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David P Taggart MD PhD FRCS FESC Professor of Cardiovascular Surgery, University of Oxford Conflicts of Interest: (i) Clinical: Cardiac Surgeon (ii) Commercial: Consultant to Medistim, Medtronic, VGS, Somahlution, Stryker) (iii) One of 25 ESC/EACTS Guidelines Writers on Myocardial Revascularization (iv) Chairman of Surgical Committee of the EXCEL trial SAHA 2017 PCI or CABG for Left Main and Multi-Vessel Disease: when I would definitely/ maybe/never refer my patient for PCI or CABG

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Page 1: SAHA 2017saheartcongress.org/2018/wp-content/uploads/2017/12/12.-15h30-Bi… · 6054 patients RR CABG vs DES for MI,RR,CVA [Siphai et al JAMA 2013] CONCLUSIONS AND RELEVANCE: In patients

David P Taggart MD PhD FRCS FESCProfessor of Cardiovascular Surgery, University of Oxford

Conflicts of Interest: (i) Clinical: Cardiac Surgeon(ii) Commercial: Consultant to Medistim, Medtronic, VGS, Somahlution, Stryker)(iii) One of 25 ESC/EACTS Guidelines Writers on Myocardial Revascularization(iv) Chairman of Surgical Committee of the EXCEL trial

SAHA 2017

PCI or CABG for Left Main and Multi-Vessel Disease:when I would definitely/ maybe/never refer my patient for PCI or CABG

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ATS [Dec 11 1967]

50 Years Ago: First report of SYSTEMATIC use of SV grafts for CABG

40 Years Ago: Gruentzig reports first PTCA (AHA 1977)

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PCI or CABG for Left Main and Multi-Vessel Disease:when I would definitely/ maybe/never refer my patient for PCI or CABG

(stable or urgent patients but NOT STEMI who should get PCI)

UK

Most interventions are RECOMMENDED by a HEART TEAM based on

① ESC/EACTS Guidelines (Evidence Based)

② Potential contra-indications to the recommended intervention ?

③ Patient Preferences (‘what is the best treatment for me ?’)

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Complex CAD should be discussed by Heart Team IC

79%

66%

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Mutlivessel Disease (No Left main)

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6054 patients: HR CABG vs PCI 0.73 (0.62-0.86); p < 0.001

JAMA 2013

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MI: RR 0.58(0.48-0.72)p<0.001

Revasc: RR 0.29 (0.21-0.41)p<0.001

Stroke: RR 1.36(0.99-1.86)p=0.06

6054 patients RR CABG vs DES for MI,RR,CVA [Siphai et al JAMA 2013]

CONCLUSIONS AND RELEVANCE: In patients with multivessel coronary disease, comparedwith PCI, CABG leads to an unequivocal reduction in long-term mortality and myocardialinfarctions and to reductions in repeat revascularizations, regardless of whether patients arediabetic or not. These findings have implications for management of such patients.

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[IJC 2016]

Survival with CABG continues to increase past 5 years with diverging survival curves

CABG results could be even better with more arterial grafts and OMT

✗✔

5 RCTS4563 patients

0.9%

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SYNTAX RCT (5 Years): 3 Vessel Disease [EHJ 2013]181 171

10.2 9.3 .81

1.8 3.9 .24

8.8 4.9 .20

17.5 14.8 .56

23. 14.6 .04

207 208

16.3 9.6 047

2.5 3.6 .53

13.8 3.1 .00

23.2 14.7 .04

25.1 11.0 000

155 166

17.8 8.8 .02

5.1 2.6 .31

8.7 1.9 .008

26.2 12.5 .002

28.2 12.6 .000

Low<23

nos

DEATH (0.9%)

CVA

MI

D+C+M

Revasc

Int23-32

nos

DEATH (7%)

CVA

MI

D+C+M

Revasc

High>32

nos

DEATH (9%)

