One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent in patients with diabetes mellitus.

Background—The safety and efficacy of the slow-release, polymer-based, paclitaxel-eluting stent after implantation in a broad cross section of de novo coronary lesions at 1 year are unknown. Methods and Results—In the TAXUS-IV trial, 1314 patients with single de novo coronary lesions 10 to 28 mm in length, with reference-vessel diameter 2.5 to 3.75 mm, coverable by a single study stent, were prospectively randomized to the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or an identical-appearing bare-metal EXPRESS stent. By actuarial analysis, the TAXUS stent compared with the bare-metal stent reduced the 12-month rates of target-lesion revascularization by 73% (4.4% versus 15.1%, P 0.0001), target-vessel revascularization by 62% (7.1% versus 17.1%, P 0.0001), target-vessel failure by 52% (10.0% versus 19.4%, P 0.0001), and composite major adverse cardiac events by 49% (10.8% versus 20.0%, P 0.0001). The 1-year rates of cardiac death (1.4% versus 1.3%), myocardial infarction (3.5% versus 4.7%), and subacute thrombosis (0.6% versus 0.8%) were similar between the paclitaxel-eluting and control stents, respectively. Between 9 and 12 months, there were significantly fewer myocardial infarctions (0% versus 1.1%, P 0.007), target-vessel revascularizations (2.4% versus 5.8%, P 0.002), and major adverse cardiac events (2.4% versus 6.3%, P 0.0009) in the paclitaxel-eluting stent than in the control stent group, respectively. Conclusions—The relative efficacy reported at 9 months for the polymer-based, paclitaxel-eluting TAXUS stent compared with the EXPRESS stent is preserved and continues to increase at 1 year, with no safety concerns apparent. (Circulation. 2004;109:1942-1947.)