Presentación de PowerPoint

Simposio FAC-CACI 2016
Congreso Nacional de Cardiologia- Federacion
Argentina de Cardiologia(FAC)
Cordoba, 23 de Junio 2016
VII
“
Alfredo E Rodriguez, MD, PhD, FACC, FSCAI,IAGS
Fundador & Director
Centro de Estudios en Cardiología Intervencionista (CECI)
Jefe de Cardiología Intervencionista
Sanatorio Otamendi /Las Lomas
Editor en Jefe Revista RACI
Director Asociado TCT 2015/2017 (CRF)
DECLARO NO TENER CONFLICTOS DE INTERÉS
Long-Term Safety and Efficacy of Percutaneous Coronary Intervention
With Stenting and Coronary Artery Bypass Surgery for Multivessel
Coronary Artery Disease
A Meta-Analysis With 5-Year Patient-Level Data From the ARTS, ERACI-II,
MASS-II, and SoS Trials
Joost Daemen, Eric Boersma, Marcus Flather, Jean Booth, Rod Stables, Alfredo E Rodriguez,
Gaston Rodriguez-Granillo, Whady A. Hueb, Pedro A. Lemos, Patrick W. Serruys,
Freedom From Death (A) and from
Death and Myocardial Infarction (B)
Daemen et al. Circulation. 2008;118:1146-1154
HRs for each trial individually and the pooled estimate for all trials
(corrected for between-trial outcome) for the end points of all-cause
mortality (A) and all-cause death, stroke, and MI (B)
Daemen et al. Circulation. 2008;118:1146-1154
PRIMARY OUTCOME – DEATH / STROKE / MI
PCI/DES
CABG
Logrank P=0.005
Death/Stroke/MI, %
30
PCI/DES
20
CABG
10
5-Year Event Rates: 26.6% vs. 18.7%
0
0
1
2
3
4
5
6
Years post-randomization
PCI/DES N
CABG N
953
848
788
625
416
219
40
s943
814
758
613
422
221
44
Farkouh et al. N Engl J Med 2012;367:2375-84.
The SYNTAX lesion score is
calculated by grading 11 types of
lesions by answering sequential
interactive questions
YES: Non Guided
-Intermediate (50 to 69%) or
Severe Stenosis (≥ 70%) with RD ≥
1.5 mm)
Goal
Complete Revascularization
Sianos G, et al. EuroIntervention. 2005 Aug;1(2):219-27.
Long-Term Outcome of PCI Versus CABG in
Insulin and Non–Insulin-Treated Diabetic
Patients - Results From the FREEDOM Trial
REVASCULARIZATION STRATEGIES IN DIABETIC
PATIENTS
Consequences of Geographical
Disparities in CABG Results
Death/MI/CVA Primary Composite Outcome
ITDM vs Non-ITDM by Treatment allocation
GD Dangas et al. J Am Coll Cardiol 2014;64:1189–97
Kaplan-Meier Event-Free Estimated Event Rates for CABG
Versus PCI (Non-ITDM and ITDM)
GD Dangas et al. J Am Coll Cardiol 2014;64:1189–97
Frequency of Angina by Treatment Group
Abdalla et al. JAMA. 2013;310(15):1581-1590.
Meta-analysis of CABG vs PCI in diabetic patients
5 years all cause of mortality
S Verma, ME Farkouh et al. Lancet Diabetes Endocrinol. 2013 Dec;1(4):317-28
REVASCULARIZATION STRATEGIES IN DM PATIENTS
PCI: Stent Design
Revascularization
BMS and First Generation DES
narrowed the gap in TVR…
Mortality
But First Generation DES created
a new gap: MORTALITY.
New Generation DES could keep the Revascularization
Gap narrow with no excess in mortality...
Bangalore S et al .Circ Cardiovasc Interv. 2014 Aug;7(4):518-25.
HOW WE IMPROVED
THESE RESULTS?
Better DES
Designs
Different PCI
Strategy
Stent thrombosis and new DES generations
Biodegradable polymers
GG Stefanini, RA Byrne, PW Serruys et al.
Eur Heart J. 2012 May;33(10):1214-22
SJ Park et al. N Engl J Med. 2015 Mar 26;372(13):1204-12
HOW WE IMPROVED
THESE RESULTS?
Better DES
Designs
Change PCI Strategy
ERACI IV STUDY DESIGN
1917 PCI
march 2013-feb 2014
8 pts excluded
didn´t met
angio criteria
233 patients with
multiple vessel CAD
and no clinical EC
225 pts with PCI with
Rapamycin Chromium Cobalt
Alloy ES
EXCLUSION CRITERIA
Pregnancy
LVEF ≤ 35%
Recent STEMI (< 72 hs)
PCI with DES in intention to treat artery
Recent PCI (6 months)
Lesion diameter ≤ 2.5 mm
CRF, CI for DAPT, thrombocitopenia, leukopenia
INCLUSION CRITERIA
ACS, SA or large area at myocardium at risk
Significant CAD suitable for PCI or CABG
ULMD
2 or 3 vessel disease
Lesions ≥ 70% by visual estimation
PRIMARY END POINT
ERACI III : 225 pts
VS 1° DES generation (Taxus/Cypher)
MACCE
Haiek C, Rodriguez AE et al. Catheter Cardiovasc Interv. 2016 Mar 7
Modifying angiographic syntax score according to PCI
strategy: lessons learnt from ERACI IV Study
YES.
-Guided
-Severe stenosis (≥ 70%) with RD ≥
2.0 mm)
NO.
-Intermediate lesions (50-69%)
-Severe lesions in vessels with RD <
2 mm
Rodriguez AE et al. Cardiovasc Revasc Med. 2015 Oct-Nov;16(7):418-20.
Classical SYNTAX score and Modified by ERACI IV Syntax score
comparison from ERACI IV trial population.
Rodriguez AE et al. Cardiovasc Revasc Med. 2015 Jul 11.(15)00182-7
DS > 70% y RD > 2.0
mm
RD < 2.0 mm
DS < 70%
PT ID:01-082
SYNTAX score=37 (Red & blue arrows) 7 DES
Modified ERACI IV SYNTAX score=31 (Red arrows) 3 DES
Rodriguez AE et al. Cardiovasc Revasc Med. 2015 Oct-Nov;16(7):418-20.
ERACI III vs ERACI IV
Events progression comparison at 2 years of follow-up
20
0.56
0.04
0.07
0.01
0.003
18
0.001
0.17
16.9
16
14
11.6
12
9.3
10
8
6.7
6
4
4.4
3.1 2.2
4.0
3.6
3.1
3.1
1.3
2
0.9
0.4
Death
AMI
CVA
D/MI/CVA
TVR
MACCE
Stent
thrombosis
Two years follow-up
Haiek C, Rodriguez AE et al. Catheter Cardiovasc Interv. 2016 Mar 7 (ahead of print)
24.5 +/- 3.8 months of follow-up results from ERACI IV study. Diabetic vs
non-diabetic subgroup analysis
Cummulative outcome of hard clinical events and primary endpoint.
Haiek C, Rodriguez AE et al. Catheter Cardiovasc Interv. 2016 Mar 7
25 Years Journey of PCI in Multiple Vessels CAD:
Insights from ERACI I to IV studies
71.4%
37.5%
33.3%
17.7%
ERACI I - 1993
ERACI II - 2001
0.09
0.02
23.4%
7.0%
5.8%
9.0%
ERACI III - 2006
0.006
ERACI IV - 2016
0.9
•
1- Los RCT que utilizaron 1ra generacion de DES los resultados de PCI
fueron inferiors a aquellos realizados dos decadas atras con BMS, por lo
tanto no deben ser utilizados como referencia en la toma de decisiones.
•
2- En la era de los nuevos disenos de DES la incidencia de eventos a largo
plazo entre pacientes diabeticos y no diabeticos no es ya mas significativa
en aquellos que fueron tratados con PCI.
