Long‐term follow‐up of the platinum chromium TAXUS element (ION) stent: The PERSEUS Workhorse and Small Vessel Trial Five‐Year Results. Issue 6 (25th February 2015) - Kereiakes, Dean J.
Abstract : Background: The TAXUS Element (ION) platinum chromium paclitaxel‐eluting stent (PtCr‐PES) incorporates a thin (81 μm) strut design with a similar polymer and drug dose density as prior PES. The pivotal PERSEUS trial program consisted of two studies: PERSEUS Workhorse (WH) and PERSEUS Small Vessel (SV). The PERSEUS WH trial demonstrated the PtCr‐PES to be non‐inferior 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. Long‐term (5‐year) clinical outcomes following PtCr‐PES have not been previously reported. Methods: 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 ≤4.0 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. Results: 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 = 0.66). In the PERSEUS SV study, 5‐year rates of MACE, and TLF were significantly lower for PtCr‐PES (vs. BMS) following adjustment for baseline characteristics and were primarily due to lower target lesion revascularization rates (27.2% BMS vs. 14.9% PtCr‐PES; P = 0.049). Conclusions: At 5 years, the PtCr‐PES provides efficacy and safety that is comparable to the TE‐PES and superior efficacy with similar safety when compared with BMS in smaller caliber vessels. Cumulative stent thrombosis rates remained low and similar through 5 years for both DES platforms. © 2015 Wiley Periodicals, Inc.