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Gregg W. Stone MD

Outcomes of the Polymer-based, Paclitaxel-eluting TAXUS Stent in Complex Lesions Principal Clinical and Angiographic Results from the TAXUS-V Pivotal Randomized Trial. Gregg W. Stone MD

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Gregg W. Stone MD

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  1. Outcomes of the Polymer-based, Paclitaxel-eluting TAXUS Stent in Complex LesionsPrincipal Clinical and Angiographic Results from the TAXUS-V Pivotal Randomized Trial Gregg W. Stone MD Stephen G. Ellis, Louis Cannon, Joel D. Greenberg, J. Tift Mann, Douglas Spriggs, Samuel DeMaio, Charles D. O'Shaughnessy, Patrick Hall, Eric Powers, Vasudeva Goli, Dean J. Kereiakes, Jeffrey J. Popma, Mary E. Russell

  2. TAXUS-IV and -V Comparison

  3. Study Organization

  4. Study Organization

  5. Top 20 Enrollers

  6. Randomized(n=1172) De-registered* (n=7) De-registered* (n=9) Intent-to-Treat(n=1156) TAXUS(n=577) 9-month Clinical F/U (n=1088; 94.1%) 9-month Angio F/U (n=990; 85.6%) TAXUS (n=540) TAXUS (n=498) Patient Flow *No study stent attempted Control(n=579) Control(n=548) Control(n=492)

  7. Navigating TAXUS-V • Overall results • Clinical and Angiographic Endpoints • Safety and Efficacy • “New” Subgroups • 2.25 mm Stents • 4.0 mm Stents • Multiple Stents

  8. Key Baseline Characteristics

  9. TAXUS (n=577) Control (n=579) p=0.33 p=0.71 p=0.60 p=0.87 p=0.06 p=0.50 Number of Implanted Study Stents Patients (%) None 1 stent 2 stents 3 stents 4 stents 5 stents

  10. Procedural Characteristics

  11. TAXUS (n=577) Control (n=579) p=0.38 p=0.25 p=0.37 N/A p=0.36 30-Day MACE Patients (%) 0/576 0/569 1/576 3/569 19/576 25/569 4/576 7/569 21/576 29/569 Cardiac Death Q-Wave MI Non-Q Wave MI TVR MACE

  12. TAXUS (n=577) Control (n=579) Freedom from TLR at 9 Months 100% 95% 90% 85% 80% 75% 91.4% Freedom from TLR Control P=0.0002 TAXUS 84.2% 0 30 60 90 120 150 180 210 240 270 300 Days

  13. TAXUS (n=577) Control (n=579) p=0.018 p=0.67 9-Month TVR and TLR p=0.0003 Patients (%) 89/567 48/560 24/567 27/560 98/567 68/560 TLR TVR-Remote TVR

  14. TAXUS (n=577) Control (n=579) p=0.73 p=0.37 p=0.78 p=0.018 p=0.008 9-Month MACE Patients (%) 5/567 3/560 1/567 3/560 25/567 27/560 98/567 68/560 120/567 84/560 Cardiac Death Q-Wave MI Non-Q Wave MI TVR MACE All Death: 1.4% (n=8) Control; 1.3% (n=7) TAXUS

  15. Stent Thrombosis 0.7% (n=4 pts) P=1.00 0.7%* (n=4 pts, 5 episodes) Stent thrombosis, % *One patient had 2 stent thromboses

  16. TAXUS (n=577) Control (n=579) p=0.53 p<0.0001 p=0.004 p<0.0001 Late Loss at 9 Months (Paired) 0.90 ±0.62 Late Loss (mm) 0.60 ±0.59 0.49 ±0.61 0.33 ±0.54 0.28 ±0.47 0.26 ±0.51 0.18 ±0.40 0.10 ±0.38 n= 456 447 492 494 476 475 492 495 Proximal Edge In-Stent Distal Edge Analysis Segment

  17. TAXUS (n=577) Control (n=579) p=0.29 p<0.0001 p=0.38 p<0.0001 Binary Restenosis at 9 Months 33.9 Patients (%) 18.9 19/458 26/453 157/492 68/496 13/477 8/477 167/492 94/497 Proximal Edge In-Stent Distal Edge Analysis Segment

  18. TAXUS (n=498) Control (n=492) p=0.25 P<0.0001 P<0.0001 p=1.00 In-Stent Restenosis Pattern 37 (7.4%) 16 (3.2%) 12 (2.4%) 3 (0.6%) Patients (%) 16 (3.3%) 27 (5.5%) 28 (5.7%) 86 (17.5%) Focal Diffuse Proliferative Total 17.9 ± 8.7 mm Control 11.0 ± 6.2 mm TAXUS ISR length: p<0.0001

  19. p<0.0001 IVUS% In-Stent Net Volume Obstruction Control TAXUS 31.8 ±15.1 % 13.1 ±12.0 N=135 N=149

  20. Baseline Characteristics2.25 mm Stent Subgroup (n=203)

  21. TAXUS (n=108) Control (n=95) p=0.03 p=0.16 p=1.00 9-Month TLR and TVR2.25 mm Stent Subgroup (n=203) Patients (%) 89/567 48/560 24/567 27/560 98/567 68/560 TLR TVR-Remote TVR

