Biodegradable Polymer Stents?

ERACI IV Registry
Treatment of Complex Multivessel PCI.
A New Sirolimus Chromiun Cobalt Alloy DES.
Study Design and Case Presentation
Carlos Fernandez-Pereira MD ,PhD, FACC,FESC
CECI-Centro de Estudios en Cardiología
Intervencionista,
Buenos Aires, Argentina
Financial disclosure
Nothing to disclose
5 years all cause of mortality
S Verma et al. Lancet, Published online Sept 13, 2013
MVD Trial Mystakes
SYNTAX, FREEDOM, CARDia,VA CARD
#Inadequate PCI strategy.
#Obsolete DES design- first generation use in Diabetic patients.
#Complex bifurcations technique including vessels with1.5mm
# Wide range differences in MACE among PCI operators .
# Low rate of complete functional revascularization .
HOW CAN WE IMPROVE
THESE RESULTS?
ERACI IV Registry
Revascularization Strategies for Patients with
Multiple Vessel Coronary Disease in the Real World.
A Prospective, Multicenter and Controlled Registry with a Cobalt-
Chromium Rapamycin Eluting Stent, FIREBIRD 2®
ERACI IV
STUDY DESIGN
Prospective Multicenter National Registry that will include
225 consecutive patients with coronary artery disease
suitable for treatment with PCI in Argentina.
PRODUCT
Firebird -2 is a second generation sirolimus eluting coronary
stent with a cobalt chromium alloy stent platform, with a
polyolefin polymer platform
Sirolimus Chromiun Cobalt Alloy DES Firebird 2
ERACI IV Registry
Principal Investigator
Dr. Alfredo E. Rodriguez, MD, PhD FACC
Sanatorio Otamendi y Miroli, Argentina
Coordinating Center
Centro de Estudios en Cardiología
Intervencionista
Matías Rodriguez Granillo
Mónica Buus
Sponsor
MicroPort Inc, Shanghai, China.
Jonathan Chen MD
María Angélica Olivero
ERACI IV Registry
Participating centers
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Sanatorio Otamendi y Miroli, Buenos Aires City, Argentina.
Sanatorio Las Lomas, San Isidro City, Buenos Aires Province, Argentina.
Clínica IMA, Adrogué City, Buenos Aires Province, Argentina.
Sanatorio San Lucas, San Isidro City, Buenos Aires Province, Argentina.
Centro Médico Talar, Tigre City, Buenos Aires Province, Argentina.
Policlínica Privada Angiocor, La Plata City, Buenos Aires Province, Argentina
Clínica Privada Provincial, Merlo City, Buenos Aires Province, Argentina
Clínica de Cuyo, Mendoza City, Mendoza Province, Argentina.
Hospital Español, Godoy Cruz City, Mendoza Province, Argentina.
Sanatorio San Miguel, San Miguel City, Buenos Aires Province, Argentina.
Sanatorio Belgrano, Mar del Plata City, Buenos Aires Province, Argentina
Hospital el Cruce, Florencio Varela City, Buenos Aires Province, Argentina.
Sanatorio de la Trinidad, Quilmes City, Buenos Aires Province, Argentina.
Hospital Español, La Plata City, Buenos Aires Province, Argentina
Hospital Militar Central, Buenos Aires City, Argentina.
FIRST Patient  2013 – 03 - 12
ERACI IV
PRIMARY ENDPOINT
Incidence of major adverse cardiovascular events
(MACCE) defined as any cause of death, acute myocardial
infarction (AMI) ST and non ST elevation, stroke and
unplanned new revascularization in patients with coronary
artery disease using Firebird-2 vs. ERACI III population
(DES and CABG arms) at 30 days, 3, 6 and 12 months of
follow-up.
SECONDARY ENDPOINTS
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Target Lesion Failure (TLF), defined as cardiac death,
AMI and target lesion revascularization (TLR)
Target Vessel Revascularization (TVR)
Overall stent thrombosis (ARC)
ERACI IV
Inclusion Criteria
• Patients ≥18 years
• Acute Coronary Syndromes ,included non STEMI.
• Significant coronary artery disease suitable for PCI or CABG
• Left Main disease
• 2 or 3 vessel disease
• Lesions ≥ 70% by visual estimation
Exclusion Criteria
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Pregnancy
LVEF ≤ 35%
STEMI during the first 72 hrs.
