Paclitaxel-eluting Stents vs Brachytherapy for In-stent Restenosis (TAXUS V ISR) Trial Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. Gregg W. Stone TAXUS V ISR Trial

www. Clinical trial results.org Angiography (Baseline) TAXUS V ISR Trial: Study Design  Primary Endpoint: Ischemia-driven target vessel revascularization at 9 months VBT using a beta-source radiation n=201 VBT using a beta-source radiation n=201 PCI with paclitaxel-eluting stents n=195 PCI with paclitaxel-eluting stents n= patients > 18 years with stable or unstable angina or inducible ischemia undergoing percutaneous coronary intervention (PCI) of a single bare-metal in-stent restenosis (ISR) lesion in a native coronary artery. Randomized. 34% female, median age 63 years, mean follow-up 9 months 396 patients > 18 years with stable or unstable angina or inducible ischemia undergoing percutaneous coronary intervention (PCI) of a single bare-metal in-stent restenosis (ISR) lesion in a native coronary artery. Randomized. 34% female, median age 63 years, mean follow-up 9 months Repeat Angiography (9 months) 170 in VBT group and 172 in Paclitaxel group Repeat Angiography (9 months) 170 in VBT group and 172 in Paclitaxel group Presented at ACC 2006

www. Clinical trial results.org TAXUS V ISR Trial: Baseline Stenosis at baseline was approximately 68% in each group, with a median lesion length of approximately 15 mm.Stenosis at baseline was approximately 68% in each group, with a median lesion length of approximately 15 mm. Presented at ACC 2006 median time since BMS implantation (days) median time since BMS implantation (days) Median time since bare-metal stent (BMS) implantation (days) p=0.43 Target lesion location left anterior descending (LAD) (%) p=0.23 percent target lesion LAD

www. Clinical trial results.org TAXUS V ISR Trial: Restenosis Pattern A diffuse pattern of restenosis occurred less often in the VBT group than the paclitaxel group (47.0% vs 60.8%; p=0.006)A diffuse pattern of restenosis occurred less often in the VBT group than the paclitaxel group (47.0% vs 60.8%; p=0.006) A focal pattern of restenosis occurred more often in the VBT group than the paclitaxel group (29.0% vs 18.6%; p=0.02)A focal pattern of restenosis occurred more often in the VBT group than the paclitaxel group (29.0% vs 18.6%; p=0.02) Presented at ACC 2006 Restenosis pattern of target lesion: diffuse vs focal (%) p=0.006 p=0.02

www. Clinical trial results.org TAXUS V ISR Trial: Primary Endpoint Ischemic Target Vessel Revascularization at 9 months (%) p=0.046 Presented at ACC 2006 The primary endpoint of ischemic target vessel revascularization was higher in the VBT group compared with the paclitaxel group at 9 months (17.5% vs 10.5%; p=0.046)The primary endpoint of ischemic target vessel revascularization was higher in the VBT group compared with the paclitaxel group at 9 months (17.5% vs 10.5%; p=0.046)

www. Clinical trial results.org TAXUS V ISR Trial: 9 month Clinical Results Ischemic target lesion revascularization was higher in the VBT group compared with the paclitaxel group at 9 months (13.9% vs 6.3%; p=0.01)Ischemic target lesion revascularization was higher in the VBT group compared with the paclitaxel group at 9 months (13.9% vs 6.3%; p=0.01) Ischemic Target Lesion Revascularization at 9 months (%) p=0.01 Presented at ACC 2006

www. Clinical trial results.org TAXUS V ISR Trial: 9 month Clinical Results Both nonischemic TVR and TLR were lower among the paclitaxel group (6.7% vs 1.6% in both cases; p=0.01)Both nonischemic TVR and TLR were lower among the paclitaxel group (6.7% vs 1.6% in both cases; p=0.01) Nonischemic TVR and TLR (%) p=0.01 for both Presented at ACC 2006

www. Clinical trial results.org TAXUS V ISR Trial: 9 month Clinical Results Any incident of TVR was greater among the VBT group (23.7% vs 12.0%; p=0.003)Any incident of TVR was greater among the VBT group (23.7% vs 12.0%; p=0.003) Any incident of TLR was greater among the VBT group (20.1% vs 7.9%; p<0.001)Any incident of TLR was greater among the VBT group (20.1% vs 7.9%; p<0.001) Any TVR and TLR (%) Presented at ACC 2006 p=0.003 p<0.001

www. Clinical trial results.org TAXUS V ISR Trial: 9 month Clinical Results Target Vessel Thrombosis (cumulative to 9 months) (%) p=0.72 Presented at ACC 2006 There was no differences in Target Vessel Thrombosis

www. Clinical trial results.org TAXUS V ISR Trial: Composite of MACE The composite of any major adverse cardiac event was greater in the VBT group compared with the paclitaxel group (20.1% vs 11.5%; p=0.02) and was primarily driven by the reduction in TVRThe composite of any major adverse cardiac event was greater in the VBT group compared with the paclitaxel group (20.1% vs 11.5%; p=0.02) and was primarily driven by the reduction in TVR There was no difference in death (n=1 vs n=0) or MI (4.6% vs. 3.7%; p=0.63)There was no difference in death (n=1 vs n=0) or MI (4.6% vs. 3.7%; p=0.63) Composite of Any Major Adverse Cardiac Event (MACE) (%) p=0.02 Presented at ACC 2006

