intervencionismo coronario y en cardiopatías estructurales · 2014. 10. 23. · park sj. n engl j...
TRANSCRIPT
Intervencionismo Coronario y en
Cardiopatías Estructurales
Fernando Alfonso
Unidad Hemodinámica. Instituto Cardiovascular
Hospital Universitario Clínico San Carlos.
Madrid
¿Qué ha Cambiado en la Enfermedad Cardiovascular en el
Último Año?
Implicaciones para la Práctica Clínica
SEC. Casa del Corazón. 27 Enero 2012
“Late Breaking Clinical Trials” (LBCT)
Congresos Anuales
2010
2011 SHCI-Valencia
SHCI-Sitges Junio
Julio
Agosto
Septiembre
Octubre
Noviembre
Diciembre
Enero
Febrero
Marzo
Abril
Mayo
Junio
ESC 2010 Stockholm
AHA 2010 Chicago
TCT 2010 Washington
ACC 2011 N Orleans
PCR 2011 Paris
122 LBCT 48
Estudios en Cardiología Intervencionista
Revisiones Anuales
Dixon SR, et al. J Am Coll Cardiol 2011:55:2207-20.
Mayo 2011 (143 Referencias)
Rev Esp Cardiol 2011;64(Supl 1):13-19.
Enero 2011 (91 Referencias)
Intervencionismo Coronario
PRECOMBAT
Park SJ. N Engl J Med 2011;363:1718-1727.
RCT Stents versus CABG for Left Main Coronary Artery Disease (13 Sites, Korea)
ACC 2011
300 Pts SES vs 300 Pts CABG
1ry EP: D, MI, Stroke, I-TVR 2ry EP: D, MI, Stroke
Noninferiority p= 0.01
PRECOMBAT
Park SJ. N Engl J Med 2011;363:1718-1727.
ACC 2011
300 Pts SES vs 300 Pts CABG RCT Stents versus CABG for Left Main Coronary Artery Disease (13 Sites, Korea)
I-TVR: 9.0% SES vs. 4.2% CABG (HR 2.18, 95%CI 1.1-4.32; p = 0.02).
Protocol: “… Routine follow-up angiography was recommeded after SES
but not recommended for CABG patients … ”.
Late FU angiography 75% SES vs 25%, p<0.001.
The superb study results affected the prespecified noninferiority margin.
IVUS used in 91.2% Pts resulted favorable outcome …. Criteria ?
Pati
ents
, %
P=0.20 P=0.52 P=0.33 P=0.09 P=0.20
n= 348 357 49 42 122 136 106 112 71 67 All LM LM
+ 1VD LM
Isolated LM
+ 2VD LM
+ 3VD
TAXUS™ Stent CABG
Cumulative KM Event Rate; log-rank P value; *Binary rates
22.3
17.0
26.7
21.2 22.8
26.8
11.9
19.4
31.7 31.1
0
10
20
30
40
Left Main (All Subsets) MACCE at 3 Years
TCT 2010 Syntax
Left Main (All Subsets) MACCE at 4 Years
TCT 2011 Syntax
P=0.79
17.7%
0
Months Since Allocation
Cum
ula
tive E
vent
Rate
(%
)
25
50
0 12 48 24 36
Before 1 year* 9.2% vs 7.0%
P=0.29
1-2 years* 2.8% vs 3.2%
P=0.76
2-3 years* 2.6% vs 3.0%
P=0.76
3-4 years* 3.7% vs 4.9%
P=0.45
17.1%
TAXUS (N=357) CABG (N=348)
Left Main (All Subsets) MACCE at 4 Years
TCT 2011 Syntax TAXUS (N=357) CABG (N=348)
ITT population
P=0.03
4.3%
0
Months Since Allocation
Cum
ula
tive E
vent
Rate
(%
)
25
50
0 12 48 24 36
Before 1 year* 2.7% vs 0.3%
P=0.009
1-2 years* 0.9% vs 0.6%
P=0.68
2-3 years* 0.3% vs 0.3%
P=1.00
3-4 years* 0.3% vs 0.3%
P=1.00
1.5%
Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates
CVA
P=0.003
14.6%
0
Cum
ula
tive E
vent
Rate
(%
)
25
50
Months Since Allocation
0 12 48 24 36
Before 1 year* 6.5% vs 11.8%
P=0.02
1-2 years* 5.0% vs 8.2%
P=0.10
2-3 years* 2.6% vs 3.9%
P=0.36
3-4 years* 3.0% vs 4.0%
P=0.50
23.5%
Repeat
Revasc
DES: UPLM Meta-analysis RCT
Capodanno D, et al. J Am Coll Cardiol 2011;58:1426–32
1,611 Pts, 1 Year:
• LEMANS
• SYNTAX Left Main,
• Boudriot
• PRECOMBAT
Capodanno D, et al. J Am Coll Cardiol 2011;58:1426–32
DES: UPLM Meta-analysis RCT
Capodanno D, et al. J Am Coll Cardiol 2011;58:1426–32
NNT 63
NNT 17
DES: UPLM Meta-analysis RCT
DES: UPLM
Levine GN. J Am Coll Cardiol 2011;58 (Ahead of print)
ROTAXUS
High-Speed Rotational Atherectomy Prior to PES
Implantation in Complex Calcified Lesions
Richardt G. TCT 2011. San Francisco, CA.
