Patient with high risk for bleeding
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1 Will Apixaban change practice in atrial fibrillation Luncheon Satellite Sponsored by Pfizer Patient with high risk for bleeding Prof. Amos Katz M.D
2 August 2012: patient background 67-year-old woman History of coronary artery disease Coronary intervention; 12/2006 PCI BMS to RCA Last Coronary angiography; 7/2011, patent RCA, D1 90%, conservative treatment Medical History: Hypertension T2 DM Dyslipidemia Lung bronchiectasis COPD Obesity ; BMI=35 egfr =55 Diagnosis of AF since 2007 DC CV; 2007, 2008, 2009 Rx Amiodarone until 2012 Rx Coumadin until 2011 Coumadin AF DCCV AF DCCV AF DCCV Amiodarone
3 August 2011: August 2011 labile INR [4.5-7] Major lung bleeding: hemoptysis Coumadin stopped Medications: Aspirin, Metformine, Valsartan, Rosuvastatin Coumadin AF DCCV AF DCCV AF DCCV Amiodarone
4 Patient with high risk for bleeding Efficacy: All stroke (ischaemic + aemorrhagic) & systemic embolism Safety: Bleeding events (major and minor) Intracranial haemorrhage MI, LFT, Death
5 Clinical Flowchart for OAC 5
6 Estimation of Bleeding Risk 6
7 Bleeding risk scores 7
8 Comparing C Indexes JACC, 28 August 2012, Pages
9 CHADS2 Stroke risk Scores CHA2DS2 VASc
10 HAS - BLED 10
11 Recommendation for Assessment of Bleeding Risk
12 August 2011: August 2013 Major lung bleeding: hemoptysis Coumadin stopped Medication: Aspirin CHADS2=2= 4% risk, CHA2DS2 VASc=5=15.2% risk HAS-BLED=4=8.7% risk Patient background 67-year-old woman CAD HT DM Diagnosis of AF Clopidogrel Coumadin AF DCCV AF DCCV AF DCCV Amiodarone
13 Patient with high risk for bleeding Efficacy: All stroke (ischaemic + aemorrhagic) & systemic embolism
14 Stroke or Systemic Embolism NOAC Warfarin No. of events (%/yr) HR 95% CI Dabi (1.44) 186 (1.58) Dabi (1.01) 186 (1.58) Riva (safety AT) 184 (1.65) 221 (1.96) Apixaban 199 (1.19) 250 (1.51) ITT: Intention to Treat AT: as treated Favors NOAC Favors warfarin Not head to head comparison For illustrative purposes only adapted from references Connolly et al. NEJM 2009; 361: Connolly et al. NEJM 2010; 363: Patel et al. NEJM 2011; 365: Granger et al. NEJM 2011; 365:
15 Patient with high risk for bleeding Safety: Bleeding events (major and minor) Intracranial haemorrhage MI, LFT, Death
16 Hemorrhagic Stroke NOAC Warfarin No. of events (%/yr) HR 95% CI Dabi (0.12) 45 (0.38) Dabi (0.10) 45 (0.38) Riva (safety AT) 29 (0.26) 50 (0.44) Apixaban 40 (0.24) 78 (0.47) Favors NOAC Favors warfarin ITT: Intention to Treat AT: as treated. Not head to head comparison For illustrative purpose only adapted from references Connolly et al. NEJM 2009; 361: Connolly et al. NEJM 2010; 363: Patel et al. NEJM 2011; 365: Granger et al. NEJM 2011; 365:
17 Intracranial Bleeding NOAC Warfarin No. of events (%/yr) HR 95% CI Dabi (0.23) 90 (0.76) Dabi (0.32) 90 (0.76) Riva 55 (0.5) 84 (0.7) Apixaban 52 (0.33) 122 (0.80) Favors NOAC Favors warfarin Not head to head comparison For illustrative purpose only adapted from references Connolly et al. NEJM 2009; 361: Connolly et al. NEJM 2010; 363: Patel et al. NEJM 2011; 365: Granger et al. NEJM 2011; 365:
18 NOAC Warfarin No. of events (%/yr) Major Bleeding HR 95% CI Dabi (2.87) 421 (3.57) Dabi (3.32) 421 (3.57) Riva 395 (3.6) 386 (3.4) Apixaban 327 (2.13) 462 (3.09) Favors NOAC Not head to head comparison For illustrative purpose only adapted from references Connolly et al. NEJM 2009; 361: Connolly et al. NEJM 2010; 363: Patel et al. NEJM 2011; 365: Granger et al. NEJM 2011; 365: Favors warfarin
