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The EffPac trial was a prospective, multicentre, randomised controlled trial (RCT) that enrolled 171 patients of Rutherford category two to four with medium-length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor drug-coated balloon (DCB) angioplasty or plain balloon angioplasty (POBA). The long-term results showed a high efficacy (fTLR 82.1%) and statistically superior primary patency for Luminor over POBA, and importantly, showed that DCB use resulted in no safety differences between the two groups.
The investigators achieved on-site patient visits in 50% of the recruited patients after five years.
“These data are pretty rare […] and actually after this whole discussion about safety of paclitaxel-coated DCBs, I think [this trial] really adds important data,” Ulf Teichgräber (Jena, Germany) tells Vascular News at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting.
This video is sponsored by iVascular.
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