CVA

MI

D+C+M

Revasc

PCI CABG

nos 546 549

Death 14.6 9.2 (-5.4%) .006

Cardiac Death 9.2 4.0 (-5.2%) .001

MI 10.6 3.3 (-7.3%) <.001

CVA 3.0 3.4 (+0.6%) .66

D+C+M 22 14 (-8%) <.001

Revasc 25.4 12.6 (-12.8%) <.001

(i) Consistent with PM registry data > 10 years(ii) Similar rate of stroke in PCI/CABG

21%

79%

Survival: Accelerating Divergence at 5 years

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[JACC 2016]

Accelerating Divergence of Survival benefit for CABG

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FREEDOM

1900 patients

MVD in DM

NEJM 2012

7.9% 5.4%

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Comparison of coronary artery bypass surgery and percutaneous coronary intervention in patients with diabetes: a meta-analysis of randomised controlled trials [Lancet Diabetes Endocrinol 2013]

Verma S et al: [LANCET DIABETES and ENDOCRINOLOGY 2013]

8 trials with 3612 patients

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Patency of RIMA to 20 years [Tatoulis et al Curr Op Cardiol 2011]

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Left Main

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o<90% of LMS are distal/bifurcation (very high risk of restenosis)o<90% have multivessel CAD (CABG already offers survival benefit)

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MAIN-COMPARE Registry of UPLM disease in 2240 Patients:

1102 stents and 1138 CABG followed for 3 years

BMS DES

Similar outcomes at 3 years for Death, and Composite Death/MI/Stroke but Much Greater Need for Target Vessel Revascularization with Stents

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o Competitive flow in CABG if low SYNTAX scores ie less proximal CAD

o Accelerating Divergence of Survival Curves in Favour of CABG in >32

o Used to define patients in the EXCEL trial (Syntax Scores <33)

SYNTAX

Left Main

705 RCT patients

CIRC 2014

LEFT MAIN

SYNTAX trial

705 RCT patients

5 years

CIRC 2014

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LM: SYNTAX <33

1903 RCT patients

1000 Registry Patients

NEJM 2016

At 5 years ?

No Difference in Stroke

CAUTION: ONLY 3 YEARS FOLLOW-UP !!!!

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From randomization to 30 days

PCI

(n=948)

CABG

(n=957)HR [95%CI]

P

value

Death, stroke or MI 4.9% 7.9% 0.61 [0.42, 0.88] 0.008

- Death 1.0% 1.1% 0.90 [0.37, 2.22] 0.82

- Stroke 0.6% 1.3% 0.50 [0.19, 1.33] 0.15

- MI 3.9% 6.2% 0.63 [0.42, 0.95] 0.02

EXCEL: The Money Shot

From 30 days to 3 years

PCI

(n=939)

CABG

(n=947)HR [95%CI]

P

value

11.5% 7.9% 1.44 [1.06, 1.96] 0.02

7.3% 4.9% 1.44 [0.98, 2.13] 0.06

1.8% 1.8% 1.00 [0.49, 2.05] 1.00

4.2% 2.5% 1.71 [1.00, 2.93] 0.05

By 3 years CABG mortality 2.3% lower (p=0.06) BUT WITH DIVERGING SURVIVAL CURVES and NO increased risk of stroke

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LM:

1201 RCT patients

No Registry Patients

Lancet 2016

Mortality

12% 9%

REVASC

16% 10%

MI

7% 2%

STROK

E

5% 2%

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3 REASONS WHY CABG HAS A SURVIVAL BENEFIT OVER PCI

Anatomically, atheroma is mainly located in the proximal coronary arteriesPlacing bypass grafts to the MID CORONARY VESSEL has TWO effects

(i) Complexity of proximal ‘CULPRIT’ lesion is irrelevant(ii) Over the long term offers prophylaxis against FUTURE proximal ‘culprit’ lesionsIn contrast, PCI only treats ‘SUITABLE’ localised proximal ‘culprit’ lesions but has NO

PROPHYLACTIC BENEFIT against new proximal disease

PCI means incomplete revascularization (Hannan Circ 2006)Of 22,000 PCI 69% had incomplete revascularization>2 vessels (+/- CTO) HR for mortality 1.4 (95% CI = 1.1-1.7)Residual SYNTAX score >8 increases mortality and MACCE (Farooq, Serruys CIRC 2013)