•
3-El uso de 2da generacion de DES + PCI “Funcionalmente” guiada estuvo
asociada a una considerable baja incidencia de eventos cardiacos
mayores tanto en poblaciones diabeticas (5.8%) como no diabeticas
(7.1%).
•
4- La penalidad a 25 meses de seguimienrto en no tratar lesiones
intermedias y/o severas en vasos de pequeno calibre fue de 1.3% de
nuevos procedimientos de revascularizacion que asociado al 6.7% de
MACCE validan la estrategia de PCI elegida.
•
5-El HEART Team es importante en la toma de decisiones solo cuando la misma
esta guiada por un criterio clínico adecuado que se debe trasladar en el momento
que la PCI o el CABG es realizado.
Baseline demographic, clinical, angiographic and procedural characteristics
Overall population and after matching results.
ERACI III
Age
65.5 +/- 10.6
Sex
83.6
Previous myocardial infarction
32.4
Diabetes mellitus
20.9
Previous revascularization
22.7
High blood pressure
79.6
High cholesterol
79.1
Peripheral vascular disease
11.6
Unstable angina IIb/IIIc
40.7
Left main disease (LMD)
5.8
3 vessel CAD+LMD
38.2
N° stents per patient
1.79+/- 0.7
ERACI IV
63.9 +/- 11.2
85.6
33.3
30.7
34.7
78.7
66.7
6.7
64.2
9.8
54.3
1.8 +/- 0.9
P value
0.06
0.89
0.68
0.02
0.007
1.00
0.04
0.07
<0.001
0.11
0.003
0.8
ERACI III
65.1 +/- 9
75.9
35.2
30.6
29.6
88.0
82.4
9.3
60.2
6.4
39.8
1.83 +/- 0.8
ERACI IV
64.3 +/- 9
82.4
37.0
28.7
35.2
90.7
69.4
5.6
71.2
10.1
56.5
1.8 +/- 0.8
P value
0.50
0.24
0.77
0.76
0.38
0.50
0.02
0.29
0.77
0.29
0.01
0.7
ERACI
III
ERACI
IV
RR (CI 95%)
Sig
level
Any cause of death (%)
3.7
0.9
0.25 (0.02 to 2.20)
0.21
Myocardial infarction (%)
5.6
0.9
0.16 (0.02 to 1.36)
0.09
Non-fatal CVA (%)
1.9
0.0
0.2 (0.009 to 4.11)
0.29
Death/Myocardial Infarction/CVA (%)
8.3
1.9
0.22 (0.04 to 1.00)
0.05
Unplanned revascularization (%)
12.0
2.8
0.23 (0.06 to 0.78)
0.01
MACCE (Death/Myocardial infarction/CVA/TVR) (%)
16.7
3.7
0.22 (0.07 to 0.6)
0.005
PROPENSITY SCORE (n=216)
Haiek C, Rodriguez AE et al. Catheter Cardiovasc Interv. 2016 Mar 7
ERACI IV Study Organization
•
Clinical Events Committee: David Antoniucci, MD (CEC Chairperson); Eduardo Gabe, MD (Sanatorio
Otamendi y Miroli, Buenos Aires, Argentina); Fernando Sokn, MD (Clínica IMA. Adrogué, Argentina) and
Pablo Stutzbach, MD (Sanatorio Las Lomas. San Isidro, Argentina).
•
Angio corelaboratory: Claudio Llauradó, Bs and Alejandro Incarbone, Bs (Centro de Estudios en
Cardiología Intervencionista. Buenos Aires, Argentina).
•
Clinical Project Management: Centro de Estudios en Cardiología Intervencionista (Alfredo M.
Rodriguez- Granillo, Project Manager; Alfredo E. Rodriguez, Director).
•
Biostatistic analysis: Centro de Estudios en Cardiología Intervencionista. (Gastón Rodríguez-Granillo,
MD, PhD; Alfredo M. Rodriguez-Granillo, MD).
