Revascularization in Multivessel Disease: Strategies for PCI Alan C Yeung, MD Li Ka Shing Professor of Medicine Chief, Division of Cardiovascular Medicine Stanford University School of Medicine (2010-2017 ) Stanford Stanford SYNTAX 5-year Endpoints 2014 ESC/EACTS Guidelines on Myocardial Revascularization Stanford AUC and Multivessel Revascularization Method of Revascularization of Multivessel Coronary Artery Disease Assumes CCS >2 or int/high risk non-invasives CABG PCI Two-vessel CAD with proximal LAD stenosis A A Three-vessel CAD with low CAD burden (i.e., three focal stenosis, low SYNTAX score) A A Three-vessel CAD with intermediate to high CAD burden (i.e., multiple diffuse lesions, presence of CTO, or high SYNTAX score) A U Isolated left main stenosis A U Left main stenosis and additional CAD with low CAD burden (i.e., one to two vessel additional involvement, low SYNTAX score) A U Left main stenosis and additional CAD with intermediate to high CAD burden (i.e., three vessel involvement, presence of CTO, or high SYNTAX score) A I Patel et al, JACC 2012;59:857-881 SYNTAX Score II Variables ANATOMICAL SYNTAX SCORE EXCEL LM/3VD AGE Cr Clearance LVEF Gender PVD COPD US Investigators’ Meeting Abbott Confidential For Internal Use Only Not to be reproduced, excerpted or distributed ©2013 Abbott Laboratories Farooq V et al Lancet 2013; 381: 639–50 SYNTAX Score II SYNTAX Score EXCEL AGE CrCl CABG LMS F CABG CABG CABG CABG CABG Diabetes PVD COPD M CABG PCI PCI PCI PCI PCI PCI 3VD EF PCI PCI CABG Findings that validated in the multinational DELTA Registry… EQUIPOISE FORwere LONG TERM MORTALITY BETWEEN CABG AND PCI US Investigators’ Meeting Anatomic vs Functional CAD 0VD (9%) 3VD (14%) Angiographic Vessel 1VD (34%) 2VD (43%) Disease Tonino, et al J Am Coll Cardiol 2010;55:2816-21 SYNTAX Score No & Dominance Location of lesion Left Main Calcification Thrombus SYNTAX SCORE Bifurcation Vessel CTO Tortuosity Serruys, et al N Engl J Med 2009;360:961-72 Can we enhance the SYNTAX Score? By incorporating FFR into the SYNTAX score, termed “Functional SYNTAX Score”, can we: Convert high/medium risk SYNTAX score patients to a lower risk group? Improve our risk stratification of patients with multivessel CAD undergoing PCI? Functional SYNTAX Score Without FFR Nam CW, et al J Am Coll Cardiol 2011;58:1211-8 Functional SYNTAX Score Reclassifies > 30% of cases Without FFR Nam CW, et al J Am Coll Cardiol 2011;58:1211-8 With FFR Functional SYNTAX Score Discriminates risk for death/MI P < 0.01 20% 32% 34% 59% Nam CW, et al J Am Coll Cardiol 2011;58:1211-8 year MACE Rates Where we go from here? % 20 19.1 10 18.4 11.2 13.2 SYNTAX FAME FAME 3: Hypothesis Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) using the 2nd generation Resolute DES in patients with multivessel coronary artery disease (CAD) will result in similar outcomes to coronary artery bypass graft surgery (CABG) FAME 3: Design Multicenter, worldwide, prospective, randomized trial Non-inferiority design 1500 patients from 50 sites Plan for years enrolment and up to year follow-up Enrolment has started! FAME 3: Major Endpoints Primary Endpoint: One year rate of Death, MI, Stroke and Revascularization Key Secondary Endpoint: Three year rate of Death, MI and Stroke FAME Study Organization Investigator-initiated trial Sponsored by Stanford University with support of a CRO (genae) Funded by research grants from Medtronic and St Jude Medical Independent DSMB and CEC FAME Trial: All Comers with V CAD (not involving LM) Heart team identifies lesions for PCI/CABG and then patient is randomized FFR-Guided PCI with DES Stent all lesions with FFR ≤ 0.80 (n=750) Perform CABG based on coronary angiogram (n=750) One Year follow-up for MACCE Three Year follow-up for death/MI/CVA Non-Inferior Design Conclusion: By incorporating FFR-guided PCI and utilizing the 2nd generation Resolute Integrity stent, FAME aims to demonstrate that FFRguided PCI is non-inferior to CABG in patients with 3-vessel coronary disease not involving the left main coronary artery Summary: Anatomical classification of burden of disease is necessary but insufficient to predict outcome after CABG/PCI Clinical factors are helpful to fine tune the risk of CABG vs PCI Anatomical classification can be further be refined by functional assessment of less than critical lesions, leading to better outcomes and lower cost [...]... notable for BP 150/90 Normal cardiovascular exam Labs reveal a troponin 2.7, total cholesterol 191, LDL 139, HDL 27 and triglycerides 234 EKG shows: What should we do now? Med Rx alone PCI Which vessels? CABG FFR RCA = 0.82 Resting Hyperemia (IV adenosine) FFR L Cx = 0.90 Resting Hyperemia (IV adenosine) Summary of Case Anatomic 3V CAD, functional 1V CAD Successfully treated with single... 2010;122:2545-50 What happens to deferred lesions? 513 Deferred Lesions in 509 FFR-Guided Patients Two Year Follow-up of Lesions Deferred in FAME 2 Years 8 9 Stent-Related or due to a New Lesion Late Myocardial Infarctions 1 Myocardial Infarction due to an Originally Deferred Lesion Only 1/513 or 0.2% of deferred lesions resulted in a late myocardial infarction Pijls, et al J Am Coll Cardiol 2010;56:177-84 Anatomic... 0VD (9%) 3VD (14%) Angiographic 3 Vessel 1VD (34%) 2VD (43%) Disease Tonino, et al J Am Coll Cardiol 2010;55:2816-21 SYNTAX Score No & Dominance Location of lesion Left Main Calcification Thrombus SYNTAX SCORE Bifurcation 3 Vessel CTO Tortuosity Serruys, et al N Engl J Med 2009;360:961-72 Can we enhance the SYNTAX Score? By incorporating FFR into the SYNTAX score, termed “Functional SYNTAX Score”, can... go from here? % 20 19.1 10 18.4 11.2 13.2 0 SYNTAX FAME FAME 3: Hypothesis Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) using the 2nd generation Resolute DES in patients with multivessel coronary artery disease (CAD) will result in similar outcomes to coronary artery bypass graft surgery (CABG) ... risk group? Improve our risk stratification of patients with multivessel CAD undergoing PCI? Functional SYNTAX Score Without FFR Nam CW, et al J Am Coll Cardiol 2011;58:1211-8 Functional SYNTAX Score Reclassifies > 30% of cases Without FFR Nam CW, et al J Am Coll Cardiol 2011;58:1211-8 With FFR Functional SYNTAX Score Discriminates risk for death/MI P < 0.01 20% 32% 34% 59% Nam CW, et al J Am Coll... cc contrast, < 1 hour procedure AngioGuided n = 496 FFRGuided n = 509 P Value Indicated lesions / patient 2.7±0.9 2.8±1.0 0.34 Stents / patient 2.7 ± 1.2 1.9 ± 1.3