Does a drug-eluting stent (DES) with sustained drug release improve patency? Yes, according to research from the IMPERIAL trial presented at TCT 2018 and simultaneously published in the Lancet.

The study randomly assigned 465 patients at 65 study centers in the U.S., Canada, New Zealand, Belgium, Germany, Austria and Japan to either the Eluvia DES (N=309) or the Zilver PTX (N=156). The primary effectiveness endpoint was primary vessel patency at 12 months post-procedure. The primary safety endpoint was rate of major adverse events, including all cause death; target limb major amputation; and target lesion revascularization.

According to researchers, led by William A. Gray, MD, FACC, the primary non-inferiority effectiveness and safety endpoints were achieved, with Eluvia demonstrating superior primary patency compared with Zilver PTX (Δ ~9 percent) at 12 months (p=0.0144) in pre-specified post hoc analysis. They also noted a significant trend toward lower CD-TLR and stent thrombosis rates for Eluvia vs Zilver PTX.

Researchers did observe increased symptomatic, functional and hemodynamic improvement through one year in both groups. Additionally, clinical outcome improvement rates were also similar. However, the revascularization rate in the Eluvia group was nearly 50 percent less than that of the Zilver PTX group.

"At one year, the Eluvia DES demonstrated superior patency compared with Zilver PTX," said Gray. However, ACC.org Editor in Chief Kim A. Eagle, MD, MACC, cautions that while the results appear to be promising, a larger trial with a bigger sample size is needed for validation.

Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Angiography, Percutaneous Coronary Intervention, Drug-Eluting Stents, Femoral Artery

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