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3-Year Meta-Analysis of TAXUS Trials: Safety and Efficacy in 3,445 Patients

This meta-analysis study, conducted by Gregg W. Stone and colleagues, examines the safety and efficacy outcomes of TAXUS trials involving 3,445 randomized patients. The study evaluates the long-term efficacy and low frequency safety events of TAXUS stents compared to bare-metal stents, with a focus on stent thrombosis, freedom from cardiac death, and freedom from major adverse cardiovascular events over a 3-year period. The analysis also delves into the impact of vessel size, lesion length, and diabetic status on target lesion revascularization rates. Findings highlight the overall positive outcomes and effectiveness of TAXUS stents in the context of various patient subgroups over a 3-year follow-up period.

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3-Year Meta-Analysis of TAXUS Trials: Safety and Efficacy in 3,445 Patients

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  1. Updated 3-Year Meta-Analysis of the TAXUS Clinical TrialsSafety and Efficacy Demonstratedin 3,445 Randomized Patients Gregg W. Stone, MD Columbia University Medical Center The Cardiovascular Research Foundation

  2. Conflict of Interest Disclosure The following relationships exist related to this presentation: • Consultant/Advisory Board (Boston Scientific)

  3. 20.6 2.79 17.2 2.69 13.4 2.75 10.5 2.75 TAXUS II, IV, V, VI: N=3,445

  4. TAXUS II, IV, V, VI: N=3,445 N/A

  5. All Patients(n=3445) TAXUS(n=1718) Control(n=1727) Analysis of All Pts, TAXUS II, IV, V, VI

  6. Baseline CharacteristicsOverall Population, TAXUS II, IV, V, VI

  7. 1 yr 2 yr 3 yr 9m ACC’05 TCT’05 TAXUS Trials Meta-Analysis: FU Duration

  8. 3445 intent-to-treat patients overall 1727 bare metal Express vs. 1718 TAXUS Express 2289with 2-year follow-up 1843with 3-year follow-up 2627 pts with angiographic follow-up 1040 pts with IVUS follow-up Long-Term Efficacy Low Frequency Safety Events Overall Subgroups TAXUS Meta-Analysis

  9. 9m 12m 6m 2 yr 3 yr ControlN = 1727 TAXUSN = 1718 Stent Thrombosis out to 3-YearsOverall Population, TAXUS II, IV, V, VI 100% 90% 80% Freedom from Stent Thrombosis 0 100 200 300 400 500 600 700 800 900 1000 1095 Days Since Index Procedure

  10. 9m 12m 6m 2 yr 3 yr 99.2% (C) 98.7% (T) p = 0.36 ControlN = 1727 TAXUSN = 1718 Stent Thrombosis out to 3-YearsOverall Population, TAXUS II, IV, V, VI 100% 90% 80% Stent Thrombosis Between 2 and 3 Years N=1 Control N=0 TAXUS Stent Thrombosis Between 6 Mo and 2 Yrs N=0 Control N=8 TAXUS Freedom from Stent Thrombosis 0 100 200 300 400 500 600 700 800 900 1000 1095 Days Since Index Procedure

  11. 9m 12m 6m 2 yr 3 yr ControlN = 1727 TAXUSN = 1718 3-Year Freedom from Cardiac DeathOverall Population, TAXUS II, IV, V, VI 98.0% (C) 100% 90% 80% 70% 97.9% (T) P=0.81 Freedom from Cardiac Death 0 100 200 300 400 500 600 700 800 900 1000 1095 Days Since Index Procedure

  12. 9m 12m 6m 2 yr 3 yr ControlN = 1727 TAXUSN = 1718 3-Year Freedom from Any DeathOverall Population, TAXUS II, IV, V, VI 100% 90% 80% 70% 60% 95.7% (C) 95.4% (T) p=0.89 Freedom from Any Death 0 100 200 300 400 500 600 700 800 900 1000 1095 Days Since Index Procedure

  13. 9m 12m 2 yr 3 yr ControlN = 1727 TAXUSN = 1718 0 100 200 300 400 500 600 700 800 900 1000 1095 3-Year Freedom from MIOverall Population, TAXUS II, IV, V, VI 100% 90% 80% 70% 60% 93.6% (C) 93.4% (T) p=0.96 Freedom from MI Days Since Index Procedure

  14. 9m 12m 2 yr 3 yr Δ9.1% Δ10.5% ControlN = 1727 TAXUSN = 1718 0 100 200 300 400 500 600 700 800 900 1000 1095 3-Year Freedom from TLROverall Population, TAXUS II, IV, V, VI 100% 90% 80% 70% 60% 90.6% (T) Freedom from TLR 80.1% (C) p<0.0001 Days Since Index Procedure

  15. p<0.0001 p<0.0001 59% 69% % Binary Restenosis at 6-9 MonthsAll Patients, TAXUS II, IV, V, VI (N=3,445) TAXUS (n=1718) Control (n=1727) Patients (%) 338/1227 105/1247 368/1229 154/1249 In-Stent Analysis Segment

  16. 9m 12m 2 yr 3 yr Control TAXUS P<0.0001 RVD≤2.5 P<0.0001 RVD2.5≤3.0 P=0.0001 RVD >3.0 0 100 200 300 400 500 600 700 800 900 1000 1095 Effect of Vessel Size on 3-Year TLR TAXUS II, IV, V, VI MetaAnalysis 100% 90% 80% 70% 60% >3.0 2.5-3.0 ≤2.5 >3.0 2.5-3.0 Freedom from TLR ≤2.5 Days Since Index Procedure

