Bibliographie : Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial

L’angioplastie au ballon actif revient d’actualité et mérite le prix « Editor’s Medal 2023 » de la revue CVIR. Il s’agit cette fois de l’équipe de Leipzig en Allemagne qui présente les résultats à 5 ans de l’étude prospectif multicentrique EffPac sur 171 patients atteints d’une AOMI en stade 2-3-4. La technologie « drug-eluting » (DE) semble toujours assurer des meilleurs résultats en termes de perméabilité, taux de ré intervention et  amélioration clinique comparée à l’angioplastie simple (« plain old balloon angioplasty » POBA). L’étude montre d’ailleurs un taux de mortalité superposable pour les 2 groupes, en remettant ainsi en cause les questionnements soulevés par certaines publications concernant le risque des ballons chargés aux antimitotiques.

Teichgräber, U., Lehmann, T., Ingwersen, M. et al. Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial. Cardiovasc Intervent Radiol 45, 1774–1783 (2022).https://doi.org/10.1007/s00270-022-03265-1

Purpose

This study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB).

Materials and Methods

The EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5 years included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), clinical improvement, and target limb amputation. Long-term vital status was ascertained in 97.1% of the participants.

Results

Kaplan–Meier curves at 5 years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank p = 0.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank p = 0.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA, p = 0.94). Major target limb amputation was necessary in one POBA-group participant. Freedom from all-cause death at 5 years was 88.5% after DCB and 86.0% after POBA (log-rank p = 0.34).

Conclusions

Primary patency after femoropopliteal DCB angioplasty remained superior to POBA throughout 5 years, however, with decreasing difference. Clinical improvement, freedom from TLR, and all-cause mortality were similar between groups over the long term. (Effectiveness of Paclitaxel-Coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral Artery [EffPac]; NCT02540018).