Previous PCI with DES in the target vessel
Recent PCI (6 months)
Lesion diameter < 2.5 mm
Renal Failure, contraindications for DAPT, thrombocytopenia,
leukopenia
ERACI IV Registry
In-Hospital and 30 days follow-up
First 150 patients
Baseline demographics characteristics
N patients
150
Age (yrs)
64.1+/-11.3
Male gender
80.8%
Previous AMI
28.6%
Previous PCI
28.7%
Previous CABG
2.6%
Diabetes mellitus
29.3%
Insulin
0.7%
Non-Insulin
28.6%
HBP (mmHg)
61.8%
High Cholesterol
61.4%
Previous CVA
2.55%
Family history CAD
30.6%
PVD
10.9%
Renal failure
1.3%
Smoking status
Current
25.4%
Previous
29.7%
Never smoked
44.9%
ERACI IV
ERACI IV
Baseline clinical characteristics
Unstable angina
1, 2, 3 A
1.B
1.C
2.B
3.B
3.C
Stable angina
I
II
III
Silent ischemia with positive
test
AMI > 72 hs <30 days
54.5%
18.5%
14.8%
1.2%
8.6%
53.0%
2.5%
38.3%
12.3%
33.3%
54.4%
10.7%
4.7%
ERACI IV
Baseline angiographic findings
EF%
N° lesions (>50%)
N° lesions per patient
N° vessels
LMD
3 vessels disease + LM
Previous PCI reference diameter
(mm)
Diameter stenosis (%)
Lesion length (mm)
Plaque type
A
B1
B2
C
ISR
Bifurcated lesions
53.3 +/- 9.6
416
2.8+/-1.1
327
7.4%
68.4%
2.99+/-0.38
85.2+/-9.9
21.2+/-9.1
4.7%
50.8%
30.1%
14.4%
12.7%
16.1%
ERACI IV
Procedural characteristics (cont)
Medication during PCI
Heparine
Thyenopyridines
Clopidogrel
Prasugrel
Ticagrelor
IIb/IIIa Inhibitors
Femoral access
Radial access
Elective procedure
N° treated lesions
N° treated lesions per patient
N° treated vessels
N° treated vessels per patient
100.0%
98.5%
55.7%
31.3%
12.9%
9.7%
93.9%
6.1%
77.4%
237
1.6+/-0.9
194
1.29+/-0.4
ERACI IV
Procedural characteristics (cont)
Treated vessel
RCA
LAD
LCX
LM
Pre-dilatation
N° of implanted FIREBIRD-2
N° FIREBIRD-2 per patient
FIREBIRD-2 diameter (mm)
FIREBIRD-2 length (mm)
Max atmospheres
Post dilatation
Overlapping
% diameter stenosis (visual
estimation)
22.2%
45.9%
24.7%
7.2%
79.7%
261
1.74
2.96+/-0.37
23.3+/-6.0
13.6+/-2.3
75.0%
23.7%
7.6+/-4.6
CASE 1
Pt 02018 UBAN
54 y.o. male with HBP, and ex smoker
Symp: UA IIIB
ANGIO RCA
ERACI IV Registry
CASE 1
Pt 02018 UBAN
Critical lesion
LM – LCX
ERACI IV Registry
CASE 1
Pt 02018 UBAN
Balloon 2,5x15 mm to LM
ERACI IV Registry
Balloon 2,5x15 mm to LCX
CASE 1
Pt 02018 UBAN
ERACI IV Registry
Post DES
FIREBIRD 2
3.5x18 mm
CASE 1
Pt 02018 UBAN
ERACI IV Registry
Post - kissing balloon
Kissing balloon
CASE 1
Pt 02018 UBAN
ERACI IV Registry
High pressure balloon
3.0x15 mm
High pressure balloon
3.5x15 mm
CASE 1
Pt 02018 UBAN
ERACI IV Registry
FINAL RESULT
CASE 1
Pt 02018 UBAN
ERACI IV Registry
IVUS
Post Left Main
CASE 1
Pt 02018 UBAN
ERACI IV Registry
FIREBIRD 2.5x23 mm to prox RCA
CASE 2
Pt 01045 PERA
72 y.o. male with DM, HBP and High Cholesterol
Symp: UA IIIB
ERACI IV Registry
MID LAD and MID LCX ,bifurcations
CASE 2
Pt 01045 PERA
ERACI IV Registry
CASE 2
Pt 01045 PERA
ERACI IV Registry
Balloon to LCX
FIREBIRD 2 3.5x23 mm
Balloon LCX
CASE 2
Pt 01045 PERA
ERACI IV Registry
FINAL RESULT (LCX)
CASE 2
Pt 01045 PERA
ERACI IV Registry
Balloon to LAD
CASE 2
Pt 01045 PERA
ERACI IV Registry
FIREBIRD2
Kissing to LAD and 1st
Diagonal
3.0 x 18 LAD
CASE 2
Pt 01045 PERA
ERACI IV Registry
FINAL RESULTS
CASE 2
Pt 01045 PERA
ERACI IV Registry
ANGIO RCA
CASE 2
Pt 01045 PERA
ERACI IV Registry
CASE 2
Pt 01045 PERA
ERACI IV Registry
FIREBIRD 2
2.5x18 mm to RCA
FINAL RESULT
ERACI III & IV
30 Days Results Comparison
ERACI III
DES
0.9%
0.9%
1.3%
1.8%
ERACI III
CABG
5.7%
5.7%
0.9%
11.4%
ERACI IV
Firebird2
0.7%
0.7%
0.0%
1.4%
P value
TVR
1.3%
0.0%
0.7%
0.23
TLR
1.3%
0.0%
0.0%
0.11
MACCE
4.4%
12.3%
3.3%
0.004
Any death
Q-MI
CVA
Death+Q MI
0.003
0.003
0.5
0.001
Conclusions
For MVD PCI better results ...
