A prospective evaluation of the safety and efficacy of TAXUS Element paclitaxel-eluting coronary stent implantation for the treatment of de novo coronary artery lesions in small vessels: the PERSEUS Small Vessel trial.

Aims: Small reference vessel diameter predicts adverse outcomes following coronary stenting. TAXUS Express and TAXUS Liberte paclitaxel-eluting stents (PES) reduce restenosis compared to bare metal stents (BMS) in small diameter vessels. TAXUS Element is a novel thin-strut, platinum chromium stent designed to enhance visibility, conformability, and drug delivery in small diameter vessels. Methods and results: The PERSEUS Small Vessel (SV) prospective, single-arm, superiority trial evaluates the TAXUS Element PES in 224 subjects with target lesion length <= 20 mm and vessel diameter >= 2.25 to <2.75 mm, compared to 125 lesion-matched historical Express BMS control subjects from the TAXUS V trial. The primary endpoint was nine-month in-stent late loss. The secondary endpoint was 12-month target lesion failure (TLF) compared to a pre-specified performance goal (PG). Outcomes were analysed with and without propensity-score adjustment. TAXUS Element was superior to the Express BMS for late loss (0.38 +/- 0.51 versus 0.80 +/- 0.53 mm respectively; P<0.001), and TLF (7.3%) was significantly less than the 19.5% PG (P<0.001). No differences in mortality, myocardial infarction, or stent thrombosis were observed through 12 months. Results were similar after adjustment. Conclusions: PERSEUS SV supports the efficacy and safety of the platinum chromium, thin-strut TAXUS Element stent in small coronary vessels.