Job Harenberg 1, Svetlana Marx 1,2, Hans C Diener 3, Gregory YH Lip 4, Victor J Marder 5, Martin Wehling 1, Christel Weiss 2
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1 XXV World Congress of the International Union of Angiology Prague, 2-5. July 2012 Impact of newer oral anticoagulants on the management of atrial fibrillation Job Harenberg 1, Svetlana Marx 1,2, Hans C Diener 3, Gregory YH Lip 4, Victor J Marder 5, Martin Wehling 1, Christel Weiss 2 Departments of Clinical Pharmacology 1, Biometry and Statistics 2, Faculty of Medicine Mannheim, Ruprecht-Karls-University Heidelberg, Germany; Department of Neurology, University of Essen, Germany 3 ; University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, UK 4 ; Division of Haematology/Medical Oncology, David Geffen School of Medicine at UCLA, Los Angeles, California USA 5
2 Disclosures for Job Harenberg, MD, PhD In compliance with CME policies, 6 th ICTHIC requires the following disclosures, related to the speaker s presentation, to the session audience : Research Support/P.I. Employee Consultant Major Stockholder Scientific Advisory Board Honoraria Other (Specify) Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Bristol-Myers Squibb Company, Novartis, Pfizer Inc, Polymedix, Roche Diagnostics, Sanofi-Aventis; Dietmar Hopp foundation [No relevant conflicts of interest to declare or Company Name(s)] AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Bristol-Myers Squibb Company, Novartis, Pfizer Inc, Polymedix, Roche Diagnostics, Sanofi-Aventis; [No relevant conflicts of interest to declare or Company Name(s)] [No relevant conflicts of interest to declare or Company Name(s)] AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Bristol-Myers Squibb Company, Novartis, Pfizer Inc, Polymedix, Roche Diagnostics, Sanofi-Aventis; [No relevant conflicts of interest to declare or Company Name(s)]
3 Background Clinical studies in AF: RE-LY: 110mg bid and 150mg bid dabigatran double blind vs open label warfarin Connolly et al, N Engl J Med. 2009;361: and 2010;363: ROCKET-AF: 20mg od rivaroxaban vs warfarin, double blind, double dummy Patel et al, N Engl J Med. 2011;365: ARISTOTLE: 5mg bid apixaban vs warfarin, double blind, double dummy Granger et al, N Engl J Med. 2011;365:981-92
4 Background The new oral anticoagulants (NOAC) Dabigatran, Rivaroxaban, and Apixaban equivalent or superior efficacy and safety for prevention of embolic events in patients withnon-valvular atrial fibrillation (AF). A direct comparison of the NOACs is highly unlikely to be performed due to the high costs and difficulut logistics Adequate stastistical methods exist to perform an indicrect comparison between the NOACs in this indication. This analysis can be performed because the individual compounds were tested against the same comparator: warfarin
5 Aim Performance of an indirect comparison also named network meta-analysis of dabigatran s RE-LY, rivaroxaban s ROCKET AF, and apixaban s ARISTOTLE trials, each assessed against warfarin in patients with AF, to obtain insights into their comparative efficacy and/or safety of the NOACs in this indication.
