Southern Thoracic Surgical Association CABG in 2012: Implications of the New ESC/EACTS Guidelines

Transcription

1 Southern Thoracic Surgical Association 2011 CABG in 2012: Implications of the New ESC/EACTS Guidelines David P Taggart MD PhD FRCS Professor of Cardiovascular Surgery, University of Oxford Conflicts of Interest: (i) Clinical: Cardiac Surgeon (ii) Political: President SCTS GB and Ireland; Chair ESC Working Group Cardiovascular Surgery (iii) Commercial: Consultant to Medtronic, Abbott, AstraZeneca, Novadaq, VGS, (iv) One of 25 ESC/EACTS Guidelines Writers on Myocardial Revascularization

2 Joint ESC/EACTS Guidelines for Myocardial Revascularization 2010 Table 9. Indications for CABG versus PCI in stable patients with lesions suitable for both procedures and low predicted surgical mortality 79% 65% 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. ACC/AHA guidelines for PCI 08/11/2011 very similar recommendations

3 Results of contemporary CABG are excellent!!! o3102 patients randomized to single or bilateral IMA grafts primary outcome is 10 year survival 67 surgeons, 28 centres, seven countries 30 day mortality 1.2%, 1 yr mortality 2.4% 1 year incidence of stroke, MI, repeat revascularization all < 2%

4 Ann Thorac Surg 2006;82: patients in total Only enrolled 5% of total potentially eligible population 65% had 1 or 2 VD all with normal LV function only 40% had proximal LAD disease only 79% received an IMA ie Trials failed to show a survival benefit of CABG over PCI as they only included patients in whom it could be predicted that there was NO prognostic benefit from any revascularization

5 Evidence Basis for an Intervention (CABG vs PCI) Strengths Potential Weaknesses RCT The Gold standard No Bias Small numbers of patients Small % of eligible population Atypical patient populations Short duration of follow-up Large numbers of cross-overs (19/20 RCT of CABG vs PCI) Registries (Propensity Matched) Large Numbers of Patients (often tens of thousands) Represent real clinical practice (1/20 RCT of CABG vs PCI) Confounding/Bias

6 3VD (No Left Main)

7 1. EVIDENCE FROM RCT of PCI vs CABG (Pre-SYNTAX) Hlatky [Lancet 2009] Studies 10 RCT CABG vs PCI Patients 7812 Median Follow-up 6 years HR for death with CABG 0.91 (p=0.12) HR for death with PCI - Death/Repeat Revasc 10% vs 25% (p=0.001) HR Death CABG in Diabetics 0.7 (p=0.014) HR Death CABG >65 yrs 0.82 (p=0.002) Jeremias [Am J Med 2009] 28 RCT CABG or PCI vs OMT years 0.62 ( ) 0.82 ( ) - - -

8 2. EVIDENCE FROM REGISTRIES of PCI vs CABG (Pre-SYNTAX) NEJM 2005 onew York Registry: 37,212 CABG and 22,102 PCI (BMS) patients with > 2VD Propensity matched for cardiac and non-cardiac co-morbidity risk Absolute Survival Benefit of 5% with CABG at 3 years Reintervention at 3 years: 35% of PCI vs 5% CABG 31% risk of death ocabg: Survival + freedom from revasc INCREASE WITH TIME!! PCI/CABG studies with <3 years follow up are only interim analyses

9 CABG Has Survival Benefit Over PCI in Real Life Clinical Practice Author Year Patients DM Stents Follow- Up CABG vs PCI Hannan NEJM ,400p - DES 1.5 yrs HR 0.8 (p=0.03) Bair CIRC ,369 - DES 5 yrs HR 0.85 (p<0.001) Javaid CIRC ,680 - DES 1 yr 97% vs 89% Hannan NEJM ,314p - BMS 3 yrs mortality 5% Malenka CIRC ,493 - BMS 7 yrs HR 0.6 (p <0.01) BARI JACC yrs 58% vs 46% Javaid CIRC DES 1 yr 3% vs 12-18% Niles JACC , yrs HR SUMMARY 102, yrs mortality oin (>100,00) REAL-LIFE patients with 3VD, by 3-5 years CABG increases ABSOLUTE survival by around 5% vs PCI CABG decreases ABSOLUTE reintervention x5 vs PCI IMPORTANT WARNING FOR SYNTAX TRIAL!!

