Revascularización en isquemia estable.

NUEVOS ESTRATEGIAS EN EL TRATAMIENTO DE LA CARDIOPATÍA ISQUÉMICA CRÓNICA

Dr. Ángel Cequier (Barcelona)

Revascularización en isquemia estable ¿Continua la polémica?

A. Cequier Área Enfermedades del Corazón

IDIBELL. Hospital Universitario de Bellvitge Universidad de Barcelona

L´Hospitalet de Ll. Barcelona

Nuevas Estrategias en el Tratamiento de la Cardiopatía

Isquémica Crónica “Revascularización en isquemia estable.

¿Continúa la polémica?”

Medicina CARDIOVASCULAR 2013 Barcelona, 8-9 Octubre 2012

Si, la polémica continúa.

1.- Fisiopatología enfermedad estable

2.- Tratamiento Médico

3.- Revascularización vs Tto Médico

4.- COURAGE y Post-COURAGE

5.- Conclusiones

Revascularización en la Enfermedad Coronaria Estable

Abrams J. N Engl J Med 2005;352:2524-2533

Typical Progression of

Coronary Atherosclerosis

Relationship Between Stenosis Severity and Number of Preceding Plaque Ruptures

Simoons ML and Windeker S. EHJ 2010; 31: 530 // Burke et al. Circulation 2001; 103: 936.

Stenosis severity (% stenosis) positively correlates with the number of previous plaque ruptures for both stable and those with acute plaque rupture

Multiple healed rupture

(2006 ESC Guidelines on the Management of Stable Angina) Fox, K, et l. EHJ 2006

CV Mortality and MI in Contemporary Trials of Stable CAD

Percutánea Angioplastia coronaria

+ Stent

Quirúrgica Bypass Coronario Tratamiento

Médico Revascularización

Aterosclerosis coronaria Objetivos del Tratamiento

Tratamiento Médico

•  Retrasar la progresión

•  Evitar la formación de nuevas placas

•  Prevenir la ruptura de placa •  Prevenir la aparición de eventos isquémicos

•  Tratamiento de la secuelas

Revascularización

•  Tratamiento de las lesiones coronarias limitantes de flujo

•  Reducción isquemia miocárdica y sus manifestaciones

•  Reducir el nº de fármacos antianginosos

•  Mejorar el pronostico de forma adicional al tratamiento médico

1.- Patofisiología enfermedad estable




5.- Conclusiones


Tratamiento Médico de la Enfermedad Coronaria Estable

(Riesgo anual de muerte o IM: 2.5%)

Ø  Control factores de riesgo Ø  Aspirina (23% reducción en riesgo relativo-RRR) Ø  Dosis standard de estatinas (30% RRR) Ø  IECA (20% RRR) Ø  Clopidogrel post-ACS (20% RRR) Ø  Nitratos, beta-bloqueantes, Ca++ antagonistas,

ivabradina, ranolazina. (reducen episodios de angina, mejoran tolerancia ejercicio y reducen necesidad de revascularización)

Effectiveness of Statin Therapy

Rosuvastatin 40 mg/d

Nissen et al. NEJM 2007; 356: 1304 Nissen et al. JAMA 2006; 295: 1556

Relationship between Change in Atheroma Volume and LDL-Cholesterol

The Natural History of Chronic Ischemia in Patients with Left Ventricular Dysfunction (1 year F/U)

Pitt M, et al. EHJ 2004; 25: 500

Delayed revascularization in ischemic left ventricular impairment results in declining function and a reduced likelihood of contractile improvement.

Temporal change in LVEF over the 3 study times points Aggregate change in echo regional segmental

function over preoperative wait

The Benefit of Revascularization on Survival is Proportional to the Amount of Ischemia

Hachamovitch R et al. Circulation 2003; 107: 2900.

Impact of revascularization on cardiac death in relation to the amount of ischemia assessed by photon emission computed tomography imaging prior revascularization.





5.- Conclusiones


Non ST - Elevation Acute Coronary Syndrome

Embolization and microvascular occlusion in non-ST ACS

Plaque rupture and thrombus in AMI

ST - Elevation Acute Myocardial Infarction

Acute Coronary Syndromes

2011 ACC/AHA Focused Update Guidelines for UA/NSTEMI

Anderson et al. Circulation/JACC 2011

Early Invasive vs Conservative Therapy Relative Risk of Outcomes. Mean F/U 2 years

All-cause mortality Recurrent non-fatal MI

PCI vs Conservative Therapy in Nonacute CAD

Katritsis DG et al. Circulation 2005; 111: 2906

A Meta-Analysis

Conclusion: In ptes with stable CAD, PCI does not offer any benefit in terms of death, MI, or need for subsequent revascularization compared with conservative medical treatment

(11 randomized trials, 2950 patients with stable CAD)

PCI vs Optimal Medical Therapy in Stable CAD

Pursnami Set al. Circul CV Interv 2012; 5: 476

A Systemic Review and Meta-Analysis of Randomized Trials

Conclusion: PCI, as compared with OMT, did not reduce the risk of mortality, CV death, nonfatal MI, or revascularization. PCI, however, provided a greater angina relief compared

with OMT.

