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Drug-eluting balloons reduced restenosis vs. conventional balloons
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Drug-eluting balloons reduced restenosis rates compared with conventional angioplasty balloons at 6 months for the treatment of multilevel arterial disease in patients with claudication and critical limb ischemia, results from the DEBELLUM trial found.
“[T]he advantage of the In.Pact DEB [Medtronic] for the treatment of lower limb arterial disease lies in achieving low restenosis rates with very limited or no need to implant a foreign body,” researchers wrote. “This is particularly important for some critical vessel districts in which the high mechanical stress can lead to stent fractures (femoropopliteal) and for extensively diseased small vessels with slow blood flow (below-the-knee). In addition, a nonstent strategy can leave the door open to future treatment options, especially in case of claudicants with a long life expectancy.”
In the study, which was published in the Journal of Endovascular Therapy, researchers randomly assigned 50 consecutive patients with 122 lesions (96 stenoses; 26 occlusions) of the femoropopliteal (75.4%) or below-the-knee arteries (24.6%) to receive either the In.Pact DEB with paclitaxel (25 patients with 57 lesions) or conventional angioplasty balloon (25 patients with 65 lesions) from September 2010 to March 2011.
Twenty patients presented with multilevel lesions. Mean lesion length was 7.5 ± 3.5 cm. Thirty-one (62%) patients were Fontaine stage IIb, whereas 19 (38%) were stage III or IV. Both types of balloons were used for dilation of de novo lesions or for postdilation after primary stenting of the superficial femoral artery.
Compared with the conventional balloon group, late lumen loss was lower in the DEB group (0.5 ± 1.4 mm vs. 1.6 ± 1.7 mm; P<.01), as was target lesion revascularization (6.1% vs. 23.6%; P=.02). Thrombosis rates were 3% in the DEB group compared with 5.2% in the conventional balloon group (P=.6), and amputation rates were 3% in the DEB group compared with 7.9% in the conventional balloon group (P=.36).
The binary restenosis rate was 9.1% in the DEB group compared with 28.9% in the control group (P=.03). Ankle-brachial index improved to a greater extent in the DEB group (0.87 ± 0.22 vs. 0.70 ± 0.13; P<.05). Researchers also observed that Fontaine stage improved in both groups, although the greatest improvement was found in the DEB-treated group (P=.04).
Disclosure: The researchers report no relevant financial disclosures.
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