19 Major Gastro-intestinal Bleeding NOAC Warfarin No. of events (%/yr) HR 95% CI Dabi (1.15) 126 (1.07) Dabi (1.56) 126 (1.07) Riva* 224 (X.XX) 154 (X.XX) (X) Apixaban 105 (0.76) 119 (0.86) *%/yr are not reported Favors NOAC Favors warfarin *p value given in the NEJM; HR not reported; Not head to head comparison For illustrative purpose only adapted from references Connolly et al. NEJM 2009; 361: Connolly et al. NEJM 2010; 363: Patel et al. NEJM 2011; 365: Granger et al. NEJM 2011; 365:
20 Myocardial Infarction NOAC Warfarin No. of events (%/yr) HR 95% CI Dabi 110 Dabi 150 Riva (safety AT) 98 (0.82) 75 (0.64) 97 (0.81) 74 (0.64) 101 (0.91) 126 (1.12) Apixaban 90 (0.53) 102 (0.61) Favors NOAC ITT: Intention to Treat AT: as treated. Not head to head comparison For illustrative purpose only adapted from references Connolly et al. NEJM 2009; 361: Connolly et al. NEJM 2010; 363: Patel et al. NEJM 2011; 365: Granger et al. NEJM 2011; 365: Favors warfarin 2.0
21 Death From Any Cause Total Mortality NOAC Warfarin No. of events (%/yr) p HR 95% CI Dabi 110 Dabi 150 Rivaroxaban Rivaroxaban (safety AT) Apixaban 446 (3.75) 487 (4.13) (3.64) 487 (4.13) (4.5) 632 (4.9) (1.87) 250 (2.21) 603 (3.52) 669 (3.94) Favors NOAC Favors warfarin Not head to head comparison For illustrative purpose only adapted from references Connolly et al. NEJM 2009; 361: Connolly et al. NEJM 2010; 363: Patel et al. NEJM 2011; 365: Granger et al. NEJM 2011; 365:
22 NOACs Trials
23 August 2013: Major lung bleeding: hemoptysis Coumadin stopped Medication: Aspirin CHADS2=2= 4% risk, CHA2DS2 VASc=5=15.2% risk HAS-BLED=4=8.7% risk My recommendation: Start Apixaban 5mg bid Best efficacy / safety balance Clopidogrel APPRISE 2 Coumadin AF DCCV AF DCCV AF DCCV Amiodarone
24 Myocardial Infarction NOAC Warfarin No. of events (%/yr) HR 95% CI Dabi 110 Dabi 150 Riva (safety AT) 98 (0.82) 75 (0.64) 97 (0.81) 74 (0.64) 101 (0.91) 126 (1.12) Apixaban 90 (0.53) 102 (0.61) Favors NOAC ITT: Intention to Treat AT: as treated. Not head to head comparison For illustrative purpose only adapted from references Connolly et al. NEJM 2009; 361: Connolly et al. NEJM 2010; 363: Patel et al. NEJM 2011; 365: Granger et al. NEJM 2011; 365: Favors warfarin 2.0 Dec 2011
25 August 2011: Major lung bleeding: hemoptysis Coumadin stopped Medication: Aspirin CHADS2=2= 4% risk, CHA2DS2 VASc=5=15.2% risk HAS-BLED=4=8.7% risk Clopidogrel Coumadin Pradaxa 150 mg bid AF DCCV AF DCCV AF DCCV Amiodarone
26 August 2012 December 2012 Amiodarone Lung toxicity Sotalol - Failure Persistent AF fast V rate Preparation for PVI (ablation) TEE LA thrombus X 2 DDDR pacemaker Total AV J Ablation Coumadin Pradaxa 150 mg bid AF DCCV AF DCCV AF DCCV Amiodarone
27 January 2013 Persistent AF fast V rate Preparation for PVI (ablation) TEE LA thrombus DDDR pacemaker Total AV J Ablation Hemoptysis Skin rash Dyspepsia Coumadin Amiodarone Pradaxa 150, 110 mg Xarelto bid 20 mg qd AF DCCV AF DCCV AF DCCV
28 April 2013 Persistent AF fast V rate Preparation for PVI (ablation) TEE LA thrombus DDDR pacemaker Total AV J Ablation Hemoptysis Coumadin AF DCCV AF DCCV AF DCCV Amiodarone Pradaxa Xarelto 20 mg- >15 mg
29 June 2013 No Hemoptysis Anterior wall MI PPCI to LAD Clopidogrel Coumadin AF DCCV AF DCCV AF DCCV Amiodarone Pradaxa Xarelto 15 mg
30 Hypothetical 2013: pre MI My recommendation: Start Apixaban 5mg bid Best efficacy / safety balance Clopidogrel Coumadin AF DCCV AF DCCV AF DCCV Amiodarone Pradaxa Xarelto
31 NOACs Trials
32 Myocardial Infarction NOAC Warfarin No. of events (%/yr) HR 95% CI Dabi 110 Dabi 150 Riva (safety AT) 98 (0.82) 75 (0.64) 97 (0.81) 74 (0.64) 101 (0.91) 126 (1.12) Apixaban 90 (0.53) 102 (0.61) Favors NOAC ITT: Intention to Treat AT: as treated. Not head to head comparison For illustrative purpose only adapted from references Connolly et al. NEJM 2009; 361: Connolly et al. NEJM 2010; 363: Patel et al. NEJM 2011; 365: Granger et al. NEJM 2011; 365: Favors warfarin 2.0
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