Current Guidelines of Myocardial Revascularisation Patients with Stable Angina Surgery or PTCA. Carlo Di Mario

Current Guidelines of Myocardial
Revascularisation: Patients with
Stable Angina: Surgery or PTCA
Carlo Di Mario
President EAPCI
Royal Brompton Hospital, London, UK
Kyiv 08.08.2011
London Dec 1-2, 2011

New recommendations vs. previous ESC Guidelines
The following ESC Guidelines are very relevant for Myocardial
Revascularisation and served as background and foundation for our Task
Force:
Silber S, Albertsson P, Aviles FF, et al.
Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions
of the European Society of Cardiology.
Eur Heart J 2005;26:804-847.
Fox K, Garcia MA, Ardissino D, et al.
Guidelines on the management of stable angina pectoris: executive summary: The Task Force on the
Management of Stable Angina Pectoris of the European Society of Cardiology.
Eur Heart J 2006;27:1341-1381.
Bassand JP, Hamm CW, Ardissino D, et al.
Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes.
Eur Heart J 2007;28:1598-1660.
Van De Werf F, Bax J, Betriu A, et al.
Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the
Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society
of Cardiology.
Eur Heart J 2008;29:2909-2945.
Joint ESC – EACTS Guidelines on Myocardial
Revascularisation
More than 70% are new (not available in previous GL)
Nearly 20% are changes from previous GL (new data)

The Expanded Heart Team
Clinical cardiologist
(non interventional)
Cardiac
surgeon
Interventional
cardiologist
The patient
with complex
CAD and
co-morbidity
The Writing Committee of the Revascular. Guidelines
9
8
8

Objective
Unbiased
Patient-oriented
Evidence-based
Up-to-date
Reliable
Understandable
Accessible
Transparent
Relevant
Consistent with legal
requirements
Scores and risk stratification
Clear agreement on indications for ad
hoc interventions
Dedicated information document and
adequate discussion of alternatives, risks
and benefits, short and longer term
Availability of site and operators results
and experience
Avoidance of anonymous treatment
Heart Team evaluation
Patient informed consent
Process for decision making and patient information

• Ad hoc PCI is convenient for the patient, associated with fewer access site
complications, and often cost-effective.
• Ad hoc PCI is reasonable for many patients, but not desirable for all, and
should not be automatically applied as a default approach.
Potential indications for ad hoc PCI versus
revascularisation at an interval

• Hospital teams without a cardiac surgical unit or with interventional cardiologists
working in an ambulatory setting should refer to standard evidence-based
protocols designed in collaboration with an expert interventional cardiologist and
a cardiac surgeon, or seek their opinion for complex cases.
Potential indications for ad hoc PCI versus
revascularisation at an interval

Recommendations for decision making and
patient information

Definitions of Stable (Chronic) Angina/Syndromes
Persistance of exertional angina with
fixed threshold for > 30 days
Development of ECG changes or
perfusion abnormalities
during provocative tests in asymptomatic
patients

Diagnosis Starts from History
•Location of Pain (+radiation)
•Character, reactive phenomena
•Relation to exercise (or emotion)
•Duration: Spontaneous relief within 1-3 min after discontinuation of
exercise
Age (Yrs) Male Female Male Female
<40 70% 26% 22% 4%
40-49 87% 55% 46% 13%
50-59 92% 79% 59% 32%
>60 94% 90% 67% 54%
TYPICAL ANGINA ATYPICAL ANGINA
Likelihood of >50% DS according to Age, Sex and Symptoms

from Yusuf et al, Lancet 1994; 344: 563
Meta-Analysis of Randomized Trials
CABG vs Medical Treatment
Veteran Administr. 332 354 SA NEJM 1984
European CSS 394 373 SA NEJM 1988
CASS 390 390 SA Circulation 1983
TEXAS 56 60 SA Card. Clin 1977
OREGON 51 49 SA Card. Clin 1985
New Zealand 101 99 Asympt Circulation 1981

0 0.5 1 1.5
1 VD (n=271) p=0.18
2 VD (n=859) p=0.45
1-2 VD (n=524) p<0.05
3 VD (n=1341) p<0.001
LM (n=150) p<0.005
LVEF > 50% (n=2095) p<0.01
LVEF < 50% (n=549) p<0.02
CCS Class 1-2 (n=1716) p<0.05
CCS Class 3-4 (n=924) p<0.001
LAD involved
from Yusuf et al, Lancet 1994;344:563
Odds Ratio Cardiovascular Death
Lower in CABG Lower Med Treat

Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
Indications for revascularisation in stable angina
or silent ischaemia
* With documented ischaemia or Fractional Flow Reserve (FFR) < 0.80 for angiographic diameter
stenosis 50-90%.

