“Randomised trials of CABG v PCI are no longer possible and cannot represent real life practice.” Dr Rod Stables The Cardiothoracic Centre Liverpool UK No Conflicts of Interest to Declare

PCI v CABG - Current Trials They can be done - they are being done ! CARDIA SYNTAX FREEDOM COMBAT Le MANS They must be done

HEART 2005 PCI Supplement

Key Article by Respected Opinion Leader “It is now especially important to compare, by randomised study, the outcome of LM stenting with CABG …..”

Err …… That’s it Thank you

If You Support This Motion …….. For multi-vessel revascularisation CABG surgery is the evidence based choice Diabetics Left main stem disease 3 vessel disease (Occlusions bifurcations diffuse disease) Many PCI operators do not accept this reality

Adoption of a New ‘Surgical’ Technology Wilson BMJ 2006;332: Time Adoption of Technology % RCT evidence proves safety and efficacy

Captain’s Log – Stardate: Early Stent Era c1994 Clinical outcomes – the reality Procedural mortality - 1.5% Immediate emergency CABG - 4% Sub-acute thrombosis (=MI) - 3% Bleeding or puncture site comps - 5% Repeat revascularisation - 16 – 45% Clinical disaster area: PCI docs think its great ! Exponential growth in procedure numbers

Sir Winston Churchill on Angioplasty ‘Success is the ability to go from one failure to another with no loss of enthusiasm’ Witness: observation of live cases at the annual LMS meeting !!

The Enthusiasm Hypothesis of Healthcare Variation Faith or belief in a procedure - Extends beyond or ignores evidence base Usually involves self-referral Control of the patient base Drives case volume expansion in PCI Stimulus for continuing advancement Improving clinical outcomes Progress charted with sequential RCTs

Clinical Outcomes : Is PCI Playing Catch-up Control of the patients and self-referral Rare, substantial and convenient power Carries great responsibility Must continue to measure against the Tx norm In the (internal) development of PCI Against alternative treatment strategies

RCTs - The Evidence Gold Standard Procedure based RCTs Limitations Challenges Obstacles

PCI v CABG : RCT Problems Scale and funding Patient consent Operator skills Keeping pace with new developments Patient selection and ability to generalise results

PCI v CABG : RCT Problems PCI doctors Initiate and control trials Design protocols and outcome measures Recruit patients Assess outcome measures Holding all the cards We MUST win (or even draw) ONCE

Lancet January

“Randomised trials of CABG v PCI are no longer possible and cannot represent real life practice.”