1 / 36

Les stents actifs « actualités »

Les stents actifs « actualités ». Victor Legrand CHU de Liège. Stents actifs. Malheurs et déceptions. ACTION Trial Event Free survival curve. Overall Intent-to-treat Population, Per patient (N=1329/1531 § ). MACE (%)*. 15.7. TVF (%)**. 16.7. Death (%). 2.3. QMI (%). 2.3. Non-QMI (%).

shirlyn
Download Presentation

Les stents actifs « actualités »

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. Les stents actifs« actualités » Victor Legrand CHU de Liège

  2. Stents actifs Malheurs et déceptions

  3. ACTION TrialEvent Free survival curve

  4. Overall Intent-to-treat Population, Per patient (N=1329/1531§) MACE (%)* 15.7 TVF (%)** 16.7 Death (%) 2.3 QMI (%) 2.3 Non-QMI (%) 2.6 TLR (%) (CABG/PCI) 8.5 (1.7/6.8) TVR (%) (CABG/PCI) 1.1 (0.1/1.0) Deliver II : Evénements à 6 mois *: MACE: Death, Q-wave MI (QMI), non-Q-wave MI (NQMI), Target lesion revascularization (TLR) by CABG or PCI **: TVF: MACE + Target vessel revascularization by CABG or PCI §89% patients came back within 200 days

  5. Stents actifs Risques

  6. All Stent Thrombosis 0.8% In Hospital 0.3% Out of Hosp (to 30 days) 0.3% Out of Hosp (31-180 days) 0.2% Out of Hosp (181-270 days) 0.0% Incomplete Apposition Resolved 5.4% Persistent 1.1% Late Acquired 2.2% Aneurysms Resolved 0.4% Persistent 0.4% Late Acquired 0.4% TAXUS IV: SafetyThrombosis, Incomplete Apposition & Aneurysms Express™ Control TAXUS™ Stent 0.6% 0.0% 0.3% 0.3% 0.0% 6.4% 3.2% 1.1% 1.0% 0.7% 0.0% All p values = ns

  7. All Stent Thrombosis 0.8% In Hospital 0.0% Out of Hosp (to 30 days) 0.2% Out of Hosp (31-180 days) 0.3% Out of Hosp (181-270 days) 0.3% Incomplete Apposition Resolved 4.9% Persistent 9.8% Late Acquired 0.0% Aneurysms Resolved Persistent Late Acquired 1.1% SIRIUS : SafetyThrombosis, Incomplete Apposition & Aneurysms BX™ Control Cypher™ Stent 0.4% 0.0% 0.2% 0.2% 0.0% 8.7% 7.5% * 8.7% 0.6% * p = 0.05

  8. Thrombose du stent (étude Taxus IV) P=0.75 0.6% (n=4) 0.8% (n=5) Thrombose du Stent %

  9. Stents actifs Efficacité

  10. Dante Pazzanese FIM - Event free survival Death, MI, CABG, Re-PTCA 100 90.1% 80 Patients without Events (%) 60 40 20 0 24 0 12 6 18 30 36 Time (Months)

  11. RAVEL Target Lesion Revascularization 97.5% 86.4% P (FE) = 0.002 P (LR) = 0.001

  12. # events prevented per 1,000 patients CYPHER™ Stent Patients: TLR Improvements (SIRIUS, 12 mos.) Sirolimus Control p-value Overall 4.9 20.0 0.0001 152 M ale 5.2 20.5 0.0001 153 Female 4.1 19.0 0.0002 149 Diabetes 8.4 26.4 0.0002 180 No Diabetes 3.7 17.6 0.0001 138 LAD 6.0 23.0 0.0001 170 Non-LAD 4.1 18.0 0.0001 140 Small Vessel (<2.75) 6.6 22.3 0.0001 157 Large Vessel 3.1 18.2 0.0001 151 Short Lesion 4.0 18.6 0.0001 146 Long Lesion (>13.5) 6.0 21.9 0.0001 158 Overlap 5.7 23.2 0.0001 175 No Overlap 4.5 18.6 0.0001 141 Hazards Ratio 95% CI 0 0.1 0.2 0.4 0.5 0.6 0.7 0.8 0.9 1.0 0.9 0.8 0.7 0.3

  13. Resténose BinaireAnalysePéri-Stent : E-SIRIUS vs SIRIUS Proximal Margin Distal Margin p = 0.285 p = 0.018 p = 0.002 p = 0.002

