Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial

Osamu Iida, Yoshimitsu Soga, Kazushi Urasawa, Shigeru Saito, Michael R Jaff, Hong Wang, Hiroko Ookubo, Hiroyoshi Yokoi, MDT-2113 SFA Japan Investigators, Osamu Iida, Yoshimitsu Soga, Kazushi Urasawa, Shigeru Saito, Michael R Jaff, Hong Wang, Hiroko Ookubo, Hiroyoshi Yokoi, MDT-2113 SFA Japan Investigators

Abstract

Purpose: To assess the safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) for the treatment of de novo and native artery restenotic lesions in the superficial femoral and proximal popliteal arteries vs percutaneous transluminal angioplasty (PTA) with an uncoated balloon in a Japanese cohort.

Methods: MDT-2113 SFA Japan ( ClinicalTrials.gov identifier NCT01947478) is an independently adjudicated, prospective, randomized, single-blinded trial that randomized (2:1) 100 patients (mean age 73.6±7.0 years; 76 men) from 11 Japanese centers to treatment with DCB (n=68) or PTA (n=32). Baseline characteristics were similar between the groups, including mean lesion length (9.15±5.85 and 8.89±6.01 cm for the DCB and PTA groups, respectively). The primary effectiveness outcome was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasonography. The safety endpoint was a composite of 30-day device- and procedure-related death and target limb major amputation and clinically-driven target vessel revascularization within 12 months.

Results: Patients treated with DCBs exhibited superior 12-month primary patency (89%) compared to patients treated with PTA (48%, p<0.001). The 12-month CD-TLR rate was 3% for DCB vs 19% for PTA (p=0.012). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Quality-of-life measures showed sustained improvement from baseline to 12 months in both groups.

Conclusion: Results from the MDT-2113 SFA Japan trial showed superior treatment effect for DCB vs PTA, with excellent patency and low CD-TLR rates. These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and effectiveness of this DCB for the treatment of femoropopliteal lesions in this Japanese cohort.

Keywords: angioplasty; claudication; drug-coated balloon; femoropopliteal segment; paclitaxel; peripheral artery disease; popliteal artery; randomized controlled trial; superficial femoral artery.

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 noncompensated advisor for Medtronic, an equity investor in PQ Bypass, and a compensated board member of VIVA Physicians, a 501c3 not-for-profit education and research organization.

Figures

Figure 1.
Figure 1.
One hundred patients enrolled in the MDT-2113 SFA Japan trial were randomized in a 2:1 ratio to treatment with DCB or standard PTA. Deaths, lost to follow-up, visits not completed, and withdrawals through 1 year are shown. DCB, drug-coated balloon; PTA, percutaneous transluminal angioplasty.
Figure 2.
Figure 2.
Kaplan-Meier estimates of (A) primary patency and (B) clinically-driven target lesion revascularization (TLR) at 12 months. Bars represent the 95% confidence intervals. DCB, drug-coated balloon; PTA, percutaneous transluminal angioplasty Number at risk represents the number of evaluable subjects at the beginning of the 30-day window prior to each follow-up interval.

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