1 -We need to improve
DES design(alloy-drug-polimers).
2-Change PCI techniques. As simple as
possible.
3-Try to get complete functional
revascularization.
4- Complete in Hospital and 30 days
Follow up of the entire group of
patients of ERACI IV, will be presented
at CIT 2014.
ERACI IV
THANK YOU¨!
Case 03
02-007 MARO
Male 55 y.o
High Cholesterol, current smoker with previous PCI
UA IIIB
2013-04-25
ERACI IV
Case 03
Prox RCA predilatation with
Riujin balloon 2.0 x 15 mm
ERACI IV
Case 03
Prox RCA post balloon
ERACI IV
Case 03
Distal RCA predilatation
Riujin balloon 2.5 x 15 mm
ERACI IV
Distal RCA post balloon
Case 03
Prox RCA
FIREBIRD 2 3.0 x 23 mm
ERACI IV
Distal RCA
FIREBIRD 2 3.0 x 33 mm
Case 04
ERACI IV
Post stents
Riujin balloon 2.5x15 mm PD RCA
Case 03
ERACI IV
FINAL RCA RESULTS
Case 04
ERACI IV
FIREBIRD2
3.0 x 18 mm to Distal LAD
Case 03
ERACI IV
Post stent to Distal LAD
Case 04
ERACI IV
Prox. FIREBIRD2 LAD
3.0 x 33 mm
Case 03
ERACI IV
Prox LAD Post stent
Case 04
ERACI IV
FINAL LAD RESULTS
biodegradable polymers and durable polymer stents?
that question was answered by the NOYA-I study, reported
by Run-Lin Gao, MD, of Fu Wai Hospital in Beijing, China,
That trial compared the sirolimus-eluting FIREBIRD 2 stent
popular in China, which uses the same durable polymer as
Taxus stents, and the novel Noya stent, which uses an
identical backbone and drug, with the exception of a
biodegradable polymer.
During nine month follow up of the 300 patients in China
randomized to treatment in the trial, in-stent late lumen loss
was comparable with the biodegradable polymer stent at
0.11 versus 0.13 mm (P<0.001 for noninferiority).
All clinical endpoints likewise came out equivalent at nine
and 12 months between the two stents.
Gao R-L, et al "NOYA I: A prospective randomized trial
of NOYA sirolimus-eluting stent with biodegradable coating
compared to FIREBIRD 2 sirolimus-eluting stent with durable
coating in patients with coronary artery disease 9-month
angiographic and 12-month clinical results"EuroPCR 2011.
Polymer-Free Stents?
The answer could be the study comparing five-year outcomes with a
polymer-free sirolimus-eluting stent (Translumina Yukon) and a
durable polymer paclitaxel-eluting Taxus stent showed that the
equivalent clinical outcomes persisted. Definite stent thrombosis
among these 450 stable patients, randomized in the ISAR-TEST study,
was numerically less common with the polymer-free stent at five years,
but not statistically significant (0.4% versus 1.3%, P=0.32).
King LA, et al "5 year clinical outcomes of a polymerfree sirolimus-eluting stent versus
a polymer-based paclitaxel-eluting stent: The ISAR-TEST trial" EuroPCR 2011.
Biodegradable Polymer Stents?
The study pooling individual patient data with biodegradable polymer stents across
ISAR-TEST 3, ISAR-TEST 4, and LEADERS studies at three years was reported by
Byrne ,Those trials randomized a total of 4,052 patients to the first-generation
Cypher stent compared with the Yukon stent or the biolimus-eluting Biomatrix
Flex stent for the biodegradable arm.
The biodegradable polymer stents halved the rate of definite stent thrombosis at three
years compared with the permanent polymer stent (1.2% versus 2.1%, hazard ratio
0.50, P=0.013). In a landmark analysis, this lower risk persisted overall, for events
past 30 days, and for very late events past one year (P=0.01 to P=0.02).
The combination of definite and probable stent thrombosis showed a non-significant
trend for three-year reduction in risk (hazard ratio 0.68, P=0.11), as did the composite
of cardiac death and myocardial infarction, (HR 0.88, P=0.28).
Target lesion revascularization, though, was significantly reduced at three years with
the biodegradable polymer stents (12.0% versus 13.2%, HR 0.82, P=0.04).
Thus the primary composite endpoint of cardiac death, MI, and target lesion
revascularization favored the biodegradable stents at 18.2% versus 20.1% (HR
0.85, P=0.04).
Byrne RA, et al "Biodegradable polymer versus durable polymer drug-eluting stents for patients
with coronary artery disease: 3-year pooled analysis of individual patient data from ISAR-TEST 3,
ISAR-TEST 4, and LEADERS randomized trials" EuroPCR2011.
Meta-analysis of CABG vs PCI in diabetic
patients
Repeat REVASCULARISATION
S Verma et al. Lancet, Published online Sept 13, 2013