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EXCELLA BD Randomized Trial 12-month Results

EXCELLA BD Randomized Trial 12-month Results. Ricardo Costa, MD On behalf of the EXCELLA BD Investigators. •••••••• Elixir Medical Confidential. Elixir Medical DESyne BD TM Novolimus Eluting Coronary Stent System . DESyne BD TM

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EXCELLA BD Randomized Trial 12-month Results

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  1. EXCELLA BD Randomized Trial12-month Results Ricardo Costa, MD On behalf of the EXCELLA BD Investigators ••••••••Elixir Medical Confidential

  2. Elixir Medical DESyne BDTM Novolimus Eluting Coronary Stent System • DESyne BDTM • Biodegradablepolymer degrades in 6-9 months, drug release over 4 weeks • Workhorse DES that leaves behind bare metal surface • Platform features • Cobalt chromium alloy stent • 81 µm thickness • Thin polymer matrix • No primer coating • < 3µm coating thickness • Novolimus drug dose of 5 mcg per mm stent length • Active metabolite of Sirolimus

  3. EXCELLA BD Randomized Clinical Trial RANDOMIZED (3:1), SINGLE BLIND, MULTI-CENTER CLINICAL TRIAL Single/Multiple De Novo Native Coronary Artery Lesions (A-B2) Vessel Diameters: 2.5-3.5 mm Stent Diameters: 2.5-3.5 mm Lesion Length: ≤24 mm Stent Lengths: 14 - 28 mm Pre-Dilatation required/ Post-Dilatation at physicians discretion Co-Principal Investigators: A. Abizaid and S.Verheye Angiographic Core Lab: CRC IVUS Core Lab: Stanford University CEC/DSMB: CRC Data Management: CRC Cobalt Alloy Stent + Bioabsorbable Polymer + Novolimus @ 5µg per mm Stent Length Clinical Follow-up Angiographic/IVUS (Subset) Follow-up Geography: Belgium, Germany and Brazil 30d 6mo 9mo 12mo 2-5yrs DESyne BD DES n= 115 ENDEAVOR DES Control n= 31 Primary Endpoint:In-Stent Late Lumen Loss at 6 months (QCA) Device and Procedure (Clinical) Success Device-oriented composite endpoint (Death, MI, or TLR) Key Secondary Endpoints:at 1, 6, 9, 12mo and 2-5 yrs Clinically driven TLR, TVR and TVF at 1, 6, 9, 12mo and 2-5 yrs Stent thrombosis rates at 1, 6, 9, 12mo and 2-5yrs ABR, LLL and % volume obstruction at 6 months Anti-Platelet Therapy for 12 months Clinical Follow-up

  4. EXCELLA BD Study Organization • Clinical Event Committee • Aurea Chaves • Dimytri Siqueira • Sergio Braga • Angiographic Core Lab • Cardiovascular Research Center, Sao Paulo, Brazil • IVUS Core Lab • Stanford University – Peter Fitzgerald • Date Coordination Center • Cardiovascular Research Center, Sao Paulo, Brazil • Principal Investigators • Alexandre Abizaid • Stefan Verheye • Steering Committee: • Alexandre Abizaid • Stefan Verheye • Peter Fitzgerald • DSMB • OtavioBerwanger • Adriana Moreira • Ricardo Pavenello

  5. EXCELLA BD Investigators

  6. Patient Flow and Follow-up 151 patients (NL=168) enrolled and randomized Novolimus-eluting stent N=115 pts (NL=127) Zotarolimus-eluting stent N=31 pts (NL=38) 1 Deregistered 3 Withdrew consent 3 no study stent 1 Deregistered 6-day clinical FUP N=115 pts 9-month clinical FUP N=31 pts 6-month clinical FUP N=31 pts Clinical FUP 100% 6-month angio FUP N=107 pts (NL= 119) (NIVUS = 35) 6-month clinical FUP N=113 pts 6-month angio FUP N=31 pts (NL= 38) (NIVUS = 16) Clinical FUP 98.6% Angio FUP 94.5% Intention to treat analysis Pts, patients; NL number of lesions; NIVUS number of IVUS

  7. Baseline Patient Characteristics *p=0.028; all others p=ns

  8. Baseline Lesion Characteristics p=ns for all characteristics

  9. Angiographic Results 6 months

  10. Primary Endpoint Analysis: 6-month In-Stent Late Lumen Loss *Least square means Zone of non-inferiority Pre-specified margin=0.20mm Zone of Superiority Zone of non-inferiority Zone of inferiority Superior -0.20 -0.10 0.30 -0.60 -0.50 -0.40 -0.30 0.00 0.10 0.20 0.40 Upper one-sided 95% CI Met Primary Non-Inferiority Endpoint and Superiority Endpoint

  11. Clinical Results –12 months Modified Intention to Treat (patients who received a study stent)

  12. Cardiac Events at 12 months

  13. Conclusions The EXCELLA BD trial demonstrated both non-inferiority and superiority of the Elixir DESynetm BD Novolimus eluting stent compared to control for the primary endpoint of in-stent late lumen loss at 6 months Angiographic binary restenosis for the DESyne BD stent was significantly less compared to control (0.0% vs. 7.9%, p=0.003) The composite endpoint of cardiac death, TV-MI and CI-TLR remains low and unchanged from 6 months for both groups demonstrating clinical safety of the Elixir DESyne BD stent There was no reported stent thrombosis through 12 months

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