in-stent

Report
EXCELLA BD Randomized Trial
12-month Results
Ricardo Costa, MD
On behalf of the EXCELLA BD Investigators
••••••••
Elixir Medical Confidential
Elixir Medical DESyne BDTM Novolimus Eluting Coronary
Stent System
Platform features
DESyne BDTM
• Cobalt chromium alloy
• Biodegradable polymer
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
degrades in 6-9 months,
drug release over 4 weeks
• Workhorse DES that
leaves behind bare metal
surface
EXCELLA BD Randomized Clinical Trial
RANDOMIZED (3:1), SINGLE BLIND, MULTI-CENTER CLINICAL TRIAL
Co-Principal Investigators:
A. Abizaid and S.Verheye
Angiographic Core Lab: CRC
IVUS Core Lab: Stanford University
CEC/DSMB: CRC
Data Management: CRC
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
Cobalt Alloy Stent + Bioabsorbable Polymer + Novolimus @ 5µg per mm Stent Length
DESyne BD DES
n= 115
Clinical Follow-up
Angiographic/IVUS (Subset) Follow-up
Clinical Follow-up
Primary Endpoint:
Key Secondary Endpoints:
Anti-Platelet Therapy for 12 months
Geography: Belgium, Germany and Brazil
30d
6mo
9mo
12mo
ENDEAVOR DES Control
n= 31
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
EXCELLA BD Study Organization
Principal Investigators
Clinical Event Committee
•
•
•
•
•
Alexandre Abizaid
Stefan Verheye
Steering Committee:
•
•
•
Alexandre Abizaid
Stefan Verheye
Peter Fitzgerald
DSMB
•
•
•
Otavio Berwanger
Adriana Moreira
Ricardo Pavenello
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
A. ABIZAID
R. BOTELHO
S. VERHEYE
K.E. HAUPTMANN
M. PERIN
H. CASTELLO
M. WIEMER
C. DUBOIS
M. WAINSTEIN
HAMBURG - GERMANY
SAO PAULO, BRAZIL
UBERLANDIA, BRAZIL
ANTWERPEN - BELGIUM
TRIER - GERMANY
SAO PAULO, BRAZIL
SAO PAULO, BRAZIL
BAD OEYNHAUSEN - GERMANY
LEUVEN - BELGIUM
PORTO ALEGRE, BRAZIL
42
28
24
23
13
6
6
5
3
1
Patient Flow and Follow-up
151 patients (NL=168)
enrolled and randomized
1 Deregistered
3 Withdrew consent
3 no study stent
1 Deregistered
Zotarolimus-eluting stent
N=31 pts (NL=38)
Novolimus-eluting stent
N=115 pts (NL=127)
6-day clinical FUP
N=115 pts
6-month clinical FUP
N=113 pts
6-month angio FUP
N=107 pts
(NL= 119) (NIVUS = 35)
Clinical FUP 100%
Clinical FUP 98.6%
Angio FUP 94.5%
Intention to treat analysis
Pts, patients; NL number of lesions; NIVUS number of IVUS
9-month clinical FUP
N=31 pts
6-month clinical FUP
N=31 pts
6-month angio FUP
N=31 pts
(NL= 38) (NIVUS = 16)
Baseline Patient Characteristics
DESyne BD
(N=115 patients)
ZES
(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
Baseline Lesion Characteristics
DESyne BD
(N=127 lesions)
ZES
(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%
14.59±5.53
15.30±5.29
2.94±0.38
3.1%
34.6%
0.8%
7.9%
3.01±0.46
2.6%
36.8%
0%
5.5%
Lesion Characteristics
Target Vessel
AHA/ACC Lesion class C
Lesion Length, mm (± SD)
Reference Vessel, mm (± SD)
Ostial Lesion
Moderate to Heavy Calcification
Thrombus
Bifurcation
p=ns for all characteristics
Angiographic Results 6 months
In-Stent Analysis
Novolimus
Zotarolimus
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)
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
Superior
-0.60
-0.50
Zone of non-inferiority
Pre-specified margin=0.20mm
Zone of noninferiority
Zone of Superiority
-0.40
-0.30
-0.20
-0.10
0.00
0.10
Zone of inferiority
0.20
0.30
0.40
Upper one-sided 95% CI
Met Primary Non-Inferiority Endpoint and Superiority Endpoint
Clinical Results –12 months
DESyne
(N=112)
Endeavor
(N= 31)
P-Value
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
0 to 360 days, % (n)
HIERARCHICAL EVENTS
DEVICE ORIENTATED COMPOSITE
-Definite/Probable Stent Thrombosis
0.0%
0.0%
Modified Intention to Treat (patients who received a study stent)
Cardiac Events at 12 months
3.5%
3.2%
3.0%
2.7%
2.5%
1.8%
2.0%
1.5%
0.9%
1.0%
0.5%
0.0%
0.0%
0.0%
DESyne BD 12m
Cardiac Death
TV-MI
0.0%
Endeavor 12m
CI-TLR
MACE (TLR, Cardiac Death, MI)
3.2%
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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