2022
DOI: 10.1007/s00270-022-03265-1
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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). Assessm… Show more

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Cited by 14 publications
(19 citation statements)
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“…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.…”
Section: Discussionsupporting
confidence: 59%
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“…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.…”
Section: Discussionsupporting
confidence: 59%
“…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.…”
Section: Discussionmentioning
confidence: 99%
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