Surgical Treatment for Ischemic Heart Failure Trial
< 35% LVEF, no >Class II AP, no LM, no valve disease
Presented Velasquez-Bonow ACC New Orleans, published NEJM 2011

90% MVD, 80% Proximal LM, 91% LIMA
Per Protocol
All Cause Mortality
Time-Varying HR
All Cause Mortality

Recommendations for patients with CHF and systolic
LV dysfunction (EF < 35%), presenting predominantly with HF
symptoms (no or mild angina: CCS 1-2)
SVR: surgical ventricular reconstruction.
Myocardial revascularisation in chronic heart failure (CHF)

Viability Substudy

Characteristic
Randomized (N)
Overall
7812
ARTS
1205
BARI
1829
CABRI
1054
EAST
392
ERACI-
II
450
GABI
323
MASS-II
408
RITA-1
1011
SoS
988
Toulouse
152
Age <55 28 28 24 27 24 28 33 32 40 26 9
55-64 37 35 37 42 36 36 40 33 44 34 26
>65 35 38 39 31 40 36 27 35 16 40 66
Female 24 23 27 22 26 21 21 31 19 21 23
Diabetes 16 17 19 12 23 17 13 28 6 14 13
Current Smoking 24 27 25 NA 20 52 11 33 17 15 52
Hypertension 45 45 49 36 53 71 42 62 26 45 42
Hypercholesterolemia 51 58 44 44 40 61 63 79 NA 52 36
Peripheral Vascular Disease 10 5 17 7 NA 23 8 0 NA 7 20
Unstable Symptoms 41 37 68 16 NA 92 13 0 NA 20 86
Prior MI 45 43 55 43 41 28 47 47 43 45 38
Heart Failure 3 0 9 0 3 0 0 0 0 6 6
Abnormal LV Function
Abnormal (of total) 16 16 19 13 16 20 8 3 14 15 9
Data Missing 13 7 3 11 2 1 39 0 45 22 0
Three-Vessel Disease 35 29 41 43 40 49 38 56 12 42 29
Proximal LAD Disease 51 NA 37 61 72 51 28 95 56 46 44
Follow-Up (median) 5.9 5.1 10.4 3 8.2 5 13 5.1 10 6 4.9
Bare Metal Stent use -- yes no no no yes no yes no yes no
Baseline Characteristics by Study (%)

Overall, unadjusted survival and survival free of myocardial infarction
after randomization to CABG or PCI
CABG 91.6%
PCI 90.0%
CABG 85.3%
PCI 83.4%
HR 0.91 (0.82-1.02), p=0.12
HR 0.87 (0.76-0.99) p=0.03 ?
CABG 84.6%
PCI 83.3%
HR 0.97 (0.88-1.06), p=0.47

Outcome CABG PCI
Hazard
Ratio p-value
Survival
91.6
(90.8-92.6)
90.0
(89.1-91.0)
0.91
(0.82-1.02) 0.12
Survival without MI
84.6
(83.4-85.8)
83.3
(82.1-84.6)
0.97
(0.88-1.06) 0.47
Survival without MI,
Repeat Revasc
79.9
(78.6-81.3)
63.6
(62.0-65.2)
0.52
(0.49-0.57) <0.001
Comparative Overall 5-Year Clinical
Outcomes by Treatment Assigned
Δ16.3

The CABG:PCI hazard ratios within clinical subgroups from a univariate
Cox proportional hazards model
The CABG:PCI hazard ratio was 0.98 in patients without diabetes, and 0.71 in patients
with diabetes (p for interaction=0.01). The evidence for an interaction of diabetes
with treatment assignment was stronger (p=0.004) after adjustment for age, sex,
smoking, hypertension, prior MI, heart failure, and three-vessel disease. The
interaction of diabetes and treatment assignment remained significant after omitting
patients enrolled in the BARI trial.

