DEBATE-SFA Favors Predilatation with Drug-Eluting Balloon Before BMS

MIAMI BEACH, FLA.—In patients with peripheral artery disease, a strategy involving predilatation with a drug-eluting balloon before BMS implantation more effectively prevents restenosis and target lesion revascularization up to 1 year after treatment compared with balloon angioplasty plus stenting. Findings from the DEBATE-SFA trial were presented in a featured clinical research session at TCT 2012.

Francesco Liistro, MD, of San Donato Hospital in Arezzo, Italy, and colleagues enrolled symptomatic patients with a total of 110 lesions located in the superficial femoral or popliteal arteries. Lesions were randomly assigned to undergo treatment with a paclitaxel-eluting balloon (IN.PACT Admiral, Medtronic/Invatec) plus nitinol stent implantation (n = 55) or conventional balloon angioplasty plus nitinol stenting (n = 55). The treatment groups received 3 months and 1 month of dual antiplatelet therapy (DAPT), respectively. Baseline characteristics were similar between the 2 lesion groups, and approximately three-quarters of the patients had diabetes.

At 12 months the primary endpoint of binary restenosis on angiography or duplex ultrasound was improved in lesions treated with drug-eluting balloons as were several other measures. The treatment also decreased the risk of target lesion revascularization (TLR) (see Table). Kaplan-Meier estimates suggested that TLR was unaffected by angiographic assessment.

DEBATE tableThe cumulative rate of major adverse events (death, acute MI, stroke, TLR and major amputation) was slightly though nonsignificantly lower with drug-eluting balloon predilatation compared with balloon angioplasty prior to stenting at 24.5% vs. 35.3%, respectively (P=.3). No patients required major amputation.

Further analyses suggested that “restenosis reduction is maintained irrespective of lesion length and recanalization technique (subintimal or true lumen),” Liistro said. Patients with lesions measuring 100 mm or longer had restenosis rates of 21% vs. 62% with drug-eluting balloon vs. angioplasty (P=.01), while those with lesions that were less than 100 mm had rates of 13% vs. 38%, respectively (P=.06). Patients who underwent true-lumen recanalization had restenosis rates of 20.9% vs. 47.4% (P=.05). Among patients who underwent subintimal recanalization, none of those who received drug-eluting balloon predilatation developed restenosis compared with 47.1% of those who received conventional angioplasty (P=.01).

Further studies may confirm whether a systematic or provisional stenting strategy is preferred when using drug-eluting balloons, Liistro concluded.

Session co-moderator S. Chiu Wong, MD, of New York-Presbyterian Hospital/Weill Cornell Medical College in New York asked why the researchers did not simply try DES as a standalone treatment. The choice was made, Liistro replied, “because at the moment, DES available for peripheral disease do not perform so well.”

Disclosures
  • Drs. Liistro and Wong report no relevant conflicts of interest.

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