Key result
Implantation of the BiodivYsio dexamethasone-eluting stent in patients with de novo single-vessel disease was feasible and safe, with a 95% technical success rate and a 3.3% 6-month MACE rate.
Why the study?
Does the BiodivYsio dexamethasone-eluting stent prevent angiographic restenosis in patients with de novo coronary lesions?
Does the BiodivYsio dexamethasone-eluting stent prevent angiographic restenosis in patients with de novo coronary lesions?
The first-in-human implantation of a dexamethasone-eluting stent is feasible and safe, demonstrating low rates of angiographic restenosis and clinical events at 6 months.
Hypothesis-generating for dexamethasone-eluting stents in single-vessel disease; randomized trials needed to test restenosis reduction.
The aim of this multicenter pilot study was to evaluate the acute safety and efficacy of the dexamethasone-eluting stent (0.5 microg/mm(2) of stent) implanted in patients with de novo single-vessel disease. This study included 71 patients, 42% of whom had unstable angina pectoris. An appropriately sized BiodivYsio Matrix Lo stent loaded with a total dexamethasone dose of 0.5 microg/mm(2) of stent was used. Technical device success rate was 95%. Six-month MACE occurred in two patients (3.3%). Binary restenosis rate was 13.3%. Late loss was 0.45. Late loss and percent diameter stenosis were lower in the unstable angina pectoris patients compared to the stable patients (0.32 +/- 0.39 vs. 0.60 +/- 0.55 mm, P < 0.07, and 26.86 +/- 14 vs. 38.40 +/- 16%, P < 0.02). This study demonstrated the feasibility and safety of the implantation of a dexamethasone-eluting stent and its effect on in-stent neointimal hyperplasia.
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Liu et al. (2003) studied de novo single-vessel disease (n=71). BiodivYsio dexamethasone-eluting stent was evaluated on Six-month MACE. Implantation of the BiodivYsio dexamethasone-eluting stent in patients with de novo single-vessel disease was feasible and safe, with a 95% technical success rate and a 3.3% 6-month MACE rate.
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