“Randomised trials of CABG v PCI are no longer possible & cannot represent real life clinical practice” “Randomised trials of CABG v PCI are no longer possible & cannot represent real life clinical practice” Nick Curzen PhD FRCP FESC Southampton University Hospitals

"If a fight lasts more than 7 seconds then you are doing something wrong………… And it's usually that you are being too soft!" "If a fight lasts more than 7 seconds then you are doing something wrong………… And it's usually that you are being too soft!"

2003 data: Ludman The Current Perception

2003 data: Ludman Mean (Range) 2004 data: Ludman Multi-vessel Treatment All Clinical Presentations The Current Perception

TrialsSingle- or Multi-Vessel n TotalCABGPCIMedical GABIMV EASTMV RITASV & MV ERACIMV CABRIMV BARIMV MASS-2MV AWESOMESV & MV (High risk)* ERACI-2MV SoSMV ARTSMV Stents used Randomised Comparisons of PCI v CABG The Current Perception

“There’s no difference in death or MI between CABG & PCI” “We just need DES to stop restenosis”

The Current Perception

So- the data from RCTs are relevant to our practice then? NO! : are there really no differences in mortality between CABG & PCI in the real world? NO! : are there really no differences in mortality between CABG & PCI in the real world?

No Differences?

Predictors of Mortality Result of Proportional-Hazard Analyses Unadjusted: PCI Covariate adjusted: Renal insufficiency Age in years Previous PCI Insulin-treated diabetes Chronic lung disease Peripheral vasc disease LVEF (  10%) Non-insulin diabetes Angiographic score (  10%) Left main disease Propensity adjusted: PCI PCI BetterCABG Better Circ 2004;109: No Differences?

So- apart from the differences, the data from RCTs are relevant to our practice then? So- apart from the differences, the data from RCTs are relevant to our practice then? NO! : Are the study populations really representative of real life ? NO! : Are the study populations really representative of real life ?

Trial Original Pool Screen 1: Clinical Criteria Screen 2: Physician Agreement Screen 3: Patient ConsentRandomized % Original Pool Randomized GABI EAST RITA 27, ERACI CABRI 42,58023, BARI 25, MASS AWESOME 22, ERACI SoS ~17-30Kn/a998~3-6 ARTSn/a 1205n/a REAL LIFE?

screened!!!! REAL LIFE?

Exclusion Criteria   Previous PCI or CABG   Any total occlusion >1 month old   LVEF<30%   Overt heart failure   H/O CVA   STEMI within 7 days   Diseased saphenous veins REAL LIFE?

Patients Undergoing Angiography 76% do not meet clinical inclusion/exclusion criteria 4% 18% cardiologist & surgeon cannot agree amenable to either revascularization methodology 2% patients will not agree to participate Patient Consent 6% 24% Surgeon & Interventional Cardiologist Agreement Clinical Criteria 100% Randomized REAL LIFE?

So- apart from the differences in mortality in the real world, and the fact that the study populations were not representative of >90% of real life populations, the data from RCTs is relevant to our practice then? NO! : Did the studies really compare complete revascularisation? NO! : Did the studies really compare complete revascularisation?

Maybe the data from these randomised studies aren’t quite so relevant to real life? Maybe the data from these randomised studies aren’t quite so relevant to real life? So……..

?

amenable for only one treatment approach Heart Team (surgeon and interventionalist) Two Registry Arms CABG 2750 captured (750followed) PCI All captured and followed reasonable doubt Goal: to define the most appropriate treatment through randomized trial methods consensus that only one treatment option (CABG vs PCI) is appropriate Goal: to define the pool of non randomizable patients and their outcomes Randomized Arm N=1800 (1:1) amenable for both treatments options TAXUS CABG vs All Patients with 3VD/LM All Comers Design

Overall enrollment are CABG registry!

ConclusionsConclusions “Randomised trials of CABG v PCI are no longer possible because they do not represent >90% of real life clinical practice ” “Randomised trials of CABG v PCI are no longer possible because they do not represent >90% of real life clinical practice ” The extent of CABG registry arm recruitment in SYNTAX so far has already told the common sense cardiologist what he/she needs to know - regardless of the outcome of the randomised group

Acknowledgements Rod Stables Keith Dawkins Boston Scientific Corp M-C Morice Peter Ludman