Intervencionismo Coronario y en Cardiopatías Estructurales · 2014. 10. 23. · Park SJ. N Engl J Med 2011;363:1718-1727. RCT Stents versus CABG for Left Main Coronary Artery Disease

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


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)


TCT 2011 Syntax TAXUS (N=357) CABG (N=348)

ITT population

P=0.03

4.3%

0


Cum

ula

tive E

vent

Rate

(%

)

25

50

0 12 48 24 36


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


0 12 48 24 36


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




NNT 63

NNT 17


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.


EES vs PES

2Y Meta-analysis

4 RCT (6,608 Pts)



EES vs PES

2Y Meta-analysis

4 RCT (6,608 Pts)


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


EES vs SES

1Y Meta-analysis

8 RCT (11,351 Pts)

EES Better SES Better



EES vs SES

1Y Meta-analysis

8 RCT (11,351 Pts)

EES Better SES Better



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


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.

*


STEMI vs NSTEMI

Alfonso F, Virmani R. JACC Cardiovasc Interv. 2011;4:83-86.


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)

http://www.nejm.org/action/showMediaPlayer?doi=10.1056%2FNEJMoa1008232&aid=NEJMoa1008232_attach_1&area=

PARTNER TCT 2010

1ry EP

Co 1ry EP


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)


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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Intervencionismo Coronario y en Cardiopatías Estructurales · 2014. 10. 23. · Park SJ. N Engl J Med 2011;363:1718-1727. RCT Stents versus CABG for Left Main Coronary Artery Disease