(12 randomized trials, 7182 patients)

Risk of freedom from angina Risk of all-cause mortality

Effects of PCI vs Medical Therapy on Angina Relief

Wijeysundera HC, et al. Ann Intern Med 2010; 152. 370.

Conclusion: PCI was associated with greater freedom from angina compared with medical therapy

Meta-Analysis Summary OR of freedom from angina





5.- Conclusiones


COURAGE Trial Optimal Medical Therapy (OMT) with or without PCI for Stable CAD

- 2287 pts with evidence of myocardial ischemia and significant CAD. - Randomized to PCI+OMT vs OMT. - Primary end-point: death and non-fatal MI. F/U: 4.6 yrs

Conclusion: As an initial management strategy in patients with CAD, PCI did not reduce the risk of death, MI when added to OMT

Bode WE, et al. NEJM 2007; 356: 1503

Death and MI Death of any cause

F/U: Cumulative Rate of Revascularization

Bode WE, et al. NEJM 2012; 367: 1059

COURAGE Trial Optimal Medical Therapy (OMT) with or without PCI for Stable CAD

1.  Bias de selección (post-coronariografia)

2.  No practica diaria (incluidos solo el 6,5 % de los ptes analizados)

3.  Población de muy bajo riesgo (0.83 ptes/mes/centro)

4.  Poder estadístico bajo para los eventos (muerte/IM)

5.  Algunas lesiones no significativas stentadas

6.  Algunas lesiones significativas no stentadas

7.  > 95 % stents metálicos

8.  ICP subóptimo

9.  Cifra elevada de crossover a PCI

10.  Ninguna nueva información

COURAGE Trial Críticas y Limitaciones

Shaw LJ, et al. Circulation 2008; 117: 1283

COURAGE Trial Nuclear Substudy

BARI 2 Study Randomized Trial of Therapies for Type 2 Diabetes and CAD

- 2368 pts with type 2 diabetes and CAD. - Randomized to prompt revascularization or intensive medical therapy. - Primary end-point: death and a composite of death, MI or CVA

Conclusion: There were no significant difference in the rates of death and major CV events between patients undergoing prompt revascularization and those undergoing medical therapy.

B Frye RL et al. NEJM 2009; 360: 2503

Rate of Revascularization (“cross-over”) in the BARI-2D Trial

Frye RL et al. NEJM 2009; 360: 2503.

The substantial proportion of patients allocated to medical treatment subsequently undergoing revascularization considerably contributes to the lack of difference in treatment

effect between the 2 strategies.

PCI for Nonacute CAD

Trikalinos TA, et al. Lancet 2009; 373: 911

Cumulative number of patients randomized in each comparison against the year of patient enrolment in each trial.

Each cross is the year of the first patient enrolled. BMS= bare metal stent; DES= drug eluting stent.

Accumulation of randomized evidence over time

A Meta-Analysis of 17 Randomized Trials of a PCI-Based Strategy in Patients with Stable CAD

Schoming A, et al. JACC 2008; 52: 894.

Conclusion: A PCI-based invasive strategy may improve long-term survival compared with a medical treatment-only strategy in patients with stable CAD.

Odds Ratios for Mortality in Individual Trials

The Impact of Revascularization on

Mortality in Patients with Nonacute CAD

Jeremias A et al. Am J Med 2009; 122: 152.

Conclusion: Revascularization by CABG or PCI in conjunction with medical therapy in patients with

nonacute CAD is associated with significant improved survival

compared with medical therapy only. Comparison of coronary revascularization vs

medical therapy for overall mortality

Meta-analysis of 28 studies, 13121 ptes, 1-10 yrs follow-up,

median 3 yrs.

Comparative Outcomes for Patients Who Do and Do Not Undergo PCI for Stable CAD in New York

Hannan EL et al. Circulation 2012; 125; 1870.

Conclusion: Ptes who received PCI experienced lower mortality, MI and

revascularization rates. Role of low medication adherence

rates ?

