EXCELLA
DESyne BD
Novolimus Elution from a Biodegradable
Polymer Coated Coronary Stent
Stefan Verheye, MD, PhD
DESyne BD is CE mark approved, not available for sale in the US
I/we have no real or apparent conflicts of interest to report.
Innovating Vascular Restoration
Broad Product Portfolio
Novolimus:
excellent performance, known safety profile
Active metabolite of Sirolimus
– Binds to FKBP12 forming an
immunosuppressive complex
– mTOR inhibitor
Known Safety Profile
– Patients treated with Sirolimus orally or via
DES implantation exposed to significant
amount of Novolimus
Potent anti-proliferative
– Inhibition of proliferation of
hSMC IC50 = 0.5nM
Sustained performance with
low drug dose
– 5 ug/mm stent length for all
product platforms
Excellent clinical outcomes
A next generation
®
Co-Cr stent platform for DESyne BD
•
Platform
features
Cobalt chromium alloy stent with low strut thickness for high flexibility
and deliverability
•
Formula
coating technology with ultra thin polymer matrix without
a primer layer
•
Novolimus drug dose of 5 mcg per mm of stent length
TM
X
DESyne
BD
platform
Comparison
to other
leading DES*
Cypher
Xience /
Promus
Resolute
Strut
Thickness
(µm)
Polymer
Thickness
(µm)
Drug Load
(µg)
*Data on file at Elixir Medical
BioMatrix
Synergy
DESyne BD leaves no polymer behind
DESyne BD
• Ultra-thin conformal coating with
•
•
•
•
•
minimal polymer load
Biocompatible byproducts
Sustained Novolimus release from
stent, distributed uniformly in vessel
Low particulates
Leaves behind true metallic strut
CE Mark approved
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
DESyne BD DES
n= 115
Geography: Belgium, Germany and Brazil
Clinical Follow-up
Angiographic/IVUS (Subset) Follow-up
Primary Endpoint:
Clinical Follow-up
(non inferiority)
Key Secondary Endpoints:
Anti-Platelet Therapy for 12 months
30d
6mo
9mo
ENDEAVOR DES Control
n= 31
12mo
2-5yrs
In-Stent Late Lumen Loss at 6 months (QCA)
Device and Procedure (Clinical) Success
Device-oriented composite endpoint (Death, MI, or TLR)
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
DESyne BD
(N=115 patients)
Endeavor
(N=31 patients)
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%
Patient Characteristics
Age, years (± SD)
*p = 0.028; all others p=ns
DESyne BD
(N=127 lesions)
Endeavor
(N=38 lesions)
Left anterior descending
43.3%
39.5%
Left Circumflex
27.6%
21.1%
Right coronary artery
29.1%
39.5%
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
3.1%
34.6%
0.8%
7.9%
2.6%
36.8%
0%
5.5%
Lesion Characteristics
Target Vessel
AHA/ACC Lesion class C
Ostial Lesion
Moderate to Heavy Calcification
Thrombus
Bifurcation
p=ns for all characteristics
In-Stent Analysis
DESyne BD
Endeavor
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
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
8.5±44
6.2±4.5
0.002
11.0±6.6
25.6±15.1
< 0.001
0.0%
7.9%
0.003
RVD. mm
P value
MLD / Late Lumen loss (LLL), (mm)
Diameter Stenosis (%)
Post-procedure
At 6-months
Binary Restenosis (%) (in-stent)
Volumetric Analysis
%Neointimal volume obstruction (%)
N(L)=35
3.6±4.2
N(L)=16
20.7±14.2
< 0.001
Primary Endpoint Analysis
6-month In-Stent Late Lumen Loss
Novolimus
Zotarolimus
DELTA*
(Upper 1-sided 95% CI)
Non-inferiority
P value
Superiority
P value
0.12
0.67
-0.55 (-0.44)
<0.001
<0.001
*Least square means
Zone of non-inferiority
Pre-specified margin=0.20mm
Zone of noninferiority
Zone of Superiority
Superior
-0.60
-0.60
-0.50
-0.50
-0.40
-0.40
-0.30
-0.30
-0.20
-0.20
-0.10
-0.10
0.00
0.00
0.10
0.10
Zone of inferiority
0.20
0.30
0.40
Upper one-sided 95% CI
Met Primary Non-Inferiority Endpoint and Superiority Endpoint
0 to 360 days, % (n)
DESyne BD
(N=112)*
Endeavor
(N= 31)
P-Value
2.7%
3.2%
1.00
0.0%
0.0%
--
§
0.9%
0.0%
1.00
1.8%
3.2%
0.52
HIERARCHICAL EVENTS
DEVICE-ORIENTATED COMPOSITE
CARDIAC DEATH
TARGET VESSEL MI
CLINICALLY-INDICATED TLR
--
Definite/Probable Stent Thrombosis
§2
0.0%
vessel intervention with peri-procedural enzyme rise and no further complications
*Modified Intention to Treat (patients who received a study stent)
0.0%
Conclusions
• The EXCELLA BD Trial demonstrated both non-inferiority and
superiority of the DESyne BD Novolimus Eluting Stent
compared to the control for the primary endpoint of in-stent late
lumen loss at 6 months
• Angiographic binary restenosis for the DESyne BD stent was
significantly lower compared to the 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 DESyne BD stent
• There were no reported stent thrombosis through 12 months
DESyne BD is CE mark approved, not available for sale in the US