Indications for CABG in 2015 and Beyond

Transcription

Indications for CABG in 2015 & Beyond
Is CABG Coming Back ?
AATS, New York, August 21, 2015
No Disclosures
Revascularization for Coronary Artery Disease
Medical vs PCI vs CABG
1980’s. The Rule of 2 / 3 – CABG
- Moderate <LVEF
Severe ? - Yes, STICH
- Severe Ischemia
Moderate? - ISCHEMIA
- 3 Vessel Disease
2vd + pLAD ? - Yes, > SS
DM?
1990’s. The Rule of 2 / 3 – PCI ?
2010’s.
Medical Therapy >, PCI <, CABG > (Diabetes)
2020,s.
Anatomical & Ischemic Score - Non Invasive
- Moderate <LVEF
- Severe Ischemia
- 3 Vessel Disease
DM?
1990’s. The Rule of 2 / 3 – PCI ?
2010’s.
2020,s.
- Moderate <LVEF
- Severe Ischemia
- 3 Vessel Disease
DM?
1990’s. The Rule of 2 / 3 – PCI ?
2010’s.
2020,s.
COMPLEX, STABLE CORONARY DISEASE
TRIAL
SYNTAX
FAME
BARI
COURAGE
FREEDOM
MVD
+
-
+
Conclusions
DM INTERV. MT. EP.-R
+
-
+
++
+
+
+
+
+
++ (+)
Methods-Interests
++
Data
CABG > PCI
SYNTAX Score ?.
+
+
PCI ?
“ISCHEMIA” Score ?
+
PCI = MT
“ISCHEMIA” >10% -Events
+
CABG / PCI = MT
X.OV.ER 42%
CABG > PCI
No Freedom of Choice?
Concerns
• Syntax Score is purely
an anatomic score of the
extent of CAD (>50%) in a pt
• Each lesion is assigned a
numerical number and then
sum of all lesions score
for a patient is
calculated to come up
with the final numerical
Syntax score
• Pt are divided in 3 groups:
Low <22
Intermediate 23-32
High >32
Sianos, P Serruys et. al. EuroInterv. 2005;1:219.
Serruys P et al. NEJM 2009;360:961.
Baseline SYNTAX Score Tercile -CABG
Cumulative Event Curves For MACCE
SYNTAX (FW Mohr, PW Serruys et. al.) Lancet 2013; 381: 629
TRIAL
SYNTAX
FAME
BARI
COURAGE
FREEDOM
MVD
+
-
+
Conclusions
+
++
+
+
+
-
+
++
Methods-Interests
+
+
++
Data
CABG > PCI
SYNTAX Score ?.
+
+
PCI ?
+
PCI = MT
(+) +
CABG / PCI = MT
X.OV.ER 42%
CABG > PCI
Concerns
Coronary Flow Reserve (CFR)
 Measures integrated hemodynamic effects of epicardial CAD,
diffuse atherosclerosis, vessel remodeling and microvascular
dysfunction on myocardial tissue perfusion
CFR = MBF peak hyperemia
MBF rest
VR Taqueti and MF Di Carli 2014
FFR As A Surrogate
For Inducible Myocardial Ischaemia
FAME I (FFR>0.8) - OMT of Non-Isch.Lesions – Prevent MI/Death
FAME II (FFR<0.8) - PCI of Isch. Lesions – Prevent MI/Death – FAME III-CABG?
TP van de Hoef Nat. Rev. Cardiol. 2013;10:439 – FAME 2 (B De Bruyne) NEJM 2014; 371:1208
1. CAC, CFR and Adjusted MACE
MACE increases with impaired CFR and zero CAC.
M Naya et. al. JACC 2013;61:2098 - M Naya et. al. Circ J 2015; 79: 15
2. CFR w/wo Epicardial CAD, Diabetes, Microv. Dis.
Relation To Cardiac Death
VL Murthy et. al. Circulation 2012;126:1858 - M Naya et. al. Circ J 2015; 79: 15
3. Presence Of Angina During Follow-up
SJ Head et. al. Eur Heart J. 2014;35:2821 – No Stad. Signif in FREEEDOM
4. Proportion of Outcome Events
by Achieved SBP - ONTARGET Trial
ONTARGET (J Redon et. al.)J ACC2012;59:74 – Microvasculature, Underperfusion ?
FREEDOM (M Farkoug, V Fuster) 2015 (In Press)
5. Mortality in the ACCORD Population
Over a Wide Range of Average On-treatment HbA1c Values
ACCORD (MC Riddle et al) Circ 2010;122:844 -
Microvascular / Catecholamines ?
