Aims: To evaluate the safety and effectiveness of fondaparinux in addition to dual antiplatelet therapy (DAPT) in patients with critical limb-threatening ischaemia (CLTI).
Methods: Fondaparinux (2.5 mg/d) was administered for 1-4 weeks after endovascular procedures together with DAPT (fondaparinux arm). Patients who received standard DAPT were retrospectively matched and generated the control arm. Demographic, angiographic and follow-up data, including (i) clinically relevant bleeding and (ii) target vessel revascularisation or major amputation after 12 months was analysed.
Results: Twenty-four patients (78.7 ± 6.9 years, 14 [58%] female, 4 TASC B, 10 TASC C and 10 TASC D lesions, total lesion length = 210 ± 98 mm, mean Rutherford class = 4.7 ± 0.6) received fondaparinux (over a period of 22 ± 9 d, range 7-28 d) and DAPT versus 24 control patients who received standard DAPT (78.3 ± 8.4 years, 14 [58%] female, 4 TASC B, 8 TASC C and 12 TASC D lesions, total lesion length = 204 ± 73 mm, mean Rutherford class = 4.6 ± 0.6). During follow-up, 3(13%) patients in the fondaparinux arm exhibited significant bleeding versus 5 (21%) in the control arm (p = ns). Four (17%) patients of the fondaparinux arm underwent target vessel revascularisation or major amputation versus 6 (25%) in the control group (p = ns).
Conclusions: Adding fondaparinux to DAPT does not seem to result in excess of clinically relevant bleeding. Our preliminary data suggest that prospective studies are now warranted in larger patient cohorts.
German clinical trials register: DRKS00015856.
Keywords: Critical limb ischaemia; drug-coated balloon; dual platelet therapy (DAPT); duplex sonography; fondaparinux; lower limb; stent placement.