PCI will ‘never’ match the results of CABG for LM/MVD (POBA;BMS;DES)

[CIRC 2007]

IMA elutes NO into coronary circulation reducing risk of further disease

impairs re-endothelialization, downstream endothelial function and creates pro-thrombotic milieu

1

2

3

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Ratio Elective PCI:CABG per 100,000 population in 24 OECD countries

4 x difference in European states with similar populations and economies

? USA

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INTERPRETATION The physician performing the diagnostic catheterization and the treating hospital were strong independent predictors of the mode of revascularization. Opportunities exist to improve transparency and consistency around the decision-making process for coronary revascularization, most notably among patients with non-emergent multivessel disease.

[CMAJ 2012]

17 cardiac centres in Ontario,CA5 x difference in PCI:CABG ratio

4% of patients discussed at MDT (96% NOT)

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[BMJ 2014]

Only 1% said for symptoms only

✗ ✗ ✗

Only 1% correctly identified that ELECTIVE PCI was for symptoms only

WHY RECOMMENDATIONS for INTERVENTION SHOULD BE BY HEART TEAM

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Multi-Vessel Disease (No Left Main): ESC Guidelines 2013

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Left Main: ESC Guidelines 2013

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AR Gruentzig 1939-1985

(NEJM 1979)“We estimate that only about 10 to 15 per cent of candidates for bypass surgery have lesions suitable for this procedure (PCI). A prospective randomized trial will be necessary to evaluate its usefulness in comparison with surgical and medical management.”

Opie LH, Commerford PJ, Gersh BJ

Lancet 2006; 367:69-78

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66%

79%

CABG would be even better with more arterial grafts and greater use of OMT

Complex CAD should be discussed by Heart Team IC

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200 patient with stable angina and significant stenoses >80% and FFR <0.7RCT of PCI vs sham invasive procedureAt 6 weeks no difference in exercise test nor frequency or severity of angina

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Summary and Conclusions: PCI vs CABG 2017① 79% of patients with 3 vessel CAD (SYNTAX >22) and 66% with LM

(SYNTAX >32) have strong survival advantage with CABG (reduced MI and repeat revasc) by 3 years and continuing to increase past 5 years

② CABG is superior to PCI despite inferior ‘OMT’ and 80% of all grafts being vein grafts (would be even better with widespread use of arterial grafts)

③ In 21% of patients with 3VD (SYNTAX scores <23) and 34% with LM (SYNTAX scores <33), similar 5 year survival between CABG and PCI but less repeat revasc with CABG

④ In contemporary trials CABG causes a non significant increase in stroke with 3VD and LM

⑤ Consistent ‘unwarranted’ variation in ratios of PCI:CABG between countries and within countries

⑥ ABSENCE of Heart Team (using approved guidelines) results both in most elective PCI patients failing to understand its rationale and also a large number of inappropriate or wrong PCI interventions

⑦ Guidelines are transparent and protect the patients (from receiving wrong interventions) and doctors (from administering wrong interventions) and should be mandatory

⑧ Professional bodies should persuade statutory bodies/payers that they only reimburse interventions which are approved by the Heart Team based on official guidelines (or clear documentation why guidelines were not followed).

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Interpreting Efficacy of PCI vs CABG: 3Key Questions

1. Are most trial patients typical of routine practice ?:

NO (except SYNTAX)

2. What is the duration of follow-up ?

USUALLY < 5 YEARS (ie Interim Analysis): few exceptions

3. Use of OPTIMAL (Guideline Based) medical therapy ?

CABG substantially inferior to PCI

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Ann Thorac Surg 2006;82:1966–75

[ALL REPORTED PCI EQUAL TO CABG for SURVIVAL]

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ASCERT 189,793 pts: NEJM 2012

FREEDOM 1,900 pts: NEJM 2012

Survival benefit of CABG increases with time (< 5 yr follow-up is ‘interim’ analyses)

5.4%

4.4% NY Registry 16,242 pts: ATS 2013

6.8%

ACCELERATING DIVERGENCE OF SURVIVAL CURVES BEYOND 5 YEARS !!!

