After CTO recanalization:which DES should be chosen?         Jean Marco       Chairman of PCR
After successful CTO recanalization: which DES ?             Objective“On which criteria could be based the   selection of...
Which DES?                AgendaI. BackgroundII. The essential from knowledge  BMS vs SES/PES  SES vs PES  SES-PES vs new ...
Which DES?                AgendaI. BackgroundII. The essential from knowledge  BMS vs SES/PES  SES vs PES  SES-PES vs new ...
CTO lesions features   and PCI in CTO Absence of endothelial cellsStents exposed to deep plaque         components
Stent: what’s the matter?             BMS & DES: Struts feature, metal             alloys, strut thickness…             DE...
Which DES?                AgendaI. BackgroundII. The essential from knowledge  BMS vs SES/PES  SES vs PES  SES-PES vs new ...
Which DES?                AgendaI. BackgroundII. The essential from knowledge  BMS vs SES/PES  SES vs PES  SES-PES vs new ...
The essential from knowledge                RCTs:     carefully selected patients             Registries:       “all-comer...
SES or PES vs BMS in CTO          Reduced risk of MACE[RR: 0.45],(95% CI: 0.34-0.60, p< 0.001)         Reduced need for TV...
SES or PES vs BMS in CTO       Reduced risk of restenosis(RR: 0.25,95% CI: 0.16-0.41, p<0.001)  Reduced risk of occlusive ...
SES or PES vs BMS in CTO  1 stent re-occlusion event     avoided by treating      15 CTO with DES                       Co...
SES or PES vs BMS in CTO             A higher rate      of late stent thrombosis?[RR:2.79],95% CI: 0.98-7.97, p<0.06)     ...
SES or PES vs BMS in CTO          Similar risk of death(RR: 0.87,95% CI: 0.66-1.16, p= 0.88)           Similar risk of MI(...
SES and PES: delayed arterial                 healing                                                         BMS         ...
SES or PES vs BMS in CTOThis benefit seems to be proportional    to baseline risk of restenosis  (ie: diabetes, length of ...
Is there any difference in safety andefficacy profile between SES and PES?  No robust clinical relevant differences       ...
PES vs SES in CTO              Multinational registry       KM estimated of 5-yr clinical follow-up                       ...
After successful CTOrecanalization: which DES ?   Are Everolimus, Biolimus,      New-Zotarolimus ES    safer and more effe...
Meta-analysis and and “all-comers”             studies: Everolimus Eluting Stent (EES),         Zotarolimus ES,        Bio...
EES vs SES         TLR @ 3 Years20      (Non –inferiority)                              15.515    12.81050       EES      ...
EES vs SES                    DES Efficacy – Risk of TLR                                                                  ...
EES versus SES         DES Safety - Risk of Definite Stent Thrombosis                            EES SES                  ...
Biodegradable polymer BES vs SES        LEADERS trial @ 4 years FU    I° End Point (cardiac death, MI, TVR)              N...
Biodegradable polymer BES vs SES            Non-inferior to SES          Hypothesis-generating                   Definite ...
DES selection        Differences in terms         of efficacy or safety     between EES, ZES, and BES?           No robust...
After successful CTOrecanalization: which DES ?            ConclusionThere is a low risk of late or very lateadverse event...
After successful CTO    recanalization: which DES ?               ConclusionAll your patient’s information can and does in...
After successful CTO    recanalization: which DES ?     In “high-risk” of adverse events(diabetics, very long lesion, need...
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Jean Marco "After CTO recanalization: which DES should bechosen ?"

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Jean Marco "After CTO recanalization: which DES should bechosen ?"

