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IMPERIAL: DES with polymer coating beneficial in diabetes, PAD
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Among patients with diabetes and peripheral artery disease, those assigned a drug-eluting stent with a polymer coating and a lower drug dose density had better outcomes compared with a DES without a polymer coating and a higher drug dose density, according to new data from the IMPERIAL trial.
As Cardiology Today’s Intervention previously reported, the DES with polymer coating (Eluvia, Boston Scientific) outperformed the DES without polymer coating (Zilver PTX, Cook Medical) in an overall cohort of patients with PAD. Stefan Müller-Hülsbeck, MD, from Ev-Luth Diakonissenanstalt zu Flensburg, Germany, presented results from the trial’s patients with diabetes at Leipzig Interventional Course.
“Patients with diabetes have an accelerated time course in developing PAD and the lesion characteristics are often challenging. They do particularly poorly if treated with bare technologies — percutaneous transluminal angioplasty or bare-metal stenting — with a high rate of reintervention,” Müller-Hülsbeck told Cardiology Today’s Intervention. “Diabetic patients treated with Eluvia had an excellent primary patency rate at 1 year, and there was a statistically significant and clinically relevant reduction in both target lesion revascularization and stent thrombosis.”
In the diabetic cohort, there were 116 patients assigned the DES with polymer coating (mean age, 67 years; 72% men) and 64 patients assigned the DES without polymer coating (mean age, 67 years; 73% men).
At 12 months, the rate of primary patency was 87.4% in the Eluvia group and 80.2% in the Zilver group (log-rank P = .2905), according to the researchers.
The DES with polymer coating was superior to the DES without polymer coating in clinically driven TLR at 12 months (3.7% vs. 13.6%; P = .0269) and stent thrombosis at 12 months (0.9% vs. 8.1%; P = .0235), whereas overall major adverse events were numerically lower in the DES with polymer-coating group (4.6% vs. 13.6%; P = .0658), Müller-Hülsbeck said during the presentation.
“Diabetic patients are the most challenging patient group to treat medically and have multiple comorbidities. Their presenting lesion morphology are likely to be more complex and challenging to treat. The results for both safety and efficacy of the Eluvia DES provides confidence that this is an effective primary interventional treatment option for these patients,” Müller-Hülsbeck told Cardiology Today’s Intervention. “It is remarkable that the Eluvia DES was able to demonstrate clear advantages over an active drug-coated device. The differentiated polymer-mediated drug release profile must be the responsible factor.” – by Erik Swain
Reference:
Müller-Hülsbeck S, et al. “To stent or not to stent?” — Latest data on stentless and stent-based treatment approaches for femoropopliteal lesions. Presented at: Leipzig Interventional Course; Jan. 22-25, 2019; Leipzig, Germany.
Disclosure: The study was funded by Boston Scientific. Müller-Hülsbeck reports he received honoraria from Boston Scientific.