Promising 12- and 24-month East Asian experiences for drug-coated balloons

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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

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

Osamu Iida

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.”

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