Patients with PAD who receive DES show positive outcomes at 2 years

LAS VEGAS — A drug-eluting stent (DES) benefited patients with lesions in the superficial femoral artery at 2 years, according to findings presented at VIVA 15.

Hiroyoshi Yokoi, MD, presented 2-year results from a postmarket surveillance study conducted in Japan of 907 patients (mean age, 74 years; 70% men) with 1,075 lesions treated with a DES (Zilver PTX, Cook Medical). Two-year follow-up was available for 624 patients.

Outcomes of interest were clinically driven target lesion revascularization, defined as reintervention for at least 50% diameter stenosis associated with recurrent symptoms of peripheral artery disease; clinical benefit, defined as freedom from persistent or worsening ischemia symptoms; and patency.

Hiroyoshi Yokoi

Compared with patients in the randomized controlled trial [EOL1] of the DES, patients in the postmarket study had more complex disease, including a higher rate of chronic kidney disease (44%; P < .01), a higher Rutherford classification (22% with critical limb ischemia; P < .01) and a longer mean lesion length (15 cm; P < .01), Yokoi, from Fukuoka Sanno Hospital, Japan, said during a presentation.

In addition, at baseline, 19% of lesions had in-stent restenosis and 7% had no patent run-off vessels[EOL2] , he said.

The rate of site-reported total occlusion of suspected thrombotic origin through 2 years was 3.6%, which is comparable to other studies [EOL3] , Yokoi said.

The rate of freedom from TLR was 85.0% at 2 years [EOL4] vs. 91.0% at 1 year, he said, noting that this is similar to the 2-year rates of 86.0 [EOL5] % in the randomized controlled trial and 83.3% in a premarket study of complex lesions.

The rate of clinical benefit was 79.3% at 2 years vs. 87.7% at 1 year, which is comparable to the 82.0% rate observed in the randomized controlled trial and the 78.6% rate seen in the premarket study, he said.

Primary patency was 72.3 [EOL6] % at 2 years vs. 86.4% at 1 year, he said, noting that the 2-year rate of primary patency was 76.3% in the randomized controlled trial and was not analyzed in the premarket study.

“The 2-year Japan Postmarket Surveillance Study results are positive and confirm the long-term benefit of the Zilver PTX technology,” Yokoi said. “Consistent results across studies provide added support for established performance of the Zilver PTX stent and reaffirm its long-term safety and effectiveness.” – by Erik Swain

Reference:

Yokoi H, et al. Late-Breaking Clinical Trials. Presented at: VIVA 15; Nov. 2-5, 2015; Las Vegas.

Disclosure: The study was funded by Cook Medical. Yokoi reports receiving honoraria from Abbott Vascular, Boston Scientific, Cook Medical, Cordis, Daiichi Sankyo, Gore & Associates, Medtronic, Takeda and Terumo, and receiving research funding from Daiichi Sankyo and Takeda.

Editor’s note: On Dec. 4, we corrected data in the study. The Editors regret this error.