ESC 2009 • Two-year Outcomes of the SYNTAX Trial • Kappetein • Slide 25
SYNTAX Trial Design
De novo 3VD and/or LM (isolated, +1,2,3 VD)
Limited Exclusion Criteria
Previous interventions , Acute MI with CPK>2x, Concomitant cardiac surgery
Two Registry Arms
N=1275
Randomized Arms
N=1800
Heart Team (Surgeon & Interventional Cardiologist
Amenable for only one
treatment approach
Amenable for both
treatment options
Stratification:
LM and Diabetes
23 US Sites62 EU Sites +

SYNTAX: Left Main Subset • Serruys TCT • 14 October 2008 • Slide 26
CABG
registry
(N=1077)
PCI registry
(N=198)
SYNTAX
Scores
≥33
SYNTAX
Scores
0-22
SYNTAX
Scores
23-32
SYNTAX Trial Patient
Distribution

Three-Vessel Disease: Diffuse Calcifications
5 Fr catheters, right femoral approach
Totally normal LV function (>70% LVEF, no MI)

SYNTAX SCORE
RCA Proximal 50-99% DS (x2) Aorto-ostial Heavy Calcium >20 mm
Segment 1 (=1) 2 1 2 2
RCA Mid 50-99% DS (x2) Heavy Calcium >20 mm
Segment 2 (=1) 2 2 2
RCA Distal 50-99% DS (x2)
Segment 3 (=1) 2

Medina & Syntax Score of Bifurcations
<70°
1-0-1 0-0-1 0,1,1 1,0,1
1-0-0 0,1,0 1,1,0

Left Main 50-99% DS (x2) Bifurcation 1,1,0 <70° angle Heavy calcium
Segment 5 (=5) 10 1 1 2
LAD Prox 50-99% DS (x2) Heavy Calcium >20 mm Tortuous
Segment 6 (=3.5) 7 2 2 2
LAD Mid 50-99% DS (x2) Calcium Bif 1,1,0 >20 mm Tortuous
Segment 7 (=2.5) 5 2 1 2 2
LCX Prox 50-99% DS (x2) Heavy Calcium >20 mm Tortuous
Segment 11 (=1.5) 3 2 2 2
Obtuse Marginal 50-99% DS (x2) Calcium
Segment 14 (=1) 2 2

TCT 2010 • Three-year Outcomes of the SYNTAX Trial: 3VD Subgroup • Mohr • Slide 31
CABG PCI P value
Death 6.8% 7.3% 0.86
CVA 3.2% 1.2% 0.20
MI 4.9% 5.1% 0.93
Death,
CVA or
MI
12.3% 11.2% 0.75
Revasc. 11.6% 18.8% 0.06
Months Since Allocation
P=0.45
3VD
TAXUS (N=181)
CABG (N=171)
MACCE to 3 Years by SYNTAX Score
Tercile Low Scores (0-22)
25.8%
22.2%
CumulativeEventRate(%)
0 12 24
40
0
20
30
10
36
Site-reported Data; ITT populationCumulative KM Event Rate ± 1.5 SE; log-rank P value
>
<
<
>
<

CABG PCI P value
Death 5.7% 10.3% 0.09
CVA 3.6% 2.5% 0.53
MI 3.1% 8.9% 0.01
Death,
CVA or
MI
11.3% 16.1% 0.16
Revasc. 8.4% 18.2% 0.004
P=0.003
3VD
TAXUS (N=207)
CABG (N=208)
Tercile Intermediate Scores (23-32)
29.4%
16.8%
0 12 24
40
0
20
30
10
36
>
<
<
>
>

3VD
TAXUS (N=155)
CABG (N=166)
Tercile High Scores (33)
P=0.004
31.4%
17.9%
0 12 24
40
0
20
30
10
36
CABG PCI P value
Death 4.5% 11.1% 0.03
CVA 1.9% 4.3% 0.28
MI 1.9% 7.2% 0.02
Death,
CVA or
MI
8.3% 17.7% 0.01
Revasc. 10.5% 21.5% 0.006
<
<
<
<
<

Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
Indications for CABG versus PCI in stable patients
with lesions suitable for both procedures
and low predicted surgical mortality
• In the most severe patterns of CAD, CABG appears to offer a survival advantage
as well as a marked reduction in the need for repeat revascularisation.

