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Interventional Cardiology Board Review 2014

Interventional Cardiology Board Review 2014 . Samin K. Sharma, MD, FACC Director, Clinical and Interventional Cardiology President Mount Sinai Heart Network Professor of Medicine. Cardiovascular Institute Mount Sinai Hospital , New York. 2002- 71% 2003- 75% 2004- 78% 2005- 83%

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Interventional Cardiology Board Review 2014

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  1. Interventional CardiologyBoard Review 2014 Samin K. Sharma, MD, FACC Director, Clinical and Interventional Cardiology President Mount Sinai Heart Network Professor of Medicine Cardiovascular Institute Mount Sinai Hospital , New York

  2. 2002- 71% 2003- 75% 2004- 78% 2005- 83% 2006- 85% 2007- 84% 2008- 85% 2009- 86% 2010- 88% 2011- 90% 2012- 88% 2013- 86%

  3. ACC/AHA Guidelines Customary ACC/AHA Classification

  4. PCI Indications and Outcomes According to Clinical Presentation For every 100 pts treated with primary angioplasty rather then thrombolytic therapy, primary angioplasty (when performed without significant delays) saves approximately how many lives? • <1 • 2-3 • 4-6 • 6-7 • >7 B

  5. Thrombolysis Vs. PCI for STEMI 30-Day Event Rate in 21 Randomized Trials Thrombolysis PCI NNT=? p<0.001 An additional 21 lives saved /1000 treated % p=0.02 p=0.007 Mortality Non-fatal MI Mortality/re-MI Stroke OR: 0.66 0.53 0.58 0.35 95% CI: 0.46-0.94 0.34-0. 0.44-0.76 0.14-0.77 Weaver et al. JAMA 1997;278:2093

  6. NNT=100/Absolute risk reduction RRR= Absolute difference/Occurrence in non-treatment arm x100 Question A randomized study of 1000 pts indicated a 13.5% event rate with treatment A vs. a 16.0% event rate with placebo; p = 0.08. Another study in a similar patient population indicated a 14.5% event rate with treatment B compared to 16.0% with placebo; p = 0.02. Which of the following is true? a. The absolute risk reduction is 2.5% with A and 1.5% with B compared to placebo; this means that A is superior to B b. Treatment B is superior to placebo, while A is not; this means that B is superior to A c. The number of patients needed to treat with B in order to prevent 1 event that would have occurred with placebo is 67 d. The number of patients needed to treat with B in order to prevent 1 event that would have occurred with placebo is 11 e. The number of patients needed to treat with A in order to prevent 1 event that would have occurred with placebo is 6 C

  7. Thrombolysis Vs. PCI for STEMI 30-Day Event Rate in 21 Randomized Trials Thrombolysis PCI NNT=48 p<0.001 An additional 21 lives saved /1000 treated % p=0.02 p=0.007 Mortality Non-fatal MI Mortality/re-MI Stroke OR: 0.66 0.53 0.58 0.35 95% CI: 0.46-0.94 0.34-0.80 0.44-0.76 0.14-0.77 Weaver et al. JAMA 1997;278:2093

  8. A patient develops sudden slow flow after PCI of the LAD without dissection. The next step is: • A Stent • B Nitroglycerin 200mcg • C Nipride 50 mcg • D Verapamil 50mcg • E TPA CNipride 50mcg, Adenosine 80-120mcg, Verapamil 250-500mcg, Cardizem 250-500 mcg.

