Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty.

ABSTRACT:

Purpose

To evaluate the 3-year safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) in a Japanese population with femoropopliteal occlusive disease.

Materials and methods

The multicenter, prospective, IN.PACT SFA Japan randomized controlled trial (ClinicalTrials.gov identifier NCT01947478) was an independently adjudicated study evaluating Japanese participants randomized 2:1 to DCB (n=68) or PTA (n=32). The effectiveness endpoint was primary patency through 36 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis (by duplex ultrasound). The effectiveness endpoint was evaluated using the Kaplan-Meier method; estimates are prese

SUBMITTER: Soga Y 

PROVIDER: S-EPMC7649941 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature