Dr. Stone presented the primary outcome of nine-month ischemia-driven target vessel revascularization (TVR) and target lesion revascularization by intention-to-treat analysis. Target lesion revascularization (TLR) was required in 11.3% of control patients and was reduced to 3% in the TAXUS group, a 73% reduction. In the left anterior descending artery, TLR was reduced from 13.4% to 3.4%. In the non-left anterior descending vessels, TLR was reduced from 9.7% to 2.8% in the treatment group. Among insulin-treated diabetics, the need for TLR was reduced 65% with a TAXUS stent. If the operator believed, by visual assessment, that the vessel was small, the need for TLR was reduced from 17.5% to 3.5%. For vessels considered large by visual assessment, the reduction in TLR was from 9.4% to 2.5%. When reference-vessel diameter was assessed by quantitative coronary angiographic analysis, vessels with a mean diameter of 2.2 mm had a marked reduction in TLR, an effect seen in intermediate and large vessels as well. ¡°The bare stents did progressively better the larger the vessels got, but the TAXUS stents still provided a greater benefit¡±, Dr. Stone said. If lesions were less than 10mm, the reduction in TLR was about 66%. For intermediate length lesions, the reduction was about 70%; for long lesions, 85%. Patients tended to have the same results with a TAXUS stent whether or not they were taking GP IIb/IIIa inhibitors.
In the entire cohort, the need for TVR was reduced from 12% in controls to 4.7% in treated patients, a 61% reduction. ¡°In both groups, as a function of TLR and TVR, the need for repeat angioplasties was markedly reduced. However, even more striking, the need for bypass surgery was reduced by approximately 65% to 80%. You¡¯ll note that when we measured TLR CABG rates, only one out of 200 patients over a nine-month period required bypass surgery because of restenosis at the site of the TAXUS stent¡±, Dr. Stone said.

Stent thrombosis occurred in 0.8% of the control group and in 0.6% of the treated group. ¡°In neither group did any stent thrombosis occur between six months and nine months, which is important because that¡¯s the period in which clopidogrel had been discontinued¡±, said Dr. Stone. Dr. Stone said 30-day major adverse cardiovascular events were rare in both groups at approximately 2.5% to 2.9% with no difference between the two groups. There was no difference between the two groups in safety measures such as cardiac death and MI.

Dr. Ellis presented the angiographic results from TAXUS-IV, which included 732 patients, and used standard definitions of in-stent measurements and an analysis measurements and an analysis measurement that included 5mm on either side of the stent. ¡°For those patients who returned for angiographic follow-up, they were well-balanced for the three principal drivers of restenosis¡±, Ellis said. Diabetes was present in about 25% of both groups. Reference vessel diameter was 2.8mm and lesion length 14.4mm in both groups. Measurements of late-loss were significantly different between the two groups with an in-stent late loss of 0.92 mm vs. 0.39 mm in the control vs. treated groups, respectively; in-analysis late loss was 0.61 mm vs. 0.23 mm, in the control and treated groups, respectively. ¡°These were highly significant reductions in favor of the TAXUS stents¡±, Dr. Ellis said.

The rate of binary restenosis dropped from 24.4% in the in-stent segment among patients with bare-metal stent, compared to 5.5% fro treated patients ? a 77% reduction. In the in-analysis segment, the rate of binary restenosis dropped from 26.6% to 7.9%, a 70% reduction. ¡°There was a reduction in focal restenosis by about half, but, more importantly from a clinical standpoint, there was a significant and striking reduction for both the diffuse and the proliferative patterns. Patients randomized to the TAXUS stent almost never came back with either diffuse or proliferative patterns of in-stent restenosis¡±, Dr. Ellis said. Dr. Ellis said that ¡°with all drug-eluting stents there is some concern about late aneurysm formation¡±. Immediately following the procedure, there were two such aneurysms in the control group, and five in the TAXUS group. At nine-month follow-up, there were two such patients in the control group and two patients in the TAXUS group. Patients tended to have a greater risk of restenosis if they had smaller vessels. ¡°However, with the TAXUS stent there is either an elimination or a great attenuation of risk with the smallest vessels benefiting the most¡±, said Dr. Ellis. A similar effect was seen in lesion length, with a reduction in restenosis in long lesions from 15.27 mm to 9.75 mm.