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IMPERIAL: Peripheral DES similar in patency, different in TLR at 2 years
LAS VEGAS — A peripheral drug-eluting stent with a polymer coating conferred lower rates of target lesion revascularization compared with a peripheral DES without a polymer coating, according to 2-year results from the IMPERIAL trial.
However, the patency advantage that the DES with polymer coating (Eluvia, Boston Scientific) held over the DES without coating (Zilver PTX, Cook Medical) at 1 year was no longer statistically significant at 2 years, researchers reported at VIVA 19.
At 2 years, the Kaplan-Meier estimates of primary patency were 83% for the Eluvia group and 77.1% for the Zilver group (log-rank P = .1), Osamu Iida, MD, associate director of the Cardiovascular Center and chief of coronary, endovascular and structure treatments at Kansai Rosai Hospital, Hyogo, Japan, said at a press conference.
“This is the highest patency rate reported in a major peripheral artery disease trial at 2 years,” he said.
The rate of clinically driven target lesion revascularization was lower in the Eluvia group (12.7% vs. 20.1%; log-rank P = .0495), he said.
There were no differences in all-cause mortality (Eluvia, 7.1%; Zilver, 8.3%; P = .6649) or freedom from major adverse events (Eluvia, 85.8%; Zilver, 79.9%; P = .1236) at 2 years, according to the researchers.
“The safety was maintained, which is important given the recent [mortality signal] news about paclitaxel,” William Gray, MD, system chief of the division of cardiovascular disease at Main Line Health and president of Lankenau Heart Institute in Wynnewood, Pennsylvania, who was the principal investigator of IMPERIAL, said in an interview with Healio. “The efficacy difference appeared to be largely maintained as well. There continues to be a very good efficacy profile in terms of freedom from TLR.”
As Healio previously reported, IMPERIAL compared the DES in 465 patients (mean age, 68 years; 66% men) with Rutherford category 2, 3 or 4; at least one lesion in the native superficial femoral artery and/or the proximal popliteal artery; stenosis greater than 70%; vessel diameter between 4 mm and 6 mm; and total lesion length between 30 mm and 140 mm.
“The 1-year data were very important for efficacy and safety, but increasingly, operators, physicians, patients and payers want to see longer-term data. These 2-year data help shore up and validate the 1-year data. That is important for anyone considering use of the Eluvia device in their patient. Now that we have longer-term data, we can use these devices with some reassurance.”
Eluvia uses a lower dose of paclitaxel compared with Zilver (0.167 µg/mm2 vs. 3 µg/mm2), Iida said. – by Erik Swain
Reference:
Iida O, et al. Late-Breaking Clinical Trials. Presented at: VIVA 19; Nov. 4-7, 2019; Las Vegas.
Disclosure: The study was funded by Boston Scientific. Iida reports he received honoraria from Bard Peripheral Vascular, Boston Scientific, Cardiovascular Systems Inc., Medtronic and W.L. Gore and Associates.
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This trial was a bit unfair because it compared a first-generation device that has been approved since 2012 with a much newer device with a proprietary coating. It’s like comparing a Maserati with a Model T. It has to be acknowledged that you are beating up on a Model T. Comparing Eluvia with a newer device would be more relevant to doctors.
We need to look at the specific lesions and the patient demographics to pick the appropriate devices for our patients. That means ones that can be used without contrast for patients with renal disease, for example. The field is moving forward. We no longer need to underdilate these devices. We can’t look in the rearview mirror at what happened before. In the future we are more likely to see trial designs against contemporary devices powered for noninferiority. The market will be driven by price, product risks and reimbursement.
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