Final 5-Year Results of the TAXUS II Trial

TLDR

The TAXUS II trial evaluated the safety and efficacy of slow‑release and moderate‑release paclitaxel‑eluting stents versus bare‑metal stents for de novo coronary lesions. This analysis reports the final 5‑year clinical outcomes of the TAXUS II trial. The study was a prospective, randomized, double‑blind, controlled trial enrolling 536 patients across two cohorts to compare TAXUS SR, TAXUS MR, and bare‑metal stents. At 5 years, TAXUS SR and MR stents reduced major adverse cardiac events, target‑vessel and target‑lesion revascularization, and stent thrombosis compared with bare‑metal stents, demonstrating sustained efficacy and long‑term safety.

Abstract

Background— The TAXUS II trial was designed to evaluate the safety and efficacy of the commercialized slow-release (SR) and an investigation-only moderate-release (MR) polymer-based TAXUS paclitaxel-eluting stent compared with a bare-metal stent for the treatment of de novo coronary lesions. Methods and Results— This prospective, randomized, double-blind, controlled trial enrolled 536 patients in 2 consecutive cohorts to compare TAXUS SR (n=131) and TAXUS MR (n=135) with an identical but uncoated bare-metal stent control (n=270). The present analysis reports final 5-year clinical outcomes of TAXUS II. At 5 years, both TAXUS SR and MR showed superior outcomes compared with control. The 5-year rates of major adverse cardiac events were 27.6%, 20.4%, and 15.1% ( P =0.01); rates of target-vessel revascularization were 22.5%, 16.6%, and 9.0% ( P =0.004); and rates of target-lesion revascularization were 18.4%, 10.3%, and 4.5% ( P <0.001) for the control, TAXUS SR, and TAXUS MR groups, respectively. The rates of all-cause death and myocardial infarction were low and similar between groups, with 2 stent thromboses with bare-metal stents compared with no event beyond 2 years with either of the TAXUS stents. Conclusions— TAXUS II is the first large TAXUS trial to have reached 5-year follow-up. Both the SR and MR stents lowered the rates of target-vessel and target-lesion revascularization, which indicates their sustained efficacy. Furthermore, the low overall rates of all death, myocardial infarction, and stent thrombosis support the long-term safety of the TAXUS stent system.