Moderate to Severe Lesion Calcification
Higher rate of angiographic procedural success in the atherectomy arm
with no crossover or stent loss (92.5% vs. 83.3%; P = 0.03).
Predilation at higher pressure was required in the control arm but
procedure duration and fluoroscopy time were longer with rotablation
The superior acute gain was counterbalanced by an increased late loss
1ryEP
ISAR-CABG
Mehilli J. Munich
ACC 2011
610 PTs SVG: 303 Pts DES (SES/PES) vs 307 Pts BMS
RCT, Superiority Trial of DES vs BMS in SVG de novo Lesions
Is Drug-Eluting Stenting Associated With Improved Results inCoronary Artery Bypass Grafts?
Similar individual rates of Cardiac Death, MI, ST
Drug Eluting Balloon in Acute Myocardial Infarction:
Stella PR, TCT 2011
DIOR™-II Technology:
DEB-AMI
OCT+Acethylcholine
endothelial testing
EXAMINATION
(clinical Evaluation of Xience-V stent in Acute Myocardial INfArcTION)
“All Comers” design. 13 Centres 3 Countries
1504 STEMI (751 Pts Xience V vs 747 Pts Multi-link Vision)
ESC 2011
Sabate M, Barcelona, Spain
1ry EP
EXAMINATION
(clinical Evaluation of Xience-V stent in Acute Myocardial INfArcTION)
1504 STEMI (751 Pts Xience V vs 747 Pts Multi-link Vision)
Sabate M, Barcelona, Spain
Second vs First Generation DES
Alfonso F, Fernandez C. J Am Coll Cardiol 2011; 58:26-29
2Y Meta-analysis (EES vs PES) 4 RCT (6,608 Pts)
Stone G, et al. JAMA 2008;299:1903-13.
SPIRIT III
COMPARE
Kedhi E, et al. Lancet 2010;375:201-09.
Serruys PW, et al. Eurointervention 2006:2:286-294.
SPIRIT II
SPIRIT IV
Stone G, et al. N Engl J Med 2010;362:1663-74.
Alfonso F, Fernandez C. J Am Coll Cardiol 2011; 58:26-29
EES vs PES
2Y Meta-analysis
4 RCT (6,608 Pts)
Second vs First Generation DES
Alfonso F, Fernandez C. J Am Coll Cardiol 2011; 58:26-29
EES vs PES
2Y Meta-analysis
4 RCT (6,608 Pts)
Second vs First Generation DES
Alfonso F, Fernandez C. J Am Coll Cardiol 2011;58:1855-8.
1Y Meta-analysis EES vs SES: 8 RCT (11,351 Pts)
• BASKET-PROVE
• EXCELLENT
• SEA-SIDE
• ISAR-TEST-4
• SORT-OUT-4
• ESSENCE-DIABETES
• X-AMI
• RESET
Second vs First Generation DES
EES vs SES
1Y Meta-analysis
8 RCT (11,351 Pts)
EES Better SES Better
Alfonso F, Fernandez C. J Am Coll Cardiol 2011;58:1855-8.
Second vs First Generation DES
EES vs SES
1Y Meta-analysis
8 RCT (11,351 Pts)
EES Better SES Better
Alfonso F, Fernandez C. J Am Coll Cardiol 2011;58:1855-8.
Second vs First Generation DES
De la Torre JM, et al, Am Coll Cardiol Intv 2010;3:911–9
From 2005 to 2008, 4,768 patients were included in 34 centers:
2,549 treated with ZES, and 2,219 with EES.
The cumulative incidence of definite/probable ST for ZES was 1.3% at 1 year and 1.7% at 2 years and
for EES 1.4% at 1 year and 1.7% at 2 years.
The increment of definite ST between the first and second year was 0.2% and 0.25%, respectively.
