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Sirolimus-eluting Stents: Present and Future

Sirolimus-eluting Stents: Present and Future. Dr Steve Fearn Director of Health Economics and Medical Affairs Cordis UK. Conflict of Interest. I am employed by Cordis. Topics. Update of Cypher in STEMI. Update of Cypher in diabetic patients. NEVO™ Sirolimus-eluting Stent. Cypher in STEMI.

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Sirolimus-eluting Stents: Present and Future

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  1. Sirolimus-eluting Stents:Present and Future Dr Steve Fearn Director of Health Economics and Medical Affairs Cordis UK

  2. Conflict of Interest • I am employed by Cordis.

  3. Topics • Update of Cypher in STEMI. • Update of Cypher in diabetic patients. • NEVO™ Sirolimus-eluting Stent.

  4. Cypher in STEMI

  5. Cypher in STEMI Dataset • Total of 10 RCTs, 3,639 patients. 9 trials, 2,769 patients

  6. Cypher in STEMI: All-cause Mortality to 12m p (overall effect) = 0.11 Heterogeneity (I2) = 0.0%, p = 0.78 RR = 0.76 (95% CI 0.53 to 1.08) Update of De Luca et al J Thromb Thrombolysis 2009 ; 28: 200-210

  7. Cypher in STEMI: Further MI to 12m p (overall effect) = 0.01 Heterogeneity (I2) = 0.0%, p = 1.00 RR = 0.65 (95% CI 0.47 to 0.92) Update of De Luca et al J Thromb Thrombolysis 2009 ; 28: 200-210

  8. Cypher in STEMI: Stent Thrombosis to 12m p (overall effect) = 0.42 Heterogeneity (I2) = 0.0%, p = 0.90 RR = 0.86 (95% CI 0.59 to 1.24) Note: Pasceri et al not shown, OR not estimable Update of De Luca et al J Thromb Thrombolysis 2009 ; 28: 200-210

  9. Cypher in STEMI: TVR to 12m p (overall effect) < 0.0001 Heterogeneity (I2) = 0.0%, p = 0.68 RR = 0.42 (95% CI 0.33 to 0.53) Update of De Luca et al J Thromb Thrombolysis 2009 ; 28: 200-210

  10. Cypher in Diabetic Patients

  11. 3-way Meta-analysis 1 x 3-way trial 153 diabetics BMS 16 trials 1,413 diabetics 8 trials 915 diabetics 35 Trials 3,852 diabetics 10,947 non-diabetics Restricted network 8 trials 800 patients Cypher Taxus 10 trials 1,371 diabetics Stettler et al BMJ 2008

  12. Cypher in Diabetes: All-cause Mortality Adapted from Stettler et al BMJ 2008

  13. Cypher in Diabetes: MI Adapted from Stettler et al BMJ 2008

  14. Cypher in Diabetes: ARC Definite Stent Thrombosis Adapted from Stettler et al BMJ 2008

  15. Cypher in Diabetes: TLR Adapted from Stettler et al BMJ 2008

  16. Cypher in Diabetes: TLR Adapted from Stettler et al BMJ 2008

  17. Cypher Summary • Cypher is safe and effective in STEMI and diabetic patients. • Further MI is reduced in STEMI patients treated with Cypher in year 1. • Trend to reduction in MI in diabetic patients. • TLR Treatment effect versus BMS is the same in diabetics and non-diabetics. Don’t assume any ‘...limus stent’ = a sirolimus stent

  18. NEVO™: Same Drug, New Technology • A sirolimus-eluting stent. • Reservoir technology. • 75% less polymer. • Polymer-free after ~90 days. • Cypher-like drug release profile and tissue content. • Flexible and conformable CoCr stent.

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