Lesion length of at least 16 cm, distal external elastic membrane area of 27 mm2 or less and minimum stent area of 12 mm2 or less were independent predictors of restenosis at 1 year among patients with peripheral artery disease who received a paclitaxel-eluting stent for femoropopliteal lesions, according to new data from the ZEPHYR registry.
Researchers performed a prospective, multicenter study to investigate the rate and predictive risk factors of 1-year restenosis in 690 patients in the ZEPHYR registry who were implanted with the Zilver PTX (Cook Medical) paclitaxel-eluting stent (PES). The study included 831 femoropopliteal lesions in 797 limbs. The mean lesion length was 17 ± 10 cm.
“[The] Zilver PTX [PES] … has shown superior long-term outcomes for femoropopliteal lesions relative to balloon angioplasty and provisional bare-metal stent placement in clinical trials. However, the population in these trials seems less severe than a real-world population in clinical practice. To date, real-world outcomes of Zilver PTX implantation for femoropopliteal lesions including challenging ones remain to be systematically studied,” researchers wrote in JACC: Cardiovascular Interventions.
One-year outcomes demonstrated that the rate of restenosis was 37%, major adverse limb events was 22% and stent thrombosis was 2%. The researchers observed a linear increase in stent thrombosis after 3 months. Major adverse limb events accounted for 58% of restenotic lesions, according to the researchers.
The researchers identified three independent predictors associated with restenosis at 1 year: angiography assessed lesion length of 16 cm or greater; distal external elastic membrane area of 27 mm2 or less; and minimum stent area of 12 mm2 or less. The rate of restenosis at 1 year was 15% among patients without any of the three risk factors and was 50% among patients with two or more risk factors. – by Rob Volansky
Disclosure: One researcher reports receiving grant support from Terumo, Japan. Another researcher reports receiving honoraria for lectures.