Key result
STENTYS paclitaxel-eluting stent shows ~10% 6-month major cardiovascular events in bifurcation lesions, driven by target lesion revascularization.
Why the study?
The long-term safety and efficacy of the STENTYS self-apposing paclitaxel-eluting stent in coronary bifurcation lesions in routine clinical practice needed evaluation.
Is the self-apposing paclitaxel-eluting stent safe and effective for the percutaneous treatment of de novo lesions in native bifurcated coronary arteries?
Observational (n=207)
Yes
Is the self-apposing paclitaxel-eluting stent safe and effective for the percutaneous treatment of de novo lesions in native bifurcated coronary arteries?
The self-apposing paclitaxel-eluting stent demonstrated acceptable safety and efficacy for treating coronary bifurcation lesions in routine clinical practice, with a 13.0% MACE rate at 12 months.
Answers are grounded in this paper and cite their sources.
May support use in bifurcation lesions; leaves open need for randomized comparisons to conventional stents.
AIMS: We aimed to evaluate the long-term safety and efficacy of the STENTYS self-apposing paclitaxeleluting stent (STENTYS-PES) in bifurcation lesions in routine clinical practice. METHODS AND RESULTS: The primary endpoint of the study was the composite major adverse cardiac events (MACE: cardiac death, myocardial infarction, clinically driven target lesion revascularisation, or emergent bypass surgery) assessed at six months after enrolment. This was reported in 21 patients (10.1%), mainly due to clinically driven target lesion revascularisation (TLR). At 12 months, 27 patients experienced MACE (13.0%). CONCLUSIONS: The long-term results of OPEN II show that the STENTYS-PES is safe and effective in the treatment of all-comers with coronary bifurcation lesions.
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Naber et al. (2016) conducted an observational in De novo lesions in native bifurcated coronary arteries (n=207). STENTYS self-apposing paclitaxel-eluting stent was evaluated on Composite major adverse cardiac events (MACE: cardiac death, myocardial infarction, clinically driven target lesion revascularisation, or emergent bypass surgery) at six months. The STENTYS self-apposing paclitaxel-eluting stent demonstrated a 6-month major adverse cardiac event rate of 10.1% in patients with coronary bifurcation lesions, primarily driven by target lesion revascularization.
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