6. PCI versus CABG in Insulin and Non-Insulin Treated
Diabetic Patients: Results from the FREEDOM Trial
FREEDOM (GD Dangas, V Fuster et. al.) JACC 2014 (In Press)
7.Possible Mechanisms of Diastolic Dysfunction
EM Jeong et. al. Circ J 2015; 79: 470
8. Time-activity Curves And A Polar Map
Of 17-segment Coronary Flow Reserve
B Tu et. al. Ann Intern Med. 2014;161:724
CFR and the Microcirculation
JACC 2014;63:1992 - JACC 2014;63:799 - JACC Imag. 2014;7: 1936
TRIAL
SYNTAX
FAME
BARI
COURAGE
FREEDOM
MVD
+
-
+
Conclusions
+
-
+
++
+
+
+
++
+
+
(+)
Methods-Interests
++
Data
CABG > PCI
SYNTAX Score ?.
+
+
PCI ?
+
PCI = MT
+
CABG / PCI = MT
X.OV.ER 42%
CABG > PCI
Concerns
TRIAL
SYNTAX
FAME
BARI
COURAGE
FREEDOM
MVD
+
-
+
Conclusions
+
-
+
++
+
+
+
+
+
++ (+)
Methods-Interests
++
+
+
+
+
Data
CABG > PCI
SYNTAX Score ?.
PCI ?
CABG / PCI = MT
X.OV.ER 42%
PCI = MT
CABG > PCI
Concerns
TRIAL
SYNTAX
FAME
BARI
COURAGE
FREEDOM
MVD
+
-
+
Conclusions
+
++
+
+
+
-
+
++
Methods-Interests
+
+
(+)
++
Data
CABG > PCI
SYNTAX Score ?.
+
+
PCI ?
+
PCI = MT
+
CABG / PCI = MT
X.OV.ER 42%
CABG > PCI
NO FREEDOM CHOICE?
Concerns
FREEDOM TRIAL – MI / DEATH / STROKE (4)
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
New Engl. J. Med . 2012; 367: 2375 – All Subgroups (Syntax etc)
(Circ Cardiovasc Interv. 2014;7:518 – Newer Generation DES, Still Gap)
1a. Recommendations for CAD Revascularization
In Patients with Diabetes
Circulation. 2014;130:1749
1b. Specific
Recommendations For
Revascularization In
Patients With Diabetes
The Task Force on Myocardial
Revascularization of the ESC
and the EACTS (S Windecker
et. al.) Eur Heart J.
2014;35:2541
2. World vs. Canada/US
For Stroke From FREEDOM Trial
MJ Domanski, V Fuster et. al. AJC 2015 (In Press).
3. MEETING TARGETS FOR RISK FACTOR CONTROL?
Risk Factors - Proportion of Participants at Goal % – 1 year
Hb A1C
Meet Goals
Base FU
Trials
LDL
SBP
DBP
BARI-2D
75
56
70
52
14
20
COURAGE
51
55
55
59
12
19
FREEDOM
55
63
53
55
12
20
Freedom, Bari-2D, Courage Investigators, JACC 2013;61:1607
PURE (S Yusuf et al.) Lancet 2011; Aug 28 - Poor Countries,7% !!!
NHANES, AHA, NHLBI-JNC-7, NHLBI-NCEP – Significant < Adherence
P Muntner, V Fuster et al., AHJ 2011; 161: 719 – 49 seconds !!!!
4. FUSTER-CNIC-FERRER POLYPILL, 2ary PREVENTION, CV EVENTS
FOOD INTERACTION
FOCUS 1 & 2
PHARMACOKINETIC
INTERACTION WITH ASPIRIN
BIO-EQUIVALENCE
Argentina
Brazil
Paraguay
Italy
Spain
FREEDOM
AETNA
EU 2020 (SECURE)
JACC , Nov 18, 2014
ASA, Statin, ACE-Inhibitor
PHARMACOKINETIC
INTERACTION WITH
SYMVASTATIN
PHARMACODINAMIC
INTERACTION WITH RAMIPRIL
PHARMACODYNAMIC
INTERACTION WITH
SYMVASTATIN
PHARMACOKINETIC
INTERACTION WITH RAMIPRIL
PHARMACODYNAMIC
INTERACTION WITH ASPIRIN
Approved in 22 Countries
- Moderate <LVEF
- Severe Ischemia
- 3 Vessel Disease
DM?
1990’s. The Rule of 2 / 3 – PCI ?
2010’s.
2020,s.
