Batimastat restenosis

Abbreviations-. AS. added support BRILLIANT-EU. batimastat (BB94) anti-restenosis trial utilizing the BiodivYsio local drug delivery FC-stent CTD. clinical trial dose OC, open cell. 

BATMAN-Pllot BATiMastat (BB94) Anti-restenosis trial utilizing the Biod/Ws/o local drug delivery PC-steNt ... 

Batimastat(BB94)anti-Restenosis trlaL utiLizIng the BiodivYsio locAl drug Delivery PC-steNT ... 

The data suggest that the Biod/VV s/o Batimastat OC Stent is safe during the period of drug elution from the stent (pharmacokinetic studies have shown that 94% of the batimastat will have eluted from the PC coating after one month). The final 30 days results suggest that the presence of the batimastat in the coating is not associated with an increased occurrence of MACE or serious adverse events, therefore, the Biod/VYs/o Batimastat OC Stent is safe in the short term for use in patients. However, the long-term (six months) data demonstrate that the Biod/VYs/o Batimastat OC Stent has no additional beneficial effect on restenosis (Table 6). 

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),... 

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. 

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