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TAXUS Landmark Analysis Impact of Long-Term Clopidogrel Usage on Death, Myocardial Infarction and Stent Thrombosis Gregg W. Stone, MD Stephen G. Ellis,

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Presentation on theme: "TAXUS Landmark Analysis Impact of Long-Term Clopidogrel Usage on Death, Myocardial Infarction and Stent Thrombosis Gregg W. Stone, MD Stephen G. Ellis,"— Presentation transcript:

1 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 Gregg W. Stone, MD Stephen G. Ellis, Antonio Colombo, David F. Kong, Mark I. Friedman, Donald S. Baim

2 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 2 TCT – October 23, 2007 – Late Breaking Trial Conflict of Interest Disclosures Study and presentation supported by Boston Scientific Corporation Moderate (M; US$10,000) sources of support are indicated. Gregg W. Stone Research Support (S): Boston Scientific Stephen G. Ellis Consultant/Advisory Board (M): Cordis, BSC, Abbot Vascular Other research support (M): Centocor David F. Kong Research grant: AHRQ, Procter and Gamble, Terumo Corporation, International Machines (IBM) (S) Speakers Bureau: Novartis (M) Consultant: Allmed Healthcare Mgmt (M) Antonio Colombo None Mark Friedman Ownership interest: Biogen Idec, BSC (M) Employment: BSC (S) Donald S. Baim Ownership interest: Biogen Idec, BSC (S) Employment: BSC (S)

3 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 3 TCT – October 23, 2007 – Late Breaking Trial Thienopyridine Landmark Study JAMA. 2007 Jan 10;297(2):159-68. Non-blinded, observational landmark study from uncontrolled registry data Thienopyridine Use >1yr May reduce death and MI in patients who have received drug-eluting stents.

4 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 4 TCT – October 23, 2007 – Late Breaking Trial Reduced 2-Year Death or MI Rates in DES Patients on Clopidogrel at 6-Months

5 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 5 TCT – October 23, 2007 – Late Breaking Trial Objective We performed a similar examination of TAXUS stent in the prospective, randomized, double- blind TAXUS trials.

6 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 6 TCT – October 23, 2007 – Late Breaking Trial Analysis Design Patients free of Death, MI, TVR, or ARC ST* at 1-year (n=2171) ON (T+) Thienopyridine n=447 ON (T+) Thienopyridine n=517 OFF (T-) Thienopyridine n=624 OFF (T-) Thienopyridine n=583 Subsequent events tabulated (to 2 years and 5 years) BMS (n=1030)TAXUS (n=1141) *Academic Research Consortium (Cutlip et al., Circulation 115:2344)

7 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 7 TCT – October 23, 2007 – Late Breaking Trial TAXUS Landmark Analysis Individual Trial Characteristics Stent PlatformNIRxExpress ITT Patients266 (SR only)13141156 Primary Endpoint % net volume obstruction (6m) TVR (9m) RVD3.0 - 3.52.5 - 3.752.25 - 4.0 Lesion Length10 - 1210 - 2810 - 46 Max. Planned Stents122 Latest Available Follow-up 5 Years 3 Years

8 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 8 TCT – October 23, 2007 – Late Breaking Trial Baseline Results in TAXUS Patients OFF (n=624)ON (n=517)P Value Age (years) 63.1±10.962.3±11.2 0.21 Male, % (n) 71.0 (443)73.1 (378) 0.47 Diabetic, % (n) 19.9 (124)29.4 (152) 0.0002 Insulin-requiring, % (n) 5.4 (34)7.9 (41) 0.09 Current Smoker, % (n) 22.6 (141)21.5 (111) 0.67 Total # of Stents 1.1±0.41.3±0.5 <0.0001 Total Stent Length (mm) 22.0±9.425.4±11.8 <0.0001 RVD (mm) 2.75±0.502.7±0.5 0.75 Lesion Length (mm) 13.7±7.015.5±8.0 0.0001 MLD (mm) 0.9±0.30.9±0.4 0.44 Diameter Stenosis (%) 66.8±10.67.4±11.3 0.34

