PACUBA I Trial Compares DCB Versus PTA to Treat Femoropopliteal In-Stent Restenosis

July 7, 2016—One-year results of the PACUBA I trial studying paclitaxel-eluting balloon angioplasty versus percutaneous transluminal angioplasty (PTA) to treat in-stent restenoses of the superficial femoral artery and proximal popliteal artery (femoropopliteal arteries) were published by Christian M. Kinstner, MD, et al in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2016;9:1386–1392).

The study was intended to test the hypothesis that paclitaxel-eluting balloon angioplasty provides higher 1-year patency rates in femoropopliteal artery in-stent restenosis compared with PTA. The background of the study is that several trials have demonstrated that paclitaxel-eluting balloon angioplasty reduces late luminal loss in comparison with PTA, noted the investigators.

As summarized in JACC: Cardiovascular Interventions, this prospective, randomized, single-blind, dual-center study enrolled 74 patients with symptomatic peripheral artery disease caused by in-stent restenosis. The patients were treated with either paclitaxel-based drug-coated balloon (DCB) angioplasty (n = 35) or standard PTA (n = 39). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months.

In the DCB group, the mean lesion length was 17.3 ± 11.3 cm. In the PTA group, the mean lesion length was 18.4 ± 8.8 cm. A single major complication (bleeding) was observed once (1.4%). The mean ankle-brachial index before endovascular treatment was 0.65 ± 0.16 in both groups and 0.79 ± 0.2 versus 0.84 ± 0.3 (P = 0.7, Student t test) in the DCB versus PTA groups at 12 months. 

The investigators reported that the 12-month primary patency rates were 40.7% (95% confidence interval [CI], 0.26–0.64) versus 13.4% (95% CI, 0.05–0.36) (log-rank P = .02) in the DCB versus PTA groups. The odds ratio for PTA versus DCB angioplasty for experiencing an event was estimated at 2.8 (95% CI, 1.2–6.6). Freedom from clinically driven target lesion revascularization was 49% (95% CI, 0.32–0.75) versus 22.1% (95% CI, 0.1–0.48) (log-rank P = .11) in the DCB versus PTA groups. Clinical improvement by ≥ 1 Rutherford-Becker category was 68.8% versus 54.5% (P = .87) in the DCB versus PTA groups at 12 months.

When treating peripheral artery disease in patients with in-stent restenosis in the femoropopliteal artery, paclitaxel-eluting balloon angioplasty provides significantly higher patency rates than standard PTA, concluded the PACUBA I investigators in JACC: Cardiovascular Interventions.