Key result
BioFreedom polymer-free stent may reduce antithrombotic duration for patients with high bleeding and thrombosis risk.
Why the study?
Polymer coatings may trigger delayed arterial wall healing and late ischemic events requiring prolonged DAPT, prompting the need to evaluate polymer-free drug-coated stents in high bleeding risk patients.
Polymer-free drug-coated stents like BioFreedom offer a promising device-based strategy for patients with combined high bleeding and thrombosis risk by potentially reducing the required duration of dual antiplatelet therapy.
May inform device choice in select high-risk patients; leaves open need for prospective RCTs.
In this state-of-the-art review, we present the findings and a critical analysis of the Leaders Free trial program, evaluating outcomes of a new stent-generation based on polymer-free technology, in this case the BioFreedom™ (Biosensors Europe, Switzerland), in patients at high bleeding risk (HBR). Polymer-free drug-coated stents were designed to obtain a device with the antirestenotic benefits of drug-eluting stents but without the polymer coating as potential trigger for delayed arterial wall healing and subsequent late ischemic adverse events, causing a prolonged dependence on dual antiplatelet therapy after stenting. This offers therefore the potential of a promising device-based strategy in a complex growing population of patients with combined HBR and high thrombosis risk, due to the possible reduction of antithrombotic duration.
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Mauler‐Wittwer et al. (2020) conducted a review in High bleeding risk (HBR). BioFreedom polymer-free drug-coated stent was evaluated. The BioFreedom polymer-free drug-coated stent offers a promising strategy for patients with combined high bleeding and thrombosis risk by potentially reducing antithrombotic duration.
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