6 Network meta-analysis Direct comparison in the trials Rivaroxaban 20 mg od Dabigatran 110 mg bid Apixaban 5 mg bid Dabigatran 150 mg bid Warfarin
7 Network meta-analysis Direct comparison in the trials Indirect comparison in the NMA Rivaroxaban 20 mg od Dabigatran 110 mg bid Apixaban 5 mg bid Dabigatran 150 mg bid Warfarin
8 Randomized trials with NOACs in atrial fibrillation Search: Pubmed, Internet N=14 Non-homogeneity between trials Sportif III and V 2003, 2005 N=2 Subroup analysis RE-LY Japanese, 2011 N=1 Comparator not warfarin AVERROES, 2011 AZD0837, 2011 N=2 Not reporting all endpoints Sportif II, 2003 PETRO, 2003 AZD0837, 2009 Edoxaban, 2010 ARISTOTLE-J, 2011 J-ROCKET, 2011 N=6 Trials included into analysis Dabigatran: RE-LY, 2009, 2010 Rivaroxaban: ROCKET AF, 2011 Apixaban: ARISOTOTLE, 2011
9 Data from the publications used for the analysis Study Drug/dose Fem. (%) (n) IS / SE (n) or (n/n) MB (n) or (n/n) ICH (n) or (n/n) MI (n) Death (n) RE-LY (ITT=OT) Dabigatran 110mg bid Dabigatran 150mg bid Warfarin 35,7 36,8 36, ROCKET AF (OT) Riva. 20mg od Warfarin 39,7 39, / 7081 (ITT) 306/7090 (ITT) ARISTOT LE (ITT) Apixaban 5mg bid Warfarin 35,5 35, /9088 (OT) 462/9052 (OT) 52/9088 (OT) 122/9052 (OT)
10 and 95% CI of the direct comparison within trials These data were used for the indirect comparison Study Drug/dose Female IS / SE MB ICH MI Mortality CI p-value CI p-value CI p-value CI p-value CI p-value CI p-value RE-LY Dabigatran 110mg bid 0,96 0,89-1,03 0,2516 0,90 0,74-1,11 0,3309 0,80 0,69-0,93 0,0033 0,30 0,19 0,46 <0,001 1,31 0,97 1,78 0,0778 0,91 0,79-1,04 0,1680 Dabigatran 150mg bid 1,00 0,93-1,08 0,9528 0,65 0,52 0,82 <0,001 0,94 0,81 1,08 0,3534 0,42 0,28 0,61 <0,001 1,29 0,95 1,74 0,1038 0,88 0,77-1,01 0,0692 ROCKET AF Riva. 20mg od 1,00 0,94-1,07 0,9972 0,88 0,81-0,94 0,0124 1,03 0,96-1,09 0,7192 0,65 0,46-0,92 <0,001 0,80 0,61 1,04 0,0980 0,92 0,81 1,03 0,1396 ARISTOTLE Apixaban 5mg bid 1,02 0,96-1,08 0,5529 0,79 0,66-0,95 0,0124 0,69 0,60-0,80 <0,001 0,42 0,30-0,58 <0,001 0,88 0,66-1,17 0,3694 0,89 0,79-0,99 0,0458
11 Indirect comparison of Dabigatran 110 mg bid versus Dabigatran 150 mg bid Ischemic stroke or embolism (95% CI) 1.38 (1.02,1.88) Major bleeding 0.85 (0.69,1.05) Intracerebral hemorrhage 0.71 (0.40,1.29) Myocardial infarction 1.02 (0.66,1.56) Mortality 1.03 (0.85,1.25) p-value Dabigatran 110 mg bid better Dabigatran 150 mg bid better
12 Indirect comparison of Dabigatran 150 mg bid versus Rivaroxaban 20 mg od Ischemic stroke or embolism (95% CI) 0.74 (0.56, 0.98) Major bleeding 0.92 (0.75,1.12) Intracerebral hemorrhage 0.65 (0.38,1.09) Myocardial infarction 1.61 (1.08,2.41) Mortality 0.96 (0.81, 1.15) p-value Dabigatran 150 mg bid better Rivaroxaban 20 mg od better
13 Indirect comparison of Dabigatran 150 mg bid versus Apixaban 5 mg bid Ischemic stroke or embolism (95% CI) 0.82 (0.61,1.10) Major bleeding 1.35 (1.10,1.66) Intracerebral hemorrhage 1.00 (0.60,1.67) Myocardial infarction 1.47 (0.97,2.23) Mortality 0.99 (0.83,1.18) p-value Dabigatran 150 mg bid better Apixaban 5 mg bid better
14 Indirect comparison of Dabigatran 110 mg bid versus Rivaroxaban 20 mg od Ischemic stroke or embolism (95% CI) 1.03 (0.79,1.34) Major bleeding 0.78 (0.63,0.96) Intracerebral hemorrhage 0.46 (0.26,0.81) Myocardial infarction 1.64 (1.09,2.45) Mortality 0.99 (0.83,1.19) p-value Dabigatran 110 mg bid better Rivaroxaban 20 mg od better
15 Indirect comparison of Dabigatran 110 mg bid versus Apixaban 5 mg bid Ischemic stroke or embolism (95% CI) 1.14 (0.87,1.49) Major bleeding 1.15 (0.94,1.42) Intracerebral hemorrhage 0.71 (0.41,1.24) Myocardial infarction 1.45 (0.98,2.26) Mortality 1.02 (0.86,1.22) p-value Dabigatran 110 mg bid better Apixaban 5 mg bid better
