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TAXUS ATLAS SMALL VESSEL and LONG LESION First Report of Nine-Month Clinical and Angiographic Results

TAXUS ATLAS SMALL VESSEL and LONG LESION First Report of Nine-Month Clinical and Angiographic Results . Mark A. Turco, MD, FACC and John A. Ormiston, MBChB On behalf of the TAXUS ATLAS Investigators. Conflict of Interest Disclosures.

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TAXUS ATLAS SMALL VESSEL and LONG LESION First Report of Nine-Month Clinical and Angiographic Results

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  1. TAXUS ATLAS SMALL VESSEL and LONG LESION First Report of Nine-Month Clinical and Angiographic Results Mark A. Turco, MD, FACC and John A. Ormiston, MBChB On behalf of the TAXUS ATLAS Investigators

  2. Conflict of Interest Disclosures • TAXUS ATLAS SV and LL and production of this presentation were supported by Boston Scientific Corporation (BSC) • The following relationships exist related to BSC and this presentation: • Mark A. Turco: • Research grants and other research support • Consultant • Member of speaker’s bureau • John A. Ormiston: • Research grants and other research support • Consultant • Member of advisory board

  3. TAXUS ATLAS Small Vessel and Long Lesion Study Enrollers

  4. Study OrganizationTAXUS ATLAS Small Vessel and Long Lesion

  5. Design Improvements in TAXUS Liberté Improved performance 27% reduced stent strut thickness Reduced stent to artery ratio More homogeneous drug distribution 15% more conformable and 15% more flexible 5 wing fold balloon: improved re-wrap and less withdrawal resistance TAXUS Express to TAXUS LibertéEvolution of the TAXUS Technology TAXUS Express TAXUS Liberté TAXUS ATLAS program: Transfer of proven drug/polymerTAXUS technology to the improved Liberté platform

  6. TAXUS ATLAS ProgramEvaluating the TAXUS Liberté Stent Global, Multi-center, Historically Controlled Trials on De Novo Lesions

  7. TAXUS ATLASSmall Vessel TAXUS ATLASLong Lesion TAXUSExpress Non-Inferiority BMSExpress TAXUSExpress Superiority Non-Inferiority TAXUS LibertéTAXUS ATLAS Expansion Program TAXUSLiberté 2.25 mm TAXUS Liberté Long (38 mm)

  8. TAXUS ATLAS Small VesselStudy Flow Intent-to-Treat BMS Control DES Control Express (BMS) N=155 TAXUS Liberté 2.25 N=261 TAXUS Express N=75 • TAXUS V pts with: • RVD≤2.5mm, lesions≤28mm • Single planned 2.5 or 2.25mm study stent • TAXUS V pts with: • RVD≤2.5mm, lesions≤28mm • Single planned 2.25mm study stent 9-Month Follow-Up Express (BMS) N=148 (95%) TAXUS Liberté 2.25 N=257 (98%) TAXUS Express N=72 (96%) 9-Month QCA Follow-Up Express (BMS) N=105 (68%) TAXUS Liberté 2.25 N=212 (81%) TAXUS Express N=55 (73%)

  9. Baseline Characteristics for Small VesselTAXUS Liberté 2.25 versus BMS Control *QCA Data

  10. P<0.0001 BMS Control (N=155) TAXUS Liberté 2.25 (N=261) Primary Endpoint Met for Small VesselTAXUS Liberté 2.25 Superior to BMS Control Late Loss % DS (Analysis Segment)Primary Endpoint In-Stent In-Segment P<0.0001 P<0.0001 45.6±23.5 0.84±0.57 % Diameter Stenosis 0.55±0.55 32.1±18.4 0.28±0.45 0.16±0.40

  11. P=1.00 P=0.78 P=0.0191 P=0.0065 P=1.00 P=1.00 P=0.0001 41% 48% 67% BMS Control (N=155) TAXUS Liberté 2.25 (N=261) 9-Month Clinical Events in Small VesselSignificant TAXUS Liberté Clinical Benefit vs. BMS Patients (%) 1.2 0.7 Cardiac Death Overall MI TLR TVR Remote Overall TVR Overall MACE All Death

