Key result
Fondaparinux added to DAPT did not significantly increase clinically relevant bleeding (13% vs 21%, p=ns) or target vessel revascularisation/major amputation (17% vs 25%, p=ns) versus DAPT alone.
Why the study?
The safety and effectiveness of adding fondaparinux to DAPT in patients with critical limb-threatening ischaemia undergoing endovascular procedures needed evaluation.
Does adding fondaparinux to DAPT increase clinically relevant bleeding or reduce target vessel revascularisation/major amputation in patients undergoing peripheral endovascular treatment for CLTI?
Cohort (n=48)
Does adding fondaparinux to DAPT increase clinically relevant bleeding or reduce target vessel revascularisation/major amputation in patients undergoing peripheral endovascular treatment for CLTI?
Absolute Event Rate: 13% vs 21%
p-value: p=ns
Adding low-dose fondaparinux to DAPT for 1-4 weeks after peripheral endovascular treatment for CLTI appears safe without increasing clinically relevant bleeding.
Fondaparinux addition was not associated with excess bleeding or fewer events; hypothesis-generating and should not yet change practice in CLTI.
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.
No takes yet. Share an insight, caveat, or question.
Giuşcă et al. (2020) conducted a cohort in Critical limb-threatening ischaemia (CLTI) (n=48). Fondaparinux in addition to dual antiplatelet therapy (DAPT) vs. Standard DAPT was evaluated on Clinically relevant bleeding (p=ns). Fondaparinux added to DAPT did not significantly increase clinically relevant bleeding (13% vs 21%, p=ns) or target vessel revascularisation/major amputation (17% vs 25%, p=ns) versus DAPT alone.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: