Biodivysio batimastat stent studies

Scanning electron micrograph showing continuous endothelial cell coverage of the stent struts after five-day implantation (preclinical study of clinical trial dose BiodivYsio Batimastat Stent). 

Clinical studies with the biodivysio batimastat stent... 

The one-month farm swine studies evaluated safety following implantation of two doses of batimastat loaded on the 18 mm BiodivYsio stent in comparison to control stent without batimastat. Two batimastat doses were evaluated as described in Table 2. No deaths occurred during the implantation procedure and no sub-acute death or stent thrombosis was observed during the follow-up period. Histological examination confirmed that all the vessels were patent, without the presence of thrombus in the vessel lumen, All sections showed stent struts to be completely covered, leading to a smooth endoluminal surface. There was no excessive inflammatory response at stent struts in BiodivYsio-Batimastat-treated sections compared with the control sections. Medial and adventitial layers appeared similar in all three groups. The perivascular nerve fibers, the adipose tissue, and adjacent myocardium appeared normal in control and Biod/VV s/o-Batimastat-treated sections. Therefore, these studies demonstrated that the Biod/VY s/o Batimastat stent at CTD and >CTD was well tolerated up to 28 days. 

In addition to the preclinical studies, the clinical studies demonstrate that stent-based delivery of batimastat in coronary artery using the Biod/VYs/o DD stents is a feasible and safe procedure. Results from the BRILLIANT study however did not show a positive effect of the BiodivYsio Batimastat OC stent on TLR, late loss, and binary restenosis. 

The long-term (three months) safety study was carried out on Yucatan mini-pigs using two doses of batimastat loaded on the 15 mm BiodivYsio stent in comparison to a control stent without batimastat, as outlined in Table 2. The evaluation criteria included vessel lumen area, neointimal thickness and area, absence/presence of thrombus, angiographic percent stenosis, and lumen loss. The QCAand histological analysis at three months follow-up are presented in Table 3. 

One hundred and seventy-three patients (134 males and 39 females), symptomatic patients with stable angina pectoris (Canadian Cardiovascular Society I, 2, 3, or 4) or unstable angina pectoris with documented ischaemia (Braunwald Class IB-C, IIB-C, or IIIB-C) or documented ischemia with a single de novo lesion in a coronary artery suitable for treatment with a single BiodivYsio DD OC-coated coronary stent preloaded with Batimastat of I 1, 15, 18, 22, or 28 mm length by 3.0, 3.5, or4.0-mm diameter were included in the study, providing they met the selection criteria. 

This study was set up to allow a comparison of the patient population and the results with the larger randomized DISTINCT study previously conducted in the U.S.A. The Biod/VV s/o Batimastat OC Stent showed no improvement in the overall unadjudicated MACE (18%) and restenosis (23%) rate at six months when compared to the nondrug-coated BiodivYsio stent used in the DISTINCT study, where the reported adjudicated MACE and restenosis rate were 17% and 19,7%, respectively. This six-month follow-up data suggest that the Biod/VYs/o Batimastat OC Stent did not offer the additional benefit over the standard BiodivYsio stent (Table 7),... 

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