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).

Long‐term outcomes after paclitaxel‐coated balloon angioplasty of femoropopliteal arteries in Asian patients of the IN.PACT Global Study

“…The freedom from CD‐TLR rate in this study was also comparable to the Zilver PTX Japan Post‐Market Surveillance Study (77.1% IN.PACT Global Asian Cohort vs. 73.4% Zilver PTX Japan Post‐Market) with equivalent lesion lengths between these two studies (17.4 cm IN.PACT Global Asian Cohort vs. 17.8 cm Zilver PTX Japan Post‐Market) 17 . This 5‐year freedom from CD‐TLR rate of 77.1% was also comparable to DCB outcomes in RCTs: 79.0% in the THUNDER trial (mean lesion length 7.4 cm), 18 74.5% in the IN.PACT SFA RCT (mean lesion length 8.9 cm), 20 77.5% in the AcoArt I (mean lesion length 14.7 cm), 10 and 82.1% in the EffPac trial (mean lesion length 5.9 cm) 21 . In the Zilver PTX randomized trial, the 5‐year freedom from TLR was 83.1% for the Zilver PTX DES arm (mean lesion length 6.6 cm) 19 and carried the risk of ISR.…”

“…There are only a handful of published long‐term reports for endovascular therapies in the femoropopliteal vessel bed. At the time of writing this article, 5‐year outcomes were reported by only one real‐world DCB study (IN.PACT Global Study, clinical cohort), 14 one postmarket surveillance subset analysis (the Zilver PTX Japan Post‐Market Surveillance Study), 17 and five RCTs (THUNDER, Zilver PTX, IN.PACT SFA RCT, AcoArt I, and EffPac) 10,18–21 . The results of the present Asian cohort study were compared with that of the full clinical cohort (IN.PACT Global Study) for literature benchmarking purposes.…”

“…At the time of writing this article, 5‐year outcomes were reported by only one real‐world DCB study (IN.PACT Global Study, clinical cohort), 14 one postmarket surveillance subset analysis (the Zilver PTX Japan Post‐Market Surveillance Study), 17 and five RCTs (THUNDER, Zilver PTX, IN.PACT SFA RCT, AcoArt I, and EffPac). 10 , 18 , 19 , 20 , 21 The results of the present Asian cohort study were compared with that of the full clinical cohort (IN.PACT Global Study) for literature benchmarking purposes. Because the inclusion/exclusion criteria were the same in these two cohorts, participant characteristics were generally similar.…”

“…In addition, despite the longer mean lesion length (17.4 20 77.5% in the AcoArt I (mean lesion length 14.7 cm), 10 and 82.1% in the EffPac trial (mean lesion length 5.9 cm). 21 In the Zilver PTX randomized trial, the 5-year freedom from TLR was 83.1% for the Zilver PTX DES arm (mean lesion length 6.6 cm) 19 and carried the risk of ISR.…”

“…Post-Market Surveillance Study), 17 and five RCTs (THUNDER, Zilver PTX, IN.PACT SFA RCT, AcoArt I, and EffPac). 10,[18][19][20][21] The results of the present Asian cohort study were compared with that of the full clinical cohort (IN.PACT Global Study) for literature benchmarking purposes. Because the inclusion/exclusion criteria were the same in these two cohorts, participant characteristics were generally similar.…”