Results from two Asian studies presented at LINC 2017 (24–27 January, Leipzig, Germany), show encouraging outcomes for drug-coated balloon versus percutaneous transluminal angioplasty treatment at 12 and 24 months. The Chinese AcoArt I trial found “sustained durability” of the Orchid drug-coated balloon (Acotec) with no late catch-up at 24 months, while the Japanese MDT-2113 SFA trial, investigating the IN.PACT Admiral (Medtronic) reported drug-coated balloon demonstrated the clinical benefits of MDT-2113 (IN.PACT Admiral) compared to percutaneous transluminal angioplasty at 12 months.
Wei Guo, Chinese PLA General Hospital, Beijing, China, presented on the randomised control trial using the Orchid paclitaxel-coated balloon to treat femoropopliteal artery disease. The study enrolled 200 patients at 10 sites, randomising 100 to drug-coated balloon treatment and 100 to percutaneous transluminal angioplasty. At 24 months, 96% of drug-coated balloon and 95% of angioplasty patients completed follow-up. Previously-published six-month data had already shown late lumen loss superiority for the drug-coated balloon group (0.05mm vs. 1.15mm for angioplasty), while 12-month primary patency was 84.1% for the drug-coated balloon group versus 46.5% for the angioplasty group.
Guo reported that at 24 months, primary patency in the drug-coated balloon group was 64.6%, compared with 31.4% in the plain balloon angioplasty group. Freedom from clinically-driven target lesion revascularisation was also better in the drug-coated balloon group, at 86.5% versus 58.9% for plain balloon angioplasty. There were 15 (15.6%) cumulative target lesion revascularisation events in the drug-coated balloon group, compared with 49 (51.5%) in the angioplasty group, while the average time to first target lesion revascularisation was 307 days for drug-coated balloon patients and 173 days for plain angioplasty patients.
Guo noted that for the study’s in-stent restenosis subgroup, freedom from clinically-driven target lesion revascularisation was 87.5% in the drug-coated balloon group and 25% in the angioplasty group (following on from 12-month rates of 95.8% and 25% for the drug-coated balloon group and angioplasty group, respectively). Primary patency for the subgroup at 24 months was 54.2% for drug-coated balloon patients, compared with just 5% for angioplasty patients. “Although the number of in-stent restenosis lesions is small,” Guo said, the results from the subset “are promising”.
There were 14 deaths overall at 24 months; eight in the drug-coated balloon group and six in the angioplasty group (p=0.59). None of these deaths were device- or procedure-related. There was one major amputation the drug-coated balloon group and three in the plain angioplasty group (p=0.37).
“AcoArt I demonstrates safety and efficacy of the Orchid drug-coated balloon in treating femoropopliteal artery disease,” Guo told delegates. “These results show sustained durability of drug-coated balloon treatment with no late catch-up through two years.”
Twelve-month drug-coated balloon results reported in Japanese trial
Following Guo’s presentation, Osamu Iida, Kansai Rosai Hospital, Hyogo, Japan, updated LINC delegates on the 12-month progress of the MDT-2113 SFA Japan trial, comparing MDT-2113 (IN.PACT Admiral drug-coated balloon) with percutaneous transluminal angioplasty in treating atherosclerotic lesions in the superficial femoral and popliteal arteries.
The prospective, randomised, single-blinded trial has enrolled 100 patients at 11 Japanese sites, with participants randomised 2:1 (n=68:32) to drug-coated balloon or plain angioplasty, respectively. Key inclusion criteria included Rutherford classification of 2–4, evidence of adequate distal run-off through the foot and single de novo or non-stented restenotic lesion 70–99% occluded of length 4–20cm, 100% occlusion of length ≤10cm. Combination and tandem lesions were allowed if the other criteria were met and lesion gap was ≤3cm.
The primary effectiveness endpoint was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularisation and freedom from restenosis as determined by duplex ultrasound-derived peak systolic velocity ration (PSVR) ≤2.4. The primary safety endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically-driven target vessel revascularisation within 12 months of the procedure.
Per protocol, primary patency rates— meaning a restoration of adequate blood flow through the treated segment of the diseased artery—were assessed at 12 months of follow-up and demonstrated 89.2% for the drug-coated balloon group and 48.4% for the plain angioplasty group (p<0.001). Primary patency at 360 days was also calculated by Kaplan-Meier survival estimates; at this specific time point, it was 93.9% for the drug-coated balloon group and 49.9% for the plain angioplasty group (p<0.001). Clinically-driven target lesion revascularisation was 2.9% for the drug-coated balloon group, compared to 18.8% in the plain angioplasty group (p=0.012).
“This study builds on the previous Medtronic drug-coated balloon clinical studies, reinforcing the consistent clinical performance in terms of primary patency and re-intervention rates of this device across patient populations,” said Iida. “We are pleased to see such substantive drug-coated balloon clinical data from a patient cohort in Japan.”