The RESOLUTE Allcomers Trial
A Randomised Comparison of Xience and Resolute Stents
Stent Thrombosis after 1 month: 0.9 Resolute and 0.4% Xience
Presented Silber ACC New Orleans, published Lancet 2011
SYNTAX Score: 16.4

Cobalt chromium
everolimus-eluting stent
Platinum chromium
everolimus-eluting stent
Patients with 1 or 2 de novo native coronary artery target lesions
RVD 2.5 to ≤4.25; Lesion length ≤24 mm
Peri-proc: ASA ≥300 mg, clopidogrel
≥300 mg load unless on chronic Rx
Randomized 1:1
Stratified by diabetes, intention to treat 1 vs. 2 target lesions, & study site
Clinical f/u only: 1, 6, 12, 18 months then yearly for 2-5 years
ASA indefinitely, thienopyridine ≥6 mos (≥12 mos if not high risk for bleeding)
PLATINUM Study Algorithm
Presented Stone ACC 2001 New Orleans, published JACC 2011

Target Lesion Failure
0 3 6 9 12
0
2
6
4
10
8
0 3 6 9 12
0
2
6
4
10
8
TargetLesionFailure(%)
CoCr-EES (N=747)
PtCr-EES (N=756)
Per Protocol Intention-to-Treat
3.5%
3.2%
3.4%
3.0%
HR [95% CI] =
1.12 [0.64, 1.95]
P = 0.70
HR [95% CI] =
1.17 [0.66, 2.09]
P = 0.59
762 747 743 735 718
768 756 751 745 730
Months Months
747 735 731 723 707
756 745 740 734 719
CoCr
EES
PtCr
EES
No. at risk
CoCr-EES (N=762)
PtCr-EES (N=768)
ST 0.4%; Ischaemia driven TVR 1.9%

P=0.003
Left Main
TAXUS (N=135)
CABG (N=149)
MACCE to 3 Yrs by SYNTAX Score Tercile
Left Main SYNTAX Score 33
37.3%
21.2%
Left Main
0 12 24
40
0
20
30
10
36
CABG PCI P value
Death 7.6% 13.4% 0.10
CVA 4.9% 1.6% 0.13
MI 6.1% 10.9% 0.18
Death,
CVA or
MI
15.7% 20.1% 0.34
Revasc. 9.2% 27.7% <0.001
>
<
<
<
<

CABG PCI P value
Death 9.0% 3.7% 0.02
CVA 3.3% 0.9% 0.09
MI 2.6% 4.6% 0.33
Death,
CVA or
MI
13.2% 8.7% 0.12
Revasc. 13.7% 15.7% 0.61
P=0.45
Left Main
TAXUS (N=221)
CABG (N=196)
MACCE to 3 Years by SYNTAX
Score Tercile
Low to Intermediate Scores (0-32)
20.5%
23.2%
0 12 24
40
0
20
30
10
36
>
<
<
>
>

SYNTAX: Vessel Distribution in LM Population
According to Syntax Score Terciles
0-22 33+23-32
66%
27%
7%
Distal
Nondistal
Both59%
29%
11%
35%
61%
4%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Low Syntax Intermediate
Syntax
Hig h Syntax
LM + 3VD
LM + 2VD
LM + 1VD
LM isolated

PRECOMBAT Trial (SES, IVUS 91%)
CABG registry N=335
PCI registry N=475
Medication registry N=44
Assigned CABG
N=300
Assigned PCI
N=300
Treated CABG
N=248
Treated PCI
N=51
Treated medical
N=1
Treated CABG
N=24
Treated PCI
N=276
Treated medical
N=0
1-year follow-up
N=296
1-year follow-up
N=298
1-year follow-up
CABG registry N=310
PCI registry N=457
Randomized Cohort
N=600
2-year follow-up
N=266
2-year F/U
N=270
2-year follow-up
CABG registry N=259
PCI registry N=289
Enrolled Patients (N=1454)
Presented SJ Park ACC 2001 New Orleans

