikum Stade
Bremervörder, Str. 111
D-21682 Stade, Germany
Tel: +49-4141-971450
Fax: +49-4141-971452
E-mail: [email protected]
Received October 01, 2012; Accepted October 22, 2012; Published October 25, 2012
Citation: Philipp S, Sack S, Kordish I, Brachmann J, Hardt S, et al. (2012) The Appraisal-Trial: Evaluating RESTEN-MPTM in Patients with Bare Metal Stent De Novo Native Coronary Artery Lesions. J Clin Exp Cardiolog 3:218. doi:10.4172/2155-9880.1000218
Copyright: © 2012 Philipp S, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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Abstract

Neointimal hyperplasia is one of the key components of the restenotic process. The aim of this study was to evaluate the efficacy and safety of a microbubble delivery of c-myc antisense peptide in reducing restenosis after coronary stenting in de novo stenosis with intravascular ultrasound. A Multi-Link Zeta bare metal stent was implanted in de novo coronary artery lesions (RD ≥ 2.5- ≤ 4.0 mm; TL ≥ 15- ≤ 30 mm in length). Serial intravascular ultrasound analyses were performed in 25 lesions. A dose of 16mg RESTEN-MPTM (AVI BioPharma supplied by Global Therapeutics LLC) was intravenously administered after stenting and again 24 hours later. In three centres in Germany a total of 50patients (51 lesions) were enrolled, 34 in Essen, 13 in Coburg and 3 in Heidelberg. Before stenting, the minimal lumen diameter (MLD) and length of stenosis were determined. 84% (43/51) of the lesions were either Type B2 or C lesions. At six-month follow-up, angiography was performed. Generally the neointimal proliferation was minor. Major adverse cardiac events (MACE) were 10.0% after 6 months and 21.9% after 12 months. The target lesion revascularization was 15.6%, the target vessel revascularization 18.8% after 12 months. Of the 34 patients studied at six-months in the IVUS sub-study, six patients required target lesion revascularization (TLR). Binary restenosis rate by intravascular ultrasound was 26 ± 4%. Generally the neointima proliferation was minor and open vessel lumen could be demonstrated during follow-up. Microbubble delivery of c-myc antisense seems to be effective in reducing neointimal tissue proliferation without the problem of late stent thrombosis. Neointima proliferation seems to be attenuated but not eliminated. MACE was not increased in this study population.

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