Long-Term PERSEUS Data Published for Boston Scientific's Taxus Element Ion PES

March 9, 2015—Dean J. Kereiakes, MD, et al published 5-year results from the PERSEUS Workhorse (WH) and Small Vessel (SV) trials of Boston Scientific’s Taxus Element Ion device. The Taxus Element Ion is a platinum-chromium paclitaxel-eluting stent (PtCr-PES) that incorporates a thin (81-μm) strut design with a similar polymer and drug dose density as previous PESs. The results are available online ahead of print in Catheterization and Cardiovascular Interventions.

The PERSEUS WH and PERSEUS SV comprised the pivotal PERSEUS trial program. The PERSEUS WH trial demonstrated the PtCr-PES to be noninferior to the predicate Taxus Express PES (TE-PES) for target lesion failure (TLF) at 1 year and in-segment angiographic percent diameter stenosis at 9 months. The PERSEUS SV trial demonstrated the PtCr-PES to be superior to a historical bare-metal stent (BMS) for angiographic late lumen loss at 9 months. The long-term (5-year) clinical outcomes after PtCr-PES have not been previously reported, noted the investigators.

As summarized in Catheterization and Cardiovascular Interventions, PERSEUS WH was a prospective, Bayesian, 3:1-randomized (PtCr-PES vs TE-PES) trial in patients with lesion length ≤ 28 mm and vessel diameter ≥ 2.75 to ≤ 4 mm. PERSEUS SV was a prospective, single-arm trial in patients with lesion length ≤ 20 mm and vessel diameter ≥ 2.25 to < 2.75 mm comparing PtCr-PES to a matched historical BMS control.

The investigators reported that among randomized subjects in the PERSEUS WH study, clinical event rates at 5 years were similar between treatment groups, including TLF (12.9% TE-PES vs 12.1% PtCr-PES; P = .66). In the PERSEUS SV study, 5-year rates of major adverse cardiac events and TLF were significantly lower for PtCr-PES versus BMS after adjustment for baseline characteristics and were primarily due to lower target lesion revascularization rates (27.2% BMS vs 14.9% PtCr-PES; P = .049).

At 5 years, the PtCr-PES provided efficacy and safety that is comparable to the TE-PES and superior efficacy with similar safety when compared with BMS in smaller-caliber vessels, and cumulative stent thrombosis rates remained low and similar through 5 years for both DES platforms, concluded the investigators in Catheterization and Cardiovascular Interventions.