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

Abstract

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).

Keywords: Angioplasty; Drug-coated balloon; Femoropopliteal; Paclitaxel.

Conflict of interest statement

UT is a consultant for iVascular. TZ is co-principal investigator of the ILICO study, a study sponsored by iVascular. All other authors declare that they have no conflict of interest with respect to this article.

© 2022. The Author(s).

Figures

Fig. 1

Participant flow in the EffPac trial through the 5-year follow-up. One hundred seventy-one patients were randomized 1:1 into groups that underwent Luminor 35 DCB angioplasty or plain old balloon angioplasty for the treatment of femoropopliteal lesions and were followed up through 60 months. Withdrawal was due to withdrawal of consent or to other reasons for loss to follow up DCB drug-coated balloon, DUS duplex ultrasonography, POBA plain old balloon angioplasty

Fig. 2

Treatment effect of Luminor 35 DCB angioplasty in femoropopliteal lesions through 5 years. A Primary patency at 5 years was achieved significantly more often with Luminor 35 DCB angioplasty than with standard balloon angioplasty and B freedom from clinically driven target lesion revascularization did not differ significantly between groups. At 60 months, standard error was 6.9% and 6.4% for primary patency and 5.2% and 5.5% for CD-TLR in the DCB and POBA group, respectively. Bars represent 95% confidence intervals. DCB drug-coated balloon, POBA plain old balloon angioplasty, CD-TLR clinically driven target lesion revascularization

Fig. 3

Post-hoc analysis of loss of primary patency by subgroups. Hazard ratios were determined over a period of 5 years and adjusted for study centers. The dotted line shows the no-effect point and the continuous line the overall treatment effect. DCB drug-coated balloon, CTO chronic total occlusion, POBA plain old balloon angioplasty

Fig. 4

Clinical improvement according to Rutherford classification. A Change in Rutherford category from baseline to follow-ups (participants who underwent TLR included), and B clinical improvement at 5 years. The boxed p-values concern differences in change from baseline between the DCB and the POBA group. Primary clinical improvement applied if the Rutherford category declined by at least one level without preceding target lesion revascularization. DCB drug-coated balloon, POBA plain old balloon angioplasty, TLR target lesion revascularization

Fig. 5

Survival through 5 years. Kaplan–Meier curves show freedom from all-cause death after Luminor 35 DCB angioplasty or standard balloon angioplasty through 5 years. At 60 months, standard error was 3.6% and 3.8% in the DCB and POBA group, respectively. Bars represent 95% confidence intervals. DCB drug-coated balloon, POBA plain old balloon angioplasty