March 21, 2016
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PADI: Paclitaxel-eluting stent improves patency, amputation rates

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Patients with critical limb ischemia due to infrapopliteal lesions had higher patency rates and fewer amputations at 6 and 12 months after treatment with a paclitaxel-eluting stent compared with percutaneous transluminal angioplasty and bailout stenting, according to results from the PADI trial.

Researchers randomly assigned patients with critical limb ischemia (CLI) due to infrapopliteal lesions to treatment with percutaneous transluminal angioplasty (PTA; n = 66 limbs in 64 patients) or paclitaxel-eluting stent (PES; n = 74 limbs in 73 patients) between October 2007 and February 2013. Patients in the angioplasty group received bailout stenting with bare-metal stents in the event of occlusion or flow-limiting dissection after treatment.

The primary endpoint was primary binary patency of the treated lesions, defined as 50% stenosis or less, at 6 months. Treatment failure was evaluated according to an ordinal score and defined as stenosis of greater than 50%, need for retreatment or major amputation and death due to CLI. Follow-up was conducted at discharge and at 3, 6 and 12 months, with subsequent annual follow-up through 5 years.

The number of lesions treated was 91 in the PTA group and 121 in the PES group, with similar lesion characteristics observed between the two. After treatment, less residual stenosis was observed in the PES group (3.2% vs. 10.7% in PTA group; P = .002).

The primary patency rate was 35.1% in the PTA group and 48% in the PES group at 6 months in modified intention-to-treat analysis (P = .096). Results from per-protocol analysis indicated patency rates of 35.1% and 51.9%, respectively (P = .037). Clinical and morphological outcomes were better in the PES group at 6 months in both modified intention-to-treat (P = .041) and per-protocol analysis (P = .009).

The researchers observed more severe treatment failure in the PTA group compared with the PES group, as indicated by ordinal score (P = .041). Major amputation was numerically less common among those treated with PES for the first 2 years after treatment (P = .066), and minor amputations were less common among these patients for 6 months after treatment (P = .03). Similar mortality rates were observed between the two groups, as were rates of death or amputation, during 2 years of follow-up. Retreatment occurred in 4.1% of patients in the PES group vs. zero patients in the angioplasty group (P = .098).

The researchers also observed similar and significant improvements in mean category, ankle-brachial index and toe pressure at 6 and 12 months. The two groups also did not differ with regard to incidence of serious adverse events or periprocedural, in-hospital and late complications.

“In patients with [critical limb ischemia] caused by infrapopliteal lesions, a treatment strategy with DES should be considered because they are associated with better patency and less amputations when compared with ... the current standard endovascular treatment,” the researchers concluded. – by Adam Taliercio

Disclosure: One researcher reports receiving speaker fees from AngioDynamics, Cook Medical and Cordis Corp.