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CORONARY STENT safety update & ROLE OF ENDOTHELIAL PROGENITOR CELL CAPTURING STENTS

CORONARY STENT safety update & ROLE OF ENDOTHELIAL PROGENITOR CELL CAPTURING STENTS. Giuseppe Biondi Zoccai, MD , FSICI-GISE University of Turin , Turin , Italy. Learnging goals. Scope of the problem Second generation drug-eluting stents

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CORONARY STENT safety update & ROLE OF ENDOTHELIAL PROGENITOR CELL CAPTURING STENTS

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  1. CORONARY STENT safety update & ROLE OF ENDOTHELIAL PROGENITOR CELL CAPTURING STENTS Giuseppe Biondi Zoccai, MD, FSICI-GISE University of Turin, Turin, Italy

  2. Learnginggoals • Scope of the problem • Second generation drug-eluting stents • Update on endothelial progenitor cell capturing stents

  3. Learnginggoals • Scope of the problem • Second generation drug-elutingstents • Update on endothelialprogenitorcellcapturingstents

  4. 25% Stent Thrombosis !

  5. The Stent Survived, thanks to...

  6. Learnginggoals • Scope of the problem • Second generation drug-elutingstents • Update on endothelialprogenitorcellcapturingstents

  7. 2nd generation DES: SPIRIT IV trial

  8. 2nd generation DES: COMPARE trial

  9. 2nd generation DES: COMPARE trial

  10. 2nd generation DES: COMPARE trial

  11. 2nd generation DES: COMPARE trial

  12. 2nd generation DES: COMPARE trial

  13. 2nd generation DES: COMPARE trial

  14. Learnginggoals • Scope of the problem • Second generation drug-elutingstents • Update on endothelialprogenitorcellcapturingstents

  15. Concept of EPC-capturing stent

  16. EPC Capture Stents

  17. EPC Capture Stents

  18. EPC Capture Stents

  19. Endothelialization of the Stent Struts: immediately after Stent Implantation accelerated endothelialization by EPC-“capturing”

  20. Pro-Healing Approach: EPC Capture Stent Endothelialization Genous Anti-CD34 coating BMS 7-days (%) 50 p=0.07 40 mean 30 20 mean 10 0 Genous BMS In rabbit iliac model

  21. Endothelialization and CD31 expression in SES with surface modification with anti-CD34 antibody stents vs. SES alone at 3 and14 days) SES-anti-CD34 SES alone 3 days 14 days Confocal

  22. EUROPE Austria 8 Belgium 3 Cyprus 2 Denmark 2 France 8 Germany 11 Greece 6 Ireland 1 Italy 26 Netherlands 5 Portugal 3 Spain 8 Switzerland 1 United Kingdom 9 NORTH AFRICA Tunisia 2 Czech Republic 5 Finland 1 Hungary 2 Poland 2 Romania 1 Russian Federation 5 MIDDLE EAST Egypt 6 Lebanon 1 Saudi Arabia 1 Syria 3 Turkey 3 LATIN AMERICA Venezuela 1 ASIA PACIFIC Australia 6 Hong Kong 1 Malaysia 9 Singapore 2 144 SITES

  23. e-HEALINGClinical Events in all Pats at 12 Months (n= 3196) Patients treated on or before Feb 22, 2007 All events reported before Aug 12, 2008; all events adjudicated by CEC Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR

  24. e-HEALINGClinical Events in Diabetes at 12 Months (n= 851) Patients treated on or before Feb 22, 2007 All events reported before Aug 12, 2008; all events adjudicated by CEC Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR

  25. e-HEALINGClinical Events at 12 Months (n= 2643) in Patients on Statins at Stent Implantation Patients treated on or before Feb 22, 2007 All events reported before Aug 12, 2008; all events adjudicated by CEC Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR

  26. e-HEALINGClinical Events at 12 Months (n= 553) in Patients off Statins at Stent Implantation Patients treated on or before Feb 22, 2007 All events reported before Aug 12, 2008; all events adjudicated by CEC Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR

  27. e-HEALING compared to the DES groups of a recent all-comers randomized study with no routine control angiography 1 All events reported before Aug 12, 2008; all events adjudicated by CEC; Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR 2 MACE = Cardiac Death, MI TVR; The Lancet, 372: 1163 – 1173, 2008 3 MACE = any death, MI, TVR, Syntax Trial, presented at the ESC meeting in Munich, Sept. 2008 4 ARC definite + probable

  28. e-HEALING compared to the DES groups of a recent all-comers randomized study with no routine control angiography 1 All events reported before Aug 12, 2008; all events adjudicated by CEC; Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR 2 MACE = Cardiac Death, MI TVR; The Lancet, 372: 1163 – 1173, 2008 3 MACE = any death, MI, TVR, Syntax Trial, presented at the ESC meeting in Munich, Sept. 2008 4 ARC definite + probable

  29. e-HEALING compared to the DES groups of a recent all-comers randomized study with no routine control angiography 1 All events reported before Aug 12, 2008; all events adjudicated by CEC; Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR 2 MACE = Cardiac Death, MI TVR; The Lancet, 372: 1163 – 1173, 2008 3 MACE = any death, MI, TVR, Syntax Trial, presented at the ESC meeting in Munich, Sept. 2008 4 ARC definite + probable

  30. e-HEALING compared to the DES groups of a recent all-comers randomized study with no routine control angiography 1 All events reported before Aug 12, 2008; all events adjudicated by CEC; Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR 2 MACE = Cardiac Death, MI TVR; The Lancet, 372: 1163 – 1173, 2008 3 MACE = any death, MI, TVR, Syntax Trial, presented at the ESC meeting in Munich, Sept. 2008 4 ARC definite + probable

  31. e-HEALING compared to the DES groups of a recent all-comers randomized study with no routine control angiography 1 All events reported before Aug 12, 2008; all events adjudicated by CEC; Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR 2 MACE = Cardiac Death, MI TVR; The Lancet, 372: 1163 – 1173, 2008 3 MACE = any death, MI, TVR, Syntax Trial, presented at the ESC meeting in Munich, Sept. 2008 4 ARC definite + probable

  32. e-HEALING compared to the DES groups of a recent all-comers randomized study with no routine control angiography 1 All events reported before Aug 12, 2008; all events adjudicated by CEC; Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR 2 MACE = Cardiac Death, MI TVR; The Lancet, 372: 1163 – 1173, 2008 3 MACE = any death, MI, TVR, Syntax Trial, presented at the ESC meeting in Munich, Sept. 2008 4 ARC definite + probable

  33. e-HEALING compared to the DES groups of a recent all-comers randomized study with no routine control angiography 1 All events reported before Aug 12, 2008; all events adjudicated by CEC; Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR 2 MACE = Cardiac Death, MI TVR; The Lancet, 372: 1163 – 1173, 2008 3 MACE = any death, MI, TVR, Syntax Trial, presented at the ESC meeting in Munich, Sept. 2008 4 ARC definite + probable

  34. TRIAS-HR PilotStudy

  35. TRIAS-HR PilotStudy

  36. TRIAS-HR PilotStudy

  37. TRIAS-HR PilotStudy

  38. GENIUS-STEMI Trial

  39. GENIUS-STEMI Trial • Study flow chart 2007:400 P-PCI 100 patientsincluded (Randomization) 50 CrCo 50 GenousTM ASA 100mg/day+clopidogrel 75mg/day 30 days; GPIIb/IIIa inhibitors and thromboaspiration at the discretion of the physician 6-month clinical, angio and IVUS FU

  40. GENIUS-STEMI Trial • 6-monthclinicaloutcome GenousTM CrCo P=0.03 P=0.04 24 4 4 P=NS P=NS 10 2 2 P=NS 14 6 4 4 6 0 4 2 MACE CV Deaths MI TLR ST (Non hierachical)

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