SYNTAX 1,095 pts: EHJ 2013

5.4%

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[NEJM 2016]

7.2%

8.8%

N=121220% of OMTX to CABG

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ATS [Dec 11 1967]

50 Years Ago: First report of SYSTEMATIC use of SV grafts for CABG

40 Years Ago: Gruentzig reports first PTCA (AHA 1977)

1986: Loop et al SYSTEMATIC Use of ITA graft 1999: Lytle et al SYSTEMATIC Use of two ITA grafts

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563

Effect of coronary artery bypass graft surgery on survival: overview

of 10-year results from randomised trials by the Coronary Artery

Bypass Graft Surgery Trialists Collaboration*

Summary

We carried out a systematic overview using individual patientdata from the seven randomised trials that have compared a

strategy of initial coronary artery bypass graft (CABG) surgerywith one of initial medical therapy to assess the effects on

mortality in patients with stable coronary heart disease (stable

angina not severe enough to necessitate surgery on grounds of

symptoms alone, or myocardial infarction).

1324 patients were assigned CABG surgery and 1325

medical management between 1972 and 1984. The

proportion of patients in the medical treatment group who had

undergone CABG surgery was 25% at 5 years, 33% at 7 years,and 41% at 10 years: 93&middot;7% of patients assigned to the

surgery group underwent CABG surgery. The CABG group had

significantly lower mortality than the medical treatment groupat 5 years (10&middot;2 vs 15&middot;8%; odds ratio 0&middot;61 [95% Cl

0&middot;48-0&middot;77], p=0&middot;0001), 7 years (15&middot;8 vs 21&middot;7%; 0&middot;68

[0&middot;56-0&middot;83], p<0&middot;001), and 10 years (26&middot;4 vs 30&middot;5%;

0&middot;83 [0&middot;70-0&middot;98]; p=0&middot;03). The risk reduction was greaterin patients with left main artery disease than in those with

disease in three vessels or one or two vessels (odds ratios at 5

years 0&middot;32, 0&middot;58, and 0&middot;77, respectively). Although relative

risk reductions in subgroups defined by other baseline

characteristics were similar, the absolute benefits of CABG

surgery were most pronounced in patients in the highest risk

categories. This effect was most evident when several

*Fully tabular version available electronically, with authorshipYusuf S, Zucker D, Chalmers TC, under the title Ten-Year Results of the

Randomized Control Trials of Coronary Artery Bypass Graft Surgery, as

Online Journal of Current Clinical Trials, 1994; 3: document no 130

(0 figures, 70 tables, 1 appendix).

National Heart, Lung, and Blood Institute, Bethesda, Maryland, USA

(Prof S Yusuf FRCP, D Zucker PhD, E Passamani MD); McMaster

University, Hamilton, Ontario, Canada (S Yusuf); Hebrew University,

Jerusalem, Israel (D Zucker); Veterans Affairs Cooperative Studies

Program, West Haven, Connecticut (P Peduzzi PhD, T Takaro MD);

University of Washington, Seattle (Prof L D Fisher PhD,

Prof J W Kennedy MD, Prof K Davis PhD); Beth Israel Hospital,New York, USA (Prof T Killip MD); Green Lane Hospital, Auckland,New Zealand (Prof R Norris FRACP); Oregon Health Sciences

University, Portland (C Morris PhD); Texas Heart Institute, Houston

(V Mathur MD); University of Goteborg, Sweden

(Prof E Varnauskas MD); Harvard School of Public Health and Tufts

University, Boston, Massachusetts, USA (T C Chalmers MD)

Correspondence to: Prof Salim Yusuf, 252 HGH-McMaster Clinic,Hamilton General Hospital, Hamilton, Ontario, Canada L8L 2X2

prognostically important clinical and angiographic risk factors

were integrated to stratify patients by risk levels and the

extension of survival at 10 years was examined (change in

survival - 1&middot;1 [SE 3&middot;1] months in low-risk group, 5&middot;0 [4&middot;2]

months in moderate-risk group, and 8&middot;8 [5&middot;4] months in

high-risk group; p for trend <0&middot;003).

