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My conflicts of interest are…

Cypher in AMI Summary of Trial Evidence Dr Steve Fearn Director of Health Economics and Medical Affairs Cordis UK. My conflicts of interest are…. I am employed by Cordis I hold J&J stock. Approved indications. Cypher has a specific CE mark for use in AMI. Also: De novo lesions

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My conflicts of interest are…

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  1. Cypher in AMISummary of Trial EvidenceDr Steve FearnDirector of Health Economics and Medical AffairsCordis UK

  2. My conflicts of interest are… • I am employed by Cordis • I hold J&J stock

  3. Approved indications • Cypher has a specific CE mark for use in AMI. • Also: • De novo lesions • In-stent restenosis • Small vessels (to 2.25mm) • Diabetes • Multivessel disease • Bifurcations • CTO • Infrapopliteal lesions

  4. Important Questions • Is Cypher safe in AMI patients • Death, further MI, stent thrombosis? • Does Cypher reduce the rate of repeat revascularisation? • What about the longer-term? • What about cost-effectiveness

  5. Abstracts Detailed summary data on 2,381 patients randomised to BMS or Cypher Most Recent Data Synthesis Kastrati et al EHJ 2007;28:2706-13

  6. Cypher-specific Trials

  7. Cypher in AMI: All-cause Mortality

  8. p (overall effect) = 0.27 Heterogeneity (I2) = 0.0% RR = 0.78 (95% CI 0.50 to 1.22) Cypher in AMI: All-cause Mortality

  9. Cypher in AMI: Further MI

  10. p (overall effect) = 0.14 Heterogeneity (I2) = 0.0% RR = 0.72 (95% CI 0.47 to 1.11) Cypher in AMI: Further MI

  11. def+prob def+prob protocol def protocol def Cypher in AMI: Stent Thrombosis

  12. p (overall effect) = 0.35 Heterogeneity (I2) = 0.0% RR = 0.79 (95% CI 0.49 to 1.29) Cypher in AMI: Stent Thrombosis

  13. Cypher in AMI: TVR

  14. p (overall effect) = <0.001 Heterogeneity (I2) = 0.0% RR = 0.37 (95% CI 0.27 to 0.49) Cypher in AMI: TVR

  15. Longer-term

  16. STRATEGY at 2 Years P = 0.01 P = 0.66 N = 175 P = 0.77 P = 0.37 P = 1.00 Valgimigli et al JACC 2007;50:138-45

  17. TYPHOON @ 3 Years N = 712 Spaulding PCR 2008

  18. Cost-effectiveness • Cypher AMI data into economic model that closely reproduces NICE’s results. • Additional procedural cost of using Cypher = £471. • Costs saved by avoiding adverse events = £435. • 12m incremental cost of using Cypher = £ 36 (a) • QALYs gained = 0.00691 (b) • Incremental cost per QALY gained (a/b) = £5,281 • (PPCI with BMS vs thrombolysis = £9,241)

  19. Summary • Death, MI, Stent thrombosis: • No significant differences between Cypher & BMS. • TVR: • Statistically significant 63% risk reduction. • Longer-term: • Consistent with 12m conclusions. • Cost-effective against NICE thresholds.

  20. Back Up

  21. Meta-analysis Key Results: All DES Kastrati et al EHJ 2007;28:2706-13

  22. OR = A/B C/D RR = A/(A+B) C/(C+D) Odds Ratio or Relative Risk?

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