ZILVER PASS: DES, bypass equally effective at 1 year in long femoropopliteal lesions

HOLLYWOOD, Fla. — A drug-eluting stent conferred similar survival, patency and freedom from target lesion revascularization compared with bypass surgery in patients with long femoropopliteal lesions, according to 12-month results of the ZILVER PASS trial.

The primary endpoint of 12-month primary patency occurred in 74.5% of patients assigned the DES (Zilver PTX, Cook Medical) compared with 72.6% of patients assigned bypass surgery (P = .5446), Constantino S. Peña, MD, FSIR, medical director of vascular imaging at Miami Cardiac & Vascular Institute and clinical assistant professor of radiology at Florida International University Herbert Wertheim College of Medicine, reported on behalf of the ZILVER PASS investigators at the International Symposium on Endovascular Therapy.

At 12 months, the rate of freedom from TLR was 80.9% in the DES group vs. 76.2% in the surgery group (P = .5379), while the rate of survival was 94.5% in the DES group vs. 96.1% in the surgery group (P = .3782).

Secondary patency at 12 months was 95.1% with the DES vs. 95.9% with surgery (P = .7542), according to the new data.

Results were similar whether patients had claudication or critical limb ischemia, Peña said.

Despite comparable outcomes at 12 months, differences between the two groups emerged, with a much shorter procedure time (59.6 minutes vs. 123.05 minutes; P < .001) and length of stay (2.52 days vs. 8.14 days; P < .001) among patients assigned the DES.

Discussing the reasons why the study was performed, Peña noted that “bypass is the gold standard in TASC C and D lesions. The objective was to evaluate the performance of the Cook Zilver PTX DES compared to bypass surgery for the treatment of femoropopliteal TASC C and D lesions.”

In total, 220 patients from 13 sites in four countries were enrolled. The mean age was 69 years, 28% were women and the mean lesion length was 247.11 mm.

Researchers for the ZILVER PASS trial will continue to look at outcomes over time. Peña also presented at ISET 2019 preliminary 24-month data from 110 patients. At 24 months, primary patency was 68.2% in the DES group vs. 63.7% in the surgery group, while freedom from TLR was observed in 80.4% of the bypass group vs. 70.3% of the surgery group.

“Zilver PTX is obtaining very good primary patency, comparable to bypass, for long and complex femoropopliteal lesions,” he said. “The preliminary 24-month data show at least noninferiority. Right now, my take-home message is both of these treatment options are comparable in this population.” – by Erik Swain

Reference:

Peña CS, et al. CLI: Treatment techniques and management. Presented at: the International Symposium on Endovascular Therapy (ISET); Jan. 27-30, 2019; Hollywood, Fla.

Disclosures: The study was funded by Cook Medical. Peña reports he has financial ties with Boston Scientific, Bridgewater Medical, Cagent Vascular, Cook Medical, C.R. Bard, Halyard Health and Prairie Research.