Hollywood, FL (January 23, 2020) – In the first and only head-to-head comparison of two paclitaxel-eluting stents used in peripheral intervention, no difference was seen for the primary endpoint of primary patency at 24 months. Clinical improvements were similar and sustained in both groups.
William Gray, MD, from Lankenau Heart Institute in Wynnewood, Pennsylvania, shared data from the IMPERIAL trial during a morning Late Breaking Clinical Trials session at the International Symposium on Endovascular Therapy (ISET).
IMPERIAL was a head-to-head comparison of the paclitaxel-eluting Eluvia stent (Boston Scientific) and the Zilver PTX paclitaxel-coated stent (Cook Medical) for treatment of patients with femoropopliteal artery disease. One-year data from the trial were reported in Lancet in 2018.1
Eluvia is the only device for peripheral intervention that uses a polymer coating to control drug elution over time.
The trial randomly assigned 465 patients (2:1) to Eluvia or Zilver PTX. At 2 years, complete follow-up was available for 258 patients treated with Eluvia and 125 treated with Zilver PTX.
Primary patency, defined as binary restenosis or clinically-driven target lesion revascularization (TLR), was seen in 83% of Eluvia patients and in 77.1% of Zilver PTX patients, a difference that was not statistically significant (P=.10).
Similarly, freedom from major adverse events was 85.8% for Eluvia and 79.9% for Zilver PTX (P=.1236). There was also no difference in 2-year all-cause mortality (7.1% and 8.3%; P=.6649).
Clinically-driven TLR, however, was lower with Eluvia (12.7% vs. 20.1%; p=0.0495). Dr. Gray reported that the TLR rate for Eluvia “stacks up well” compared to non-drug therapies.
Noting that “it doesn't matter what we think of the patency unless the patient feels better,” Rutherford category improvements were impressive and sustained through 24 months for both Eluvia and Zilver PTX.
- Gray WA, Keirse K, Soga Y, et al. A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet. 2018;392:p1541-1551.