Slow-rate release polymer-based paclitaxel- eluting stent compared with bare stent in patients with single complex coronary lesions TAXUS V Presented at The American College of Cardiology Scientific Sessions 2005 Presented by Dr. Gregg Stone

www. Clinical trial results.org Paclitaxel- eluting stent  Slow-release formulation  mm in diameter  8 – 32 mm in length  n = 577 Paclitaxel- eluting stent  Slow-release formulation  mm in diameter  8 – 32 mm in length  n = 577 Endpoints:  Primary – Symptom-driven target vessel revascularization at 9 months  Secondary – 9 month late loss and overall MACE (cardiac death, target vessel revascularization, Q-wave and non-Q-wave MI, stent thrombosis) Endpoints:  Primary – Symptom-driven target vessel revascularization at 9 months  Secondary – 9 month late loss and overall MACE (cardiac death, target vessel revascularization, Q-wave and non-Q-wave MI, stent thrombosis) TAXUS V ACC ,156 patients with single complex coronary lesions 31% diabetic, 31% female, 33% received multiple stents Mean stent length = 28 mm; Mean patient age = 63 Cocomitant medications: aspirin indefinitely, clopidogrel 6 months + 1,156 patients with single complex coronary lesions 31% diabetic, 31% female, 33% received multiple stents Mean stent length = 28 mm; Mean patient age = 63 Cocomitant medications: aspirin indefinitely, clopidogrel 6 months + Bare metal stent  mm in diameter  8 – 32 mm in length  n = 579 Bare metal stent  mm in diameter  8 – 32 mm in length  n = 579

www. Clinical trial results.org TAXUS V: Primary Endpoint % ACC 2005 p=0.018 p = The primary endpoint of 9 month target vessel revascularization was lower in the TAXUS group than in the bare metal stent group. The difference was driven by a significant reduction in target lesion revascularization, with no difference in non-TLR between the two groups.

www. Clinical trial results.org TAXUS V Trial: Overall MACE The significant reduction in overall MACE in the paclitaxel-eluting stent group was driven solely by a lower rate of TVR. The two groups showed no difference in all other components of the MACE endpoint, including cardiac death, Q-wave and non-Q-wave MI, and stent thrombosis. Overall MACE at 9 months ACC 2005 p=0.008

www. Clinical trial results.org TAXUS V Trial: angiographic endpoints In-stent late lumen loss p< In-stent binary restenosis p< ACC 2005

www. Clinical trial results.org TAXUS V: Small-vessel subgroup % ACC 2005 p=0.03 p =0.23 In a subgroup of 203 small-vessel patients (2.25 mm stents,) the primary endpoint of 9 month TVR was lower (but not significantly) in the TAXUS group than in the bare metal stent group, driven by a significantly lower rate of TLR. 9-month MACE rates were not significantly different between the two groups.

www. Clinical trial results.org TAXUS V: small-vessel subgroup ACC 2005 Among patients in the small-vessel subgroup, the paclitaxel-eluting stent was also associated with significant reductions in 9 month binary restenosis and late-loss compared to treatment with a bare metal stent. The groups showed statistically equal rates of stent thrombosis (1%). p=0.01 p=0.004

www. Clinical trial results.org TAXUS V Trial: Large-vessel subgroup In a subgroup of 202 large vessel patients (4.0 mm stents), there was no difference in 9 month TLR, TVR or MACE between the two groups. The TAXUS stent was associated with a significant reduction in binary restenosis compared to bare metal stent at 9 months. Both groups had 0% stent thrombosis at 9 months. Binary Restenosis at 9 months ACC 2005 p=0.016

www. Clinical trial results.org TAXUS V Trial: Multiple-stent group ACC 2005 p=0.047 p=0.016 In a subgroup of 379 patients receiving multiple stents, the paclitaxel-eluting stent was associated with a near significant increase in 9 month MACE due to a marked increase in non-Q-wave MIs in the TAXUS stent group compared with the bare metal stent group. The increase in non-Q-wave MI is probably driven by the significant increase in branch TIMI flow reduction in the TAXUS group.

www. Clinical trial results.org TAXUS V: Multiple-stent group ACC 2005 p= p =0.002 p =< However, there were no differences between the TAXUS and bare metal stent groups in the clinical endpoints of death, cardiac death, or stent thrombosis. The TAXUS stent was associated with significantly improved angiographic endpoints of TLR, TVR, binary restenosis, and late loss.

www. Clinical trial results.org TAXUS V Trial: Summary Among patients with single complex lesions, treatment with the slow-release paclitaxel-eluting stent was associated with a significant reduction in the primary endpoint of 9-month target vessel revascularization compared with treatment with bare metal stent. Earlier TAXUS studies showed a similar reduction in TVR with paclitaxel-eluting stents in more simple lesions; this trial expands these findings to include more complex lesions, including longer lesions and lesions requiring multiple and overlapping stents. The secondary angiographic endpoints of 9 month in-stent late lumen loss and in-stent binary restenosis were significantly lower in the paclitaxel-eluting stent group compared with the bare metal stent group. As in previous TAXUS trials, paclitaxel-eluting stents were not associated with a reduction in other components of overall MACE, including the clinical endpoints of cardiac death or MI at 9 months. The overall findings of the trial held true for subgroups of both small and large vessel patients. However, a third subgroup of patients receiving multiple stents showed a significant increase in MACE (all of which were MI, all but one of which were non-Q-wave MI) and a significant increase in branch TIMI flow reduction in the TAXUS stent group compared with the bare metal stent group. Among patients with single complex lesions, treatment with the slow-release paclitaxel-eluting stent was associated with a significant reduction in the primary endpoint of 9-month target vessel revascularization compared with treatment with bare metal stent. Earlier TAXUS studies showed a similar reduction in TVR with paclitaxel-eluting stents in more simple lesions; this trial expands these findings to include more complex lesions, including longer lesions and lesions requiring multiple and overlapping stents. The secondary angiographic endpoints of 9 month in-stent late lumen loss and in-stent binary restenosis were significantly lower in the paclitaxel-eluting stent group compared with the bare metal stent group. As in previous TAXUS trials, paclitaxel-eluting stents were not associated with a reduction in other components of overall MACE, including the clinical endpoints of cardiac death or MI at 9 months. The overall findings of the trial held true for subgroups of both small and large vessel patients. However, a third subgroup of patients receiving multiple stents showed a significant increase in MACE (all of which were MI, all but one of which were non-Q-wave MI) and a significant increase in branch TIMI flow reduction in the TAXUS stent group compared with the bare metal stent group. ACC 2005