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

Yoshimitsu Soga, Osamu Iida, Kazushi Urasawa, Shigeru Saito, Michael R Jaff, Hong Wang, Hiroko Ookubo, Hiroyoshi Yokoi, Yoshimitsu Soga, Osamu Iida, Kazushi Urasawa, Shigeru Saito, Michael R Jaff, Hong Wang, Hiroko Ookubo, Hiroyoshi Yokoi

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 presented with the 95% confidence intervals (CIs). The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 36 months.

Results: Primary patency by Kaplan-Meier estimate was higher in the DCB group (68.9%, 95% CI 57.5% to 80.2%) vs the PTA group (46.9%, 95% CI 29.6% to 64.2%) at 36 months (log-rank p=0.001). The CD-TLR rates were 14.9% (10/67) for the DCB group and 20.7% (6/29) for PTA (p=0.554). The safety composite endpoint occurred in 83.6% (56/67) of DCB participants and 75.9% (22/29) of PTA participants (p=0.402). All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group.

Conclusion: The final report of the IN.PACT SFA Japan trial showed that the IN.PACT Admiral DCB is safe and had durable outcomes through 3 years in Japanese participants with femoropopliteal occlusive disease.

Keywords: amputation; balloon angioplasty; drug-coated balloon; femoropopliteal segment; mortality; restenosis; target lesion revascularization.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Hong Wang and Hiroko Ookubo are full-time employees of Medtronic. Michael R. Jaff is a compensated advisor for Biotronix, Medtronic, Philips/Spectranetics, Sanofi, and Vactronix and is an equity investor of PQ Bypass.

Figures

Figure 1.
Figure 1.
Participant flow in the MDT-2113 SFA Japan trial through 36 months. Values for death, lost to follow-up, and withdrew consent are cumulative; other exits were due to progressive dementia and PTA for other disease. Compliance rates include follow-up completed in and outside of the follow-up window. DCB, drug-coated balloon; PTA, percutaneous transluminal angioplasty; SFA, superficial femoral artery.
Figure 2.
Figure 2.
Kaplan-Meier analyses of (A) primary patency and (B) freedom from clinically-driven target lesion revascularization (CD-TLR) through 36 months. Bars represent the 95% confidence intervals. DCB, drug-coated balloon; PTA, percutaneous transluminal angioplasty.

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