  9. Which of the following is not true regardingabciximab and stents • Reduces 1 year mortality • Reduces TVR in diabetics at 6 months. • Reduces TVR at 6 months. • No effect on stent thrombosis C

  10. Stent + placebo (173 DM / 635 no DM) Stent + abciximab (162 DM / 632 no DM) PTCA + abciximab (154 DM / 640 no DM) EPISTENT Trial: One-year Outcome p=0.035 p=0.01 p=NS % p=0.005 p=0.002 p=NS p=NS p=NS p=NS Death MI TVR Death MI TVR Diabetic patients (n=489) Non-diabetic patients (n=1907) Topol et al. Lancet 1999;354:2019

  11. The REPLACE 2 Trial showed a major bleed rate of • 4.1 v 2.4 • 3.0 v 2.0 • 5.2 v 3.1 • 6.1 v 4.2 A

  12. DANAMI 2 Showed a Reduction of the Primary endpoint of Death, MI, CVA from: • 20 to 10% • 14 to 8% • 15 to 9% • 9 to 5% B No difference in mortality

  13. In a patient undergoing PCI on bivalirudin with CrCL< 30 ml/Min • The bolus should be reduced to 0.5 mg/Kg • The infusion should be reduced to 1.0 mg/Kg/Hr • The infusion should be reduced to 0.25 mg/Kg/Hr • The infusion should remain 1.75 mg/Kg/Hr B

  14. You are about to perform PCI of a 70% lesion of the LAD with heparin and eptifibatide when you are informed that the ACT is 170. The correct next step is: • Give another 50U/ Kg IV bolus and check an ACT • Give another 25U/Kg IV bolus and check an ACT • Give another 70U/KG IV bolus and check an ACT • Give another 60U/KG IV bolus and check an ACT B

  15. GP IIb/IIIa Inhibitors Major differences in pharmacodynamics / pharmacokinetic

  16. A patient is undergoing rotational atherectomy on heparin and abciximab when there is a perforation. What is the next step? • Order a platelet transfusion • Check an ACT • Check the level of platelet inhibition (PAU) • The drug will reverse on its own. A

  17. A 60 year old patient is started on enoxaparin for ACS with aspirin and clopidogrel. The last dose of enoxaparin was 7 hours prior to PCI. Your best option is: • PCI without any extra anticoagulation • Add a IIB/IIIA inhibitor and proceed with PCI • Add a IIB/IIIA inhibitor and heparin 50U/KG and proceed to PCI • Add enoxaparin 30mg IV and proceed to PCI A (1/3rd after 8-12 Hrs)

  18. Question A 65-year-old woman with recent non-Q-wave MI is scheduled to undergo coronary intervention. Diagnostic angiography performed 2 days ago revealed complex 20 mm long lesion of the proximal RCA. She has been on chronic therapy with ASA and has received Plavix 600mg loading and 75 mg daily for the past two days. She has also been treated with IV unfractionated heparin infusion, which is interrupted at the time of sheath insertion. Her weight is 80 kg and her height is 165 cm. Use of weight-adjusted dose of abciximab has been opted. Which of the following statements regarding the appropriate next step for this patient’s management is correct? • Abciximab plus 7,000 units of IV heparin should be administered immediately after insertion of the femoral sheaths • 10,000 units of IV heparin should be administered immediately after insertion of the femoral sheaths; abciximab should be administered when the activated clotting time value is 200-300 seconds • Abciximab plus 5,600 units of IV heparin should be administered immediately after insertion of the femoral sheaths • 5,600 units of IV heparin should be administered immediately after insertion of the femoral sheath & abciximab should be administered when ACT is 200-300 seconds • None of the above

  19. A 65-year-old woman with recent non-Q-wave MI is scheduled to undergo coronary intervention. Diagnostic angiography performed 2 days ago revealed complex 20 mm long lesion of the proximal RCA. She has been on chronic therapy with ASA and has received Plavix 600mg loading and 75 mg daily for the past two days. She has also been treated with IV unfractionated heparin infusion, which is interrupted at the time of sheath insertion. Her weight is 80 kg and her height is 165 cm. Use of weight-adjusted dose of abciximab has been opted. Which of the following statements regarding the appropriate next step for this patient’s management is correct? Question • Abciximab plus 7,000 units of IV heparin should be administered immediately after insertion of the femoral sheaths • 10,000 units of IV heparin should be administered immediately after insertion of the femoral sheaths; abciximab should be administered when the activated clotting time value is 200-300 seconds • Abciximab plus 5,600 units of IV heparin should be administered immediately after insertion of the femoral sheaths • 5,600 units of IV heparin should be administered immediately after insertion of the femoral sheath & abciximab should be administered when ACT is 200-300 seconds • None of the above. B/c ACT has to be measured first before any heparin is given E