  22. TAXUS (n=108) Control (n=95) p=1.00 p=1.00 p=0.45 p=1.00 p=0.23 p=1.00 9-Month Safety Summary2.25mm Stent Subgroup (n=203) Patients (%) 1/93 2/106 0/93 1/106 2/93 5/106 25/93 20/106 2/94 2/95 1/92 1/104 All Death Cardiac Death Q-Wave MI Non-Q Wave MI MACE Stent Thrombosis

  23. TAXUS (n=93) Control (n=85) p<0.0001 p=0.004 p=0.007 p=0.01 9-Month Angiography2.25 mm Stent Subgroup (n=203) 0.90 ±0.63 0.61 ±0.59 0.49 ±0.61 0.36 ±0.53 85 93 85 93 38/85 23/93 42/85 29/93 In-stent In-Segment In-stent In-Segment Late Loss Binary Restenosis

  24. Baseline Characteristics4.0 mm Stent Subgroup (n=202)

  25. TAXUS (n=99) Control (n=103) p=0.06 p=1.00 p=0.38 9-Month TLR and TVR 4.00 mm Stent Subgroup (n=202) Patients (%) 5/101 0/93 4/101 4/93 8/101 4/93 TLR TVR-Remote TVR

  26. TAXUS (n=99) Control (n=103) N/A N/A p=1.00 p=0.07 p=0.50 p=1.00 9-Month Safety Summary4.00 mm Stent Subgroup (n=202) Patients (%) 1/101 0/93 0/101 0/93 6/101 3/93 15/101 6/93 2/101 1/94 0/100 0/93 All Death Cardiac Death Q-Wave MI Non-Q Wave MI MACE Stent Thrombosis

  27. TAXUS (n=86) Control (n=90) p<0.0001 p<0.0001 p=0.005 p=0.016 9-Month Angiography4.00 mm Stent Subgroup (n=202) 0.87 ±0.60 0.54 ±0.57 0.42 ±0.47 0.22 ±0.40 90 86 90 86 13/90 3/86 13/90 2/86 In-stent In-Segment In-stent In-Segment Late Loss Binary Restenosis

  28. Multiple Overlap Stents in TAXUS V All Patients (n=1156) Received no stents (n=8) Single Stents (n=769) Planned multiple stents (n=281) Multiple Stents in Target Vessel (n=379) Bailout multiple stents (n=98) No overlap (n=53) Planned multiple stents (n=248) QCA-confirmed Overlapping Stents (n=326) Bailoutmultiple stents (n=78)

  29. Baseline CharacteristicsMultiple Stent Subgroup (n=379)

  30. 30 Day MACEMultiple Stent Subgroup (n=379)

  31. Side Branch Analysis in Multiple Stenting Core Laboratory Analysis (blinded) Per Patient

  32. TAXUS (n=285) Control (n=263) 12.9% 12.9% 10.3% 3.8% 1.5% 22.1% 20.7% 15.1% 6.3% 2.5% p=0.05 p=0.02 p=0.10 p=0.24 p=0.55 After First Stent After Additional Stent(s) After Pre- Dilatation Baseline Final Side Branch Analysis in Multiple StentingTIMI Flow : Timing, Any Time Point Timeline

  33. TAXUS (n=195) Control (n=184) p=0.0003 p=1.00 p=0.002 9-Month TLR and TVR Multiple Stent Subgroup (n=379) Patients (%) 51/181 24/191 11/181 11/191 54/181 31/191 TLR TVR-Remote TVR

  34. TAXUS (n=195) Control (n=184) p=0.01 p=0.68 p=1.00 p=0.18 p=0.50 p=1.00 9-Month Safety SummaryMultiple Stent Subgroup (n=379) Patients (%) 1/181 1/191 0/181 2/191 7/181 14/191 58/181 39/191 3/182 2/190 1/180 2/190 All Death Cardiac Death Q-Wave MI Non-Q Wave MI MACE Stent Thrombosis

  35. TAXUS (n=173) Control (n=161) p<0.0001 p<0.0001 p<0.0001 p<0.0001 9-Month AngiographyMultiple Stent Subgroup (n=379) 1.17 ±0.61 0.85 ±0.62 0.60 ±0.67 0.45 ±0.61 92/161 31/173 93/161 47/173 161 173 161 173 In-stent In-Segment In-stent In-Segment Late Loss Binary Restenosis

  36. Conclusions I • TAXUS V represents the most complex patient and lesion cohort yet subjected to a blinded, randomized controlled DES trial • In this complex patient population, the slow-release, polymer-based paclitaxel-eluting TAXUS stent compared to an identical bare metal stent: • Was safe, with overall similar rates of death, MI and stent thrombosis at 30 days and 9 months • Was highly effective, with marked reductions in clinical and angiographic restenosis, though angiographic late loss and TLR rates were higher than previously noted in less complex lesions

  37. Conclusions II: Subsets • The 2.25 mm TAXUS stent  reduced TLR and restenosis rates • The 4.0 mm TAXUS stent  marked  in angiographic restenosis with a strong trend toward reduced TLR • Multiple TAXUS stents  • Statistically significant increase in peri-procedural MACE due to greater myonecrosis from side branch narrowing with decreased flow • No differences in death, cardiac death or stent thrombosis • Marked  in clinical and angiographic restenosis

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