A strategy of initial CABG surgery is associated with lower

mortality than one of medical management with delayed

surgery if necessary, especially in high-risk and medium-risk

patients with stable coronary heart disease. In low-risk

patients, the limited data show a non-significant trend towards

greater mortality with CABG.

Introduction

During the 25 years since coronary artery bypass graft(CABG) surgery was introduced, it has become clear that

the operation relieves angina pectoris and probablyimproves quality of life.’ However, because of the highlyvariable course of the underlying coronary artery disease

and the influence of many concomitant factors, such as the

degree of left-venticular (LV) dysfunction, the effect of

CABG surgery on prognosis has been more difficult to

establish. During the 1970s and early 1980s, several

randomised comparisons of early CABG surgery and initial

medical therapy were done.2-7

Although their general goals were similar, these trials

varied in their design, the types of patients recruited, when

they took place, and the methods of reporting. Perhaps

partly because of the dissimilarities and differences in the

numbers and types of patients studied, these trials were

perceived as producing widely disparate results on the

effect of CABG surgery on mortality. The three largetrials2-4 each included only about 800 or fewer patients;

although large reductions in mortality (eg, a 50% reductionin risk at 5 years) could be detected or excluded, smaller (say

30%) though worthwhile risk reductions might have beenmissed. In such circumstances, a formal overview of all the

relevant data by appropriate methods8 is likely to clarify theeffects of CABG surgery on mortality. Provided that data

are obtained in a reasonably standard way, it should be

possible to assess whether the effects of CABG surgery aremodified by various patient characteristics.The aim of this collaborative project was to obtain data on

every patient from all appropriately randomised trials of

stable coronary heart disease for follow-up of at least 10

years. The primary aims were to compare the effects of a

strategy of routine CABG surgery with one of initial

[Lancet 1994]

• CABG first systematically performed in 1967 and PCI in 1977• Trials of coronary revascularization by CABG or stents (PCI) >30 years• CABG remains one of the most commonly performed major operations

(in 2016 worldwide > 1 million CABG)• No other surgical operation has ever been subjected to the same

scientific scrutiny as CABG

1. Are RCT patients typical of ‘routine’ patients?

① CABG: BETTER if 2 or 3 vessel CAD involving proximal LAD② CABG: NO benefit for 1 or 2 VD NOT involving proximal LAD

Could this information be used to design a trial to show that PCI is as ‘effective’ as CABG ?

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CIRC 2015

Substantially inferior OMT in CABG group mortality and MACCE

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Original population:100%

Angiographic proven multivessel CAD

Original population:24 %Angiographic Criteria

Original population:6%Cardiologist/Surgeon Agree

Original population:4%Randomized patients (1 or 2 VD + good LV)

EXCLUDE 76%(outcome known to be betterwith CABG: severe 3VD, LM,occluded vessels, poor LV)

EXCLUDE 18%(CABG can treat all lesions butstents cannot)

EXCLUDE 2%(Patients Refuse Participation)

(i) Can now Confidently Predict: No difference in survival (Yusuf 1994)(ii) Generalize results in publications:All patients with coronary disease(iii) Organize ‘Sympathetic’ EditorialsIgnore major flaws/limitations of RCT(iv) Use Trials to Underpin Guidelines

Q: Could industry (who want to sell stents) ‘design’ an RCT to ‘prove’ that stents are equal to CABG

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Surely this could not REALLY happen: ESPECIALLY in such a prestigious field of medicine dominated by EBM and RCTs (led by distinguished and famous investigators) ?