  20. An invasive strategy with adjunctive glycoprotein IIb/IIIa inhibition compared with a conservative strategy has been shown to: a. Have a higher mortality b. Have a lower mortality c. To reduce death or MI d. To increase death or MI C

  21. PCI Indications and Outcomes According to Clinical Presentation The mortality/morbidity of NSTEMI as compared to STEMI is: • Similar in-hospital and at 6 months • Lower in-hospital and higher at 6 months • 4-6% • 6-7% • >7% B

  22. Prognostic Value of the Admission ECG inAcute Coronary Syndromes: GUSTO Trials Kaplan-Meier Estimates of Probability of Death 30-Day Mortality (%) 6-Month Mortality & Re-MI (%) 6.6% 9.1% 8.9% ST  and  8.9% 9.2% 5.1% ST  and  ST  ST  5.1% 6.8% 6.8% ST  ST  3.4% 5.4% 1.7% Isolated T wave inversion Isolated T wave inversion Days from randomization Days from randomization Savonitto et al. JAMA 1999;281:707

  23. PCI Indications and Outcomes According to Clinical Presentation Which of the following trials found no major benefits of routine early invasive strategy compared to conservative treatment in ACS? • COURAGE • ICTUS • ACUITY • TACTICS-TIMI 18 • FRISC II B

  24. 18.6 14.6 Cons. Inter. All Combined Recent Randomized Trials of ACS Primary Endpoints: Death, Re-MI, & Re-hospitalization Conservative Early Intervention % p=0.33 25% NNT=25 P=0.001 p=0.025 p=0.001 p=0.32 p=0.04 TACTICS* INTERACT** RITA-3*** ISAR-COOL** ICTUS*** (n=2210) (n=746) (n=1810) (n=410) (n=1200) *At 6 mths, ** At 30-days, ***At 1-year

  25. PCI Indications and Outcomes According to Clinical Presentation A 64 yrs old man has been treated with ASA, a statin, nitrates and a beta-blocker for stable angina, hypertension and hyperlipidemia. He successfully controls his DM with diet alone. He recently had somewhat more frequent angina, and a Thallium stress test revealed a reversible anterior perfusion defect. Coronary angiography showed an 80% prox-LAD lesion, 40% circumflex and 40% RCA; LVEF is 55%. Which of the following options is correct? • Surgical therapy offers a survival advantage over medical therapy • Both PCI and surgery offer a survival advantage over medical therapy • Strict HTN control is not necessary after successful revascularization • According to the BARI trial, surgery should offer a survival advantage over PCI in this pt • None of the above E

  26. TIMI Risk Score for UA / Non-STEMI Characteristics for development of TIMI risk score: Rate of composite endpoint Death, MI, UA requiring revasc. % • Age 65 years • 3 risk factors for CAD • Significant coronary lesion • ST segment deviation • Severe anginal symptoms • Use of aspirin in last 7 days •  serum cardiac markers 0/1 2 3 4 5 6/7 Low Risk Intermed risk High risk No. of risk factors Test cohort: No. 85 339 627 573 267 66 % 4.3 17.3 32.0 29.3 13.6 3.4 Antman et al. JAMA 2000;284:835

  27. Pathophysiology of ACS: Platelet Activation Vessel wall

  28. One-Month & One-Year Composite Endpoint* PCI-CURE Trial (*Death, MI, or urgent TVR) CREDO Trial (*Death, MI, or stroke) Clopidogrel (n=1053) Placebo (n=1063) Clopidogrel (n=1313) Placebo (n=1345) %  16% p=0.03  27% p=0.02  19% p=NS  30% p=0.03 At 28 days At 1 year At 30 days At 1 year Steinhubl et al. JAMA 2002;288:2411 Mehta et al. Lancet 2001;358:527