1. Future For PCI / CABG Procedure – 2015-2020
PCI
OMT
CABG
SCAAR (ML Fokkema et.al.) JACC 2013;61:1222 - Swedish Registry (VF.Modified)
Diabetes Trialists’ Collaboration – 2015 (In Press)- FREEDOM, BARI 2D, COURAGE
2. Etiologies of Chest Pain Without Obstructive CAD
MA Marinescu et. al. J Am Coll Cardiol Img 2015;8:210
Treatment Options for Refractory Angina
TD Henry et. al. Nat. Rev. Cardiol. 2014;11: 78
Coronary Sinus Reducer System
S Herheye et. al. NEJM 2015; 372: 519
Indications for CABG in 2015 & Beyond
CABG is Coming Back
AATS, New York, August 21, 2015
No Disclosures
•
PCI vs Coronary Artery Bypass Grafting: A Meta-Analysis
CABG had a lower risk of death in multivessel CAD or diabetes, a
lower risk of repeat revascularization, but a higher risk of stroke
Y Smit et al., J Thorac Cardiovas Surg 2015; 149:831
• DES on the Comparative Effectiveness of CABG and PCI
The introduction of DES did not alter the comparative
effectiveness of CABG and PCI on hard cardiac outcomes.
CP Hodgkinson et al., Am Heart J 2015; 169:149
• Comparison of Five-Year Outcome of PCI With CABG in 3VCD
CABG compared with PCI was associated with better long-term outcome in
patients with 3VCAD.
H Shiomi et al., Am J Cardiol 2015; 116:59
• Survival Probability PCI Compared with CABG
Compared with PCI, CABG leads to a significant reduction in late-phase
mortality across all age groups.
U Benedetto et al., J Thorac Cardiovas Surg 2015; 149:479
Comparison of Coronary Artery Bypass Surgery and
Percutaneous Coronary Intervention in Patients With Diabetes:
A Meta-Analysis of Randomised Controlled Trials
S Verma et al., Lancet Diabetes Endocrinol 2013; 1:317
Outcomes With Coronary Artery Bypass Graft Surgery Versus
Percutaneous Coronary Intervention for Patients With
Diabetes Mellitus
S Bangalore et al., Circ Cardiovasc Interv. 2014; 7:518
Comparing Coronary Artery Bypass Grafting With Drug-Eluting
Stenting in Patients With Diabetes Mellitus and Multivessel
Coronary Artery Disease: A Meta-Analysis
X Li et al., Interactive Cardiovasc Thorac Surg 2014; 18:347
Mortality in Patients Treated With Extended
Duration DAPT post DES: Meta-Analysis
T Palmerini et. al. Lancet. 2015;385: 2371
COX-2 Selectivity
as a Continuous Variable
C Patrono et. al. Circulation. 2014;129:907
Mechanism Of Formation
And Action Of Prostanoids
Effects Of Coxib Rx on Major Vascular Events,
HF, Mortality And Upper GI Complications
Effects Of Coxib Rx on
HF, Mortality And Upper GI Complications
Plasma Catecholamine Levels Of Patients
With Takotsubo Cardiomyopathy or MI
PT Wright et. al. Circ J 2014;78:1550
Integrated Pathophysiology for Acute
Apical Dysfunction In Takotsubo Syndrome
YJ Akashi et. al. Nat. Rev. Cardiol. 2015;12: 387
Epidemiological Studies of CHD
and the Evolution of Preventive Cardiology
Hypertension, cigarette smoking, diabetes or
elevated glucose level, elevated cholesterol, and
obesity or being sedentary, are the top six causes of
death globally. Evaluation of risk factors and
screening for subclinical atherosclerosis can help to
identify individuals at highest CV risk. Future
research efforts will determine the screening and
intervention strategies that have the greatest effect
on CAD prevention.
ND Wong. Nat Rev Cardiol 2014; 11:276
STICH – SVR Hypothesis
CABG Alone Versus CABG Plus SVR
There was a lack of significant difference in all-cause mortality
between the 2 groups.
CABG Versus Medical Therapy Alone
CABG provides the potential for incremental survival benefit,
particularly among the highest-risk patients with multivessel
disease and the most severely remodeled ventricles. The
longer-term survival benefit in patients who undergo CABG
compared with medical therapy alone tends to offset the shortterm perioperative mortality risk.
RO Bonow et al., J Thorac Cardiovasc Surg 2014; 148:2461
Indications For Revascularization In Patients
With LV Dysfunction: Evidence And Uncertainties
The impact of having CABG on survival in patients with left
ventricular (LV) dysfunction, particularly severe LV
dysfunction, remains a subject of considerable debate and
uncertainty. In the three classical trials of CABG vs.
medical therapy (CASS, European, VA), patients with a
severely reduced LV ejection fraction (EF) were excluded
from randomization.