  12. TAXUS ATLASSmall Vessel TAXUS ATLASLong Lesion Superiority Met BMSExpress TAXUSExpress TAXUSExpress Superiority Non-Inferiority Non-Inferiority TAXUS LibertéTAXUS ATLAS Expansion Program TAXUSLiberté 2.25 mm TAXUS Liberté Long (38 mm)

  13. Baseline Characteristics in Small VesselTAXUS Liberté 2.25 versus DES Control *QCA Data

  14. Primary Endpoint Met for Small VesselT. Liberté 2.25 non-inferior (superior) to T. Express % Diameter Stenosis (Analysis Segment): ITT Population P<0.0001 for Non-inferiority P=0.0351 for Superiority Pre-specifiedMargin 10.0% 95%Confidence Interval -1.4% 38.4±23.6 32.1±18.4 Difference-6.3% % Diameter Stenosis 95% CI is less than prespecified margin -10% -5% 0 5% 10% T. Express Control T. Liberté 2.25 Difference (T. Liberté – T. Express) Non-inferiority met in ITT population (P<0.0001) T. Liberté 2.25 is Superior to T. Express Control (ITT population) Non-inferiority also demonstrated in per protocol population (P<0.0001)

  15. P=0.02 P=0.69 P=1.00 P=0.02 T. Express Control (N=75) T. Liberté 2.25 (N=261) 9-Month QCA Outcomes in Small VesselSignificant benefit for TAXUS Liberté 2.25 Binary Restenosis (% pts) Late Loss (mm) P=0.03 P=0.0085 0.44±0.61 0.33±0.52 0.28±0.45 0.16±0.40 ProximalEdge In-Stent DistalEdge In-Stent Analysis Segment Paired lesion analysis

  16. 38% 43% 58% T. Express Control (N=75) T. Liberté 2.25 (N=261) 9-Month Clinical Events in Small VesselSignificant ClinicalBenefit for TAXUS Liberté P=0.21 P=0.46 P=0.024 P=1.00 P=0.07 P=0.10 P=0.30 Patients (%) 2.7 1.2 Cardiac Death Overall MI TLR TVR Remote Overall TVR Overall MACE All Death

  17. Stent Thrombosis (Per Protocol) in SVSimilar Rates for all 3 Arms Acute &Subacute Late Total ST P= P= 0.22 0.14 1.00 1.00 0.39 0.56 % ST (per protocol) (n=2) (n=2) (n=1) (n=2) (n=1) (n=2) 0 – 30 days 31 – 284 days 0 – 284 days T. Express Control (N=75) T. Liberté 2.25 (N=261) BMS Control (N=155) Rates were identical using ARC Definite/Probable Definition

  18. TAXUS ATLAS Small VesselSummary • Efficacy Outcomes: • Primary endpoint of 9-month % DS (analysis segment) was met: • TAXUS Liberté 2.25 is superior to Express BMS Control • TAXUS Liberté 2.25 is non-inferior (and actually superior) to TAXUS Express Control • Significant reductions in Late Loss and Restenosis with TAXUS Liberté vs. both TAXUS Express and BMS • Significantly reduced TLR in TAXUS Liberté vs. both Controls • Safety Outcomes: • Rates for death, cardiac death, MI, and stent thrombosis for the TAXUS Liberté 2.25 group low and comparable to TAXUS Express and BMS

  19. TAXUS ATLASSmall Vessel TAXUS ATLASLong Lesion Non-Inferiority Met Superiority Met BMSExpress TAXUSExpress TAXUSExpress Superiority Non-Inferiority Non-Inferiority TAXUS LibertéTAXUS ATLAS Expansion Program TAXUSLiberté 2.25 mm TAXUS Liberté Long (38 mm)

  20. TAXUS ATLAS Long LesionStudy Flow T. Express Control T. Liberté 38mm Intent-to-Treat TAXUS Express N=145 TAXUS Liberté N=150 • TAXUS IV and V pts with: • RVD≥2.5 - ≤4.0mm • Lesions ≥26 - ≤34 mm 9-Month Follow-Up TAXUS Express N=138 (95.2%) TAXUS Liberté N=145 (96.7%) 9-Month QCA Follow-Up TAXUS Express N=91 (62.8%) TAXUS Liberté N=126 (84.0%)