  29. CURRENT OASIS 7 Trial: A 2x2 Randomized Trial of Optimal Clopidogrel and ASA Dosing in Pts with ACS Undergoing an Early Invasive Strategy with Intent for PCI Study Design, Flow and Compliance • 25,087 ACS Patients (UA/NSTEMI 70.8%, STEMI 29.2%) • Planned Early (<24 h) Invasive Management with intended PCI • Ischemic ECG Δ (80.8%) or ↑cardiac biomarker (42%) Randomized to receive (2 X 2 factorial): CLOPIDOGREL: Double-dose(600 mg then150 mg/dx7d then 75 mg/d) vsStandard dose (300 mg then 75 mg/d) ASA: High Dose (300-325 mg/d) vsLow dose(75-100 mg/d) Angio 24,769 (99%) No PCI 7,855 (30%) PCI 17,232 (70%) CAD 2,430 CABG 1,809 No Sig. CAD 3,616 Clop in 1st 7d (median) 7d 7 d 2 d 7d Efficacy Outcomes: CV Death, MI or stroke at day 30 Stent Thrombosis at day 30 Safety Outcomes: Bleeding (CURRENT defined Major/Severe and TIMI Major) Key Subgroup: PCI v No PCI Complete Follow-up 99.8%

  30. CURRENT OASIS 7: Randomized Trial of Optimal Clopidogrel and ASA Dosing in Pts with ACS Clopidogrel Double vs. Standard Dose – Major Efficacy Outcomes in PCI Patients Clopidogrel Standard Dose (n= 8684) Clopidogrel Double Dose (n= 8548) P = 0.036 % 4.5 P = 0.012 P = 0.002 3.9 P = 1.00 P = 0.68 2.6 2.3 2.3 2.3 2.0 1.9 1.9 P = 0.59 1.6 0.4 0.4 Stent thrombosis MI Death Stroke Death/MI/Stroke Major Bleed Yusuf et al. NEJM 2010;363:930.

  31. Ticagrelor Clopidogrel Prasugrel No in vivo biotransformation CYP-dependent oxidation CYP3A4/5 CYP2B6 CYP2C19 CYP2C9 CYP2D6 Ticagrelor Binding Hydrolysis by esterase Prasugrel Platelet P2Y12 Clopidogrel CYP-dependent oxidation CYP2C19 CYP3A4/5 CYP2B6 CYP-dependent oxidation CYP1A2 CYP2B6 CYP2C19 Active compound Intermediate metabolite Prodrug New Players in the Antiplatelet Therapy Field Biotransformation and Mode of Action of Clopidogrel, Prasugrel, and Ticagrelor Ticagrelor, a cyclopentyl triazolopyrimidine, is rapidly absorbed in the intestine and does not require further biotransformation for activation. It directly and reversibly binds to the platelet adenosine diphosphate (ADP) receptor P2Y12. The half-life of ticagrelor is 7 to 8 hours. The thienopyridines prasugrel and clopidogrel are prodrugs. Their active metabolites irreversibly bind to P2Y12 for the platelet's life span. After intestinal absorption of clopidogrel, it requires two cytochrome P-450 (CYP)–dependent oxidation steps to generate its active compound. After intestinal absorption of prasugrel, it is rapidly hydrolyzed, by means of esterases, to an intermediate metabolite and requires one further CYP-dependent oxidation step to generate its active compound.

  32. TRITON-TIMI 38 Trial Study Design ACS (STEMI or UA/NSTEMI) and Planned PCI N = 13,600 ASA Double-blind Clopidogrel 300 mg LD/ 75 mg MD Prasugrel 60 mg LD/ 10 mg MD Median duration of therapy – 12 months Primary end point: CV death, MI, Stroke Secondary end points: CV death, MI, Stroke, Recurrent Ischemia CV death, MI, UTVR Stent thrombosis Safety endpoints: TIMI major bleeds, life-threatening bleeds Key sub studies: Pharmacokinetic, Genomic Wiviott S et al. NEJM 2007;357:2001