10 7235 patient pairs propensity matched for 32 factors with 8 yr FU PCI CABG CABG HR numbers All Deaths 29% 22% 0.68 ( ) <0.001 LAD DISEASE nos PCI death CABG death CABG HR 3 VD Proximal % 22% 0.68 ( ) < VD Non Proximal % 22% 0.53 ( ) < VD Proximal % 21% 0.78 ( ) < VD Non Proximal % 23% 0.70 ( ) < VD None % 25% 0.78 ( ) <0.05 DES have not been shown to have survival benefit over BMS

11 Taggart DP. Lancet 2009; 373: 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. [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: [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:

12 THE SYNTAX TRIAL Landmark trial (most important trial ever of PCI vs CABG) odesigned to look at 5 year outcomes death and MACCE o All comer trial (vs highly select patients in all previous RCTs) oparallel Registry (35% of patients straight to CABG!!)

13 SYNTAX RCT Results (4/5 Years): 3 Vessel Disease PCI CABG nos Death Cardiac Death MI <.001 CVA D+C+M Revasc <.001 Consistent with PPM registry data Similar rate of stroke in PCI/CABG Low <23 Intd High >32 nos death CVA MI D+C+M Revasc nos death CVA MI D+C+M Revasc nos death CVA MI D+C+M Revasc

14 Fundamental Question WHY DOES CABG HAVE SUCH A SURVIVAL BENEFIT OVER PCI? Anatomically, atheroma is mainly located in the proximal coronary arteries During CABG placing bypass grafts to the MID CORONARY VESSEL has TWO effects (i) treats the CULPRIT lesion (of ANY complexity) (ii) over the long term, CABG offers prophylaxis against FUTURE culprit lesions by protecting whole zones of vulnerable proximal myocardium in diffusely unstable coronary endothelium In contrast, PCI with stents ( ) only treats SUITABLE localised proximal culprit lesions but has NO PROPHYLACTIC BENEFIT against new disease (proximal to, within or distal to the stent) which nullifies the benefit of the stent 2. 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 = ) PCI will never match the results of CABG for LM/MVD (POBA;BMS;DES)

15 Left main (+/- 1,2,3 vcad)

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

17 SYNTAX RCT Results (4/5 Years): Left Main: n=705 PCI CABG nos Death *.94 Cardiac Death *.26 MI CVA *.03 D+C+M Revasc * = different from 3VD EXCEL TRIAL (Abbott Vascular) 2600 patient RCT: PCI vs CABG only in SYNTAX Score < registry patients ie 3600 in total started Sept 2010 Low <23 Intd High >32 nos death CVA MI D+C+M Revasc nos death CVA MI D+C+M Revasc nos death CVA MI D+C+M Revasc <001

18 o PRECOMBAT : 600 patient RCT (300 PCI vs 300 CABG) Cohort of 1454 LM patients (59% NOT randomized) Mean SYNTAX score: 25 (vs 30 in SYNTAX) Mean Euroscore: 2.7 (vs 3.8 in SYNTAX) Primary endpoint: Death; CVA; MI; Repeat Revasc Primary Endpoint Primary Endpoint (-Revasc) oincidence of stroke 0.4% PCI vs 0.7% CABG ono increase in mortality or stroke with CABG c/w SYNTAX

19 ojoint Cardiology (ESC) and Cardiac Surgery (EACTS) 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

20 Class of Recommendation and Level of Evidence Class of Recommendation I II III IIa IIb Evidence and /or general agreement that treatment or procedure is beneficial, useful, effective Conflicting evidence and/or opinion about usefulness/efficacy Weight of evidence in favour Evidence/opinion less well established Evidence or general agreement that treatment/procedure is NOT useful/effective and in some cases may be dangerous Means Do it Consider it Should consider Could consider Do NOT do it Level of Evidence A B C Data from multiple RCT or meta-analyses Single RCT or large non-randomized studies Consensus of expert opinions and/or small studies/ retrospective studies/ registries

