The TAXUS II trial compared different formulations of the TAXUS stent, which releases the restenosis-inhibiting drug paclitaxel over a period of time. Investigators presented the 6 month results of the TAXUS II trial at a previous medical conference. Results showed that in coronary arteries, both formulations of the stent efficiently and safely reduced in-stent neointimal formation, binary restenosis and the need to perform repeat revascularizations.

The objective of the 12-month follow-up analysis is to evaluate continued safety and efficacy of the stent 6 months after discontinuation of antiplatement treatment with clopidogrel. Dr. Colombo reported the 12-month clinical follow-up of the TAXUS II trial here at an ACC late breaking clinical trial session.

The randomized trial included more than 500 patients randomized to TAXUS SR (slow release), TAXUS MR (moderate release) or a control arm that received a bare metal stent.

The data at 6 months showed that the cumulative incidence of major adverse coronary events is higher among patients who did not receive the drug-eluting stent. Events occurred in 19.8% (52 of 263) patients in the bare metal stent group, but only 8.5% (11 of 130) patients who received TAXUS SR and 7.8% (10 of 129) patients who received TAXUS MR.

The overall benefit of the drug-eluting stent continued at 12 months, Dr. Colombo said. Cumulative event rates are now 21.7% (57 of 263) for the control group, 10.9% (14 of 129) for TAXUS SR, and 9.8% (13/132) for TAXUS MR.

Similar data emerged when Dr. Colombo compared incidence of target vessel revascularization at 6 and 12 months. Target vessel revascularization at 6 months was higher in the bare metal stent group: 13.2% (35 of 265) patients versus 4.6% (6 of 130) and 3.1% (4 of 129) in the TAXUS SR and MR groups, respectively.

Again, the benefit of the drug-eluting stent continued at 12 months. Only 1 of 260 patients receiving a TAXUS stent needed target vessel revascularization beyond 6 months after implantation, compared with 3 additional patients in the control group.

Survival free of major adverse coronary events at 6 months in the patients that received TAXUS stents was 8.8 percentage points higher than patients who received the bare metal stent. At 12 months, the difference in survival free of events was 10.5 percentage points. Dr. Colombo said these data suggest TAXUS stents do not delay in-stent restenosis, but actually prevent its occurrence.