Hôpital Privé Jacques Cartier, Institut Cardio-vasculaire Paris-sud (ICPS), Ramsay-Santé, Massy, France.
Future Cardiol. 2021 Mar;17(2):239-255. doi: 10.2217/fca-2020-0069. Epub 2020 Sep 7.
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.
在这篇最先进的综述中，我们展示了 Leaders Free 试验项目的结果和批判性分析，评估了基于无聚合物技术的新型支架在高出血风险（HBR）患者中的应用，在这种情况下是 BioFreedom（Biosensors Europe，瑞士）。无聚合物药物涂层支架旨在获得一种具有药物洗脱支架抗再狭窄益处的器械，但没有聚合物涂层作为潜在的触发因素，从而延迟动脉壁愈合和随后的晚期缺血不良事件，导致支架置入后对双联抗血小板治疗的依赖性延长。因此，由于可能减少抗血栓治疗的持续时间，这种方法为具有高出血风险和高血栓风险的复杂患者群体提供了一种有前景的器械策略。