Definitive ST Definitive / Probable ST
Second vs First Generation DES
ESTROFA II
1ry EP was target-lesion failure (TLF) (cardiac death, MI, ITL at 1Y)
Serruys PW, et al. N Engl J Med 2010;363:136-46.
RESOLUTE “All Comers”
1ry EP (TLF)
2292 Pts. Noninferiority
ST (2.3% vs 1.5%, p=0.17)
In-stent late lumen loss was 0.27+04 mm ZES vs 0.19+0.4 mm EES, p=0.08)
PLATINUM
Stone GE, Columbia, NY
ACC 2011
A Prospective, Randomized Investigation of a Novel Platinum Chromium Everolimus-Eluting Coronary Stent:
The PLATINUM Trial
Target Lesion Failure (Cardiac D, MI-TV, I-TVR) at 12 Mo
Noninferiority
P = 0.001
P = 0.0009
Similar individual EP. Similar ST (0.4%) in both groups
Inadequate L coverage and unplanned stenting better PtCr Group
ISAR TEST 5 TCT 2010
Mehilli J, Munich
Dual-DES:Rapamycin / Probucol / Natural Resin
No polymer
(ZES):(Endeavor Resolute)
BioLinx polymer
N = 2002 N = 1000
All Individual end-points at 1Y SIMILAR
1ry Endpoint Device-oriented (Cardiac Death, TVR-MI, I-TLR)
ABSORB-B
45 Pts
The backscattering of the polymeric
struts did not decrease over time
The strut design and the manufacturing process were modified lower hydrolysis
(in vivo degradation) rate of the polymer.
Late loss (Absorb-B vs Absorb-A)
Serruys PW, et al. Circulation. 2010;122:2301-2312
Técnicas Diagnóstico
Intracoronario
PROSPECT
Sotne G, et al. N Engl J Med 2011;364:226-35.
697 ACS Pts 3V IVUS VH after PCI. Follow-up 3.4 years 1ry EP (Cardiac D, cardiac arrest, MI, hospitalization: UA or progressive angina)
“Non-culprit lesion” Events: 12% of patients after PCI
SATURN
Atorvastatin 80 mg
(N=641)
Rosubastatin 40 mg
(N=694) 2 Yr
Nicholls SJ, AHA 2011. Orlando FL
Prospective Application of Predefined Intravascular Ultrasound Criteria for Revascularization of
Intermediate Left Main Coronary Artery Lesions
LITRO
MC+MI+RTC
0 150 300 450 600 750
100
90
80
70
60
50
40
30
20
10
0
Time
Surv
ival p
robabili
ty (
%)
Survival free of cardiac death, MI
and LMCA revascularizacion
at 2 years:
94.2 ± 1.8%
Pts with deferred revascularization (MLA >6 mm2)
354 Pts in 22 centers. LMCA revascularization 91% (152 of 168) of Pts with an
MLA <6 mm2) and deferred in 96% (179 of 186) of Pts with MLA of >6 mm2
De la Torre JM et al. J Am Coll Cardiol 2011 Jul 19;58(4):351-8.
Inflammation & Pathological Substrate
Plaque Rupture Plaque Erosion
Ferrante G. Circulation 2011;122;2505-2513
25 ACS Pts
Inflammation & Pathological Substrate
Serum Levels Myeloperoxidase
Ferrante G. Circulation 2011;122;2505-2513
Underlying Pathological Substrate:
STEMI vs NSTEMI
* *
STEMI
Ino Y, et al. JACC Cardiovasc Interv. 2011;4:76-832.
*
*
NSTEMI
*
Ino Y, et al. JACC Cardiovasc Interv. 2011;4:76-832.
*
Underlying Pathological Substrate:
STEMI vs NSTEMI
Alfonso F, Virmani R. JACC Cardiovasc Interv. 2011;4:83-86.