Indications For Revascularization In Patients
With LV Dysfunction: Evidence And Uncertainties
The Surgical Treatment For Ischemic Heart Failure Trial
The STICH trial emerged as the first designed to determine the
impact of CABG in CAD and an EF  35%. Hypothesis:
2) That CABG plus surgical ventricular reconstruction (SVR)
provides a survival advantage compared with CABG alone, in
LV anterior akinesia or dyskinesia or the SVR hypothesis. LM
stenosis or significant angina (class III-IV) were eligible to
participate only in the SVR hypothesis
1) That survival is enhanced with CABG compared with medical
therapy alone or the revascularization hypothesis
STICH – SVR Hypothesis
CABG Alone Versus CABG Plus SVR
There was a lack of significant difference in all-cause mortality
between the 2 groups.
CABG Versus Medical Therapy Alone
CABG provides the potential for incremental survival benefit,
particularly among the highest-risk patients with multivessel
disease and the most severely remodeled ventricles. The
longer-term survival benefit in patients who undergo CABG
compared with medical therapy alone tends to offset the shortterm perioperative mortality risk.
Coronary Microvascular Dysfunction (CMD),
Microvascular Angina, and Treatment Strategies
Angina without CAD has substantial morbidity and is present in 10% to
30% of patients undergoing angiography. CMD is present in 30% of these
patients. The optimal treatment of this cohort is undefined. We performed
a systematic review to evaluate treatment strategies for objectively-defined
CMD in the absence of CAD. We included studies assessing therapy in
human subjects with angina and CFR or myocardial perfusion reserve <2.5
by CT, PET, CMRI, dilution methods, or intracoronary Doppler in the
absence of coronary artery stenosis 50% or structural heart disease. Only
8 papers met the strict inclusion criteria. No benefit was found with Larginine, doxazosin, pravastatin, and diltiazem.
MA Marinescu et al., 2015; 8:210 (Virginia)
1. Mortality in Patients Treated With Extended
Duration DAPT post DES: Meta-Analysis
The athors identified ten trials published between Dec
16, 2011, and Nov 16, 2014, including 31,666 randomly
assigned patients. Although treatment with DAPT
beyond 1 year after DES implantation reduces MI and
stent thrombosis, it is associated with increased
mortality because of an increased risk of non-CV
mortality not offset by a reduction in cardiac mortality.
T Palmerini et al., Lancet 2015; 385:2371
Stent Thrombosis And Significant Bleeding
Clinical Trials Of DAPT Duration After Stent
RC Becker et. al. Circulation. 2015;131:2010
Stent Thrombosis And Significant Bleeding
Clinical Trials Of DAPT Duration After Stent
RC Becker et. al. Circulation. 2015;131:2010
2. Ezetimibe Added to Statin Therapy After ACS
IMPROVE-IT (CP Cannon et. al.) NEJM. 2015;372: 2387
CV Events in Long-Term PCSK9 Trials
RP Giuliano et al. J Am Coll Cardiol 2015;65:2638
Treatment of Refractory Angina
Patients not Suitable for Revascularization
A growing number of patients, particularly those with
advanced CAD, experience symptoms of angina that
are refractory to treatment with -blockers, calciumchannel blockers, and long-acting nitrates, despite
revascularization. The management of patients with
refractory angina is contingent on local resources and
available expertise. Individualized, patient-centered
care in interdisciplinary, specialized clinics, is
evolving
TD Henry et al., Nat Rev Cardiol 2014; 11:78
Metabolic Factors Influencing Angina
TD Henry et. al. Nat. Rev. Cardiol. 2014;11: 78
EDTA Chelation Therapy Alone & in Combination With
High-Dose Multivitamins & Minerals for CAD
This trial of 1,708 post-MI patients  50 years and with
creatinine  2.0 mg/dL randomized to receive 40 EDTA
chelation or placebo infusions plus 6 caplets daily of a 28component multivitamin-multimineral mixture or placebo.
The primary end point was a composite of total mortality, MI,
stroke, coronary revascularization, or hospitalization for
angina. In stable post-MI patients the combination of oral
high-dose vitamins and chelation therapy reduced clinically
important CV events to an extent that was both statistically
significant and of potential clinical relevance.
GA Lamas et al., Am Heart J 2014; 168:37
EDTA Chelation Therapy Alone & in Combination
With High-Dose Multivitamins & Minerals for CAD
GA Lamas et. al. Am Heart J 2014;168:37

Indications for CABG in 2015 and Beyond

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Presenter Disclosure Information Valentin Fuster, M.D., Ph.D.