Presentation is loading. Please wait.

Presentation is loading. Please wait.

Le retour des stents auto-expansibles ? Didier CARRIE CHU TOULOUSE RANGUEIL High Tech Marseille Jeudi 26 Janvier 2012 Aucun conflit d’intérêt.

Similar presentations


Presentation on theme: "Le retour des stents auto-expansibles ? Didier CARRIE CHU TOULOUSE RANGUEIL High Tech Marseille Jeudi 26 Janvier 2012 Aucun conflit d’intérêt."— Presentation transcript:

1 Le retour des stents auto-expansibles ? Didier CARRIE CHU TOULOUSE RANGUEIL High Tech Marseille Jeudi 26 Janvier 2012 Aucun conflit d’intérêt

2 1986 : 1 ère implantation de stent coronaire Jacques Puel WALLSTENT IVA PROXIMALE

3 POURQUOI CE RETOUR 25 ANS APRES ? MEILLEURE CONNAISSANCE DU VAISSEAU MALAPPOSITION THROMBOSE INTRASTENT

4 REMODELAGE VASCULAIRE EVOLUTION DE LA PLAQUE D ’ATHEROSCLEROSE Glagov NEJM 87; Mc Pherson Surface de la lumière longtemps conservée, tant que la surface de la plaque est < 40% de la surface totale de la paroi vasculaire Défaut de remodelage accidents aigus

5 Risque : sous dimensionner le stent dans le SCA Le vasospasme comme conséquence des STEMI Diamètre coronaire (mm) Basal (+nitrés) Après stent  -bloqueurs *: p<0.05 vs basal IRA-proximalIRA-distal Gregorini et al. Circulation 1999;99: * * IRA : Infarct related artery

6 Cook S, Circulation 2007 Pôle Cardiovasculaire et Métabolique

7 Predictors of stent thrombosis (ACS/STEMI) Van Werkum JW, JACC 2009

8 Concept Self-expanding, Self apposing Nitinol stent which can increase in size after implantation Reduce acute and acquired malapposition Minimize embolization and no-reflow by avoiding aggressive post dilatation Pôle Cardiovasculaire et Métabolique

9 Radial force Data on Stentys files

10 SITUATIONS ANATOMIQUES POTENTIELLEMENT FAVORABLES ? Syndrome Coronaire Aigu ST+ (thrombus) Incongruence Artérielle ou veineuse Bifurcation

11 Background: stent sizing dilemma in STEMI 3.0? 3.5? 3.0 Malapposition Underexpansion Malapposition Underexpansion Stent thrombosis Stent thrombosis 3.5 Overdilation Dissection/ Perforation No reflow Restenosis

12 Pôle Cardiovasculaire et Métabolique Gonzalo et al Jacc Intervention 2009 OCT à 9mois

13 StudyIndicationStentFollow-up# patientsMACE OPEN IBifurcationDES6 months273.7% APPOSITION I & IISTEMIBMS12 months688.8% APPOSITION IIISTEMI BMS/ DES 30 days, interim % all patients, 2.4% Cohort B* STENTYS Clinical Proof OPEN I: S. Verheye et al., Eurointervention 2011;7: APPOSITION I & II – 12 month results presented at TCT 2011 by S. IJsselmuiden APPOSITION III – interim 30 day results presented at TCT 2011 by K.T. Koch * In Cohort B (N=210), post dilatation was generally recommended, at low pressures

14 APPOSITION I DESIGN: Prospective, non-randomized, single- arm, multi-center feasibility study OBJECTIVE: To evaluate the safety and efficacy of the STENTYS ® stent in AMI ENDPOINTS: –Stent apposition and expansion at 3 days –MACE at discharge and at 30 days Independent monitoring: Medpass Core lab: Cardialysis Statistical analysis: INSERM U970 (Paris); Prof. J.P. Tijssen (Amsterdam) 25 patients enrolled between March 2009 and October 2009 in 5 European clinical sites 25 patients with STENTYS ® stent Angiographic and IVUS follow-up at 6 months IVUS at 0 and 3 days Clinical follow-up at 30 days Post-PCI IVUS image of a STENTYS stent in AMI patient IVUS image 3 days after procedure in this patient: 19% increase in reference lumen area Results: IVUS at baseline and 3 days Mean Reference area (distal) (mm²)+19% Mean Stent area (mm²)+18% Mean Lumen area (mm²)+17% Minimum Lumen area (mm²)+19% p<0.02 G. Amoroso et al. EuroIntervention 2011;7:

15 At implantation 3 day follow-up 20% lumen area increase Pôle Cardiovasculaire et Métabolique

16 Evolution over time Baseline2 years 6 months Pôle Cardiovasculaire et Métabolique

17 Stabilization of stent expansion below unconstrained diameter (6.5mm) Long term expansion by IVUS +25% +3% Time Mean stent diameter Pôle Cardiovasculaire et Métabolique

18 DESIGN: International, prospective, randomized, two-arm multi-center trial OBJECTIVE: To compare the STENTYS® Stent with balloon-expandable stents in AMI ENDPOINTS: ‒ Stent strut apposition and expansion at 3 days (measured by OCT) ‒ days and 6 months Independent monitoring: Genae Core Lab: Cardialysis 80 STEMI patients enrolled between 12/09 and 06/10 in 9 European centerssites STENTYS® stent Clinical follow-up at 30 days and 6 months Invasive follow-up at 3 days (QCA, OCT) VISION / Driver Balloon-expandable Stent - Day 3 STENTYS ® Stent – Day 3 APPOSITION II * Stent Malapposition defined as more than 5% of struts malapposed under OCT. p<0.001 Patients with Stent Malapposition Presented by R.J. van Geuns & S.Verheye at TCT 2010

19 STENTYS ® Coronary Stent Balloon- expandable stent Day 3Day 0 Balloon vs Self-expanding

20 Stentys n=40 Control n=36 P Value Post-PCI Mean Lumen area (mm 2 )7.88 ± ± 2.22NS Mean Stent area (mm 2 )7.57 ± ± 2.38NS Stent volume (mm 3 )191 ± ± 83NS 3 days follow-up Mean Lumen area (mm 2 )8.99 ± ± 2.18NS Mean Stent area (mm 2 )9.02 ± ± 2.26NS Stent volume (mm 3 )228 ± ± 86NS Optical Coherence Tomography 15% increase

21 APPOSITION III DESIGN: Prospective, non-randomized, single-arm, multi-center trial OBJECTIVE: To evaluate the safety and performance of the STENTYS stent in routine clinical practice in a large population of STEMI patients PRIMARY ENDPOINT: ‒ MACE at 12 months SECONDARY ENDPOINTS: ‒ MACE at 30 days and 24 months PROCEDURAL GUIDELINES on post-dilatation: ‒ Cohort A: only when residual stenosis > 30% ‒ Cohort B: recommended, at low pressures 1000 patients to be enrolled in 40 European clinical sites 600 patients enrolled to date Cohort A: 390 patients Cohort B: 210 patients Clinical follow-up at 30 days Interim analysis Interim results: MACE at 30 days All patients (N=600) Cohort B (N=210) Death0.8%0.9% Re-AMI1.5%1.0% Clinically-driven TLR1.5%0.5% Total3.8%2.4% Interim results presented at TCT 2011 by K. Koch MACE at 30 days in STEMI trials

22 APPOSITION IV Study Design Design DESIGN Prospective, randomized, two- arm multi-center study OBJECTIVE To compare the endothelization of the STENTYS ® DES with a balloon- expandable DES in AMI ENDPOINTS % of uncovered struts at 4 & 9 months MACE up to 12 months 60 STEMI patients Conventional DES stent STENTYS ® DES stent OCT & QCA at 4 & 9 months months Clinical FU at 12 months

23 SITUATIONS ANATOMIQUES POTENTIELLEMENT FAVORABLES ? Syndrome Coronaire Aigu ST+ (thrombus) Incongruence Artérielle ou veineuse Bifurcation

24 Courtesy of Dr Souteyrand (Clermont-Ferrand) Pôle Cardiovasculaire et Métabolique

25 SITUATIONS ANATOMIQUES POTENTIELLEMENT FAVORABLES ? Syndrome Coronaire Aigu ST+ (thrombus) Incongruence Artérielle ou veineuse Bifurcation