16 Indirect comparison of Rivaroxaban 20 mg od versus Apixaban 5 mg bid Ischemic stroke or embolism (95% CI) 1.11 (0.86,1.42) Major bleeding 1.48 (1.21,1.81) Intracerebral hemorrhage 1.55 (0.96,2.50) Myocardial infarction ,1.34) Mortality 0.91 (0.73,1.13) p-value Rivaroxaban 20 mg od better Apixaban 5 mg bid better
17 Summary of significant results Efficacy D150 bid better than D110 bid and R Safety MB D110 bid better than R A better than D150 bid and R ICB D110 bid better than R MI R better than D110 bid and D150 bid
18 Indirect comparison of NOAC in AF Comparison of 4 independent publications Harenberg Lip Mantha Wells HR IS / SE D300 vs R D200 vs D300 na na MB D220 vs R D300 vs A R vs A D220 vs D300 ns na na ICH D220 vs R MI D300 vs R na D220 vs R na Wells G et al, published internet Aril 9, 2012, Lip GYH et al, J. Am. Coll. Cardiol. May 9, 2012; Harenberg J et al, Intern Angiol, July 2012, Mantha S et al, Thromb Haemost, August 2012 = significant
19 Conclusion In the absence of head-to-head comparisons, this network meta-analysis suggests that
20 Conclusion In the absence of head-to-head comparisons, this network meta-analysis suggests that apixaban 5mg bid and dabigatran110mg bid best benefit-risk balance for stroke prevention in NVAF
21 Conclusion In the absence of head-to-head comparisons, this network meta-analysis suggests that apixaban 5mg bid and dabigatran110mg bid best benefit-risk balance for stroke prevention in NVAF dabigatran 150mg bid for patients with NVAF and high risk for embolism.
22 Conclusion In the absence of head-to-head comparisons, this network meta-analysis suggests that apixaban 5mg bid and dabigatran110mg bid best benefit-risk balance for stroke prevention in NVAF dabigatran 150mg bid for patients with NVAF and high risk for embolism. Only a direct comparison of the NOACs would fully answer the question of efficacy/safety issues for stroke prevention in NVAF. Data analysed by 4 independent groups with minor differences of results of interpetation of data
23 Limitations Unblinded versus double-blinded study design Differences in definition of major bleeding across trials Age: reported differently in publications TTR values of INR values reported differently in publications CHADS-2 score reported differently in publications Creatinine clearance reported differently in publications Consequence: the impact of these differences cannot be analysed
24 Hazard Ratio versus Odds Ratio Hazard-function ht () Time interval length h ht ( ) lim h 0 P( t T t h T t) h Data of the individual study groups required for every endpoint This information not available for independent network analyses Odds Ratio = N events group A N events group B N without events group A N without events group B Time to event not available from publications Odds Ratio prferrable to Hazzard Ratio for indirect comparison
25 Summary: significant results of the NMA of NOACs in AF A versus B (95% CI) P-value IS + SE Da Da 300 1,38 (1,02-1,88) 0,0364 Da Ri 20 0,74 (0,56-0,98) 0,0388 MB Da Ri 20 0,78 (0,63-0,96) 0,0184 Da Ap 10 1,35 (1,10-1,66) 0,0038 Ri 20 - Ap 10 1,48 (1,21-1,81) 0,0002 ICB MI Da Ri 20 0,46 (0,26-0,81) 0,0070 Da Ri 20 1,64 (1,09-2,45) 0,0163 Da Ri 20 1,61 (1,09-2,41) 0, A better B better
26 Background Patients with non-valvular atrial fibrillation (AF) expose an increased risk for ischemic stroke and systemic embolism. Mortality and morbidity following stroke associated with AF are higher than in patients who suffer ischemic strokes in the absence of AF. Anticoagulation with vitamin K antagonists (VKA) reduces the incidence of ischemic stroke and systemic embolism, as well as mortality, in patients with AF, but severe bleeding complications, including intracranial haemorrhage occur. Due to these and other limitations of VKA, new oral anticoagulants (NOACs) were developed.
4/9/2015. Risk Stratify Our Patients. Stroke Risk in AF: CHADS2 Scoring system JAMA 2001; 285: 2864-71
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