Controversies in Coronary Revascularization. Atlanta CCU April 15, 2016
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1 Controversies in Coronary Revascularization Atlanta CCU April 15, 2016 Habib Samady MD FACC FSCAI Professor of Medicine Director, Interventional Cardiology, Emory University Director, Cardiac Catheterization Laboratory, Emory University Hospital Grant Support Disclosures Medtronic, PI SHEAR STENT Trial Abbott Vascular, PI Restoration Study (Subanalysis of ABSORB III Img.) Gilead, PI MARINA Trial Giliead Volcano Therapeutics, Research Grants and Steering Comm ADVISE II St. Jude Medical, Research Grants and Steering Comm ILUMIEN III American Heart Association, Mentor Fellowship Awards National Institute of Health, Co-I NIH ROI/PPG American College of Cardiology, Deputy Editor, JACC Interventions 1
2 Controversies in Coronary Revascularization SIHD - How much Ischemia to Revascularize - How to revascularize 3 VD: CABG vs PCI vs HCR - How to revascularize LMCA: CABG vs PCI ACS - Non culprit vessel in STEMI: PCI vs Med tx. - Culprit vessel in STEMI: Angio vs OCT guided Controversies in Coronary Revascularization SIHD - How much Ischemia to Revascularize - How to revascularize 3 VD: CABG vs PCI vs HCR - How to revascularize LMCA: CABG vs PCI ACS - Non culprit vessel in STEMI: PCI vs Med tx. - Culprit vessel in STEMI: Angio vs OCT guided 2
3 Clinical Presentation Ischemia Tests/Prognostic Factors* Medical Therapy Anatomic Disease 4/11/2016 Appropriateness Criteria: Key Variables STEMI CCS Class IV High risk Max LM + 3v CAD A Stable angina Severity of Angina ASx, CCS Class I None, Low risk * CHF, DM, Low LVEF None No sig. CAD U I Patel, et al. JACC 2009; 53: Controversies in Coronary Revascularization SIHD - How much Ischemia to Revascularize - How to revascularize 3 VD: CABG vs PCI vs HCR - How to revascularize LMCA: CABG vs PCI ACS - Non culprit vessel in STEMI: PCI vs Med tx. - Culprit vessel in STEMI: Angio vs OCT guided 3
4 Cardiac Death Rate 4/11/2016 Courage Trial N-2287 pt Stable angina Boden et al. NEJM. 2007; Volume 356: Survival Benefit with Revascularization Stratified by Ischemic Risk N= undergoing MPI with 1.9±0.6 year f/u propensity matched. 10% Medical Rx Revasc 8% 6.7% P < % 4.8% 4% 2.9% 3.7% 3.3% 2% 1.0% 1.8% 2.0% 0% % 5-10% 11-20% >20% % Total Myocardium Ischemic Hachamovitch et al Circulation. 2003; 107:
5 % patients 4/11/2016 SPECT MPI Does Not Localize Regional Ischemia in Severe Multivessel Disease N=143 pts, with severe 3 VD who underwent Gated SPECT with 1 month Perfusion alone Perf + Func 0 No defect 1 vessel pattern 2 vessel pattern 3 vessel pattern multivessel pattern Lima..Samady JACC, 2003;42:64-70 Complexity of Angiographic Lesion Assessment Entrance effects Separation losses Friction loss Kern and Samady. JACC 2010;55:
6 Fractional Flow Reserve P a Pd NHJ Pijls et al. Circulation 1993 Validation of FFR For Intermediate Lesion Assessment Kern and Samady. JACC 2010;55:
7 Cumulative incidence (%) 4/11/2016 FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable Flow CAD Chart Stable CAD patients scheduled for 1, 2 or 3 vessel DES-PCI N = 1220 Randomized Trial FFR in all target lesions Registry At least 1 stenosis with FFR 0.80 (n=888) When all FFR > 0.80 (n=332) Randomization 1:1 PCI + MT 73% MT 27% MT 50% randomly assigned to FU Follow-up after 1, 6 months, 1, 2, 3, 4, and 5 years FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Primary Outcomes 30 PCI+MT vs. MT: HR 0.32 ( ); p<0.001 PCI+MT vs. Registry: HR 1.29 ( ); p= MT vs. Registry: HR 4.32 ( ); p< No. at risk MT PCI+MT Registry Months after randomization
8 Event Rates (%) 4/11/2016 Relationship Between FFR and Outcomes FAME 2: Patients with angiographically significant stenoses treated with OMT FFR > <0.50 PCI Stenosis Severity (FFR) Courtesy of: Bernard De Bruyne, MD, PhD 4.3 8
9 Controversies in Coronary Revascularization SIHD - How much Ischemia to Revascularize - How to revascularize 3 VD: CABG vs PCI vs HCR - How to revascularize LMCA: CABG vs PCI ACS - Non culprit vessel in STEMI: PCI vs Med tx. - Culprit vessel in STEMI: Angio vs OCT guided 9
10 AUC 2012: At the Bedside Patel, et al. JACC 2009; 53: HCR Clinical Significance Combines IMA graft to LAD & PCI to non-lad targets for multi-vessel CAD that includes proximal LAD (or LM) & 1 other vessel Presumed to optimize outcomes by combining Durability and benefit of surgical LIMA to LAD Minimal invasiveness of PCI Avoid morbidity and late SVG failure of multi-vessel CABG Minimize repeat revascularization, esp LAD 10
11 Risk-Adjusted MACCE-Free PCI (n=98) Survival Analysis HCR (n=200) FAME Study: One Year Outcomes % 20 Angio-Guided FFR-Guided ~30% ~40% ~35% ~30% ~35% Death MI Repeat Revasc Death/MI p=0.04 MACE p=0.02 New Engl J Med 2009;360:
12 MACE in SYNTAX 3VD and FAME % SYNTAX FAME Functional SYNTAX Score: Without FFR Nam CW, et al. J Am Coll Cardiol 2011;58:
13 Functional SYNTAX Score: Reclassifies > 30% of Cases Without FFR With FFR Nam CW, et al. J Am Coll Cardiol 2011;58: FAME pts with multivessel CAD - Considered candidates for CABG + PCI - Randomized to FFR guided PCI vs CABG - Non-inferiority trial design - Primary: One Year follow-up for Death, MI, CVA, Revascularization - Key Secondary: Three Year follow-up for Death/MI/CVA 13
14 Controversies in Coronary Revascularization SIHD - How much Ischemia to Revascularize - How to revascularize 3 VD: CABG vs PCI vs HCR - How to revascularize LMCA: CABG vs PCI ACS - Non culprit vessel in STEMI: PCI vs Med tx. - Culprit vessel in STEMI: Angio vs OCT guided No Adverse Events with Deferred CABG for FFR>0.80 N=213 patients with 30-70% Left main stenosis FFR>0.80=Medical Therapy FFR<0.80=CABG Hamilos. Circulation 2009;120:
15 PCI vs. CABG for Left Main Disease Meta-analysis of 4 RCTs, 1,611 Patients 1 Year Mortality PCI CABG OR (95%CI) p-value OR (95%CI ) LEMANS 1/52 4/ ( ) 0.21 SYNTAX left main 15/355 15/ ( ) 0.88 Boudriot et al. 2/100 5/ ( ) 0.27 PRECOMBAT 6/300 8/ ( ) 0.59 Fixed effects estimate 3.0% 4.1% 0.74 ( ) 0.29 (24/807) (32/790) Random effects estimate 0.74 ( ) 0.29 I 2 =0% Favors PCI Favors CABG Capodanno et al, JACC 2011;58: PCI vs. CABG for Left Main Disease Meta-analysis of 4 RCTs, 1,611 Patients 1 Year Myocardial Infarction PCI CABG OR (95%CI) p-value OR (95%CI ) LEMANS 1/52 3/ ( ) 0.34 SYNTAX left main 15/355 14/ ( ) 0.97 Boudriot et al. 3/100 3/ ( ) 0.99 PRECOMBAT 4/300 3/ ( ) 0.71 Fixed effects estiamate 2.8% 2.9% 0.98 ( ) 0.95 (23/807) (23/790) Random effects estimate 0.98 ( ) 0.95 I 2 =0% Favors PCI Favors CABG Capodanno et al, JACC 2011;58:
16 PCI vs. CABG for Left Main Disease Meta-analysis of 4 RCTs, 1,611 Patients 1 Year Stroke PCI CABG OR (95%CI) p-value OR (95%CI ) LEMANS 0/52 2/ ( ) 0.30 SYNTAX left main 1/355 8/ ( ) 0.04 Boudriot et al. PRECOMBAT 0/300 2/ ( ) 0.30 Fixed effects estiamate 0.1% 1.7% 0.15 ( ) 0.01 (1/707) (12/689) Random effects estimate 0.15 ( ) 0.01 I 2 =0% Favors PCI Favors CABG Capodanno et al, JACC 2011;58: PCI vs. CABG for Left Main Disease Meta-analysis of 4 RCTs, 1,611 Patients 1 Year MACCE -2.8 (-11.7, 6.4) P= (-11.2, 3.2) P= (-3.9, 10.0) P= (1.3, 13.6) P=0.03 Isolated LMCA LMCA + 1VD LMCA + 2VD LMCA + 3VD Capodanno et al, JACC 2011;58:
17 Follow- 1-Year up Initial Hospitalization SYNTAX LM Cohort Total 1-Year Costs $60,000 $50,000 $40,000 $33,196 D=$6341 (P<0.001) $39,538 $30,000 $20,000 $10,000 Cohen. LM Summit 2011 $0 PCI CABG Patient Profiling in LM Revascularization Local Heart team (surgeon & interventional cardiologist) assessed each patient in regards to: Calcification Thrombus Dominance No. & Location of lesion SYNTAX SCORE Left Main 3 Vessel Patient s operative risk Coronary lesion complexity (SYNTAX score) Goal: SYNTAX score to provide guidance on optimal revascularization strategies for patients with high risk lesions Sianos et al, EuroIntervention 2005;1: Valgimigli et al, Am J Cardiol 2007;99: Serruys et al, EuroIntervention 2007;3: Bifurcation Tortuosity CTO BARI classification of coronary segments Leaman score, Circ 1981;63: Lesions classification ACC/AHA, Circ 2001;103: Bifurcation classification, CCI 2000;49: CTO classification, J Am Coll Cardiol 1997;30:
18 EXCEL: Study Design and Patient Flow EXCEL N= 3600 Sites= 165 global Meets eligibility criteria RCT N=2600 Universal Registry N=1000 Does not meet eligibility criteria CABG N=1300 PCI N=1300 Sub-group (Intermediate Lesion Subjects) N=100 Analysed Separately Unprotected left main coronary artery disease patients with low and mid tertile SYNTAX scores potentially suitable for both PCI and CABG UPLM PCI to Improve Survival (ACS) COR LOE IIa For UA/NSTEMI if not a CABG candidate IIa For STEMI when distal coronary flow is <TIMI grade 3 and PCI can be performed more rapidly and safely than CABG B C GNL
19 Controversies in Coronary Revascularization SIHD - How much Ischemia to Revascularize - How to revascularize 3 VD: CABG vs PCI vs HCR - How to revascularize LMCA: CABG vs PCI ACS - Non culprit vessel in STEMI: PCI vs Med tx. - Culprit vessel in STEMI: Angio vs OCT guided AUC 2012: At the Bedside Patel, et al. JACC 2009; 53:
