Is the TAXUS Stent Benefit Extended to the Most Complicated Patients and Lesions?

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Alfred Caldwell
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1 Angioplasty Summit 2005, Korea Is the TAXUS Stent Benefit Extended to the Most Complicated Patients and Lesions? Eberhard Grube MD FACC, FSCAI Heart Center Siegburg, Siegburg, Germany Stanford University, School of Medicine, CA, USA

2 SVG In-stent Bifurcation Diffuse

3 DES Clinical Trial Programs Single and Multicenter Registries Megatrials Cypher vs. Taxus Studies Pivotal & Core Studies safety efficacy durability Complex Patient and Lesion Studies Endovascular Studies Drug Dose and Stent Design Studies

4 DES Clinical Trial Programs Single and Multicenter Registries Megatrials Cypher vs. Taxus Studies Pivotal & Core Studies safety efficacy durability Complex Patient and Lesion Studies Endovascular Studies Drug Dose and Stent Design Studies

5 TAXUS Clinical Development Increasing complexity Vessels Stent Diameter Lesion Length Lesions TV non- TV Dose Formulation TAXUS I mm 0-2 mm single 0 SR TAXUS II mm 0-2 mm single 0 SR & MR TAXUS III- ISR mm 0-2 mm ISR 0 SR TAXUS IV mm 0-28 mm single SR TAXUS VI mm 40 mm multiple overlap MR TAXUS V mm 46 mm multiple overlap SR TAXUS V- ISR mm 46 mm ISR SR

6 TAXUS Program Clinical strategy TAXUS I TAXUS II Vessels Stent Diameter Lesion Length Lesions TV non-tv mm mm feasibility 0-2 mm & single safety 0-2 mm efficacy single 0 0 Dose Formulation SR SR & MR TAXUS III-ISR mm 0-2 mm ISR 0 SR TAXUS IV TAXUS VI TAXUS V TAXUS V-ISR mm mm mm mm 0-28 mm 40 mm 46 mm 46 mm pivotal single multiple overlap multiple overlap indication expansion ISR SR MR SR SR

7 Complex Lesions Long Lesions Small vessels Multiple Stenting Chronic Total Occlusions Unprotected left mains Bifurcations

8 Complex Lesions Long Lesions TAXUS VI Small vessels Multiple Stenting Chronic Total Occlusions Unprotected left mains Bifurcations

9 TAXUS VI: International Long Lesion Study TAXUS I ACTION ENDEAVOR I ASPECT ELUTES TAXUS II RAVEL FUTURE I DELIVER I FUTURE II C-SIRIUS TAXUS IV E-SIRIUS SIRIUS DELIVER II Mean lesion length (mm) TAXUS VI

10 Complex Lesions & Procedures Long Lesions ( 26 mm) Small Vessels (RVD < 2.5 mm) Multiple Overlapping Stents Additional intervention in Nontarget vessel 8.6% % of Patients N= % 27.8% 23.5%

11 Long Lesions in TAXUS VI Randomized N=446 Lesion Length <26 mm N=360* N=88 TAXUS MR N=72 Lesion Length 26 mm N=83* N=38 TAXUS MR N=45 *Patients with 2-month follow-up

12 Impact of Lesion Length on TLR (2 Months) TAXUS MR P=0.02 P=0.005 TLR rate (%) 8.9 % 47% 27.0 % 84% 9.9% 4.4 % 35/85 7/7 Lesion length <26 mm 0/37 2/45 26 mm

13 Small Vessels in TAXUS VI Randomized N=446 RVD <2.5 mm N=24* N=64 TAXUS MR N=60 RVD 2.5 mm N=322* N=63 TAXUS MR N=59 *Patients with 2-month follow-up

14 Impact of Vessel Size on TLR (2 Months) TAXUS MR P= P=0.0 TLR rate (%) 30.6% 84% 6.8% 40% 0.% 5.0% 9/62 3/60 RVD <2.5 mm 27/6 6/58 RVD 2.5 mm

15 Multiple Overlapping Stents in TAXUS VI Randomized N=446 Single Stents N=274* N=40 TAXUS MR N=34 Multiple Stents N=66* Overlapping Stents N=24* N=6 TAXUS MR N=63 *Patients with 2-month follow-up

16 TLR with Overlapping Stents TAXUS MR 23.3 % P= TLR 93%.6 % 4/60 /63

17 Multi-Vessel Procedures Randomized N=446 Only Target vessel treatment N=34 N=73 TAXUS MR N=68 Non-Target Vessel Treated N=05* N=54 TAXUS MR N=5 *Patients with 2-month follow-up

18 TLR in Patients with Non-Target Vessel Treated TAXUS MR 26.4% P=0.04 TLR 63% 9.8% 4/53 5/5

19 2-Month TLR: Subset Summary All patients RR 0.42 (%) 8.7 TAXUS (%) 20.6 P Lesion length 26 mm RVD <2.5 mm Multiple overlapping stents Non-target vessel treated RR [95% CI]

20 TLR Independent of Classic Risk Factors P=0.005 P= TAXUS MR P= P= TLR (%) % 84% 93% % /37 2/45 Long lesions 26mm 9/62 3/60 Small vessels <2.5mm 4/60 /63 Overlapping stents 4/53 5/5 Non-target vessel treated

21 TAXUS VI Summary TAXUS benefit in TAXUS VI trial is independent of classic risk factors Long lesions TLR reductions in Small vessels Overlapping stents Multivessel procedures 84% 84% 93% 63%

22 Siegburg Taxus ISR Registry 94 patients with 04 lesions over a 2 months period Type of stent used in previous intervention, n (%) Bare metal stent 89 (85.6%) Drug-eluting stents 5 (4.4%) Paclitaxel-eluting 9 Tacrolimus-eluting 5 Everolimus-eluting

23 Siegburg Taxus ISR Registry 6-MONTH CLINICAL FOLLOW-UP (n=94 pts) Target lesion revascularization, n (%) 7 (7.4%) PCI with DES 3 (3.2%) PCI with balloon angioplasty 2 (2.%) CABG (.%) Brachytherapy (.%) Stent thrombosis, n (%) (.%) Myocardial infarction, n 0 Death, n 0

24 Siegburg Taxus ISR Registry 6-MONTH FOLLOW-UP (n=04 lesions) Late loss, mm proximal 0.35 ± 0.65 in-stent 0.30 ± 0.50 distal 0.09 ± 0.66 in-segment 0.49 ± 0.6 Binary restenosis, n (%) proximal 5 (4.8%) in-stent 4 (3.8%) distal 4 (3.8%) in-segment 8 (7.6%)

25 Siegburg Taxus ISR Registry PATTERN OF IN-STENT RESTENOSIS, n (%) PRE 6-m FU Mehran I (Focal) 34 (32.7%) 4 (3.8%) Mehran II (Diffuse intra-stent) 50 (48.%) 0 Mehran III (Diffuse proliferative) 5 (4.4%) 2 (.9%) Mehran IV (Total occlusion) 5 (4.8%) 2 (.9%)

26 Conclusions Efficacy of the TAXUS stent in the overall is extended to patients with classic risk factors for restenosis Larger studies are needed to prospectively evaluate contemporary DES use in high-risk cases

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