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

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.