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Gregg W. Stone, MD

TAXUS Landmark Analysis Impact of Long-Term Clopidogrel Usage on Death, Myocardial Infarction and Stent Thrombosis. Gregg W. Stone, MD Stephen G. Ellis, Antonio Colombo, David F. Kong, Mark I. Friedman, Donald S. Baim. Thienopyridine Landmark Study. JAMA. 2007 Jan 10;297(2):159-68.

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Gregg W. Stone, MD

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  1. TAXUS Landmark AnalysisImpact of Long-Term Clopidogrel Usage on Death, Myocardial Infarction and Stent Thrombosis Gregg W. Stone, MD Stephen G. Ellis, Antonio Colombo, David F. Kong, Mark I. Friedman, Donald S. Baim

  2. Thienopyridine Landmark Study JAMA. 2007 Jan 10;297(2):159-68. Thienopyridine Use >1yr May reduce death and MI in patients who have received drug-eluting stents. • Non-blinded, observational landmark study from uncontrolled registry data

  3. Objective • We performed a similar examination of TAXUS stent in the prospective, randomized, double-blind TAXUS trials.

  4. BMS (n=1030) TAXUS (n=1141) Analysis Design Patients free of Death, MI, TVR, or ARC ST* at 1-year (n=2171) OFF (T-)Thienopyridinen=583 ON (T+)Thienopyridinen=447 OFF (T-)Thienopyridinen=624 ON (T+)Thienopyridinen=517 Subsequent events tabulated (to 2 years and 5 years) *Academic Research Consortium (Cutlip et al., Circulation 115:2344)

  5. Baseline Results in TAXUS Patients

  6. Baseline Results in BMS Patients

  7. IndexProcedure 1y 2y P=0.82 P=0.51 PES (T+): 1.8% (9) PES (T-): 1.9% (12) BMS (T+): 2.5% (11) BMS (T-): 1.9% (11) Impact of Thienopyridine Use onDeath or MI to 2-Years 15% 10% Cumulative Event Rate 5% 0% Events After 1 Year(in patients death/MI/ST/TVR free at 1 year) 0-1 yr Events(all patients) Event Rate ± 1.5 SE, Log-Rank p value

  8. IndexProcedure 1y 2y 3y 4y 5y P=0.75 P=0.28 PES (T+): 8.3% (35) PES (T-): 9.8% (51) BMS (T+): 7.9% (25) BMS (T-): 9.2% (48) Impact of Thienopyridine Use onDeath or MI to 5-Years 15% 10% Cumulative Event Rate 5% 0% Events After 1 Year(in patients death/MI/ST/TVR free at 1 year) 0-1 yr Events(all patients) Event Rate ± 1.5 SE, Log-Rank p value

  9. IndexProcedure 1y 2y P=0.07 P=0.25 PES (T+): 0.0% (0) PES (T-): 0.7% (4) BMS (T+): 0.2% (1) BMS (T-): 0.0% (0) Impact of Thienopyridine Use onStent Thrombosis* to 2-Years 15% 10% Cumulative Event Rate 5% 0% Events After 1 Year(in patients death/MI/ST/TVR free at 1 year) 0-1 yr Events(All patients) Event Rate ± 1.5 SE, Log-Rank p value *ARC Definite/Probable

  10. IndexProcedure 1y 2y 3y 4y 5y P=0.43 P=0.59 PES (T+): 0.8% (4) PES (T-): 1.4% (8) BMS (T+): 0.2% (1) BMS (T-): 0.7% (3) Impact of Thienopyridine Use onStent Thrombosis* to 5-Years 15% 10% Cumulative Event Rate 5% 0% Events After 1 Year(in patients death/MI/ST/TVR free at 1 year) 0-1 yr Events(All patients) Event Rate ± 1.5 SE, Log-Rank p value *ARC Definite/Probable

  11. IndexProcedure 1y 2y P=0.82 P=0.51 PES (T+): 1.8% (9) PES (T-): 1.9% (12) BMS (T+): 2.5% (11) BMS (T-): 1.9% (11) Impact of Thienopyridine Use onDeath, MI, or Stent Thrombosis* to 2-Years 15% 10% Cumulative Event Rate 5% 0% Events After 1 Year(in patients death/MI/ST/TVR free at 1 year) 0-1 yr Events(All patients) Event Rate ± 1.5 SE, Log-Rank p value *ARC Definite/Probable

  12. IndexProcedure 1y 2y 3y 4y 5y P=0.75 P=0.28 PES (T+): 8.3% (35) PES (T-): 9.8% (51) BMS (T+): 7.9% (25) BMS (T-): 9.2% (48) Impact of Thienopyridine Use onDeath, MI, or Stent Thrombosis* to 5-Years 15% 10% Cumulative Event Rate 5% 0% Events After 1 Year(in patients death/MI/ST/TVR free at 1 year) 0-1 yr Events(All patients) Event Rate ± 1.5 SE, Log-Rank p value *ARC Definite/Probable

  13. Off Thienopyridine On Thienopyridine Thienopyridine Use and Stent Thrombosisin TAXUS-treated Patients Individual ST Patients (each bar represents 1 patient) (days to ST) OFFat1 Yr ONat1 Yr Procedure 1 Yr 2 Yrs 3 Yrs 4 Yrs 5 Yrs Time Post-Procedure

  14. Conclusions • Patients on thienopyridines at 1 year are more likely to remain on it at 5 years • Patients on thienopyridines at 1 year display a trend toward fewer safety events through 5 years – a trend that does not reach statistical significance • It is impossible to attribute any observed benefit to thienopyridine use itself (rather than to disease-specific factors) given the significant differences at baseline • Benefit in other high-risk groups not examined in this analysis cannot be excluded e.g. CTO, AMI, etc. • This analysis does not provide clear evidence for routinely extending thienopyridine usebeyond 1 year

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