Polymer Free Drug Coated Stents and Long Term Outcomes

In patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) it is often be desirable to minimise the duration of subsequent dual antiplatelet therapy (DAPT). The BioFreedom stent, a polymer-free, carrier-free, drug-coated stent (DCS), has a microporous abluminal surface from which controlled release of Biolimus A9 (a highly lipophilic sirolimus analogue) achieves therapeutic local tissue concentrations for 28 days post implantation. Previous angiographic studies have reported similar late loss to conventional drug eluting stents while the absence of surface polymer may facilitate early stent healing and shorter DAPT duration.

In the LEADERS FREE study, 2,466 high bleeding risk patients were randomised to a BioFreedom-DCS or a bare metal stent followed by 1-month only of DAPT. Study inclusion required 1 or more high bleeding risk criteria, including age>75 years, planned prolonged oral anticoagulation, planned major surgery, anaemia renal insufficiency, prior cancer

Use of BioFreedom vs. bare metal stents was associated with a marked reduction in the primary efficacy endpoint of target-lesion revascularization (HR 0.50; 5.1% vs 9.8% by 390 days; HR 0.54; 6.8% vs. 12.0% by 2 years) plus a reduction in the primary safety endpoint of cardiovascular death, stent thrombosis or myocardial infarction (HR 0.71; 9.4% vs. 12.9; by 390 days; HR 0.8; 12.6% vs. 15.3%; by 2 years).

Practical aspects of PCI using BioFreedom DCS will be discussed along with results from a pre-specified substudy of 879 patients planned for longterm oral anticoagulation after PCI, and updates from the ongoing LEADERS FREE II and LEADERS FREE III studies.