Clinical safety of low-dose anticoagulation with fondaparinux in patients undergoing peripheral endovascular treatment due to critical limb-threatening ischaemia - a pilot study

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.