26 SELF-EXPANDING STENT PLATFORM SELF EXPANDING STENT Nitinol platform Excellent wall apposition Spans both vessels at the same time Two models: -Reference diameter 3.0 ± 0.25 mm - Max *. proximal stent diameter = 3.75 mm - Max *. distal stent diameter = 6.00 mm -Reference diameter 3.5 ± 0.25 mm - Max *. proximal stent diameter = 4.25 mm - Max *. distal stent diameter = 6.50 mm DEDICATED BIFURCATION STENT Conical shape Does no cover the carina itself Lengths 11 and 14 mm

27 The Axxess™ stent implantation sequence Simulations 4 Two wires 1 Sheath off Position 2 2 Deploy partially at carina 3 3 Advance 4 Deploy 5 5 6

28 Biolimus A9 TM / Abluminal Biodegradable Polymer Bifurcation DES Axxess™ Clinical Program AXXESS N=43 AXXESS N=43 AXXESS PLUS N=139 AXXESS PLUS N=139 DIVERGE N=302 DIVERGE N=302 AXXENT N=33 AXXENT N=33 France and Germany Pilot study using bare metal stent Axxess Platform In-segment restenosis at 6 months 6 month follow-up completed, study completed France and Germany Pilot study using bare metal stent Axxess Platform In-segment restenosis at 6 months 6 month follow-up completed, study completed Europe, Brazil and New Zealand FIM Safety and performance evaluation of Axxess DES In-stent late loss at 6 months 5 year follow-up completed, study completed Europe, Brazil and New Zealand FIM Safety and performance evaluation of Axxess DES In-stent late loss at 6 months 5 year follow-up completed, study completed Europe, Australia and New Zealand Evaluated best practices from AXXESS PLUS MACE 1 at 9 months 3 year follow-up available, follow-up planned up to 5 years Europe, Australia and New Zealand Evaluated best practices from AXXESS PLUS MACE 1 at 9 months 3 year follow-up available, follow-up planned up to 5 years Europe Pilot study for Axxess Left Main DES MACE 2 at 6 months 12 month follow-up available, study completed Europe Pilot study for Axxess Left Main DES MACE 2 at 6 months 12 month follow-up available, study completed COBRA 3 N=40 COBRA 3 N=40 Europe Randomized multicenter trial to compare Axxess DES along with BioMatrix Flex™ with Cullotte technique using Xience V® Stent strut coverage assessed by OCT at 9 months Enrolling Europe Randomized multicenter trial to compare Axxess DES along with BioMatrix Flex™ with Cullotte technique using Xience V® Stent strut coverage assessed by OCT at 9 months Enrolling

29 DIVERGE - MACE Components 3-year Outcomes DeathMIid-TLR Any In-segment bifurcation restenosis: 6.4% (9/140 at 9 months) 1,2 Pôle Cardiovasculaire et Métabolique 1.Verheye S. et al, J Am Coll Cardiol, Verheye S. et al, oral presentation, TCT 2009 Agostoni P., oral presentation, EuroPCR 2011

30 DIVERGE - Stent Thrombosis up to 3 Years ProtocolARC Definite*ProbableDefinite*ProbablePossible Acute ( In-hospital) Subacute (30 days) 0.7%0 00 Late (>30 days - 1 year) 0.7%00.3% § 00 Very Late ( 1 year - 3 years) 1.0%0.7%1.0%0.7%2.4% Pôle Cardiovasculaire et Métabolique

31 CONCLUSION Balloon-expandable stents’ efficacy may be limited by : - Mal apposition - Over expansion - Side branch occlusion Stentys® and Axxess self-apposing stents for STEMI and Bifurcation have been proven : ✔ To be feasible ✔ To be safe To be effective ? Pôle Cardiovasculaire et Métabolique

32 Strut Width Data on Stentys files µ


Download ppt "Le retour des stents auto-expansibles ? Didier CARRIE CHU TOULOUSE RANGUEIL High Tech Marseille Jeudi 26 Janvier 2012 Aucun conflit d’intérêt."

Similar presentations


Ads by Google