Ptes with stable CAD underwent cardiac catheterization between

2003 -2008 in NY state. Propensity matched cohort of 933 ptes

Death and MI: PCI: 16.5% vs MT: 21.2%;

p= 0.003

Mortality PCI: 10.2% vs MT: 14.5%;

p= 0.02

FAME 2 Trial

Fractional Flow Reserve-Guided PCI vs Medical Therapy in Stable Coronary Disease

De Bruyne, B, et al. NEJM 2012; 367: 991

Recruitment halted after 1220 ptes with stable CAD. At least 1 stenosis with FFR ≤ 0.80. Randomized: FFR-PCI+OMT vs OMT. Primary End-Point: death, MI or urgent revasc.

Conclusions: In patients with stable CAD and functionally significant stenosis, FFR-guided PCI + OMT, as compared with OMT, decrease the need for urgent

revascularization

De Bruyne, B, et al. NEJM 2012; 367: 991

Landmark Analysis of the Primary End Point and Its Components

Patients with Angina Class II to IV

FAME 2 Trial

Fractional Flow Reserve-Guided PCI vs Medical Therapy in Stable Coronary Disease





5.- Conclusiones


TRA 2ºP TIMI 50 Secondary Prevention

n= 26449 ptes. Prior MI,CVA or PAD

Muerte CV, IM o Ictus (Ambas dosis de rivaroxabán,

dos estratos)

Pacientes en riesgo Placebo 5.113 4.307 3.470 2.664 1.831 1.079 421 Rivaroxabán 10.229 8.502 6.753 5.137 3.554 2.084 831

Meses desde la aleatorización

HR=0,84 (0,74-0,96) RAR=1,7%

ITTm p=0,008

ITT p=0,002

NNT=56

10,7%

8,9%

Estim. Kaplan–Meier a 2 años Tasa

acu

mul

ada

estim

ada

(%)

Rivaroxabán

Placebo

12

0 0 16

10

8

6

4

2

20 12 8 4 24

ATLAS ACS-2 TIMI 51 (Rivaroxaban en Prevención Secundaria)

Mega JL et al, NEJM 2012; 366: 9

HR (95% CI) ≤ 1 Year: 0.99 (0.84, 1.16)

HR (95% CI) > 1 Year: 0.72 (0.54, 0.97)

Primary Efficacy Endpoint to 30 Months (Age < 75 years)

HR (95% CI): 0.91 (0.79, 1.05)

P = 0.21

Interaction P = 0.07

Trilogy ACS Secondary Prevention

n= 7243 ptes, < 75 yo. ACS without revascularization Primary end-point: Death, MI, CVA

Roe MT et al. NEJM 2012; September on line.

Tratamiento de la Cardiopatía Isquémica Crónica (I)

1.  Todos los pacientes con aterosclerosis coronaria se benefician de un tratamiento médico a largo plazo.

2.  Un tratamiento médico óptimo incluye: estilo de vida apropiado, control de los factores de riesgo, fármacos y revascularización en pacientes seleccionados.

3.  La revascularización coronaria puede ser adecuada en determinados momentos durante el seguimiento.

4.  La revascularización tiene un efecto favorable sobre síntomas, calidad de vida, capacidad de ejercicio y supervivencia, particularmente en pacientes con enfermedad coronaria extensa e isquemia moderada-severa.

5.  EL ICP y la cirugía deben considerarse como un valor adicional y no como una alternativa al tratamiento medico.

6.  El debate no debe ser tratamiento médico vs revascularización, sino que pacientes deben ser revascularizados y cuando.

7.  Pacientes asintomáticos o con mínimos síntomas y mínima isquemia pueden ser manejados medicamente. Por el contrario, pacientes con síntomas moderados o severos y/o con isquemia moderada o extensa deben ser remitidos para revascularización.

Tratamiento de la Cardiopatía Isquémica Crónica (II)

2004

340 340

170 170

0 0 1983 1983 1989 1989 1995 1995 2001 2001

510 510

680 680

Años

Pac

ient

es

850 850

1020 1020

1190 1190

2007

1360 1360

1700 1700

1530 1530

1986 1986 1992 1992 1998 1998 2010

Revascularización Coronaria

Revascularización quirúrgica

Revascularización percutánea

España 2010

710 ICPs / Centro

Revascularización Coronaria Hospital Universitario de Bellvitge

Cirugía Coronaria (CABG) Relación entre Nº de Intervenciones Anuales y Pronóstico

Peterson ED et al. JAMA 2004; 291:195 Marcin JP et al. Health Research 2008; 43: 174

Mortalidad Ajustada al Riesgo y Volumen Anual de CABG

Hospitales España (2009: 90 CABG/Centro)

Tratamiento de la Cardiopatía isquémica Crónica

Internistas/ Cardiólogos Clínicos

&

Cardiólogos Intervencionistas / Cirujanos

Internista/ Cardiólogo

Cardiólogo Interv.

Revascularización en isquemia estable.

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