CABG vs PCI: What do the Guidelines Say?

Transcription

1 AATS International Cardiovascular Symposium: Sao Paolo 2017 CABG vs PCI: What do the Guidelines Say? David P Taggart MD PhD FRCS FESC Professor of Cardiovascular Surgery, University of Oxford Conflicts of Interest: (i) Clinical: Cardiac Surgeon (ii) One of 25 ESC/EACTS Guidelines Writers on Myocardial Revascularization

2 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

3 Society ACC/AHA Circulation 2006 ESC Eur Heart J 2005 BCS Heart 2005 Recommendations for PCI Patients with 2 or 3 vessel disease who are otherwise eligible for CABG including diabetes NO SURGICAL OPINION RECOMMENDED all patients except diabetics with multivessel disease, unprotected left main, CTO NO SURGICAL OPINION RECOMMENDED patients to be fully informed in decisions, treatment options (GMC Good Medical Practice) NO SURGICAL OPINION RECOMMENDED [ATS 2006] Written by 23 cardiologists 1 surgeon 46 cardiologists 0 surgeon 8 cardiologists 1 surgeon Summary of Guidelines almost all patients can be treated by PCI NONE RECOMMEND SURGICAL OPINION 77 cardiologists 2 surgeons I believe that surgical societies should no longer provide a token surgeon on cardiology guidelines 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 be comparable numbers of surgeons on writing committees.

4 CORONARY: What Changed Guidelines and the need for Heart Teams? SYNTAX SCORE: <23= PCI; >23 =CABG

5 23 cardiologists and 1 surgeon!! Inserted 2 Flow Algorithms for LM and MVD

6 ojoint Cardiology (ESC) and Cardiac Surgery (EACTS): A First 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

7 14 chapters 270 references

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10 [ JTCVS 2016] Broadly Similar Some Minor Differences in Class of Recommendation (COR) and Levels of Evidence (LOE)

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12 Heart Team COR: I LOE: C

13 Current evidence: PCI and CABG in multi-vessel and left main AND ALSO DOCUMENTED 1. 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 PREFERENCE 3. Widespread Inappropriate use of investigations and interventions (PCI) 4. Most patients misunderstand the rationale for PCI (improved survival etc

14 Complex CAD should be discussed by Heart Team IC 66% 79% CABG would be even better with more arterial grafts and greater use of OMT

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

16 Left Main: ESC Guidelines 2013

17 Complex CAD should be discussed by Heart Team IC 66% 79% CABG would be even better with more arterial grafts and greater use of OMT

18 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 similar o? PLACEBO EFFECT of PCI

19 Accelerating Divergence of Survival benefit for CABG [JACC 2016]

20 NEJM 2016 LM: EXCEL Trial SYNTAX scores < RCT patients (of 2600) 1000 Registry Patients 3 years follow-up At 5 years? No Difference in Stroke

21 EXCEL: The Money Shot From randomization to 30 days From 30 days to 3 years PCI (n=948) CABG (n=957) HR [95%CI] P value PCI (n=939) CABG (n=947) HR [95%CI] P value Death, stroke or MI 4.9% 7.9% 0.61 [0.42, 0.88] % 7.9% 1.44 [1.06, 1.96] Death 1.0% 1.1% 0.90 [0.37, 2.22] % 4.9% 1.44 [0.98, 2.13] Stroke 0.6% 1.3% 0.50 [0.19, 1.33] % 1.8% 1.00 [0.49, 2.05] MI 3.9% 6.2% 0.63 [0.42, 0.95] % 2.5% 1.71 [1.00, 2.93] 0.05 Repeat Revasc 12.6% PCI vs 7.5% CABG (p<0.001) By 3 years CABG mortality 2.4% lower (p=0.06) BUT: 1 DIVERGING SURVIVAL CURVES in favour of CABG 2 NO increased risk of stroke with CABG

22 LM: NOBLE 1201 RCT 5 years No Registry Patients Lancet 2016 Mortality 12% 9% MI 7% 2% REVASC 16% 10% STROK E 5% 2%

23 What do the Guidelines Say?: Summary and Conclusions Guidelines give clear indications when intervention is appropriate and emphasize the role of the Heart Team in making recommendations Guidelines state that ad hoc PCI should not be a default procedure Guidelines recommend that institutional protocols can be used to avoid systematic need to review every case 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 Consistent unwarranted variation in ratios of PCI:CABG between countries, within single countries and within single regions 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 Guidelines are transparent and protect the patients (from receiving wrong interventions) and doctors (from administering wrong interventions) and should be mandatory 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)