L'apport des mailles fines dans le stenting moderne - Marc SILVESTRI GCS Axium-Rambot - High ...
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Mailles épaisses = plus de thrombogenicité Thrombus formation assessed by immunofluorescence staining for platelet marker CD61 after 1 hour in ex-vivo pig AV shunt model Thick strut DES Thin strut DES Ultra-thin strut DES Adapted from J Am Coll Cardiol 2012; 59: 1337-49.
Avantages des mailles fines Court terme: Moins de traumatisme,d’inflammamtion et de formation de thrombus1 Moyen terme: Endothelialisation rapide et cicatrisation précoce2 Long terme: Moins de risque de mailles non recouvertes et malapposées 1Kolandaivelu. Circulation 2011; Soucy. EuroIntervention 2010; Kastrati. Circulation 2001; Pache. JACC 2003 2Cassese S et al. Eur Heart J Cardiovasc Imaging. 2018 Jan 2.
10 RCTs, 11,658 pts, 3 ultrathin DES: Orsiro(60µm), Mistent(65µm) and BioMime(65µm) vs. 2nd generation DES: Xience (7 trials), Resolute (1 trial) and Nobori (1 trial) TLF @ 1 year
Metaanalyse 9 études ( 2017-2020),11000 patients, Orsiro vs 6 Xience + 3 Resolute Suivi 2.8 ans Monjur MR et al. Open Heart 2020;7:e001394 1.3% Absolute Risk Reduction in Target Lesion Failure
Mailles fines et petits vaisseaux BIO-RESORT RA Buiten et al JAMA cardio 2019 Iglesias JF et al Circ Cardiovasc Interv 2019
Supraflex CRUZ SES Platform Stent material CoCr (L605) with highly flexible ‘S–link’ interconnector Strut 60 µm across all stent diameters (2.0 to thickness 4.5mm) Carrier Biodegradable - Top layer polymer matrix • 0% drug • Protective layer (PVP: poly-vinylpyrrolidone) PVP - Base layer PLLA/PLGA with Sirolimus • 100% drug (Sirolimus) • PLLA and PLGA Coating Circumferential The average thickness: 4-5 µm Drug Sirolimus 1.4 µg/mm2 Release profile 1. Initial burst - 70% released within 7 days - Aiming to prevent excessive cell growth 2. Sustained release up to 48 days 14
TALENT TRIAL: Per-protocol analysis at 2 years Zaman A, et al. Lancet. 2019 Supraflex Xience Percentage difference p n=660 n=685 (95% CI) value DOCE 5.5% (36) 7.2% (49) -1.7% (-4.3 to 1.0%) 0.223 Cardiac death 1.4% (9) 1.6% (11) -0.2% (-1.6 to 1.1%) 0.736 TV-MI 2.6% (17) 3.8% (26) -1.2% (-3.1 to 0.7%) 0.216 CI-TLR 3.3% (21) 4.5% (30) -1.2% (-3.3 to 0.9%) 0.267 DOCE CI-TLR -1.7% (95%CI: -4.3 to 1.0) -1.2% (95%CI: -3.3 to 0.9) Log-Rank p=0.223 7.2% Log-Rank p=0.267 4.5% 5.5% 3.3% 18
TAKE HOME MESSAGE STENTS MAILLES FINES - Probablement moins d’infarctus et de thrombose de stent - Possiblement moins de TLR dans les petits vaisseaux - Difficile de départager entre 60 et 80 microns - Succès TLF plurifactoriel - Importance du soin à apporter à l’apposition - A utiliser préférentiellement dans le stenting moderne pour essayer de faire un petit plus (1 à 2% ?) - En attendant l’étude Multitalent…
Multi-TALENT study design De novo 3VD patients Screening with SYNTAX Scores (SS) I & II R 775 775 Supraflex Cruz Everolimus-eluting stent Primary endpoint: POCE at 1 year (non-inferiority) Powered Secondary Endpoint: VOCE at 2 year (superiority) Chair/Co-Chair: Patrick W. Serruys, William Wijns, Corelab/Deputy Chair: Yoshi Onuma
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Concerns with thinner struts strut design Radial strength Xience 81µm Ring Resolute Onyx 81µm Helix Synergy 79µm Ring Orsiro 60µm* Double Helix Acute Recoil 0 1 2 3 81µm Ring Xience 81µm Helix Resolute Onyx 79µm Ring Synergy Advances in stent design Orsiro helps overcome potential 60µm* Double Helix disadvantages of0 ultra 5thin struts 10 *For 2.25 mm to 3.0 mm Ø stents, 80 µm for > 3.0 mm Ø stents ** Bench test performed by independent laboratory - IIB // BIOTRONIK data on file Source: S James, Evaluating the broad clinical utility of ultrathin bioabsorbable polymer DES; Oral presentation; Presented at: EuroPCR 2018; MAY 24
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