20 Controversies in Coronary Revascularization SIHD - How much Ischemia to Revascularize - How to revascularize 3 VD: CABG vs PCI vs HCR - How to revascularize LMCA: CABG vs PCI ACS - Non culprit vessel in STEMI: PCI vs Med tx. - Culprit vessel in STEMI: Angio vs OCT guided Case 1: FFR for Assessment Of Non-Culprit Lesions in STEMI 68 yr old male, HTN, DM, high chol, with 2 hours of severe substernal chest pain and inferior ST segment elevations Brought emergently to the cath lab.. 20
21 AUC 2012: At the Bedside Patel, et al. JACC 2009; 53: FFR in Non-Culprit Bed Acute Setting N=101 patients undergoing PCI for AMI (75 STEMI and 26 N-STEMI) N= 112 lesions FFR of non-culprit lesions was measured at time of culprit vessel PCI and repeated 35+4 days later In a subgroup of 14 patients, IMR was also measured at time of culprit vessel PCI and repeated 35+4 days later Ntalianis et al. JACC Int. Volume 3, Issue 12, December 2010, Pages
22 FFR in Non-Culprit Bed Acute Setting Acute Phase (n = 101) Follow-Up (n = 101) p Value LVEF (%) 59 ± ± 14 NS LVEDP (mm Hg) 18 ± 7 17 ± 7 NS FFR nonculprit 0.77 ± ± 0.13 NS IMR nonculprit (IU) 20 ± 3 24 ± 6 NS DS nonculprit (%) 56 ± ± 14 NS MLD nonculprit (mm) 1.32 ± ± 0.50 NS RD nonculprit (mm) 2.9 ± ± 0.70 NS TIMI flow nonculprit 2.93 ± ± 0.20 NS ctfc nonculprit 15 ± 6 15 ± 6 NS Values are mean ± SD. ctfc = corrected TIMI frame count; DS = diameter of stenosis; FFR = fractional flow reserve; IMR = index of microcirculatory resistance; LVEDP = left ventricular end-diastolic pressure; LVEF = left ventricular ejection fraction; MLD = minimum lumen diameter; RD = reference diameter. Ntalianis et al. JACC Int. Volume 3, Issue 12, December 2010, Pages Preventative Angioplasty in MI 450 pts with STEMI MVD, 5 UK Centers HR was 0.35 For composite and each individual endpoint Wald DS et al. N Engl J Med 2013;369:
23 Controversies in Coronary Revascularization SIHD - How much Ischemia to Revascularize - How to revascularize 3 VD: CABG vs PCI vs HCR - How to revascularize LMCA: CABG vs PCI ACS - Non culprit vessel in STEMI: PCI vs Med tx. - Culprit vessel in STEMI: Angio vs OCT guided Position of MLA in relation to Plaque Rupture not necessarily coincident: prox or distal Plaque Rupture MLA site Proximal Reference Courtesy of Dr. Giulio Guagliumi 23
24 OCT for Identification of Culprit Lesion Morphology cap cavity thrombus Plaque Rupture Plaque Erosion Courtesy of Dr. Giulio Guagliumi Plaque Erosion in STEMI patients Tx with DAPT Only At 753 days follow up all patients were asymptomatic Prati et al. JACC CV Img, Vol 6, No 3,
25 Controversies in Coronary Revascularization SIHD - How much Ischemia to Revascularize - How to revascularize 3 VD: CABG vs PCI vs HCR - How to revascularize LMCA: CABG vs PCI ACS - Non culprit vessel in STEMI: PCI vs Med tx. - Culprit vessel in STEMI: Angio vs OCT guided Controversies in Coronary Revascularization Atlanta CCU April 15, 2016 Habib Samady MD FACC FSCAI Professor of Medicine Director, Interventional Cardiology, Emory University Director, Cardiac Catheterization Laboratory, Emory University Hospital 25
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