Paclitaxel-Coated Balloons Reduce Restenosis After Femoro-Popliteal Angioplasty: Evidence From the Randomized PACIFIER Trial
What is the efficacy of a drug-eluting balloon (DEB) for reducing restenosis in patients undergoing femoral-popliteal angioplasty?
The authors randomized 85 patients (91 limbs) with symptomatic femoro-popliteal atherosclerotic disease undergoing percutaneous transluminal angioplasty to paclitaxel-coated IN.PACT Pacific or uncoated Pacific balloons. The primary endpoint was late lumen loss at 6 months, assessed by blinded angiographic corelab quantitative analyses.
The trial was performed at three hospitals. A total of 44 lesions were treated with a DEB and 47 with an uncoated balloon. Average lesion length was 7.0 ± 5.3 cm for DEB and 6.6 ± 5.5 cm for the control arm. Stents were provisionally implanted in nine (20.5%) lesions treated with DEB and 16 cases (34.0%, p = 0.17) treated with the uncoated balloon. Procedural success was obtained in all cases. Six-month quantitative angiography showed that DEB were associated with significantly lower late lumen loss (−0.01 mm [95% confidence interval, -0.29; 0.26] vs. 0.65 mm [0.37; 0.93]; p = 0.001) and fewer binary restenoses (3 [8.6%] vs. 11 [32.4%]; p = 0.01). At 6-month follow-up, target lesion revascularization was performed in nine (21.4%) cases in the uncoated group, as compared with three cases (7.1%) in the DEB group (p = 0.12).
The authors concluded that the paclitaxel-eluting balloon is associated with a lower late loss and reduction in restenosis in patients undergoing femoral-popliteal angioplasty.
The femoral-popliteal arterial bed has a high risk of restenosis after endovascular interventions, and drug-eluting balloons appear to be highly effective at prevention of this outcome. The study is small, but corroborates earlier data (Tepe G, et al. N Engl J Med 2008;358:689-99). A large well-designed trial is necessary to clearly establish the clinical safety and efficacy of this promising device.
Keywords: Paclitaxel, Risk, Pacifiers, Follow-Up Studies, Coronary Restenosis, Cardiology, Angioplasty, Stents
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