Complex Coronary Cases Supported by: Abbott Vascular Inc Boston Scientific Corp Terumo Vascular Corp Vascular Solutions Inc Cardiovascular Science Inc St Judes medical Abiomed Inc Trireme Medical Roxwood Medical

Disclosures Samin K. Sharma, MBBS, FACC Speaker’s Bureau – Boston Scientific Corporation, Abbott Vascular Inc, ABIOMED, CSI, Trireme Medical Annapoorna S. Kini, MBBS, FACC Nothing to disclose Sameer Mehta, MBBS, FACC Consulting Fees – The Medicines Company

June 21st 2016 Case #84: PA, 55 yrs F Presentation: Patient presented with new onset CCS Class III angina and stress MPI revealed moderate antero-septal, and inferior ischemia with mild inferior infarct. Cardiac cath on May 6th 2016 revealed 2 V CAD; 95% prox RCA, 100% distal RCA BMS ISR and distal vessel fills via LAD collaterals, 90% mid LAD with LVEF 60% and Syntax score of 16. Pt underwent successful PCI of LAD (Promus Premier DES) and did well Prior History: Hypertension, Hyperlipidemia, ESRD on HD, SAQ score-89 Medications: All once daily dosage ASA 81mg, Clopidogrel 75mg, Metoprolol XL 50mg, ISMN 30mg, Atorvastatin 40mg, Ranitidine 300mg 3

Case# 84: cont… Cardiac Cath 5/6/2016: Right Dominance SYNTAX Score was: 16 Cardiac Cath 5/6/2016: Right Dominance II V CAD with LVEF 60% LM: no obstruction LAD: 80% prox LAD and 50% D2 lesion LCx: mild diffuse disease RCA: 95% prox and 100% distal RCA BMS ISR, distal vessel fills retrograde via LAD collaterals Hospital course: Pt underwent DES of pLAD (Promus Premier 3.5/16) with excellent results. Pt was discharged home & has Class II angina Plan Today: Planned for IVUS/OCT guided rotational atherectomy and DES staged PCI of CTO RCA 4

Appropriateness Criteria for Coronary Revascularization

Issues Involving The Case Risk score for coronary thrombosis and major bleeding post DES Recent update on outcomes of trans-radial intervention

Issues Involving The Case Risk score for coronary thrombosis and major bleeding post DES Recent update on outcomes of trans-radial intervention

Elements of Clinical Prediction Score and Distribution of DAPT Score Among Randomized DAPT Study Pts (N=11,648 Pts) Clinical Prediction ScoreVariable Points Age, y ≥ 75 -2 65-<75 -1 <65 Cigarette smoking 1 Diabetes mellitus MI at presentation Prior PCI or prior MI Paclitaxel-eluting S Stent diameter <3 mm CHF or LVEF <30% 2 Vein graft stent Total Score range: -2 to 10 Yeh et al., JAMA Epub March 29, 2016

Low Score Group (<2) n=5731 Observed Rates Outcomes from 12 Through 30 Mos After PCI Among Randomized Pts by Clinical Prediction Score Group in the Derivation Cohort Low Score Group (<2) n=5731 MI or Stent thrombosis High Score Group (≥2) n=5917 Yeh et al., JAMA Epub March 29, 2016

Observed Rates Outcomes from 12 Through 30 Mos After PCI Among Randomized Pts by Clinical Prediction Score Group in the Derivation Cohort Low Score Group (<2) n=5731 Moderate or Severe Bleeding High Score Group (≥2) n=5917 Yeh et al., JAMA Epub March 29, 2016

Master Treatment Algorithm for Duration of P2Y12 Inhibitor Therapy in Pts with CAD Treated with DAPT Levine et al., Circulation 2016 Accepted Manuscript

Patients Enrolled in PARIS Study 5031 enrolled in PARIS following PCI 841 patients excluded Not discharged on DAPT (n=18) Received bare metal stent (n=811) In-hospital major bleed (n=12) In-hospital stent thrombosis or myocardial infarction (n=5) In-hospital death (n=1) 4190 patients included in risk score development Coronary Thrombotic Event (CTE) 151: stent related (45) or non-stent MI (106) Major Bleeding (MB): BARC 3 or 5 (133) Baber et al., J AM Coll Cardiol 2016;67:2224

PARIS Study: Baseline Clinical Characteristics in Pts with vs without 2-Yr Coronary Thrombotic or Major Bleeding Events Baber et al., J AM Coll Cardiol 2016;67:2224

PARIS Study: Procedural Characteristics in Pts with vs without 2-Yr Coronary Thrombotic or Major Bleeding Events Baber et al., J AM Coll Cardiol 2016;67:2224

PARIS Study: Independent Predictors of 2-Yr Coronary Thrombosis and Major Bleeding Baber et al., J AM Coll Cardiol 2016;67:2224

PARIS Study Integer Risk Score for Major Bleeding Integer Risk Score for Coronary Thrombotic Events Baber et al., J AM Coll Cardiol 2016;67:2224

PARIS Study: Histograms Displaying the Frequency of Thrombotic and Bleeding Risk Scores Probability of coronary thrombotic events by thrombotic integer risk score Probability of major bleeding events by bleeding integer risk score Baber et al., J AM Coll Cardiol 2016;67:2224

PARIS Study: Thrombotic Risk and Bleeding Risk High Thrombotic Risk (n=696) 5-10 Intermediate Thrombotic Risk (n=1261) 3-4 Number of Patients Low Thrombotic Risk (n=2233) 0-2 Low Bleeding Intermediate Bleeding High Bleeding Risk (0-3) Risk (4-7) Risk (8-14) Baber et al., J AM Coll Cardiol 2016;67:2224

