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Published on 18 February 2008

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Paclitaxel-coated balloons aid peripheral angioplasty

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Using a paclitaxel-coated angioplasty balloon in percutaneous treatment of femoral artery disease significantly reduces subsequent restenosis and the need for target-lesion revascularisation, research shows.

Percutaneous transluminal angioplasty for revascularisation of the superficial femoral artery is initially technically successful in more than 95% of cases, but restenosis occurs in 40–60% of treated segments after 6–12 months, according to a research team led by Dr Gunnar Tepe of Tübingen University, Germany.

However, in contrast to experience with coronary stenting, no advantage has so far been seen with local drug delivery during angioplasty of the femoral artery using drug-eluting stents compared with uncoated stents.

Dr Tepe’s team performed angioplasty in 154 symptomatic peripheral artery disease patients with a mean age of 68 years.

The patients had one or more obstructive lesions – either new or restenosed lesions of at least 70% of vessel diameter and at least 2cm long – in the superficial femoral artery, the popliteal artery, or both.

The researchers randomly assigned the patients to one of three groups.

They treated the first group using paclitaxel-coated balloons and standard non-ionic contrast medium, the second using standard uncoated balloons with paclitaxel added to the medium, and the third (control) group with standard uncoated balloons and the standard medium.

Previous preliminary study findings indicate that using paclitaxel-coated angioplasty balloons significantly inhibits recurrent restenosis in restenosed coronary stents, while adverse event rates have been deemed acceptable in dose escalation studies of paclitaxel dissolved in contrast medium, the researchers note.

As reported in the New England Journal of Medicine, the mean late lumen loss, defined as the difference between the minimum lumen diameters after dilation and at six months’ follow-up, was significantly lower among patients treated with the paclitaxel-coated balloon than in control patients, at 0.4mm vs 1.7mm (p<0.001).

However, mean late lumen loss was not reduced in patients who received treatment with paclitaxel in the contrast medium compared with control patients, at 2.2mm.

Similarly, the rate of revascularisation of target lesions at six months was significantly lower among patients treated with paclitaxel-coated balloons, at 4%, than the control patients, at 37% (p<0.001), but not significantly different from control patients among those treated with paclitaxel in the contrast medium, at 29%.

The authors say that the target lesion revascularisation rate remained low at 12 months in the group treated with paclitaxel-coated balloons, at 10%, compared with 48% in the control group and 35% in the paclitaxel-in-medium group.

Despite the encouraging findings, the authors stress that this was a preliminary study, which was “limited in scope and observation period”.

They write: “Additional and larger trials will be necessary to provide definitive evidence of benefit.”

N Engl J Med



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