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Society Recommendations for stents vs CABG based on 15 RCTs

ACC/AHA

Circulation

2006

‘Patients with 2 or 3 vessel disease who are otherwise eligible for CABG including diabetes’

NO SURGICAL OPINION RECOMMENDED

ESC

Eur Heart J

2005

‘all patients except diabetics with multivesseldisease, unprotected left main, CTO’

NO SURGICAL OPINION RECOMMENDED

BCS

Heart

2005

‘patients to be fully informed in decisions, treatment options’ (GMC Good Medical Practice)

NO SURGICAL OPINION RECOMMENDED

Summary of Guidelines

almost all patients can be treated by PCI

NONE RECOMMEND SURGICAL OPINION

46 cardiologists0 surgeon

8 cardiologists1 surgeon

77 cardiologists2 surgeons

23 cardiologists1 surgeon

Written by

[ATS 2006]

‘surgical societies should no longer provide a ‘token’ surgeon on cardiology guidelines as they arehopelessly ‘outgunned’ and ineffectual against what are, in effect, exclusive cardiology dictates. Ifsurgical opinion is genuinely to be heard, there must be comparable numbers of surgeons on writingcommittees’

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‘Most significantly, the randomized trials only enrolled around 5%-10% of the

eligible population, the majority of whom had single or double vessel disease and

normal left ventricular function [2], a group in whom it was already well

established that there was no prognostic benefit of CABG [3]. By largely

excluding patients with a known survival benefit from CABG (left main+/- triple

vessel coronary artery disease and especially with impaired ventricular function [3]),

the trials ignored the prognostic benefit of surgery in more complex coronary artery

disease. Nevertheless, the inappropriate generalization of the trial results from their

highly select populations to most patients with multivessel disease has been

ubiquitous in the literature and has, at least in part, justified the explosive growth in

PCI in developed countries.’

Taggart DP. Lancet 2009; 373:1150-2

[2] Taggart DP. Thomas B. Ferguson Lecture. Coronary artery bypass grafting is still the best treatment for multivessel and left main disease, but patients need to know. Ann Thorac Surg 2006;82:1966-75. [3] Yusuf S, et al. Effect of coronary artery bypass graft surgery on survival: overview of 10-year results from randomised trials by the Coronary Artery Bypass Graft Surgery Trialists Collaboration. Lancet 1994 ;344:563-70.

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[2016]

Primary outcome is 10-year survival (in 2018)

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[CIRC 2014]

15,583 patients followed for a mean of >9 years

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Has the difference in mortality between percutaneous coronary intervention and coronary artery bypass grafting in people with heart disease and diabetes changed over the years? A systematic review and meta-regressionPeter Herbison, Cheuk-Kit Wong [BMJ 2015]

In DM even with 3rd generation stents CABG still has strong survival advantage

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Left Main (+/- Mutlivessel Disease)

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DEATH (5 yr):No Difference

MI: ( PCI @ 1-3yrs)

TVR: ( PCI @ 1-5 yr)

CVA:( CABG @ 1-5yr)

Different from 3VD where CABG death, MI, RR and NS for CVA

5 yr:1.7% vs 4.7%(Δ 0.9% vs 1.9%): ? OMT

1 yr: 0.8% vs 2.8%

24 studies (3 RCT) with 14,203 patients followed to 5 years

[JACC Cardiovasc Intervention 2013]

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DEATH MI

MACCE TVR

LM: CABG BEST ONLY FOR HIGH TERCILES (>32)

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LEFT MAIN

SYNTAX trial

705 RCT patients

5 years

CIRC 2014

Different from

3VD !!

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BMJ 2005

The current tendency of some cardiologists to exclusivelyinvestigate and treat patients with severe multivessel diseasewithout a surgical opinion not only belittles the traditionalmultidisciplinary approach but ensures that the best and mostbalanced advice is unlikely to be consistently offered. Mostimportantly, by effectively denying patients the opportunity ofmaking a fully informed choice, it falls far short of best practice.

Politics of PCI vs CABG

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✔Current evidence for PCI and CABG in multi-vessel and left main

✗ Documented unwarranted variations in ratio of PCI and CABG✗ Documented inappropriate use of investigations and interventions✗ Documented poor patient understanding of the rationale(s) for treatment

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[EJCTS 2014]

13 x difference for lowest (0.36) and highest (4.74) although only 40 miles apart !!