www. Clinical trial results.org TAXUS V ISR Trial: 9 month Angiography A trend toward greater late loss was present in the VBT group (0.22 mm vs 0.13 mm; p=0.08)A trend toward greater late loss was present in the VBT group (0.22 mm vs 0.13 mm; p=0.08) A smaller MLD was present in the VBT group in the analysis segment (1.55 mm vs 1.99 mm; p<0.001)A smaller MLD was present in the VBT group in the analysis segment (1.55 mm vs 1.99 mm; p<0.001) MLD (mm) Minimum Lumen Diameter at 9 months (mm) p<0.001 Late Loss at 9 months (mm) p=0.08 Late loss (mm) Presented at ACC 2006

www. Clinical trial results.org TAXUS V ISR Trial: 9 month Angiography A higher rate of binary restenosis was present in the VBT group (31.2% vs 14.5%; p<0.001)A higher rate of binary restenosis was present in the VBT group (31.2% vs 14.5%; p<0.001) The final post-procedure diameter stenosis in the analysis segment was greater for the VBT group (29.3% vs 20.6%; p<0.001)The final post-procedure diameter stenosis in the analysis segment was greater for the VBT group (29.3% vs 20.6%; p<0.001) Diameter stenosis (%) Final post-procedure diameter stenosis in the analysis segment (%) p<0.001 Binary Restenosis at 9 months (%) p<0.001 Binary restenosis (%) Presented at ACC 2006

www. Clinical trial results.org TAXUS V ISR Trial: Limitations Future studies should take a closer look at the role of brachytherapy in the treatment of in-stent restenosis of drug-eluting stents.Future studies should take a closer look at the role of brachytherapy in the treatment of in-stent restenosis of drug-eluting stents. Future trials need to consider the long-term durability of drug-eluting stents for the treatment of in-stent restenosis.Future trials need to consider the long-term durability of drug-eluting stents for the treatment of in-stent restenosis. Future studies should take a closer look at the role of brachytherapy in the treatment of in-stent restenosis of drug-eluting stents.Future studies should take a closer look at the role of brachytherapy in the treatment of in-stent restenosis of drug-eluting stents. Future trials need to consider the long-term durability of drug-eluting stents for the treatment of in-stent restenosis.Future trials need to consider the long-term durability of drug-eluting stents for the treatment of in-stent restenosis. Presented at ACC 2006

www. Clinical trial results.org TAXUS V ISR Trial: Summary Among patients with restenotic coronary lesions, treatment with paclitaxel- eluting stents was associated with a reduction in ischemic driven target vessel revascularization at 9 months compared with vascular brachytherapy.Among patients with restenotic coronary lesions, treatment with paclitaxel- eluting stents was associated with a reduction in ischemic driven target vessel revascularization at 9 months compared with vascular brachytherapy. Intravascular brachytherapy is the only currently approved treatment for in- stent restenosis. However, brachytherapy is complicated to perform and is only performed at a limited number of sites. While not approved for ISR, drug-eluting stents have been used for the treatment of ISR and the present study is now the second large-scale randomized trial to show superiority with drug-eluting stents over VBT for treatment of ISR.Intravascular brachytherapy is the only currently approved treatment for in- stent restenosis. However, brachytherapy is complicated to perform and is only performed at a limited number of sites. While not approved for ISR, drug-eluting stents have been used for the treatment of ISR and the present study is now the second large-scale randomized trial to show superiority with drug-eluting stents over VBT for treatment of ISR. The SISR study evaluated brachytherapy compared with sirolimus-eluting stents for ISR treatment, and showed a reduction in target vessel failure with sirolimus-eluting stents.The SISR study evaluated brachytherapy compared with sirolimus-eluting stents for ISR treatment, and showed a reduction in target vessel failure with sirolimus-eluting stents. Among patients with restenotic coronary lesions, treatment with paclitaxel- eluting stents was associated with a reduction in ischemic driven target vessel revascularization at 9 months compared with vascular brachytherapy.Among patients with restenotic coronary lesions, treatment with paclitaxel- eluting stents was associated with a reduction in ischemic driven target vessel revascularization at 9 months compared with vascular brachytherapy. Intravascular brachytherapy is the only currently approved treatment for in- stent restenosis. However, brachytherapy is complicated to perform and is only performed at a limited number of sites. While not approved for ISR, drug-eluting stents have been used for the treatment of ISR and the present study is now the second large-scale randomized trial to show superiority with drug-eluting stents over VBT for treatment of ISR.Intravascular brachytherapy is the only currently approved treatment for in- stent restenosis. However, brachytherapy is complicated to perform and is only performed at a limited number of sites. While not approved for ISR, drug-eluting stents have been used for the treatment of ISR and the present study is now the second large-scale randomized trial to show superiority with drug-eluting stents over VBT for treatment of ISR. The SISR study evaluated brachytherapy compared with sirolimus-eluting stents for ISR treatment, and showed a reduction in target vessel failure with sirolimus-eluting stents.The SISR study evaluated brachytherapy compared with sirolimus-eluting stents for ISR treatment, and showed a reduction in target vessel failure with sirolimus-eluting stents. Presented at ACC 2006