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Peripheral DES shows long-term benefit in real-world cohort
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LAS VEGAS — A drug-eluting peripheral stent showed long-term benefits through 4 years in real-world patients with a variety of comorbidities, according to data presented at VIVA 17.
The postmarket surveillance study consisted of the first 905 patients implanted with the DES (Zilver PTX, Cook Medical) in Japan, with no exclusion criteria. Michael D. Dake, MD, the Thelma and Henry Doelger professor of cardiovascular surgery and medical director of the catheterization and angiography laboratories at Stanford Health Care, presented subgroup analyses that evaluated performance of the DES in patients with chronic renal failure, no patent runoff vessels and in-stent restenosis.
The study allowed researchers to analyze “subcohorts traditionally thought to be at high risk of failure after endovascular revascularization,” Dake said during a presentation.
Among the patients, 44% had chronic kidney disease and 21% had critical limb ischemia. Among the 1,080 lesions, mean length was 14.6 cm, 42% were total occlusions, 7% had no patent runoff vessels and 19% had in-stent restenosis.
At 4 years, in the overall cohort, the rate of freedom from clinically driven target lesion revascularization was 78.4% and the rate of clinical benefit, defined as freedom from persistent or worsening claudication, rest pain, ulcer or tissue loss, was 72.7%, Dake said here.
Overall results were similar to those seen in randomized controlled trials of the device, he said.
Among patients with chronic renal failure, 81.4% were free from clinically driven TLR at 2 years, which was no different from those without chronic renal failure (84.9%; P = .24), according to results presented.
Patients with no continuous patent infrapopliteal runoff vessels had a similar rate of freedom from clinically driven TLR at 2 years vs. patients with them (81.3% vs. 83.8%, respectively; P = .87), he said, noting that the no-runoff group had a much higher rate of CLI (45% vs. 20%). The data also show no difference in the 2-year amputation rate between the groups.
The findings demonstrated a trend toward lower freedom from clinically driven TLR at 2 years for patients with in-stent restenosis vs. those without in-stent restenosis, but it was not statistically significant (76.6% vs. 85.3%; P = .05), Dake said. Of note, this device is not indicated for patients with in-stent restenosis in the United States.
“The current study continues to show positive outcomes for the Zilver PTX DES through 4 years in a real-world patient population with complex lesions,” Dake said. “Results indicate that the Zilver PTX DES appears safe and effective for patients with chronic renal failure, patients with no patent runoff vessels and patients with in-stent restenosis.” – by Erik Swain
Reference:
Dake MD, et al. Late-Breaking Clinical Trials. Presented at: VIVA 17; Sept. 11-14, 2017; Las Vegas.
Disclosures: The study was funded by Cook Medical. Dake reports he received honoraria from Bard Peripheral Vascular, Cook Medical and W.L. Gore and Associates; consulted for Cook Medical, Novate and W.L. Gore and Associates; and received research grants from Cook Medical, Manta, Novate, Shockwave Medical and W.L. Gore and Associates.
Perspective
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D. Christopher Metzger, MD, FACC, FSCAI
This study showed nice, durable results in real-world lesions long-term with stenting. Freedom from TLR, for me, is a challenging endpoint to assess because, for example, if a patient has a long lesion with in-stent restenosis treated the first time with a DES, and it occludes again, do the clinicians decide not to do another procedure? Otherwise, the results look very good in very long, real-world, complex lesions.
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