  14. Control BMS TAXUS DES SIRIUS DES Resténose et dimensions vasculaires TAXUS IV SIRIUS P<0.001 P<0.001 P<0.001 P<0.001 P<0.001 P=0.08 * TAXUS: 9 month analysis; SIRIUS: 8 month analysis

  15. SIRIUS - Restenosis vs. Stent Length In-Stent 52.4 44.3 36.7 Control 29.7 23.5 Sirolimus 6.5 4.1 2.6 1.7 1.0

  16. 30 days 6months 30 days 6 months Death - 1 - - Q MI - 1 1 1 nonQMI 5* 5 1 1 TLR 1 4 1 1 CABG - 1 - - TOTAL 6 12(19%) 3 3(13.6%) BIFurcation StudyT stenting vs provisional T stenting Stent+Stent (n=63) Stent+PTCA (n=22) * : 2 stent thrombosis

  17. VBT/DES for in-stent restenosis

  18. Left Main DiseaseCypher stent Experience (Colombo)

  19. Control BMS TAXUS DES SIRIUS DES Resténose et diabète In-stent Analysis segment P<0.001 P<0.001 P<0.001 P<0.001 n=58 n=78 n=104 n=93 n=58 n=78 n=104 n=93 TAXUS-IV SIRIUS TAXUS-IV SIRIUS * TAXUS: 9 month analysis; SIRIUS: 8 month analysis

  20. Control BMS TAXUS DES SIRIUS DES Resténose et diabète insulino dép. In-stent Analysis segment P=0.38 P=0.01 P=0.007 P=0.03 n=54 n=51 n=44 n=38 n=54 n=51 n=44 n=38 TAXUS-IV SIRIUS TAXUS-IV SIRIUS * TAXUS: 9 month analysis; SIRIUS: 8 month analysis

  21. Stents actifs Registres cliniques

  22. Research Registry • Pts treated with at least 1SES 1072pts/2346sts • Multivessel dilatation 338 (32%) • stent diameter = 2.25mm 205 (19%) • bifurcation stenting (stent+stent) 214 (20%) • total stent length>48mm 332 (31%) • LM 51 (5%) • CTO 71 • Unstable angina 462 (43%) • Diabetes 224 (21%) • AMI(primary PCI) 241 (16%)

  23. Stents actifs Evaluations en cours

  24. TAXUS Clinical Trials Feasibility Study TAXUS I Slow release TAXUS IV Slow Release TAXUS V Slow Release Safety & Performance Study TAXUS II Cohort I Slow release TAXUS II Cohort II Moderate release TAXUS VI Moderate Release In-stent Restenosis TAXUS III Slow release

  25. THE REALITY STUDY A Prospective, Randomized, Multi-Center Comparison of the CYPHERTM Sirolimus-Eluting and the TAXUSTM Paclitaxel-Eluting Stent Systems Primary Endpoint: in-lesion restenosis rate by QCA at 8 mths

  26. Compagnie Nom Drogue Polymère J&J/Cordis Cypher Rapamycin Yes Boston Scientific TAXUS Paclitaxel Yes Cook Logic PTX Paclitaxel No Guidant/Cook Achieve Paclitaxel No Guidant LifeFloActinomycin D Yes Conor ? Paclitaxel No Biocompatibles ? Batimastat / Yes (dexamethosone) Medtronic ? Antisense Yes Medtronic/Abbott ? ABT 578 Yes Jomed ? Tacrolimus Yes Guidant ? Everolimus Yes Le paysage des stents actifs

  27. Pour conclure... • Deux stents actifs ( Cypher et Taxus) ont prouvé leur efficacité pour prévenir la resténose. • Les données cliniques à court et moyen terme sont rassurantes. • La place de ces endoprothèses dans certaines indications ( resténose instent, pontages, multitronculaires,…) reste à préciser. • De nouvelles drogues, des associations de médicaments, de nouveaux modes de libération thérapeutique et des nouveaux stents sont en cours d ’évaluation.

  28. Drug Eluting Stent Trials Comparison of % Neointimal Volume(Neointimal Volume / Stent Volume) 22.6 16.7 12.8 7.9 7.8 7.2 2.9 2.9 1.1 1.0 FUTURE FI F2 S-Stent ASPECT Low High TAXUS IISR MR TAXUS I RAVEL SIRIUS

  29. Drug Eluting Stent Trials Comparison of In-Stent Late Loss 0.85 0.57 0.39 0.36 0.31 0.29 0.30 0.17 0.12 0.11 -0.05 S-Stent FUTURE FI F2 TAXUS I SIRIUS ASPECT Low High TAXUS IISR MR RAVEL TAXUS IV

More Related