  33. Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes: TRITON Trial Cumulative Kaplan–Meier Estimates of Primary Efficacy End Point (death from CV causes, MI or stroke) and Key Safety End Point (TIMI major bleeding) 15 10 5 0 Primary Efficacy End Points 12.1 Clopidogrel 138 events P <0.001 9.9 Prasugrel % 35 events 2.4 Key Safety End Points P = 0.03 1.8 0 30 90 180 270 360 450 Days after Randomization Number at risk Clopidogrel 6795 6169 6036 5835 5043 4369 3017 Prasugrel 6813 6305 6177 5951 5119 4445 3085 Wiviott et al. N Engl J Med 2007;357:2001

  34. TRITON Trial: Stent Thrombosis in DES and BMS % Wiviott et al. Lancet 2008;371:1353

  35. TRITON Trial: Greater Clinical Benefit of More Intensive Oral Antiplatelet Therapy With Prasugrel in Pts With DM Kaplan–Meier curves for Prasugrel vs. Clopidogrel stratified by DM status Efficacy end point (death/ MI/ stroke) TIMI major bleeding non-CABG Wiviott et al, Circulation 2008;118:1626

  36. TRITON-TIMI 38 Trial: Net Clinical Benefit Bleeding Risk Subgroups – Therapeutic Consideration Avoid Prasugrel Prior CVA/TIA Reduced MD guided by PK Age 75 or Wt <60 Kg 4% 16% Subgroups with +Benefit: - STEMI - Diabetes - Stent thrombosis on plavix - Clopidogrel Non-responders - Complex High Risk Lesions Significant Net Clinical Benefit with Prasugrel 80% MD 10 mg Wiviott S et al. Circulation 2007;116:2923

  37. Ticagrelor Compared with Clopidogrel in Pts with ACS: PLATO trial Study Design NSTE-ACS (moderate-to-high risk) STEMI (if primary PCI) Clopidogrel-treated or -naive; randomised within 24 hours of index event (N=18,624) Clopidogrel If pre-treated, no additional loading dose; if naive, standard 300 mg loading dose, then 75 mg qd maintenance; (additional 300 mg allowed pre PCI) Ticagrelor 180 mg loading dose, then 90 mg bid maintenance; (additional 90 mg pre-PCI) 6–12-month exposure Primary endpoint: CV death + MI + Stroke Primary safety endpint: Total major bleeding PCI = percutaneous coronary intervention; ASA = acetylsalicylic acid; CV = cardiovascular; TIA = transient ischaemic attack Wallentin L et al, N Engl J Med 2009;361:1045

  38. PLATO Trial K-M estimate of time to first primary efficacy event (composite of CV death, MI or stroke) 13 12 11.7 Clopidogrel 11 10 9.8 9 Ticagrelor 8 7 Cumulative incidence (%) 6 5 4 3 2 HR 0.84 (95% CI 0.77–0.92), p=0.0003 1 0 0 60 120 180 240 300 360 Days after randomisation No. at risk Ticagrelor 9,333 8,628 8,460 8,219 6,743 5,161 4,147 Clopidogrel 9,291 8,521 8,362 8,124 6,743 5,096 4,047 K-M = Kaplan-Meier; HR = hazard ratio; CI = confidence interval Wallentin L et al, N Engl J Med 2009;361:1045

  39. PLATO Trial K-M estimate of primary efficacy (composite of CV death, MI or stroke) & Bleeding P <0.001 P = 0.43 Ticagrelor (n= 5640) Clopidogrel (n= 5649) 11.7 11.6 11.2 9.8 P = 0.001 P = 0.005 % 6.9 5.8 5.1 P = 0.009 P = 0.22 4.0 1.9 1.5 1.3 1.3 Stent MI Death Stroke Death/MI/ TIMI major Thrombosis Stroke Bleeding Wallentin L et al, N Engl J Med 2009;361:1045

