Debate: What Does the Future Hold for the Treatment of Unprotected Left Main Disease? More PCI No More Routine Surgery Ron Waksman, MD, FACC Washington DC

Disclosures Ron Waksman serves on the advisory board of : Medtronic vascular Boston Scientific Abbott Vascular

What’s missing from the PCI vs. CABG trial data discussion? Why does the debate seem to always focus on mortality and repeat revascularization? Shouldn’t we include morbidity endpoints? What about return to work? What about pain?

BACKGROUND Percutaneous revascularization of left main coronary artery disease is potentially attractive because: Large diameter vessel Proximal location And potentially unattractive because: Up to 80% of LM disease involves the bifurcation (high risk of restenosis) Up to 80% of patients have multivessel CAD: with potential survival benefit with CABG Serruys, PW; presented at TCT 2010

Main Compare

SYNTAX Eligible Patients Serruys PW et al. NEJM 2009;360:961-72 De novo disease (n=1800) Limited Exclusion Criteria Previous interventions Acute MI with CPK>2x Concomitant cardiac surgery Left Main Disease (isolated, +1, +2 or +3 vessels) N=705 3 Vessel Disease (revasc all 3 vascular territories) N=1095 Serruys PW et al. NEJM 2009;360:961-72 6

Syntax LM

ACC/AHA/SCAI guidelines in 2009 In the 2009 focused update of the guidelines on PCI Class IIb, LoE B recommendation “the best case for PCI as an alternative to CABG for LM CAD is in ostial and mid-body lesions without additional multivessel disease” The writing group also decided that routine angiographic follow-up after LM PCI should be omitted from the guidelines Kushner et al.; JACC; 2009

Wijns et al.; European Heart Journal; 2010

PCI to LM Get Simpler & Better You Ain’t Seen Nothing Yet Techniques and pharmacology have evolved in the past 5 years More stage procedure More vessel preparation No need for Hemodynamic Support IVUS guidance mandatory Post dilatation and kissing technique Improved stents second generation Better antiplatelet therapy

IVUS Guidance Reduce Restenosis

IVUS Guidance for LM Treatment (145 propensity matched pairs – DES) Park SJ et al, Circulation Cardiovascular Intervent 2009

FFR guidance for LMCA Hamilos et al, Circulation 2009

Unprotected LMCA CABG vs PCI Meta-analysis of 3,773 patients in 10 studies • CABG: 2,114 patients, Study range of patients 53-542 • PCI: 1,659 patients Study range of patients 35-542 Naik H et al: J Am Coll Cardiol Intv 2:739-47, 2009

Unprotected LMCA CABG vs PCI Conclusions Naik H et al: J Am Coll Cardiol Intv 2:739-47, 2009

4134 pts with left main disease Consensus agreement by heart team EXCEL: Study Design Draft design 4134 pts with left main disease SYNTAX score ≤32 Consensus agreement by heart team Yes (N=2634) No (N=1500) PCI and CABG registries (limited in-hosp data) R PCI (Xience Prime) (N=1317) CABG (N=1317) Clinical follow-up: 30 days, 6 months, yearly through 5 years

If this study meets its endpoint??? We will see more PCI for unprotected LM

How are the surgeons are doing???

DES IN NON-BIFURCATED LM PCI

DES IN NON-BIFURCATED LM PCI

Is it time to debate the other side of the equation? “Isolated Non-bifurcation Left Main Stenosis amenable to PCI is Class III indication for CABG”

Conclusions With Team Approach and evidence based medicine there is a change in paradigm No more routine surgery for LM Definitely more PCI now If EXCEL meets the endpoint more PCI in the future