1 / 30

Prison II

Prison II. Randomised Trial of Sirolimus-Eluting and Bare Metal Stents in Patients with CTO. (Presented at TCT 2005 Suttorp and Laarmen, Nieuwegein and Amsterdam). MY CONFLICTS OF INTEREST ARE I have accepted support for the purpose of attending

aulii
Download Presentation

Prison II

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Prison II Randomised Trial of Sirolimus-Eluting and Bare Metal Stents in Patients with CTO (Presented at TCT 2005 Suttorp and Laarmen, Nieuwegein and Amsterdam)

  2. MY CONFLICTS OF INTEREST ARE I have accepted support for the purpose of attending professional educational meetings from Boston Scientific, Cordis, Medtronic and Guidant I am in receipt of research funding from Boston Scientific

  3. Background • Angiographic restenosis rates with bare metal stents in CTO : • 22% Prison I (POBA 33%) • 32% SICCO (POBA 74%)

  4. Methods • Single blind RCT, two centres • Randomised after crossing a CTO > 2 weeks old • Bx velocity vs. Cypher (n=200) • Primary end point • Binary Angiographic Restenosis at 6 months • Secondary end points • Clinical - MACE, TVF • Angiographic - MLD, late loss, % stenosis

  5. Results • Baseline characteristics well matched: • Mean age 59 years • Diabetics 13% • Single vessel disease 49% • Mean stent length 30 mm

  6. ResultsBinary angiographic restenosis 73% 85% 41 36 % 11 7

  7. ResultsSecondary End Points • Angiographic • Late loss +0.64 vs. -0.07 mm (p<0.001) • % stenosis 53.3% vs. 31.9% (p<0.001) • Clinical • MACE 20% vs. 4% • TLR 19% vs. 4% • Stent thrombosis 0% vs. 2%

  8. Conclusions • First RCT showing that DES reduce restenosis in CTO • Is CTO another indication for DES?

  9. ISAR TEST Randomised comparison of a polymer free sirolimus coated stent vs. polymer based paclitaxel coated stent (Taxus) Presented at TCT 2005 Kastrati et al. Munich

  10. Background Polymers may induce chronic inflammatory reaction causing: • delayed or incomplete re- endothelialization • stent thrombosis • restenosis

  11. Methods • Prospective RCT comparing a polymer-free sirolimus stent with the polymer-based paclitaxel (!) stent (Taxus Express2) • n =450 • Primary end point: in-stent late loss at 6 months - Powered to determine non-inferiority (not equivalence) with a margin of difference in late loss of 0.13 mm • Secondary end points: BAR & TLR at 6 months

  12. Stent Coating Machine and Stent with Microporous Surface before after

  13. Baseline Characteristics • Well matched • 43% unstable • Mean lesion length 12.8 mm • Mean vessel diameter 2.7 mm • 1.1 stents per case

  14. P = 0.98 P = 0.09 mm mm (in-stent) (in-segment) Results: Late Lumen Loss Polymer-Free Sirolimus Stent Polymer-Based Paclitaxel Stent

  15. Angiographic and ClinicalRestenosis Incidence, % Incidence, % P = 1 P = 0.73 (TLR) Polymer-Free Sirolimus Stent Polymer-Based Paclitaxel Stent

  16. Conclusion • The polymer-free sirolimus-eluting stent has an anti-restenotic effect that is not inferior to that of polymer-based paclitaxel-eluting stent.

  17. Interpretation • Early evidence of angiographic efficacy of non polymer ‘DIY’ sirolimus eluting stent • Clinical efficacy? • How important is the polymer ? • Results attributable to lack of polymer or different drug?

  18. ENDEAVOR III Prospective randomized comparison of Endeavor zotarolimus-eluting stent with Cypher sirolimus-eluting stent (Presented at TCT 2005 PIs David E. Kandzariand Martin B. Leon)

  19. ENDEAVOR III Hypothesis: Treatment with the Endeavor zotarolimus-eluting stent will be non-inferior compared with the Cypher sirolimus-eluting stent with respect to in-segment late lumen loss

  20. Head to Head Non Inferiority Trial

  21. ENDEAVOR III - Design 3:1 Randomization Single de novo native coronary lesion Vessel diameter: 2.5-3.5 mm Lesion length: 14-27 mm Stent lengths: 18-33 mm Endeavor Stent n=327 Cypher Stent n=109 436 patients 30 U.S. sites Io Endpoint: In-segment late loss at 8 months (powered for a margin of difference of 0.2 mm) 2o Endpoints: Angiographic binary restenosis at 8 months; Clinical TLR, TVR, TVF at 9 months

  22. Baseline Characteristics • Imbalanced for gender • 65% male Endeavor, 85% male Cypher (p<0.01) • Otherwise well balanced • Diabetes 29%, unstable 53%, • Procedure success • 99% Endeavor, 95% Cypher (p<0.002)

  23. Non-Inferiority Margin of Difference: 0.20 mm Observed Difference: 0.21 mm p = NS for non-inferiority, <0.001 for Cypher superiority Results: Primary End PointIn-segment Late Loss 0.21 mm (mm) 0.34 0.13

  24. 0.34±0.44 0.13±0.32 Distribution of Late Loss

  25. Angiographic End Points % mm Late Loss BinaryRestenosis

  26. Clinical End PointsTVF Free Survival to 270-days 88.5% 88. 0% P=0.923, log rank No difference in MACE, TVF, TLR, death…

  27. Conclusions • The non-inferiority primary endpoint of in-segment late loss was not met i.e. Endeavor was not not (= was) inferior to Cypher • No significant differences in 9 month clinical outcomes (TLR, MACE, TVR and TVF)

  28. Interpretation • “Endeavor angiographically inferior but clinically equivalent”? • Which is the better discriminator of restenosis propensity: angiographic late loss or clinical events ?

  29. “Late loss is more reliable than restenosis rates for discriminating restenosis propensity between new drug eluting stent platforms…” Circ 2005,112 2833

  30. BM En Ta Cy Circ 2005; 111: 3435

More Related