Final TAXUS II Data Published

October 13, 2009—Sigmund Silber, MD, et al, published final 5-year results from the TAXUS II trial in Circulation (2009;120:1498-1504). The TAXUS II trial was designed to evaluate the safety and efficacy of the commercialized slow-release (SR) and an investigation-only moderaterelease (MR) polymer-based Taxus paclitaxel-eluting stent (Boston Scientific Corporation, Natick, MA) compared with a bare-metal stent for the treatment of de novo coronary lesions. TAXUS II is the first large TAXUS trial to reach 5-year follow-up.

The investigators found that 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, the investigators concluded.

As detailed in Circulation, this prospective, randomized, double-blind, controlled trial enrolled 536 patients in two consecutive cohorts to compare Taxus SR (n = 131) and Taxus MR (n = 135) with an identical but uncoated baremetal stent control (n = 270).

The investigators reported that at 5 years, both Taxus SR and MR showed superior outcomes compared with the control. The 5-year rates of major adverse cardiac events were 27.6%, 20.4%, and 15.1% (P = .01); rates of target vessel revascularization were 22.5%, 16.6%, and 9% (P = .004); and rates of target lesion revascularization were 18.4%, 10.3%, and 4.5% (P < .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 two stent thromboses with bare-metal stents compared with no event beyond 2 years with either of the Taxus stents.