9 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 9 TCT – October 23, 2007 – Late Breaking Trial Baseline Results in BMS Patients OFF (n=583)ON (n=447)P Value Age (years) 61.8±10.862.5±10.4 0.29 Male, % (n) 71.5 (417)73.2 (327)0.58 Diabetic, % (n) 23.2 (135)26.2 (117)0.27 Insulin-requiring, % (n) 8.2 (48)6.5 (29)0.34 Current Smoker, % (n) 21.4 (125)20.1 (90)0.64 Total # of Stents 1.1±0.41.2±0.5 0.03 Total Stent Length (mm) 21.6±9.224.5±11.4 <0.0001 RVD (mm) 2.78±0.512.73±0.51 0.08 Lesion Length (mm) 13.9±7.015.0±8.3 0.02 MLD (mm) 0.9±0.4 0.13 Diameter Stenosis (%) 66.2±10.966.9±11.70.33

10 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 10 TCT – October 23, 2007 – Late Breaking Trial Thienopyridine Use to 5 Years BMS (T+): 56.5% % Patients PES (T+) PES (T-) BMS (T+) BMS (T-) PES (T+): 56.9% 5-Years BMS (T-): 15.7% PES (T-): 14.7% ON Thienopyridine at 1 Year OFF Thienopyridine at 1 Year

11 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 11 TCT – October 23, 2007 – Late Breaking Trial Impact of Thienopyridine Use on All-cause Death to 2-Years Events After 1 Year (in patients death/MI/ST/TVR free at 1 year) 5% 0% 10% Cumulative Event Rate Event Rate ± 1.5 SE, Log-Rank p value 15%2y1y Index Procedure 0-1 yr Events (all patients) PES (T+):1.4% (7) PES (T-): 0.6% (4) BMS (T+):2.0% (9) BMS (T-):1.4% (8) P=0.22 P=0.41

12 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 12 TCT – October 23, 2007 – Late Breaking Trial Impact of Thienopyridine Use on All-cause Death to 5-Years Events After 1 Year (in patients death/MI/ST/TVR free at 1 year) 5% 0% 10% Cumulative Event Rate Event Rate ± 1.5 SE, Log-Rank p value 15%2y3y4y5y1y Index Procedure 0-1 yr Events (all patients) PES (T+):6.0% (25) PES (T-): 7.4% (37) BMS (T+):6.9% (21) BMS (T-):6.6% (35) P=0.83 P=0.67

13 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 13 TCT – October 23, 2007 – Late Breaking Trial Impact of Thienopyridine Use on Death or MI to 2-Years Events After 1 Year (in patients death/MI/ST/TVR free at 1 year) 5% 0% 10% Cumulative Event Rate Event Rate ± 1.5 SE, Log-Rank p value 15%2y1y Index Procedure 0-1 yr Events (all patients) PES (T+):1.8% (9) PES (T-): 1.9% (12) BMS (T+):2.5% (11) BMS (T-):1.9% (11) P=0.82 P=0.51

14 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 14 TCT – October 23, 2007 – Late Breaking Trial Impact of Thienopyridine Use on Death or MI to 5-Years Events After 1 Year (in patients death/MI/ST/TVR free at 1 year) 5% 0% 10% Cumulative Event Rate Event Rate ± 1.5 SE, Log-Rank p value 15%2y3y4y5y1y Index Procedure 0-1 yr Events (all patients) PES (T+):8.3% (35) PES (T-): 9.8% (51) BMS (T+):7.9% (25) BMS (T-):9.2% (48) P=0.75 P=0.28

15 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 15 TCT – October 23, 2007 – Late Breaking Trial Impact of Thienopyridine Use on Stent Thrombosis* to 2-Years Events After 1 Year (in patients death/MI/ST/TVR free at 1 year) 5% 0% 10% Cumulative Event Rate Event Rate ± 1.5 SE, Log-Rank p value 15%2y1y Index Procedure 0-1 yr Events (All patients) *ARC Definite/Probable PES (T+):0.0% (0) PES (T-): 0.7% (4) BMS (T+):0.2% (1) BMS (T-):0.0% (0) P=0.07 P=0.25