  1. 1. After CTO recanalization:which DES should be chosen? Jean Marco Chairman of PCR
  2. 2. After successful CTO recanalization: which DES ? Objective“On which criteria could be based the selection of DES in the light of the best available knowledge, local experience and constraints”
  3. 3. Which DES? AgendaI. BackgroundII. The essential from knowledge BMS vs SES/PES SES vs PES SES-PES vs new generation of DESIII.Conclusion-Messages
  4. 4. Which DES? AgendaI. BackgroundII. The essential from knowledge BMS vs SES/PES SES vs PES SES-PES vs new generation of DESIII.Conclusion-Messages
  5. 5. CTO lesions features and PCI in CTO Absence of endothelial cellsStents exposed to deep plaque components
  6. 6. Stent: what’s the matter? BMS & DES: Struts feature, metal alloys, strut thickness… DES: Polymer coating Permanent, biodegradable, kinetic drug release DES: Drug Limus, Paclitaxel Safety EfficacyStent Thrombosis (ST), MI, death Clinically-driven TLR
  7. 7. Which DES? AgendaI. BackgroundII. The essential from knowledge BMS vs SES/PES SES vs PES SES-PES vs new generation of DESIII.Conclusion-Messages
  8. 8. Which DES? AgendaI. BackgroundII. The essential from knowledge BMS vs SES/PES SES vs PES SES-PES vs new generation of DESIII.Decision-making and Messages
  9. 9. The essential from knowledge RCTs: carefully selected patients Registries: “all-comers” patients Meta-analysis:explore the efficacy & safety of DES
  10. 10. SES or PES vs BMS in CTO Reduced risk of MACE[RR: 0.45],(95% CI: 0.34-0.60, p< 0.001) Reduced need for TVR[RR: 0.40],95% CI: 0.28-0.58, p< 0.001) Colmenarez et al. JACC 2010
  11. 11. SES or PES vs BMS in CTO Reduced risk of restenosis(RR: 0.25,95% CI: 0.16-0.41, p<0.001) Reduced risk of occlusive restenosis(RR: 0.30,95% CI: 0.18-0.49, p<0.001) Colmenarez et al. JACC 2010
  12. 12. SES or PES vs BMS in CTO 1 stent re-occlusion event avoided by treating 15 CTO with DES Colmenarez et al. JACC 2010
  13. 13. SES or PES vs BMS in CTO A higher rate of late stent thrombosis?[RR:2.79],95% CI: 0.98-7.97, p<0.06) Hypothesis-generating Colmenarez et al. JACC 2010
  14. 14. SES or PES vs BMS in CTO Similar risk of death(RR: 0.87,95% CI: 0.66-1.16, p= 0.88) Similar risk of MI(RR: 0.89,95% CI: 0.54-1.46, p=0.80) Colmenarez et al. JACC 2010
  15. 15. SES and PES: delayed arterial healing BMS PES8 6.36 5,742 1,1 1 0,9 0,10 Malapposed and Uncovered Struts Uncovered Struts Protruding Struts Guagliumi et al. Circulation 2011
  16. 16. SES or PES vs BMS in CTOThis benefit seems to be proportional to baseline risk of restenosis (ie: diabetes, length of occluded segment stented and final lumen diameter) Claessen et al. Am J Cardiol 2011
  17. 17. Is there any difference in safety andefficacy profile between SES and PES? No robust clinical relevant differences up to 5-year follow-up were convincly identified
  18. 18. PES vs SES in CTO Multinational registry KM estimated of 5-yr clinical follow-up PES SES P (n=208) ( n=555) value MACE 22.5% 24.4% 0.73 Death 2.1% 6.9% 0.21 MI 6.5% 3.9% 0.49 TVR 16.2% 17.2% 0.77Definite/probable ST 1.2% 2.1% 0.19 Mehram et al. JACC Intv 2011
  19. 19. After successful CTOrecanalization: which DES ? Are Everolimus, Biolimus, New-Zotarolimus ES safer and more effective than SE or PES in CTO? This hypothesis still has to be demonstrated 19
  20. 20. Meta-analysis and and “all-comers” studies: Everolimus Eluting Stent (EES), Zotarolimus ES, Biolimus ES (BES) showed a better outcome as compared to PES
  21. 21. EES vs SES TLR @ 3 Years20 (Non –inferiority) 15.515 12.81050 EES SES (N=652) (N=652) Byrne R et al. JACC 2011
  22. 22. EES vs SES DES Efficacy – Risk of TLR RR (95% CI) EES SES ISAR-TEST 4 77/652 95/652 0.81 (0.61, 1.07) SORT-OUT 4 20/1390 23/1384 0.87 (0.48, 1.57) EXCELLENT 26/1079 6/364 1.46 (0.61, 3.52) BASKET-PROVE* 29/774 33/775 0.88 (0.54, 1.43) ESSENCE-DIABETES 1/149 4/151 0.25 (0.03, 2.24) Long DES 7/224 5/226 1.41 (0.46, 4.38) * Burzotta et al. 5/75 5/75 1.00 (0.30, 3.31) RESET 65/1597 76/1600 0.86 (0.62, 1.18) Overall (I-squared = 0.0%, p = 0.827) 0.87 (0.73, 1.03) * TVR .1 .2 .5 1 2 5 10 Risk ratioN = 11,167 Favors EES Favors SES Kalesan, Windecker
  23. 23. EES versus SES DES Safety - Risk of Definite Stent Thrombosis EES SES RR (95% CI) ISAR-TEST 4 4/652 9/652 0.44 (0.14, 1.44) SORT-OUT 4 2/1390 9/1384 0.22 (0.05, 1.02) BASKET-PROVE 2/774 3/775 0.67 (0.11, 3.98) RESET 5/1597 6/1600 0.83 (0.26, 2.73) ESSENCE-DIABETES 0/149 0/151 (Excluded) Burzotta et al. 0/75 0/75 (Excluded) Overall (I-squared = 0.0%, p = 0.579) 0.51 (0.26, 0.99) .1 .2 .5 1 2 5 10 Risk ratioN = 11,167 Favors EES Favors SES Kalesan, Windecker
  24. 24. Biodegradable polymer BES vs SES LEADERS trial @ 4 years FU I° End Point (cardiac death, MI, TVR) Non-inferiority 18·7% vs 22·6% [RR: 0·81], (95% CI: 0·66–1·00) Windecker Lancet 2011
  25. 25. Biodegradable polymer BES vs SES Non-inferior to SES Hypothesis-generating Definite ST [RR: 0·62],( 95% CI: 0·35–1·08, p=0·09) Very late definite ST between years 1 and 4 [RR 0·20, 95% CI 0·06–0·67, p=0·004] Windecker Lancet 2011
  26. 26. DES selection Differences in terms of efficacy or safety between EES, ZES, and BES? No robust evidence The overall low frequency of ST eventsmakes it unlikely for any of the RCTs alone to show a significant difference 26
  27. 27. After successful CTOrecanalization: which DES ? ConclusionThere is a low risk of late or very lateadverse events related to DES safety 27
  28. 28. After successful CTO recanalization: which DES ? ConclusionAll your patient’s information can and does influence a personalized decision-making process 28
  29. 29. After successful CTO recanalization: which DES ? In “high-risk” of adverse events(diabetics, very long lesion, need to overlapping stents, < 3mm vessel diameter) EES, ZES, BES might be advised, according to local regulation/constraints

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