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

Conflicts of Interest: (i) Clinical: Cardiac Surgeon(ii) One of 25 ESC/EACTS Guidelines Writers on Myocardial Revascularization

CABG vs PCI: What do the Guidelines Say ?

AATS International Cardiovascular Symposium:Sao Paolo 2017

CABG vs PCI: What do the Guidelines Say ?

① Development of Joint Guidelines by the Heart Team

① Role of the Heart Team in the Rationale for Guidelines

② Current Guidelines

① Main Guideline Recommendations

② Differences in Guidelines in Europe and North America ?

③ Likely Changes in Guideline Recommendations Based on New Evidence

Society Recommendations for PCI

ACC/AHACirculation 2006

‘Patients with 2 or 3 vessel disease who are otherwise eligible for CABG including diabetes’NO SURGICAL OPINION RECOMMENDED

ESCEur Heart J 2005

‘all patients except diabetics with multivesseldisease, unprotected left main, CTO’NO SURGICAL OPINION RECOMMENDED

BCSHeart 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 PCINONE RECOMMEND SURGICAL OPINION

46 cardiologists0 surgeon

8 cardiologists1 surgeon

77 cardiologists2 surgeons

23 cardiologists1 surgeon

Written by

[ATS 2006]

‘I believe that surgical societies should no longer provide a ‘token’ surgeon on cardiologyguidelines as they are hopelessly ‘outgunned’ and ineffectual against what are, in effect,exclusive cardiology dictates. If surgical opinion is genuinely to be heard, there must becomparable numbers of surgeons on writing committees.’

SYNTAX SCORE: <23= PCI; >23 =CABG

CORONARY: What Changed Guidelines and the need for Heart Teams ?

23 cardiologists and 1 surgeon !!Inserted 2 Flow Algorithms for LM and MVD

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): A First

14 chapters270 references

[ JTCVS 2016]

Broadly Similar

Some Minor Differences in Class of Recommendation (COR) and Levels of Evidence (LOE)

Heart TeamCOR: ILOE: C

✔Current evidence: PCI and CABG in multi-vessel and left main✔AND ALSO DOCUMENTED1. GROSS variations (up to 20 fold !) in ratio of PCI vs CABG (between countries, within single countries, within single regions) 2. DIFFERENCES LARGELY DICTATED by PHYSICIAN PREFERENCE3. Widespread Inappropriate use of investigations and interventions (PCI)4. Most patients misunderstand the rationale for PCI (improved survival etc

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

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

Left Main: ESC Guidelines 2013

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

o 200 patient with stable angina and significant stenoses >80% and FFR <0.7

o RCT of PCI (DES) vs ‘sham’ invasive procedure (FFR)o At 6 weeks improvements in exercise test and frequency and severity

of angina similaro ? PLACEBO EFFECT of PCI

[JACC 2016]

Accelerating Divergence of Survival benefit for CABG

LM: EXCEL TrialSYNTAX scores <331905 RCT patients (of 2600)1000 Registry Patients3 years follow-up

At 5 years ?

No Difference in Stroke

NEJM 2016

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’ ShotFrom 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 2.4% lower (p=0.06) BUT:① DIVERGING SURVIVAL CURVES in favour of CABG② NO increased risk of stroke with CABG

Repeat Revasc 12.6% PCI vs 7.5% CABG (p<0.001)

LM: NOBLE1201 RCT patients @ 5 yearsNo Registry PatientsLancet 2016

Mortality12% 9%

REVASC16% 10%

MI7% 2%

STROKE5% 2%

What do the Guidelines Say ?: Summary and Conclusions① Guidelines give clear indications when intervention is appropriate and

emphasize the role of the Heart Team in making recommendations② Guidelines state that ‘ad hoc’ PCI should not be a default procedure③ Guidelines recommend that institutional protocols can be used to avoid

systematic need to review every case④ 79% of 3 vessel disease (SYNTAX >22) and 65% of all left main

disease (SYNTAX >32) have strong survival advantage with CABG continuing to increase past 5 years

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

⑥ Strong evidence that ABSENCE of Heart results in the majority of 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 to only reimburse interventions which are approved by the Heart Team based on guidelines (or documented as to why guidelines were not followed)