16 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 16 TCT – October 23, 2007 – Late Breaking Trial Impact of Thienopyridine Use on Stent Thrombosis* to 5-Years Events After 1 Year (in patients death/MI/ST/TVR free at 1 year) 5% 0% 10% Cumulative Event Rate Event Rate ± 1.5 SE, Log-Rank p value 15%2y3y4y5y1y Index Procedure 0-1 yr Events (All patients) *ARC Definite/Probable PES (T+):0.8% (4) PES (T-): 1.4% (8) BMS (T+):0.2% (1) BMS (T-):0.7% (3) P=0.43 P=0.59

17 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 17 TCT – October 23, 2007 – Late Breaking Trial Impact of Thienopyridine Use on Death, MI, or Stent Thrombosis* to 2-Years Events After 1 Year (in patients death/MI/ST/TVR free at 1 year) 5% 0% 10% Cumulative Event Rate Event Rate ± 1.5 SE, Log-Rank p value 15%2y1y Index Procedure 0-1 yr Events (All patients) *ARC Definite/Probable PES (T+):1.8% (9) PES (T-): 1.9% (12) BMS (T+):2.5% (11) BMS (T-):1.9% (11) P=0.82 P=0.51

18 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 18 TCT – October 23, 2007 – Late Breaking Trial Impact of Thienopyridine Use on Death, MI, or Stent Thrombosis* to 5-Years Events After 1 Year (in patients death/MI/ST/TVR free at 1 year) 5% 0% 10% Cumulative Event Rate Event Rate ± 1.5 SE, Log-Rank p value 15%2y3y4y5y1y Index Procedure 0-1 yr Events (All patients) *ARC Definite/Probable PES (T+):8.3% (35) PES (T-): 9.8% (51) BMS (T+):7.9% (25) BMS (T-):9.2% (48) P=0.75 P=0.28

19 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 19 TCT – October 23, 2007 – Late Breaking Trial Summary Rate, % (n)P Values HR [95% CI]T+T- Treat- ment Inter- action 2-YEAR EVENTS Death PES0.47 [0.14, 1.61] 1.4% (7)0.6% (4)0.22 0.66 BMS0.67 [0.26, 1.74] 2.0% (9)1.4% (8)0.41 Death or MI PES1.11 [0.47, 2.63] 1.8% (9)1.9% (12)0.82 0.53 BMS0.76 [0.33, 1.74] 2.5% (11)1.9% (11)0.51 ST PES N/A0.0% (0)0.7% (4)0.07 N/A BMS N/A0.2% (1)0.0% (0)0.25 Death, MI, or ST PES 1.11 [0.47, 2.63]1.8% (9)1.9% (12)0.82 0.53 BMS 0.76 [0.33, 1.74]2.5% (11)1.9% (11)0.51 5-YEAR EVENTS Death PES 1.06 [0.63, 1.76]6.0% (25)7.4% (37)0.83 0.94 BMS 1.13 [0.66, 1.94]6.9% (21)6.6% (35)0.66 Death or MI PES 1.07 [0.70, 1.65]8.3% (35)9.8% (51)0.75 0.58 BMS 1.31 [0.80, 2.12]7.9% (25)9.2% (48)0.28 ST PES 1.61 [0.49, 5.36]0.8% (4)1.4% (8)0.43 0.81 BMS 1.84 [0.19, 17.84]0.2% (1)0.7% (3)0.59 Death, MI, or ST PES 1.07 [0.70, 1.65]8.3% (35)9.8% (51)0.75 0.58 BMS 1.31 [0.80, 2.12]7.9% (25)9.2% (48)0.28 1.0 (Log-rank) (Cox model) T+ Worse T+ Better

20 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 20 TCT – October 23, 2007 – Late Breaking Trial Thienopyridine Use and Stent Thrombosis in TAXUS-treated Patients Time Post-Procedure 1 Yr2 Yrs3 Yrs4 Yrs5 Yrs Individual ST Patients (each bar represents 1 patient) Procedure Off Thienopyridine On Thienopyridine ON at 1 Yr OFF at 1 Yr (days to ST)

21 TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 21 TCT – October 23, 2007 – Late Breaking Trial 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 use beyond 1 year

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