A drug-coated balloon was more effective than and just as safe as an uncoated balloon among patients with in-stent restenosis in the superficial femoral artery, according to recent study findings.
Although angioplasty with a DCB is known to be better for restenosis prevention than angioplasty with an uncoated balloon, the difference between them for treatment of in-stent restenosis was unknown, according to the study background.
Researchers randomly assigned 119 patients with in-stent restenosis in the superficial femoral artery and chronic limb ischemia (mean lesion length, 82.2 mm; 28.6% chronic total occlusions; 25.2% moderately or heavily calcified lesions) to angioplasty with a paclitaxel DCB (IN.PACT Admiral, Medtronic) or an uncoated balloon (Admiral Xtreme, Medtronic).
The primary outcome was recurrent in-stent restenosis as determined by ultrasound at 6 months.
Hans Krankenberg, MD, and colleagues found that at 6 months, in-stent restenosis occurred in 15.4% of the DCB group and in 44.7% of controls (P = .002). Freedom from target lesion revascularization was 96.4% in the DCB group vs. 81% in controls at 6 months (P = .0117) and 90.8% in the DCB group vs. 52.6% in controls at 12 months (P < .0001).
Krankenberg, from the department of angiology at HGZ Cardiovascular Center in Bad Bevensen, Germany, and colleagues observed that at 12 months, improvement in at least one Rutherford category without need for TLR occurred in 77.8% of patients in the DCB group and in 52.3% of controls (P = .015).
They reported that there were no cases of amputation, MI or major bleeding, and that although two patients in the DCB group and three patients in the control group died over the course of the study, no deaths were related to the procedure.
“Based on the clinical results of the present study, paclitaxel-coated balloons are as effective in restenotic lesions as in native vessels,” Krankenberg and colleagues wrote. ˗ by Erik Swain
Disclosure: The study was initiated by investigators but funded in part by Medtronic. One researcher reports past consulting for and current employment by Medtronic.