•
Safety monitoring: Comité de Ética en Investigación Clínica, Buenos Aires, Argentina.
•
Study Sites and PI: Sanatorio Otamendi y Miroli, Buenos Aires; Clínica IMA, Adrogué, Buenos Aires
(Carlos Fernández-Pereira, Carlos Mauvecín); Sanatorio Las Lomas, San Isidro, Buenos Aires (Juan
Mieres); Sanatorio de la Trinidad, Quilmes, Buenos Aires (Carlos Haiek); Clínica provincial de Merlo,
Merlo, Buenos Aires (Omar Santaera); Sanatorio San Miguel, San Miguel, Buenos Aires (Juan Lloberas);
Hospital Español, Mendoza (Miguel Larribau); Hospital El Cruce, Buenos Aires (Ricardo Sarmiento);
Instituto de Diagnóstico y Tratamiento de Afecciones Cardiovasculares, La Plata, Buenos Aires (Ignacio
Rifourcat); Centro Médico Talar, Pacheco, Buenos Aires (Antonio Pocoví); Hospital Militar Central, Buenos
Aires (Oscar Carlevaro); Clínica Privada Angiocor, La Plata, Buenos Aires (Elías Sisu); Sanatorio
Belgrano, Mar del Plata, Buenos Aires (Alejandro Delacasa); Sanatorio San Lucas, San Isidro, Buenos
Aires (Antonio Pocoví);
Take Home Message
In Conclusion, this observational, prospective, multicenter and
controlled study with Firebird 2 DES in patients with multiple
vessel disease including left main stenosis, showed at two years
a remarkable low MACCE rate, just as lower rates for all
individual components of the end points.
Low events rate was also seen in Diabetic patients and this was
an unique finding in all ERACI studies.
This new Angiographic Risk Score appears to be useful to guide
PCI operators during stent implantation and it was validated by
low cardiac events and TLR rate at 2 years ( treated / non
treated lesions ).
Limitations
• Patients treated with 2nd generation DES were prospectively included years
later than those treated with the first generation ones, and during those
years, significant improvement in medical therapies have been introduced,
in fact ERACI IV patients with complex CAD were under more active P2Y12
such as prasugrel or ticagrelor.
• Secondly it is clear that FFR is the most accurate tool to assess functional
revascularization strategy and lesion assessment .FFR was not used in this
• study, also, is well known that incomplete revascularization were linked
with poor outcome after PCI, however, long term outcome of those patients
with incomplete anatomical or functional revascularization would be
different if the residual non-treated lesions were intermediate or critical.
• Finally, baseline clinical and angiographic characteristics between both
groups were not equal, although all differences associated with poor
outcome during PCI are more frequently present in ERACI IV, moreover, low
MACCE rate in patients treated with 2nd generation DES remained after a
matched propensity score was performed.
Conclusion
• El uso de Score de Riesgo Funcionales ya sea mediante la utilizacion
de mediciones Funcionales durante la PCI como FFR, la valoracion
clinica funcional del paciente previo al procedimiento y/o la
utilizacion de un analisis critico de las lesiones coronarias, Score de
riesgo ERACI IV, considerando solo lesiones severas en vasos
importantes, permiten una estrategia mas racional y conservadora
durante la angioplastia evitando la implantacion innecesaria de
multiples stents en comparacion al uso de Score de riesgo
puramente anatomicos como el Syntax original.
• Lo anterior conjuntamente con el uso de 2da generacion de DES es
lo que podria explicar los resultados sorprendentemente bajos a dos
años de eventos cardiacos adversos incluyendo muerte/IAM/ACV
demostrado en el estudio ERACI IV( 6.7% y 3.6% respectivamente)
hallazgo que tambien fue observado en el subgrupo de pacientes
diabeticos (5.8% y 1.4% respectivamente).
Mensaje para la Audiencia
• Antes y /o durante la PCI electiva
evaluar funcionalmente al
paciente y o a la lesion parece ser
mandatorio !! = Guided PCI
Abdalla et al. JAMA. 2013;310(15):1581-1590.