EXCELLA BD Randomized Trial12-month Results
••••••••Elixir Medical Confidential
Ricardo Costa, MDOn behalf of the EXCELLA BD Investigators
Elixir Medical DESyne BDTM Novolimus Eluting Coronary Stent System
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
DESyne BDTM
• Biodegradable polymer degrades in 6-9 months, drug release over 4 weeks
• Workhorse DES that leaves behind bare metal surface
Co-Principal Investigators:A. Abizaid and S.VerheyeAngiographic Core Lab: CRCIVUS Core Lab: Stanford UniversityCEC/DSMB: CRCData Management: CRC
RANDOMIZED (3:1), SINGLE BLIND, MULTI-CENTER CLINICAL TRIAL
EXCELLA BD Randomized Clinical Trial
Single/Multiple De Novo Native Coronary Artery Lesions (A-B2)Vessel Diameters: 2.5-3.5 mmStent Diameters: 2.5-3.5 mmLesion Length: ≤24 mmStent Lengths: 14 - 28 mmPre-Dilatation required/ Post-Dilatation at physicians discretion
Cobalt Alloy Stent + Bioabsorbable Polymer + Novolimus @ 5µg per mm Stent Length
Clinical Follow-up
30d 6mo 9mo 12mo 2-5yrs 30d 6mo 9mo 12mo 2-5yrsClinical Follow-upAngiographic/IVUS (Subset) Follow-up
ENDEAVOR DES Control n= 31
Geography: Belgium, Germany and Brazil
DESyne BD DES n= 115
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 monthsAnti-Platelet Therapy for 12 months
EXCELLA BD Study Organization
Principal Investigators• Alexandre Abizaid• Stefan Verheye
Steering Committee:• Alexandre Abizaid• Stefan Verheye• Peter Fitzgerald
DSMB• Otavio Berwanger• Adriana Moreira• Ricardo Pavenello
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
EXCELLA BD Investigators
J. SCHOFER HAMBURG - GERMANY 42A. ABIZAID SAO PAULO, BRAZIL 28R. BOTELHO UBERLANDIA, BRAZIL 24S. VERHEYE ANTWERPEN - BELGIUM 23K.E. HAUPTMANN TRIER - GERMANY 13M. PERIN SAO PAULO, BRAZIL 6H. CASTELLO SAO PAULO, BRAZIL 6M. WIEMER BAD OEYNHAUSEN -
GERMANY5
C. DUBOIS LEUVEN - BELGIUM 3M. WAINSTEIN PORTO ALEGRE, BRAZIL 1
Novolimus-eluting stentN=115 pts (NL=127)
Zotarolimus-eluting stentN=31 pts (NL=38)
1 Deregistered3 Withdrew consent
3 no study stent
6-day clinical FUPN=115 pts
Intention to treat analysisPts, patients; NL number of lesions; NIVUS number of IVUS
151 patients (NL=168)enrolled and randomized
Angio FUP 94.5%
6-month clinical FUPN=113 pts
9-month clinical FUPN=31 pts
6-month clinical FUPN=31 ptsClinical FUP
98.6%
Clinical FUP 100%
Patient Flow and Follow-up
6-month angio FUPN=107 pts
(NL= 119) (NIVUS = 35)
6-month angio FUPN=31 pts
(NL= 38) (NIVUS = 16)
1 Deregistered
Baseline Patient Characteristics
Patient Characteristics DESyne BD
(N=115 patients)ZES
(N=31 patients)
Age, years (± SD) 65.0±9.3 60.4±10*
Male 63.5% 77.4%
Diabetes mellitus 28.7% 25.8%
Current Smoker 18.3% 29.0%
Hypercholesterolemia 72.2% 80.7%
Hypertension 80.9% 80.7%
Previous myocardial infarction 25.2% 32.3%
Previous CABG 5.2% 0.0%
Previous PCI 20.0% 25.8%
Unstable angina 10.4% 9.7%
*p=0.028; all others p=ns
Baseline Lesion Characteristics
Lesion Characteristics DESyne BD
(N=127 lesions)ZES
(N=38 lesions)
Target Vessel
Left anterior descending 43.3% 39.5%
Left Circumflex 27.6% 21.1%
Right coronary artery 29.1% 39.5%
AHA/ACC Lesion class C 16.5% 21.1%
Lesion Length, mm (± SD) 14.59±5.53 15.30±5.29
Reference Vessel, mm (± SD) 2.94±0.38 3.01±0.46
Ostial Lesion 3.1% 2.6%
Moderate to Heavy Calcification 34.6% 36.8%
Thrombus 0.8% 0%
Bifurcation 7.9% 5.5%
p=ns for all characteristics
Angiographic Results 6 months
In-Stent Analysis Novolimus Zotarolimus P value
RVD. mm N(L)=119 N(L)= 38
Post-procedure 3.00±0.37 3.08±0.35 0.31
At 6-months 2.95±0.37 2.99±0.38 0.67
MLD / Late Lumen loss (LLL), (mm)
Acute gain 1.87±0.42 2.01±0.43 0.09
MLD post-procedure 2.76±0.37 2.90±0.34 0.04
MLD at 6-months 2.64±0.39 2.22±0.53 <0.001
LLL at 6-months (in-stent) 0.12±0.15 0.67±0.47 < 0.001
Diameter Stenosis (%)
Post-procedure 8.5±44 6.2±4.5 0.002
At 6-months 11.0±6.6 25.6±15.1 < 0.001
Binary Restenosis (%) (in-stent) 0.0% 7.9% 0.003
Zone of Superiority
0.40-0.50 -0.40 -0.30 0.300.00 0.10 0.20-0.60
Upper one-sided 95% CI
Zone of non-inferiorityPre-specified margin=0.20mm
-0.20 -0.10
Novolimus
0.12
Zotarolimus
0.67
DELTA*(Upper 1-sided 95% CI)
-0.55 (-0.44)
Non-inferiority P value
<0.001
Superiority P value
<0.001*Least square means
Primary Endpoint Analysis: 6-month In-Stent Late Lumen Loss
Met Primary Non-Inferiority Endpoint and Superiority Endpoint
Zone of non-inferiority
Zone of inferioritySuperior
Clinical Results –12 months
0 to 360 days, % (n)DESyne (N=112)
Endeavor(N= 31)
P-Value
HIERARCHICAL EVENTS
DEVICE ORIENTATED COMPOSITE 2.7% 3.2% 1.00
CARDIAC DEATH 0.0% 0.0% --
TARGET VESSEL MI 0.9% 0.0% 1.00
CLINICALLY-INDICATED TLR 1.8% 3.2% 0.52
Definite/Probable Stent Thrombosis 0.0% 0.0% --
Modified Intention to Treat (patients who received a study stent)
Cardiac Events at 12 months
DESyne BD 12m Endeavor 12m0.0%
0.5%
1.0%
1.5%
2.0%
2.5%
3.0%
3.5%
0.0% 0.0%
0.9%
0.0%
1.8%
3.2%
2.7%
3.2%
Cardiac Death TV-MICI-TLR MACE (TLR, Cardiac Death, MI)
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