PARIS Study: Observed and Predicted Rates of Events Over 2 Yrs Across the Respective Risk Score Categories Observed Predicted Coronary Thrombotic Events Major Bleeding Events Two-Year Event Rate, % Two-Year Event Rate, % (n=2,233) (n=1,261) (n=696) (n=2,079) (n=1,713) (n=398) Baber et al., J AM Coll Cardiol 2016;67:2224

PARIS Study: Coronary Thrombosis and Major Bleeding Hypothetical Risk/Benefit Trade-Off with Prolonged DAPT as a Function of Thrombotic and Bleeding Risk Baber et al., J AM Coll Cardiol 2016;67:2224

Optimal Duration of Dual Antiplatelet Therapy After DES Implantation Patient should be prescribed dual antiplatelet therapy for 6 months Shortened Duration (new DES, <6M) - Bleeding events within 6 months - Need for non-cardiac surgery - High bleeding risk Anticoagulation need (e.g. Afib) Renal failure Co-morbidities at risk of bleeding (GI, Stroke, Cirrhosis, bleeding diathesis, Frail) Extended Duration (1-3yrs+) - Thrombotic events within 6-12 mths - First generation DES - High ischemic risk Prior MI, Diabetes Multiple stents >3, LM stent Bifurcation 2 stents Prior Stent Thrombosis

Issues Involving The Case Risk score for coronary thrombosis and major bleeding post DES Recent update on outcomes of trans-radial intervention

Study Flow Diagram Andò G, Capodanno D J AM Coll Cardiol Intv 2016;9:660

Meta-Analysis of Radial vs Femoral Access for Mortality Andò G, Capodanno D J AM Coll Cardiol Intv 2016;9:660

Radial Access vs Femoral Access in the Meta-Analysis Reducing death (RR: 0.73; 95% CI: 0.60-0.88; p=0.001 Reducing MACE (RR: 0.86; 95% CI: 0.77-0.95; p=0.005) Reducing access site bleeding (RR: 0.37; 95% CI: 0.30-0.46; p=<0.01) Reducing major bleeding (RR: 0.60; 95% CI: 0.48-0.76; p=<0.001) No difference in recurrent MI (RR: 0.91; 95% CI: 079-1.04; p=0.16) No difference in stroke (RR: 1.19; 95% CI: 0.77-1.84; p=0.42) Higher risk of crossover (RR: 3.38; 95% CI:2.09-5.49; p=<0.001) Andò G, Capodanno D J AM Coll Cardiol Intv 2016;9:660

Detailed Assessment of Wrist Access for Cath and PCI In the prospective multicenter study, 191 patients underwent the following tests and measurements in both the arm used for radial access (intervention) and the other arm at baseline, 24 hours, 2 weeks, 1 month, and 6 months: Echo Doppler to assess vessel anomalies and radial artery occlusion. Volumetry of the hand and forearm to assess swelling. The Weinstein and Heart Sensory Test to determine sensibility of the fingers. Dynamometer testing for key and Palmar grip. Isometric strength measurements at the wrist and elbow. Filled questionnaires to evaluate pain, disability of the arm, shoulder, and hands, and carpal-tunnel syndrome. A binary score was compiled for upper extremity dysfunction at 2 weeks vs baseline and the score validated by hand surgeons. EuroPCR, May 25, 2016

Trans Radial Intervention (PCI) Advantage Mortality Vascular complications Major bleeding-access Comfort to patient Early ambulation Overall PCI cost No Effect MI MACE ST Stroke Non-access site bleeding Disadvantage Crossover (=62%) Radiation exposure Femoral complication Radial; artery occlusion (4-10%) Hand dysfunction Learning curve

Take Home Message: Thrombotic and bleeding risk score post DES and Radial intervention update Coronary thrombotic and bleeding events at long-term post DES can easily be predicted by simple clinical characteristics but not by the procedural factors. Pt at high bleeding risk are also have higher thrombotic risk and hence decision about prolonging DAPT needs to be individualized Recent meta-analysis have demonstrated that trans-radial intervention is associated with lower mortality in ACS pts. Hand impairment post radial intervention is of clinical concern and it’s incidence and long-term impact needs to prospectively evaluated in large series of pts.

Question # 1 Following statement is false Integer risk score for major bleeding in the PARIS study: Age <50yrs Anemia C. Triple therapy on discharge D. CKD stage III or more E. Current smoking

Question # 2 Following is the false integer risk score for coronary thrombotic events in the PARIS study; Diabetes mellitus ACS Current smoking Prior PCI Higher BMI

Question # 3 A recent study showed that Trans radial intervention was associated with hand dysfunction in ……% of cases: A. 100% B. Approx 75% C. Approx 50% D. Approx 25% E. <25%

Question # 1 The correct answer is A Following statement is false Integer risk score for major bleeding in the PARIS study: Age <50yrs Anemia C. Triple therapy on discharge D. CKD stage III or more E. Current smoking The correct answer is A

Question # 2 The correct answer is E Following is the false integer risk score for coronary thrombotic events in the PARIS study; Diabetes mellitus ACS Current smoking Prior PCI Higher BMI The correct answer is E

Question # 3 The correct answer is B A recent study showed that Trans radial intervention was associated with hand dysfunction in ……% of cases: A. 100% B. Approx 75% C. Approx 50% D. Approx 25% E. <25% The correct answer is B