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 D

SUBMITTER: Teichgraber U 

PROVIDER: S-EPMC9705448 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature