Paclitaxel-eluting balloon angioplasty yielded higher patency rates than standard percutaneous transluminal angioplasty (PTA) when treating peripheral artery disease with in-stent restenosis in the femoropopliteal artery, according to 1-year results of the PACUBA trial published in JACC: Cardiovascular Interventions.
PACUBA (Paclitaxel Balloon Vs Standard Balloon in In-Stent Restenoses of the Superficial Femoral Artery) was a prospective, randomized, single-blind, dual-center trial that evaluated 1-year patency rates in femoropopliteal artery in-stent restenosis compared with PTA.
Christian M. Kinstner, MD, from the Division of Cardiovascular and Interventional Radiology at the Medical University of Vienna, and colleagues measured clinical outcomes and patency rates of 74 patients with symptomatic peripheral artery disease at 1, 6, and 12 months. Thirty-five patients were treated with a paclitaxel-based drug-eluting balloon (DEB) angioplasty, and 39 patients were treated with a standard PTA.
The mean lesion length was 17.3 ±11.3 cm among patients treated with DEB and 18.4 ± 8.8 cm among patients treated with PTA. Researchers observed complications in 5 of 74 patients, including 1 patient with severe bleeding that required fasciotomy, 2 patients with embolization in tibial arteries that was treated with aspiration embolectomy, and 2 patients with groin hematomas.
Before endovascular treatment, the mean ankle-brachial index for both groups was 0.65 ± 0.16, and after 12 months, the index was 0.79 ± 0.2 in the DEB group vs 0.84 ± 0.3 in the PTA group (P=.70).
The 12-month primary patency rate among patients treated with DEB was 40.7% (95% confidence interval [CI]: 0.26-0.64) compared with 13.4% in patients treated with PTA (95% CI: 0.05-0.36; log rank P=.02).
Researchers noted that the higher patency rate “was more evident in TASC [Transatlantic Intersociety Consensus] A and B lesions, and there was no difference in clinical parameters such as ankle brachial index, improvement in Rutherford-Becker category, and clinically driven target lesion revascularization.”
Patients who were treated with PTA were more likely to experience an event compared to patients treated with DEB angioplasty (odds ratio: 2.8; 95% CI: 1.2-6.6). Patients in the DEB group were also more likely to have freedom from clinically driven target lesion revascularization (49.0%; 95% CI: 0.32-0.75) compared to patients in the PTA group (22.1%; 95% CI: 0.10-0.48; log rank P=.11). At 12 months, clinical improvement by ≥1 Rutherford-Becker category was 68.8% vs 54.5% (P=.87) in the DEB group compared with the PTA group.
“The primary end point, 1-year primary patency rate, was met with a significance level of P=.02 (log-rank), but this did not translate into a significant improvement of clinical benefit,” the authors noted.
They added that further research should be conducted to compare DEB with drug-eluting stents and covered stents in patients with in-stent restenosis in peripheral artery disease.
Kinstner CM, Lammer J, Willfort-Ehringer A, et al. Paclitaxel-eluting balloon vs standard balloon angioplasty in in-stent restenosis of the superficial femoral and proximal popliteal artery: 1-year results of the PACUBA trial. JACC Cardiol Interv. 2016;9(13):1386-1392.