  21. Baseline Characteristics in Long LesionTAXUS Libertéused in Complex Populations * QCA Data

  22. Procedural Characteristics * QCA Data

  23. P=0.71 Primary Endpoint Met for Long LesionTAXUS Liberté Non-inferior to TAXUS Express % Diameter Stenosis (Analysis Segment): ITT Population Non-inferiority met Pre-specifiedMargin 6.89% 32.6±19.3 31.7±17.2 95% CI 3.19 Difference-0.93 Analysis Segment % DS 95% CI is less than prespecified margin -1% 0 1% 2% 3% 4% 5% 6% 7% T. Express Control T. Liberté 38 mm Difference (T. Liberté – T. Express) T. Liberté 38 mm is similar to T. Express Control Non-inferiority (P=0.001) Non-inferiority also met in per protocol population (P=0.001) and after propensity adjustment (P<0.0001)

  24. 79% T. Express Control (N=145) T. Liberté 38 mm (N=150) 9-Month Clinical Events for Long LesionSignificantly Reduced MI Compared to T. Express P=0.06 P=0.026 P=0.73 P=0.45 P=0.93 P=0.16 P=0.21 Patients (%) 2.8 0.7 Cardiac Death Overall MI TLR TVR Remote Overall TVR Overall MACE All Death

  25. QMI(n=2) P=0.013 P=1.00 NQMI(n=7) NQMI(n=2) Breakdown of MI EventsReduced In-Hospital Non-Q MI in TAXUS Liberté Non-Q-Wave MI In-Hospital Discharge – 9m 4.1% Patients (%) CK-MB≥5x (n=3) CK-MB≥5x (n=2) CK-MB≥5x (n=1) CK-MB≤3 (n=3) 0.0% TAXUSExpress TAXUSLiberté TAXUSExpress TAXUSLiberté

  26. Breakdown of MI EventsSingle vs. Multiple Stents SINGLE STENT MULTIPLE STENTS P=0.0213 P=1.00 Patients (%) (n=6 ) (n=2) (n=3) (n=0) TAXUSExpress(N=67) TAXUSLiberté(N=126) TAXUSExpress(N=78) TAXUSLiberté(N=24)

  27. P=0.24 P=0.49 P=0.24 P=0.49 T. Express Control (N=75) T. Liberté 38mm (N=150) Stent Thrombosis to 9 MonthsNo ST Events with TAXUS Liberté Acute, Subacute(0-30 Days) Late(31-284 Days) Total ST(0-284 days) ProtocolDefinition Patients (%) (n=1) (n=1) ARC*Def/Prob Patients (%) (n=2) (n=2) *Academic Research Consortium

  28. TAXUS ATLAS Long LesionSummary • Efficacy Outcomes: • Primary endpoint of 9-month % DS (analysis segment) was met: • T. Liberté 38 mm non-inferior to T. Express Control • Safety Outcomes: • No cardiac death or stent thrombosis in TAXUS Liberté • Significantly reduced myocardial infarction rate in TAXUS Liberté compared to TAXUS Express, even in single stents • Procedural Observations: • Reduced procedural time and increased procedural success rate compared to TAXUS Express

  29. Primary endpoint met in both studies TAXUS ATLAS SV and LLOverall Summary Clinical Benefits: • SAFETY: Maintained or improved • Similarly low death, MI and ST rates for TAXUS Liberté 2.25mm compared to TAXUS Express • Significantly reduced MI for TAXUS Liberté Long (38mm) compared to TAXUS Express, with comparable death and ST • RESTENOSIS: Reduced • Late Loss, Binary Restenosis Reduced: • In TAXUS Liberté 2.25 mm compared to both BMS and TAXUS Express • TLR Reduced: In T. Liberté 2.25 compared to BMS and T. Express • DELIVERABILITY: Enhanced • Design improvements in TAXUS Liberté platform vs. TAXUS Express • Reduced procedure time

  30. Conclusions • The TAXUS ATLAS Small Vessel and Long Lesion studies demonstrate successful transfer of the paclitaxel technology to the next generation TAXUS Liberté stent. • The new TAXUS Liberté stent design leads to improved clinical outcomes in small vessels and long lesions compared to TAXUS Express.

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