21 Joint ESC/EACTS Guidelines for Myocardial Revascularization 2010 Table 9. Indications for CABG versus PCI in stable patients with lesions suitable for both procedures and low predicted surgical mortality 79% 65% 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. By Aug 2011 endorsed by 29 European Societies of Cardiology and 4 CT Surgery

22 14 chapters 270 references

23 Do we really need guidelines and multidisciplinary teams? Joint ESC/EACTS Guidelines for Myocardial Revascularization 2010 Adherence of Catheterization Laboratory Cardiologists to ACC/AHA Guidelines for PCI and CABG: What happens in Actual Practice? [Hannan et al Circ 2010] o16142 catheter lab patients in New York otreatment decision made by catheter lab cardiologist alone in 64% ACC/AHA Recommendation Numbers % CABG % PCI % Medical None CABG PCI <1 CABG or PCI <1 Neither Total <1 o92% of PCI procedures ad hoc (ie no time for real choice/ genuine consent) ochance of PCI increased in hospitals with PCI facilities

24 10 studies of 1458 patients (1016 PCI; 442 CABG) 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Improve Angina X X X Extend Life Prevent MI Offered Alternative owidespread misunderstanding of rationale for PCI ono surgical opinion in 85%!!! oneed for Guideline/MDT approach to recommend intervention CAB G

25 onational Cardiovascular Data Registry 01/07/09-30/09/10 o1091 US hospitals o PCIs o71% Acute: 98.6% Appropriate; 0.3% uncertain; 1.1% Inappropriate o29% NonAcute: 50% Appropriate; 38% uncertain; 12% Inappropriate Inappropriate: No angina 54%; No ischaemia 72%; Suboptimal medication 96% Inappropriate: Median 11% (IQ 6%-17%); Range 0-55%

26 Joint ESC/EACTS Guidelines for Myocardial Revascularization Patient Information Patient information needs to be objective and unbiased, patient orientated, evidence based, up-to-date, reliable, understandable, accessible, relevant and consistent with legal requirements. Informed consent requires transparency, especially if there is controversy about the indication for a particular intervention. Specialty bias and self referral should not interfere with the process. For patients with stable CAD and multivessel or LM disease all relevant data should be reviewed by a non-invasive cardiologist, a cardiac surgeon and an interventional cardiologist (Heart Team) to determine the likelihood of safe and effective revascularization with either PCI or CABG. Myocardial revascularization should in general not be performed at the time of diagnostic angiography, thereby allowing the Heart team sufficient time, to assess all available information, reach a consensus and clearly explain and discuss the findings with the patient. Standard evidence-based interdisciplinary institutional protocols may be used for common case scenarios, but complex cases should be discussed individually to find the best solution. 4.2 Multidisciplinary decision making (Heart Team) The creation of a Heart Team serves the purpose of a balanced multidisciplinary decision process. Standard protocols compatible with the current Guidelines may be used to avoid the systematic need for case-by-case review of all diagnostic angiograms. Ad Hoc percutaneous coronary intervention With the exception of unstable patients or candidates for ad hoc PCI (Table 4), the patient should be offered enough time, up to several days as required, between diagnostic catheterization and intervention, to reflect Ad hoc PCI is therefore reasonable for many patients, but not desirable for all, and should not automatically be applied as a default approach. Institutional protocols defined by the Heart Team should be used to define specific anatomical criteria and clinical subsets that can or cannot be treated by ad hoc PCI.

27 Summary and Conclusions: CABG vs PCI in 2012 o79% of ALL 3VD (SYNTAX>22) and 65% ALL LM (SYNTAX >32) CABG has superior survival, freedom from MI and repeat revasc at 3yrs Consistent with registry evidence in the literature CABG has same risk of CVA as PCI for 3VD but 4.0% vs 1.2% for LM PCI may be best treatment for ostial/mid shaft LM (EXCEL trial) PCI has an important role in patients unfit for or who refuse CABG o Strong evidence that most PCI patients misunderstand its rationale MDTs/Heart Team must ensure patients receive appropriate information If intervention follows guideline recommendations no need for MDT Ad hoc PCI denies real patient choice and genuine informed consent o Results of contemporary CABG are excellent but could be even better More use of arterial grafts (especially 2 nd IMA) More off pump CABG in higher risk patients Confirmation of graft patency in operating room