  40. P = 0.06 P = 0.05 13.2 12.3 Enoxaparin Fondaparinux P <0.001 % 5.8 4.3 Death/MI/Refractory Major Ischemia Bleeding Enoxaparin (n = 10021) Fondaparinux (n = 10057) Fondaparinux Vs. Enoxaparin in ACS: OASIS-5 Trial Death Rates and Events at 180-Days Follow-Up 6.5% 5.8% 0.06 0.04 0.02 0.00 mm Cumulative hazard 0 30 60 90 120 150 180 Follow-up period (Days) No. at risk Enoxaparin Fondaparinux • 9673 9574 9495 8594 8506 8321 • 10057 9762 9664 9585 8611 8549 8386 Issue was catheter induced thrombus in PCI pts OASIS-5 Trial, N Engl J Med 2006;354:1464

  41. ACUITY Trial: MACE and Major Bleeding after PCI Heparin*+ IIb/IIIa vs. Bivalirudin + IIb/IIIa vs. Bivalirudin Alone: 30-Day Events Heparin+GPI (N=2561) Bivalirudin+GPI (N=2609) Bivalirudin alone (N=2619) P = 0.16 P = 0.32 P = 0.16 % P = 0.31 P < 0.001 P = 0.37 Composite ischemia Death MI urgent Major bleeding Revascularization *Heparin=unfractionated or enoxaparin Stone GW et al. NEJM. 2006;355:2203

  42. Prasugrel versus Clopidogrel for ACS without Revascularization: TRILOGY Trial @ 30 months Follow up Prasugrel (N = 4663) Clopidogrel (N = 4663) P = 0.45 P = 0.58 P = 0.38 % P = 0.52 CV death / MI / Stroke CV death MI Stroke Roe et al. NEJM 2012;367:1297

  43. Question • Following are the PCI versus CABG trials for multivessel disease, • except: • EAST • BARI • CABRI • ERACI • CASS E

  44. Revascularization Trials for Angina Old: Medicine vs. Surgery – VA, ECSS, CASS New: Single vessel disease: Medicine vs. Angioplasty – ACME Angioplasty vs. CABG – GOY Medicine, Angioplasty vs. CABG – MASS Multivessel disease: PTCA vs. CABG – ERACI, RITA, CABRI, GABI, EAST, BARI Medicine vs. PTCA – RITA II Recent Trials: Stent vs. Surgery – SOS, ARTS, ERACI II

  45. CABG Vs. Medical Therapy Trials VACS, ECSS, CASS – Results CABG is superior to medical therapy: • Left main disease >70% (VACS, ECSS) • 3-vessel disease (ECSS, VACS) • 3-vessel disease with mild LV dysfunction (CASS, VACS) • 2-vessel disease with one being prox LAD (ECSS) • 2 or 3-vessel disease with high-risk features • - ST segment depression • - Early positive ETT • - Old age or LVH No difference in Q-wave MI and return to work.

  46. PTCA Vs. Medical (CABG) Therapy Trials ACME, MAAS, GUY Trials – Results PTCA is superior to medical therapy: • Improvement in symptoms • Better exercise duration • Less angina & anti-anginals drugs • Better quality of life • But: • Higher initial cost and cardiac procedures No difference in MI, death or long-term revascularization.

  47. PTCA Versus CABG Trials Results

  48. Question • Which of the following statements regarding the trials • of PCI versus CABG is true: • Diabetics did better with PCI than with CABG • CABG has lower MI versus PCI • CABG has higher restenosis versus PCI • PCI is cheaper than CABG D

  49. Diabetes and Coronary Revascularization: BARI Investigators • 343 patients in BARI had treated diabetes at study entry and • were followed for 5.4 years. IMA graft n=140 2.9 SVG only n=33 18.2% p<0.005 BARI Investigators. Circulation 1997

  50. Bypass Angioplasty Revascularization Investigation: BARI Registry Vs. Trial Seven-year mortality p<0.05 BARI Registry (n=1814) BARI Trial (n=1476) p=0.001 p=NS p<0.01 % p=NS p=NS p=NS p=NS n=106 n=202 n=625 n=1189 n=180 n=173 n=734 n=742 CABG PTCA CABG PTCA Diabetics Overall Feit et al. Circulation 2000;101:2795

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