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1,225,562 angiograms: 25% ASYMPTOMATIC (range 1%-76%)

JAMA Int Med 2014

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ACC/AHA Recommendation

Numbers % CABG % PCI % Medical None

CABG 1337 53 34 12 1

PCI 6071 2 94 4 <1

CABG or PCI 1722 5 93 2 <1

Neither 1223 6 21 71 2

Total 10333 10 77 13 <1

o16142 catheter lab patients in New York 2005-07oTreatment decision made by catheter lab cardiologist alone in 64%

o92% of PCI procedures ad hoc (ie no time for real choice/ genuine consent)oChance of PCI increased in hospitals with PCI facilities

Adherence of Catheterization Laboratory Cardiologists to ACC/AHA Guidelines for PCI and CABG: What happens in Actual Practice ? [Hannan et al Circ 2010]

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JAMA Int Med 2014

In taped interviews benefits of PCI were accurate in 5% BUT overstated in 48% [explicitly (13%) or implicitly (35%)]

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PCI vs CABG in 2017

1. EFFICACY of PCI vs CABG: Four important issues

(i) Are RCT patients typical of routine practice ? (ii) Duration of follow-up ?(iii) SYNTAX scores ? ie severity of CAD(iv) Use of OPTIMAL (guideline based) medical therapy ?

2. EVIDENCE BASIS

for PCI and CABG in Multivessel and Left MainDisease

3. ‘POLITICS’ of PCI vs CABG (Rationale for the Heart Team)

THREE KEY AREAS TO ADDRESS

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Relative Efficacy of PCI and CABG: 4 Questions

1.Are patients enrolled in RCTs typical of routine practice?

✗ USUALLY NO. With the single exception of the ‘all-comer’ SYNTAX trial, 19 other RCTs of PCI vsCABG enrolled <10% of the eligible population ie those with low severity CAD (but then generalized the results to the whole population)

2. What is the duration of follow-up?

✗ SHOULD BE AT LEAST 5 YEARS. The benefits of CABG (improved survival, reduced MI and repeat revascularization) continue to increase with time (< 5yr follow up is only an ‘interim’ analyses)

3. What are the SYNTAX scores of the study population?

✗ NO SYNTAX SCORE = NO IDEA OF SEVERITY OF CAD Cannot recommend best treatment

4. Did CABG patients in RCTs receive Optimal Medical Therapy?

✗ USUALLY NO. In most trials CABG patients received substantially inferior guideline based medical therapy (OMT) leading to increased mortality and MACCE

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o25 members from 13 European countries•9 non interventional cardiologists, •8 interventional cardiologists, •8 cardiac surgeons

Reflects the ‘Heart Team’ !!!

oExtensively reviewed by external referees before publication

oJoint Cardiology (ESC) and Cardiac Surgery (EACTS)

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14 chapters270 references

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% progression of native CAD

IMA SVG

Kitamura (1987) 18 46

Loop (1996) 39 67

Manninen (1998) 26 45

Hamada (2001) 12 38

Borges (2010) 17 44

AVERAGE 22 48

CIRC 2007

✗ impairs re-endothelialization, ✗ creates pro-thrombotic environment ✗ impairs distal endothelial function

Increased EDRFs (especiallyNO) produced by IMA results(i) in superior graft patency(ii) protects native coronary

artery circulation

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Sir William Osler 1849-1919Regius Professor of Medicine Oxford 1905-19

James McGill 1744-1813Glasgow University 1756

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[ATS 2009]

1899-1984

Scottish forefathers !!

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MAIN-COMPARE Registry of UPLM disease in 1102 stents and 1138 CABG

there was a trend toward higher rates of death and the composite end point in the group that

received DES

BMS DES

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SYNTAX

3VD @ 5 years

1095 RCT patients

EHJ 2014

5.4%

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JAHA 2013

DEATH

CARDIAC DEATH

Death

Cardiac Death

REVASC