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DEB bests PTA for primary patency at 1 year; ‘jury still out’ on treatment decisions for SFA in-stent restenosis
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In the PACUBA trial, a paclitaxel-eluting balloon was associated with significantly higher primary patency at 1 year compared with standard PTA in patients with in-stent restenosis in the femoropopliteal artery.
However, results showed no significant difference in clinical parameters such as clinically driven target lesion revascularization, improvement in Rutherford-Becker category and ankle-brachial index.
The 1-year PACUBA results were previously presented by Johannes Lammer, MD, from Medical University Vienna, Austria, in February at the International Symposium on Endovascular Therapy.
However, “the jury is still out” on the treatment of superficial femoral artery in-stent restenosis, Bruce H. Gray, DO, and Jack A. Buchan wrote in an editorial accompanying the new study publication in JACC: Cardiovascular Interventions.
Bruce H. Gray
Complex decision
“The treatment decision for in-stent restenosis involving the superficial femoral artery is complex. … The durability of any treatment to maintain patency is critical since in-stent restenosis impacts function and quality of life,” Gray and Buchan wrote.
The prospective, randomized, single blind PACUBA trial included 74 patients (mean age, 68 years; 43 men) with symptomatic peripheral artery disease, in-stent restenosis of the superficial femoral artery and Rutherford classification of 2 or 3 who were assigned to treatment with a drug-eluting balloon (DEB; Freeway 035, Eurocor) or standard percutaneous transluminal angioplasty (PTA). Mean lesion length was 17 cm in the DEB group and 18 cm in the PTA group. Rates of Tosaka class III, signifying total occlusion, were 31% in the DEB group and 28% in the PTA group.
After bailout stenting, the technical success rate was 98.6%.
Complications occurred in five patients, including one case of severe bleeding.
The primary outcome was primary patency at 1 year, defined as < 50% stenosis without TLR. Primary patency at 1 year was 40.7% in the DEB group vs. 13.4% in the PTA group (P = .02). Freedom from clinically driven TLR at 1 year was 49% in the DEB group vs. 22.1% in the PTA group (P = .11). The researchers calculated an OR of 2.8 (95% CI, 1.2-6.6) for experiencing an event with PTA vs. DEB.
The difference in primary patency was “more evident in TASC A and B lesions,” according to the researchers. Primary patency at 1 year was 55% in the DEB group vs. 9.5% in the PTA group.
Patients assigned DEB or PTA had a mean ankle-brachial index of 0.65 at baseline. At 1 year, mean ankle-brachial index was 0.79 in the DEB group vs. 0.84 in the PTA group (P = .7). Clinical improvement of at least one Rutherford-Becker category was observed in 69% of the DEB group vs. 54% of the PTA group at 1 year (P = .87).
“The clinical implication of the present study is that it demonstrates that when treating PAD in patients with in-stent restenosis of the femoropopliteal artery segment, paclitaxel-eluting balloon angioplasty provides significantly higher patency rates than standard PTA,” Christian M. Kinstner, MD, from the Medical University of Vienna, Austria, and colleagues wrote in JACC: Cardiovascular Interventions.
Useful comparator needed
Two catheter therapies are currently approved by the FDA for superficial femoral artery in-stent restenosis: excimer laser-assisted angioplasty and PTFE-covered nitinol stents (Viabahn, W.L. Gore). Off-label therapies available for use include DEB and drug-eluting stents, the editorial authors noted. “Any further studies should use an [FDA]-approved device as the comparator,” Gray and Buchan wrote.
Based on the 1-year results of the PACUBA trial, “paclitaxel-coated balloons do provide benefit at 6 months, but this benefit may not last. PTA is not an effective treatment strategy for superficial femoral artery in-stent restenosis, especially for longer lesions. Furthermore, these data suggest that PTA has outrun its usefulness as a comparator for superficial femoral artery in-stent restenosis trials from an ethical standpoint. … There is no single ‘default strategy’ for the treatment of superficial femoral artery in-stent restenosis, allowing the practitioner to use their best judgment to make this on-table decision,” Gray and Buchan wrote. – by Katie Kalvaitis
Disclosure: The researchers and Buchan report no relevant financial disclosures. Gray reports serving as a committee member for the National Cardiovascular Data Registry.
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