Performing angioplasty with new drug-coated balloons to treat femoropopliteal artery disease results in lower rates of late lumen loss and clinically-driven target lesion revascularisation compared with plain angioplasty at both six- and 12-month follow-up, according to new data.
The data were presented at the 2016 Leipzig Interventional Course (LINC; 26–29 January, Leipzig, Germany), and examined results from the use of the SeQuent Please (B Braun) balloon at six months and the Orchid (Acotec Scientific) balloon at 12 months.
Thomas Albrecht, Institut für Radiologie und Interventionalle Therapie, Vivantes Klinikum Neukölln, Berlin, Germany, presented the six-month SeQuent Please balloon data, taken from the CONSEQUENT trial, which is being conducted at eight German centres. Albrecht and colleagues were using the balloon to treat steno-occlusive lesions of the superficial femoral artery and the two proximal segments of the popliteal artery.
One hundred and fifty-three patients (104 male and 49 female, average age 68.1±8.7 years) were randomised 1:1 to either drug-coated balloon treatment or plain balloon angioplasty. Follow-up was scheduled at six, 12 and 24 months post-procedure. The trial included patients with Rutherford classification 2–4, lesion lengths of 4–27cm and preprocedural diameter stenosis ≥70%. The primary endpoint was late lumen loss at the six-month follow-up. Sixteen (13.5%) of the total patient population exhibited TASC C/D lesions (26 TASC C, 10 TASC D), and importantly the average lesion length of 13.2±10.4cm represents “longer lesions than in any other previously-published drug-coated balloon study,” Albrecht said.
One hundred and six patients returned for the six-month angiographic analysis. The angiographic results showed that late lumen loss in the drug-coated balloon group was 0.49±1.14mm compared with 0.98±1.01mm in the uncoated balloon group (p=0.017). Furthermore, binary restenosis of >50% had occurred in 21.2% of patients in the drug-coated balloon group compared with 47.2% in the uncoated balloon group (p=0.005). Positive remodelling was observed in 36.5% of drug-coated balloon patients, compared with 13% in the uncoated balloon group.
These positive results were mirrored in the clinical follow-up, with target lesion revascularisation of 11.6% in the drug-coated balloon group compared with 25.7% in the uncoated balloon group (p=0.033). The team also reported increases in 85 patients’ walking distance as a secondary outcome, finding that the drug-coated balloon group saw an average increase of 137±160m, far higher than the uncoated balloon group increase of 71±130m (p=0.039). Target leg ankle brachial index was 0.97±0.14 for the drug-coated balloon group and 0.89±0.22 in the uncoated balloon group.
AcoArt I trial
Wei Guo, Chinese PLA General Hospital, Beijing, China, presented 12-month data from the 200-patient (147 male) AcoArt I trial on behalf of the trial investigators. The trial is the first Chinese prospective, randomised, multicentre trial for the Orchid drug-coated balloon in treating femoropopliteal artery disease. The enrolled patients were randomised 1:1 to either the Orchid balloon or plain angioplasty, with angiographic late lumen loss at six months as the primary outcome measure.
Rutherford classification of all patients was 2–5, diameters of stenoses were ≥70% and lesion lengths were
At six months, late lumen loss was shown to be significantly lower in the drug-coated balloon group (0.05±0.73mm) than in the plain angioplasty group (1.15±0.89mm) (p<0.001), Wei commenting that “the gap is huge.” The drug-coated balloon’s superior performance was repeated in the angiographic and clinical secondary endpoint data, with: higher minimal lumen diameter (2.38±0.89mm vs. 1.16±0.96mm, p<0.001); lower restenosis rate ≥50% (22.5% vs. 70.8%, p<0.001); lower clinically-driven target lesion revascularisation (6.1% vs. 38.98%, p<0.001); and a higher percentage improvement in patients’ Rutherford class (78.6% vs. 56.8%, p=0.0012).
Wei also shared 12-month imaging and clinical outcome data, with Doppler ultrasound analysis finding patency in the drug-coated balloon group of 76.1% compared with 33.7% in the plain angioplasty group (p<0.001). Clinically-driven target lesion revascularisation rates followed the same pattern at 12 months as at six months, with the drug-coated balloon (7.2%) outperforming plain angioplasty (60.2%) (p<0.001). Late lumen loss also remained notably lower in the drug-coated balloon group after 12 months, at -0.04±0.69mm vs. 1.69±0.71mm in the angioplasty group (p<0.001).
“Although this trial dealt with significantly more complex and longer lesions, it demonstrates that drug-coated balloons have a lower rate of late lumen loss and higher primary patency, as well as a lower clinically-driven target lesion revascularisation after six- and 12-month follow-up compared with plain angioplasty,” Wei told the audience.