PRECOMBAT Trial (SES, IVUS 91%)
Presented SJ Park ACC 2001 New Orleans
Death MI Stroke Ischaemia Driven TLR

Subgroup Analysis
0.1 1 10
Subgroup MACCE
PCI CABG
Cumulative inciden ce, %
Overa ll 12.2 8.1
Age
≥ 65 yr 11 .9 9.7
<65 yr 12.5 6.7
Sex
Male 11 .7 7.0
Female 13.9 11.7
LM stenosis
>70 % 10.8 9.0
50-70 % 13.6 7.1
Vascu lar e xtent
LM only 3.8 8.8
LM with 1VD 4.1 5.8
LM with 2VD 13.0 12.2
LM with 3VD 16.8 5.8
Bifurcation involvement
Yes 11 .8 7.3
No 13.2 9.1
RCA involvement
Yes 15.8 8.3
No 8.7 7.9
ACS
Yes 15.1 11.7
No 9.6 3.9
Diabetes
Yes 16.3 11.1
No 10.2 6.8
SYNTAX sco re
>29 15.9 11.1
>19 to 2 9 13.9 5.7
19 8.5 5.9
Hazard Ratio (95% CI) P value P value for
Interaction
1.50 (0.90, 2.52 ) 0.12 -
0.44
1.87 (0.88 , 3.97) 0.10
1.24 (0.60 , 2.56) 0.57
0.59
1.65 (0.88 , 3.07) 0.12
1.22 (0.48 , 3.08) 0.68
0.63
1.19 (0.57, 2.47) 0.64
1.90 (0.89, 4.03) 0.10
0.14
0.39 (0.04 , 3.72) 0.41
0.70 (0.11, 4.16) 0.69
1.04 (0.47 , 2.32) 0.93
3.05 (1.29 , 7.21) 0.01
0.83
1.62 (0.82 , 3.20) 0.16
1.46 (0.64 , 3.32) 0.37
0.27
1.95 (0.99 , 3.84) 0.05
1.07 (0.48 , 2.40) 0.86
0.44
1.34 (0.70, 2.55) 0.38
2.07 (0.85, 5.02) 0.11
0.92
1.43 (0.65 , 3.16) 0.37
1.51 (0.76 , 2.99) 0.24
0.80
1.60 (0.73 , 3.54) 0.24
2.32 (0.82 , 6.57) 0.11
1.38 (0.40 , 4.21) 0.57
PCI better CABG better

Sousa J, Costa J, Abizaid A. JACC Cardiovasc Interv. 2010;3:556–8
10 Years Safety and Efficacy of DES

Specific PCI devices and pharmacotherapy
*Recommendations are only valid for specific devices with
proven efficacy/safety profile, according to the respective lesion
characteristics of the studies.
Procedural aspects of PCI

Validated drug-eluting stents (DES) for clinical use
Selection is based on adequately
powered RCT with a primary
clinical or angiographic endpoint.
With the exception of LEADERS
and RESOLUTE (all-comers trials),
efficacy was investigated in
selected de novo lesions of native
coronary arteries.
* Promus Element device elutes
everolimus from a different stent
platform.

EXCEL: LM with SYNTAX SCORE < 33
Primary Endpoint: Death, MI, Stroke at 3 Years

2st patient recruited at RBH
• 64 year-old hypertensive woman
• Presented to local hospital for severe retrosternal
discomfort under stress
• ECG: SR on presentation, TnI negative
• TTE: normal LV and valve function, EF 60%
• SYNTAX score 18

IVUS to LAD and LM
D
Diam 3.0mm;
Area 8.4mm2
Diam 4.1mm;
Area 11.6mm2
Diam 2.4mm;
Area 5.2mm2
Diam 3.3mm;
Area 9.3mm2

Final Angiogram / OCT
Distal LM
MLD 3.8mm; MLA 11.1 mm2
Ostial LCX
MLD 3.1mm; MLA 7.5 mm2

Current Guidelines of Myocardial Revascularisation Patients with Stable Angina Surgery or PTCA. Carlo Di Mario

Current Guidelines of Myocardial Revascularisation Patients with Stable Angina Surgery or PTCA. Carlo Di Mario

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