  17. 9m 12m 2 yr 3 yr Control TAXUS P<0.0001 <18mm P=0.0006 18-26mm P=0.002 >26mm 0 100 200 300 400 500 600 700 800 900 1000 1095 Effect of Lesion Length on 3-Year TLR TAXUS II, IV, V, VI MetaAnalysis 100% 90% 80% 70% 60% <18 18-26 >26 18-26 <18 Freedom from TLR >26 Days Since Index Procedure

  18. Effect of Vessel Size and Lesion Length on 3-Year TLR Control TAXUS RVD in terciles (mm) 3-Year TLR (%) ≤2.5 >2.5<3.0 ≥3.0 <11 <11 ≥17 ≥17 ≥11≤17 ≥11≤17 Lesion Length in terciles (mm)

  19. 9m 12m 2 yr 3 yr 0 100 200 300 400 500 600 700 800 900 1000 1095 Effect of Diabetic Status on 3-year TLRTAXUS II, IV, V, VI MetaAnalysis 100% 90% 80% 70% 60% NonD Diab NonD Freedom from TLR Diab Control TAXUS P<0.0001 Non-Diabetic P<0.0001 Diabetic Days Since Index Procedure

  20. TAXUS Control p<0.0001 p<0.0001 p=0.005 53% 52% 61% Effect of Diabetic Status on 3-year TLR TAXUS II, IV, V, VI MetaAnalysis 3-Year TLR (%) N= 1312 1319 279 279 136 120 Diabetic (Oral Agents) Diabetic (Insulin-Requiring) Non-Diabetic

  21. Single vs. Multiple StentsTAXUS II, IV, V, VI Meta-Analysis Single Stents(n=2740) Control(n=1378) TAXUS(n=1362) All Patients Multiple Stents(n=684) Control(n=336) TAXUS(n=348)

  22. Baseline CharacteristicsMultiple Stent Patients, TAXUS II, IV, V, VI

  23. p=1.00 p=1.00 p=0.015 p=0.027 p=1.00 p=1.00 MACE, Cumulative to 30 DaysMultiple Stent Patients, TAXUS II, IV, V, VI TAXUS (n=348) Control (n=336) Adverse events (%) Cardiac Death Q-Wave MI Non-Q Wave MI MACE All Death ST

  24. p=0.67 p=0.49 p=0.21 p=0.0002 p=0.03 p=0.51 MACE, Cumulative to 3 YearsMultiple Stent Patients, TAXUS II, IV, V, VI TAXUS (n=348) Control (n=336) Adverse events (%) Cardiac Death Q-Wave MI Non-Q Wave MI MACE All Death ST

  25. 9m 12m 2 yr 3 yr ControlN = 336 TAXUSN = 348 0 100 200 300 400 500 600 700 800 900 1000 1095 3-Year Freedom from Cardiac DeathMultiple Stent Patients, TAXUS II, IV, V, VI 100% 90% 80% 70% 60% 99.1% (T) 98.4% (C) p=0.67 Freedom from cardiac death Days Since Index Procedure

  26. 9m 12m 2 yr 3 yr ControlN = 336 TAXUSN = 348 0 100 200 300 400 500 600 700 800 900 1000 1095 3-Year Freedom from MIMultiple Stent Patients, TAXUS II, IV, V, VI 100% 90% 80% 70% 60% 90.0% (T) Freedom from MI 88.3% (C) p=0.40 Days Since Index Procedure

  27. 9m 12m 2 yr 3 yr Δ16.6% Δ19.9% ControlN = 336 TAXUSN = 348 0 100 200 300 400 500 600 700 800 900 1000 1095 3-Year Freedom from TLRMultiple Stent Patients, TAXUS II, IV, V, VI 100% 90% 80% 70% 60% 88.5% (T) p<0.0001 Freedom from TLR 68.6% (C) Days Since Index Procedure

  28. TLR up to 3-Years: Subgroup SummaryAll Pts, TAXUS II, IV, V, VI Meta-analysis HR [95% CI] 0 0.5 1.0 1.5

  29. SummaryTAXUS II, IV, V, VI Meta-Analysis to 3-Years • Overall safety with the TAXUS stent to 3-years has been demonstrated • No increased risk of early stent thrombosis • Stent thrombosis rates at 3 years are comparable with control • Increased late ST between 6 mos and 2 yrs seen (8 TAXUS vs. 0 control) – but 0 stent thrombosis with TAXUS between 2 and 3 years (vs. 1 case with control) • Comparable rates of all cause death, cardiac death, and MI with TAXUS and control • Marked reduction in TLR with TAXUS compared to control for 3 years with no late catch-up apparent

  30. SummaryTAXUS II, IV, V, VI Meta-Analysis to 3-Years • Subgroups • Significant benefit in all patient groups stratified by vessel size, lesion length and diabetic status; increasedabsolutebenefit in higher risk cohorts • Multiple stent group • Increase peri-procedural non-Q MI in TAXUS pts • 3-year results demonstrate similar rates of cardiac death and MI, and a marked reduction in TLRand binary restenosis

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