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Paclitaxel-eluting balloon fails to reduce restenosis after scaffold implantation
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Treatment of femoral artery lesions with drug-eluting balloon angioplasty before implantation of a biodegradable scaffold was safe, but associated with a high rate of in-stent restenosis during the first 6 months of follow-up, researchers reported in the Journal of Endovascular Therapy.
The prospective, single-center, nonrandomized trial was designed to evaluate the safety and efficacy of angioplasty with a paclitaxel-coated balloon (IN.PACT Admiral, Medtronic) followed by implantation of a biodegradable scaffold (Igaki-Tamai, Igaki Medical Planning Company). The study included 20 patients with symptomatic, de novo lesions of the superficial femoral artery. The median age of the cohort was 67 years and 14 were men.
The primary endpoint was in-stent binary restenosis, defined as a 50% or greater reduction in vessel diameter. Secondary outcomes included technical success; incidence of target lesion revascularization and other adverse events; improvement in ankle-brachial index; and changes in quality of life, as indicated by responses to walking-impairment questionnaires. Follow-up was conducted at 1, 6, 9 and 12 months.
At baseline, the average diameter stenosis was 89.7%, which was reduced to 24% after angioplasty and to 4.8% after scaffold implantation. Four patients also underwent postdilation, further reducing average diameter stenosis to 3.5%, according to the results.
Within the first 6 months, no patients experienced TLR and two patients exhibited restenosis. The restenosis rate increased to 42% at 9 months and 58% at 12 months. Primary patency was 42% at 12 months, and secondary patency was 100%.
One patient died due to HF considered unrelated to the treatment or device. No major CV-related events were observed.
Thirty-three serious events occurred during extended follow-up, including eight cases of TLR. Apart from revascularization, none of the events were related to the procedure or device.
Mean ankle-brachial index increased from 0.71 ± 0.16 before treatment to 1.15 ± 0.17 after the procedure. At 12 months, mean ankle-brachial index was 0.99 ± 0.3 (P < .05 vs. baseline), with an improvement of 0.15 or greater observed in 12 patients. Results of walking-impairment questionnaires at 12 months indicated improvements to walking distance compared with baseline in 16 patients, with improvements to speed in 12 patients and to stair-climbing ability in nine patients.
“The antiproliferative effects of paclitaxel have the potential to reduce restenosis due to scaffold degradation in the first 6 months,” the researchers wrote. “Thereafter, the antiproliferative actions of paclitaxel in the vessel wall are not effective in preventing restenosis. ... Any balloon coating or formula that provides antiproliferative action in the vessel wall for the entire duration of scaffold resorption (2-3 years) would presumably provide better results in terms of patency.” – by Adam Taliercio
Disclosure: One researcher reports consulting for Kyoto Medical, which supported the study.
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