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PACUBA: DEB effective for in-stent restenosis in SFA

Issue: March 2016

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HOLLYWOOD, Fla. — In terms of patency, a drug-eluting balloon was superior to plain old balloon angioplasty in patients with in-stent restenosis in the superficial femoral artery, according to 1-year results of the PACUBA trial.

However, rates of primary patency and freedom from target lesion revascularization were less than 50% in both groups at 1 year, Johannes Lammer, MD, from Medical University Vienna, Austria, said during a presentation at the International Symposium on Endovascular Therapy.

Johannes Lammer

Lammer and colleagues assigned 74 patients (mean age, 68 years; 43 men) with symptomatic peripheral artery disease, in-stent restenosis in the superficial femoral artery and Rutherford Class 2 or 3 to receive a drug-eluting balloon (DEB; Freeway 035, Eurocor) or plain old balloon angioplasty (POBA).

Mean lesion length was 17.3 cm in the DEB group and 18.4 cm in the POBA group (P = .65). The rates of Tosaka Class III, signifying total occlusion, were 31% in the DEB group and 28% in the POBA group (P = .52), Lammer said.

The primary outcome was 1-year primary patency, defined as < 50% stenosis without TLR.

At 1 year, primary patency was 40.7% in the DEB group and 13.4% in the POBA group (P = .016). Both groups had a sharp decline from their 6-month rates (DEB group, 58.8%; POBA group, 31.3%), Lammer said.

The DEB, which elutes paclitaxel, had a trend toward better rate of freedom from TLR at 12 months compared with POBA (49% vs. 22%; P = .11), Lammer said, noting that both rates were much lower than the 6-month rates (DEB, 88.2%; POBA, 83.8%).

The results were consistent across Tosaka classes, with both interventions performing slightly better in 1-year primary patency in Class I and II patients, Lammer said.

Both groups showed improvement in Rutherford class, but the difference between the groups was not statistically significant, according to Lammer.

“In in-stent restenosis of femoropopliteal arteries, [DEBs} have a significantly higher primary patency rate, and obviously treatment of in-stent restenosis with POBA is not a recommended therapy,” Lammer concluded. – by Erik Swain

Reference:

Lammer J, et al. Session IX: Peripheral Intervention: State of the Art. Presented at: International Symposium on Endovascular Therapy; Feb. 6-10, 2016; Hollywood, Fla.

Disclosure: Lammer reports no relevant financial disclosures.