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Four Drug Eluting Stent Trials

Four Drug Eluting Stent Trials. Keith D Dawkins MD FRCP FACC Southampton University Hospital. The Trials. Endeavour I (TCT 2003) Driver + ABT 578 (Medtronic) Future II (TCT 2003) S-Stent + Everolimus (Guidant) New Sirius (AHA 2003) Bx Velocity + Sirolimus (Cordis/J&J)

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Four Drug Eluting Stent Trials

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  1. Four Drug Eluting Stent Trials Keith D Dawkins MD FRCP FACC Southampton University Hospital

  2. The Trials • Endeavour I (TCT 2003) Driver + ABT 578 (Medtronic) • Future II (TCT 2003) S-Stent + Everolimus (Guidant) • New Sirius (AHA 2003) Bx Velocity + Sirolimus (Cordis/J&J) • Taxus IV (AHA 2003) Express2 + Paclitaxel (Boston Scientific)

  3. Endeavour I (Medtronic) • Safety Study (n=100) • Device Driver cobalt-chrome stent PC coating ABT 578 : anti-proliferative action blocks mTOR signal transduction

  4. Endeavour I (Medtronic) • Inclusion Criteria Single de novo lesion Native coronary arteries ACC/AHA A-B2 Reference vessel diameter 3.0 – 3.5mm Lesion length <15mm Diameter stenosis ≥50% - <100% • Follow-up Clinical 1, 4, 9 months, 1- 5 years Angio + IVUS 4 and 12 months

  5. Endeavour I (MACE) *Hierarchical

  6. In-Stent In-Segment 70.3% 70.3% Diameter stenosis (%) 21.7% 16.5% 14.4% 5.4% Pre Post 4m Pre Post 4m Endeavour I (QCA 4 months)

  7. Endeavour I (QCA 4 months) In-Segment 0.2mm 0.09 mm 0.11mm 0.33mm Proximal Distal In-Stent Late loss (mm)

  8. Future II (Guidant) • RCT (2:1) (n=64) • Device S-Stent (stainless steel) Bioabsorbable polymer matrix Everolimus : proliferation signal inhibitor, causes cell cycle arrest in the G1 phase, prevents clonal expansion of activated T-cells

  9. Future II (Guidant) • Inclusion Criteria Single de novo lesion Native coronary arteries ACC/AHA A-B2 Reference vessel diameter 2.5 – 4.0mm Lesion length ≤18mm Diameter stenosis ≥50% - <100% • Follow-up Clinical 1, 6, 12 months Angio + IVUS 6 months

  10. Future II (MACE 6 months) *Hierarchical

  11. Future II (QCA 6 months) In-Stent In-Segment 30.6% Binary restenosis (%) 19.4% p=0.04 p=ns 4.8% 0.0% MS EES MS EES

  12. Future II (QCA 6 months) In-Stent In-Segment 0.85 0.54 Late Loss (mm) p<0.0001 p=0.002 0.17 0.12 EES MS EES MS

  13. New Sirius*(Cordis/Johnson & Johnson) • RCT (1:1) (n= 452) • Device Bx Velocity stainless steel stent Two polymers PEVA & PBMA Sirolimus : proliferation signal inhibitor, causes cell cycle arrest in the G1 phase, upregulates natural cell cycle inhibitors (p27) *Combined data from E-Sirius and C-Sirius

  14. New Sirius*(Cordis/Johnson & Johnson) • Inclusion Criteria Single de novo lesion Native coronary arteries ACC/AHA A-C Reference vessel diameter 2.5 - 3.0mm Lesion length 15 - 32mm Diameter stenosis ≥50% - 100% • Follow-up Clinical 1, 9, 12 months Angio + IVUS 8 months *Combined data from E-Sirius and C-Sirius

  15. New Sirius (QCA 8 months) In-Stent In-Segment 44.2% 42.7% Diameter restenosis (%) p<0.001 p<0.001 5.1% 3.1% Bx Cypher Bx Cypher

  16. New Sirius (QCA 8 months) Distal Margin Proximal Margin In-Stent 42.3% p<0.001 p=0.018 p<0.001 Binary restenosis (%) 11.0% 7.4% 3.1% 2.0% 2.1% Bx Cypher Bx Cypher Bx Cypher

  17. New Sirius (Diabetics 12 months)

  18. Taxus IV (Boston Scientific) • RCT (1:1) (n=1326) • Device Express2 stainless steel stent Translute™ elastomeric polymer Paclitaxel : binds tubulin interfering with microtubular dynamics, inhibits SMC proliferation & migration, ECM synthesis & secretion

  19. Taxus IV (Boston Scientific) • Inclusion Criteria Single de novo lesion Native coronary arteries ACC/AHA A-C Reference vessel diameter 2.5 - 3.0mm Lesion length 15 - 32mm Diameter stenosis ≥50% - 100% • Follow-up Clinical 1, 4, 9 months, 1 – 5 years Angio + IVUS 9 months

  20. 96.8% 95.6% Δ 9.3%P<0.0001 TAXUS Δ 10.7% P<0.0001 Control 87.5% 84.9% TAXUS benefit for TLR sustained to 12-months Taxus IV: Target lesion revascularisation 100 % patients 90 80 0 30 60 90 120 150 180 210 240 270 300 330 365 Days since index procedure

  21. Impact of Vessel Size & Lesion Length Taxus IV: Impact of vessel size & lesion length Control TAXUS TLR at 12 months (%) < 2.5 2.5-3.0 RVD (mm) > 3.0 Lesion Length (mm)

  22. P=0.12 P=0.0016 P<0.0001 N=489 N=507 N=163 N=155 N=54 N=51 Impact of Diabetes Mellitus Taxus IV: Impact of Diabetes TLR at 12 months (%) No Diabetes Diabetes Diabetes (Insulin)

  23. Conclusions • Four effective drugs at reducing restenosis • Stent delivery system is critical in optimising drug placement • All four devices/drugs are safe (12 months) • The ‘ideal’ late loss is yet to be determined (viz. no restenosis vs. minimal restenosis) • Cost will be a major factor in selecting a particular product

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