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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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slide1

EXCELLA BD Randomized Trial12-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
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
excella bd randomized clinical trial
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

excella bd study organization
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
patient flow and follow up
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

baseline patient characteristics
Baseline Patient Characteristics

*p=0.028; all others p=ns

baseline lesion characteristics
Baseline Lesion Characteristics

p=ns for all characteristics

slide10

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

clinical results 12 months
Clinical Results –12 months

Modified Intention to Treat (patients who received a study stent)

conclusions
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