Underlying Pathological Substrate:
STEMI vs NSTEMI
0
0,2
0,4
0,6
0,8
1
0 0,2 0,4 0,6 0,8 1
FFR
iFR
r = 0.90
Definition: Instantaneous
pressure gradient, across a stenosis
during the wave-free period, when
resistance is constant and minimised
in the cardiac cycle
iFR = instantaneous wave-free ratio
Pa
Pd
0 100 200 300 400 500 600 700 800 900
70
120
Pre
ssure
(m
m H
g)
Time (ms)
Wave-free period
ADVISE
Adenosines Vasodilation Independent Stenosis Evaluation
Davies J, TCT 2011
Otras Alternativas Terapeúticas
RIVAL
Jolly SS, Canada
ACC 2011
RadIal Vs femorAL access for coronary interventions in ACS Canadian Institutes of Health Research
Primary and Secondary Outcomes
(Large hematoma, PSA, Fistula, Vascular surgery)
Radial : > Cross-over and Fluoroscopy times. Better in STEMI
• Net Adverse Clinical Event (NACE) = MACCE + bleeding
• Major Adverse Cardiac and Cerebrovascular event (MACCE) = composite of cardiac
death, myocardial infarction, target lesion revascularization, stroke
• Cardiac mortality significantly reduced
Events @ 1 Month
RIFLE STEACS
p = 0.003
p = 0.029 p = 0.026
21.0%
11.4%
7.2%
12.2%
7.8%
13.6%
1,001 Pts Randomized
501 Femoral - 500 Radial
Romagnoli E, TCT 2011. San Francisco , CA..
PROTECT II ACC 2011
RCT Comparing Prophylactic Impella to IABP in High-Risk PCI
O´Neill W,
223 Pts 224 Pts
447 Pts
Different Procedural Characteristics (Medication & Devices)
1ry EP: MI, Any Revascularization, Angio failue, Renal dysf, Severe hypotension …)
CRISP-AMI ESC 2011
1ry EP (NMR) Infarct size similar in both groups:
IABC+PCI: 42.1% vs 37.5% ICP alone P=.06.
Time to coronary device was 77 minutes for IABC+PCI
group vs 68 minutes for the PCI alone group (P=.04).
Patel MR, et al. JAMA. 2011;306(12):1329-1337
ACT AHA 2010
Acetylcysteine for the prevention of Contrast-induced nephropaThy:
Berwanger O, Brasil
Similar clinical outcomes
even in high-risk patients
“Pragmatic” Randomization
REMEDIAL II
Briguory C, Naples, Italy
ACC 2011
REnal Insufficiency Following Contrast MEDIA Administration II TriaL
RenalGuard system in high risk patients for contrast induced acute kidney injury
RenalGuard:
Automated
Hydration
Matching
System
High-risk Pts for CI-AKI
(Mehran risk score ≥11 and/or eGFR≤30 ml/min/1.73 m2)
Sodium Bicardonate & Acetylcysteine
(147 Pts)
RenalGuard + 0.25 mg/Kg Furosemide
(147 Pts)
Contrast-induced acute kidney injury (CI-AKI)
Primary Endpoint:
sCr ≥0.3 mg/dL at 48 h
Dialysis 4.8% 0.7% p=0.03
Intervencionismo Estructural
PARTNER TCT 2010
Leon MB. N Engl J Med 2010;363:1597-1607.
328 Pts SAS (21 Centers) TAVI vs Medical Management (including BAV)
PARTNER TCT 2010
1ry EP
Co 1ry EP
Leon MB. N Engl J Med 2010;363:1597-1607.
PARTNER TCT 2010
At 30 days, TAVI, as compared with standard therapy, was associated with a
higher incidence of major strokes (5.0% vs. 1.1%, P = 0.06) and major vascular
complications (16.2% vs. 1.1%, P<0.001)
Leon MB. N Engl J Med 2010;363:1597-1607.
PARTNER
Smith CR,
ACC 2011
“High-Risk” SAS Operative Mortality >15%
STS score >10
Assessment Transfemoral Access
Early Devices. Most sites no previous TAVR experience
PARTNER ACC 2011
“High-Risk” SAS Primary Endpoint: All Cause Mortality 1Y
Pre-specified Noninferiority Margin 7.5%
Non-inferiority p = 0.001
Smith CR, et al. N Engl J Med 2011;364:2187-98.
CLOSURE I AHA 2010
Furlan AJ, Cleveland
STARTFlex
Pts <60 y, cryptogenic stroke or TIA and
PFO documented with TEE (Presumed paradoxical embolism through a Patent Foramen Ovale)
N = 447 N = 462
1ry EP Composite
Stroke/TIA 2Y
<30d Death
>30d Neuro Death
EVEREST II
279 Pts 3+/4+ MR randomized (2:1) to undergo percutaneous
repair or conventional surgery for repair/replacement
1ry EP (12 Months) for efficacy was freedom from death,
surgery for mitral-valve dysfunction and 3+/4+ MR
55% percutaneous vs 77% surgical (p=0.007)
Major adverse events (1 Month):
15% percutaneous vs 48% surgical (p<0.001).
At 12 months, both groups improved:
- left ventricular size
- NYHA
- QOL
Feldman T, et al. N Engl J Med 2011;364:1395-406.
ACC 2011
Cardiología Intervencionista
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