Drug‐coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2‐year results of the MDT‐2113 SFA Japan randomized trial

Abstract

Objectives To assess the longer‐term safety and efficacy of the IN.PACT Admiral (MDT‐2113) drug‐coated balloon (DCB) for the treatment of de novo and non‐stented restenotic lesions in the superficial femoral and/or proximal popliteal arteries versus uncoated percutaneous transluminal angioplasty (PTA) in a Japanese cohort. Background Although DCBs are the newest endovascular strategy for patients with peripheral artery disease presenting with femoropopliteal lesions, there remains a paucity of results in non‐Caucasian populations. Methods IN.PACT SFA Japan is an independently‐adjudicated, prospective, multicenter, randomized, single‐blinded trial. Endpoints through 2 years included primary patency and a composite safety endpoint of freedom from device‐ and procedure‐related death through 30 days, freedom from target limb major amputation and freedom from clinically‐driven target vessel revascularization at 24 months. Results One hundred patients were assigned by 2:1 randomization to treatment with the IN.PACT Admiral DCB (n = 68) or PTA (n = 32). The groups were well‐matched at baseline. Mean lesion length for the DCB and PTA groups were 9.15 ± 5.85 and 8.89 ± 6.01 cm ( P = 0.838), respectively. Patients treated with DCB exhibited superior 24‐month primary patency compared to PTA (79.8% vs. 46.9%; log rank P < 0.001). The 24‐month clinically driven target lesion revascularization rate was 9.1% for DCB versus 20.7% for PTA ( P = 0.177). There were no device‐ or procedure‐related deaths, major amputations, or thromboses in either group. Conclusions Two‐year results from IN.PACT SFA Japan demonstrated persistently superior patency and low CD‐TLR rates through 2 years when compared to uncoated PTA in Japanese patients. These data are consistent with other IN.PACT DCB trials.

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

“…14,25 At 24 months, primary patency in IN.PACT SFA Japan was higher than in the AcoArt I trial of Chinese patients (64.6%), though AcoArt I may have enrolled a more challenging patient population. 21,30 The DCB group in AcoArt I had longer lesions (mean length 14.7 cm) and a higher percentage of patients with total occlusions (57.0%) compared with IN.PACT SFA Japan. Other 24-month outcomes were consistent between the studies, including rates of CD-TLR (13.5% AcoArt I) and all-cause mortality (8.3% AcoArt I).…”

“…Other 24-month outcomes were consistent between the studies, including rates of CD-TLR (13.5% AcoArt I) and all-cause mortality (8.3% AcoArt I). 21,30 To date, the only other DCB studies that have published 36-month results are IN.PACT SFA, IN.PACT Global, REAL-PTX, ILLUMENATE EU, and ILLUMENATE US (Table 6). All-cause mortality in the DCB group from IN.PACT SFA Japan (6.0%) was within range of IN.PACT SFA (10.7%), IN.PACT Global (11.6%), REAL-PTX (10.7%), ILLUMENATE EU (9.4%), and ILLUMENATE US (10.1%).…”

“…The primary effectiveness and safety endpoints were previously reported through 12 and 24 months. 25 , 30 Through 36 months, the effectiveness endpoint was primary patency, defined as freedom from CD-TLR and freedom from restenosis as determined by a duplex ultrasound–derived peak systolic velocity ratio ≤2.4. Each component of the endpoint was independently adjudicated by the blinded CEC (for CD-TLR) or by the core laboratories (for restenosis).…”

“…The primary effectiveness and safety endpoints were previously reported through 12 and 24 months. 25,30 Through 36 months, the effectiveness endpoint was primary patency, Severe calcification defined as calcification with circumference ≥180° (both sides of vessel at the same location) and length greater than or equal to half of the total lesion length. e Normal-to-normal by core laboratory quantitative vascular analysis.…”

Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts

“…The IN.PACT SFA and MDT-2113 SFA Japan (IN.PACT SFA Japan) were prospective, multicenter, randomized, single-blind trials comparing the outcomes with IN.PACT Admiral DCB to those with PTA, the details of which have been previously reported. [5][6][7][8][9][10] In brief, in randomized trials, after successful PTA, the subjects were randomly assigned to IN.PACT DCB or PTA balloon at the discretion of the operator. However, all the studies had mandated that the inflation time with PTA was the same as the inflation time with the DCB.…”