Principal Findings:

Baseline characteristics were well matched between the treatment groups, with 58% hypertensives, 20% diabetics, and 72% with hyperlipidemia. Baseline minimum lumen diameter was 0.84 mm versus 0.87 mm (p=0.39) and diameter stenosis was 70.2% versus 68.6% (p=0.12) for the paclitaxel-eluting stent group versus the bare metal stent group, respectively. Average lesion length was 20.9 mm versus 20.3 mm (p=0.36). Procedural success was reported in 92.7% of the paclitaxel-eluting stent group and 95.2% of the bare metal stent group (p=0.32).

At nine-month angiographic follow-up, in-stent binary restenosis was lower in the paclitaxel-eluting stent group (9.1% vs. 32.9%, p<0.0001), as was late lumen loss (0.39 mm vs. 0.99 mm, p<0.0001). Percent diameter stenosis at nine months was smaller in the paclitaxel-eluting stent group both in-stent (22.2% vs. 42.8%, p<0.0001) and in the analysis segment (30.4% vs. 45.4%, p<0.0001).

The primary endpoint of target vessel revascularization at nine months was lower in the paclitaxel-eluting stent group (9.1% vs. 19.4%, p=0.003). There was no significant difference in major cardiac adverse events at nine months (16.4% vs. 22.5%, p=0.12). There was also no difference in cardiac death (0% vs. 0.9%, p=0.50), Q-wave myocardial infarction (MI) (1.4% vs. 1.3%, p=1.0), or non-Q-wave MI (6.8% vs. 4.8%, p=0.42). Stent thrombosis occurred in 0.5% of the paclitaxel-eluting stent group and 1.3% of the bare metal stent group (p=0.62).

Two-year follow-up was obtained in >95% of patients (n=428). Target lesion revascularization occurred in 9.7% of the paclitaxel-eluting stent group compared with 21% of the bare-metal stent group.