congresso interregionale a.r.c.a. del nord genova, 23-24 ottobre 2015 dott. sergio agosti dirigente...
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Congresso Interregionale A.R.C.A. del Nord
Genova, 23-24 Ottobre 2015
Dott. Sergio AgostiDirigente MedicoSOC Cardiologia Ospedale Novi Ligure
NAO: vi sono reali vantaggi rispetto al Warfarin?
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➢A new drug comes to the market. Compared to NAOs, the new drug has:- cheaper- antidote- requirement for monthly monitoring to adjust dose- many food and drug interactions- 25% increased relative risk of stroke/systemic embolism- nearly 50% increased relative risk of major bleeding- approx. 2.5 times the rate of ICH- 10% increased relative risk of mortality
➢Would Warfarin be approved by regulatory authorities now?
Assume that NAOs have been on the market for 5 year
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A new era of anticoagulation?
Diener H-C et al. Int J of Stroke: Vol 7, February 2012, 139–141
A new era of anticoagulation?
WOULD WARFARIN BE
APPROVED TODAY?
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Lancet, published online December 4, 2013
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STROKE OR SYSTEMIC EMBOLISM
Ruff CT, Lancet, December 4, 2013
NNT 173
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MAJOR BLEEDING
Ruff CT, Lancet, December 4, 2013
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EFFICACY AD SAFETYSECONDARY ENDPOINTS
ICH NNT 141
Ruff CT, Lancet, December 4, 2013
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Intracranial hemorrhage risk with the new oral anticoagulants: a systematic review and meta analysis Daniel Caldeira et al. J Neurol 2014
Haemorrhagic stroke
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Mackmann, Anesth Analg. 2009 May; 108(5):1447-52The role of tissue factor and factor VIIa in hemostasis.
Haemorrhagic stroke (TF receptor)
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http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm
Antidoto
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In which patients
Elderly patients
Patients with renal insufficiency
Patients with valvular atrial fibrillation
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NOA in Elderly patients
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Risk of non prescription of OAC by age
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NAO vs Warfarin nei pazienti > 75 anniMAJOR BLEEDING
J. Am Geriatr. Soc. 2014 May; 62: 857-64. NAO in elderly adults: evidence from a meta-analysis of randomized trials. Sardar P, Lip G.
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NAO vs Warfarin nei pazienti > 75 anniSTROKE OR SE
J. Am Geriatr. Soc. 2014 May; 62: 857-64. NAO in elderly adults: evidence from a meta-analysis of randomized trials. Sardar P, Lip G.
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NOA in patients with renal insufficiency
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Chronic kindney disease is common among AF patients
Kooiman et al. J Thromb Haemost 2011;9:1652–3
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Chronic kindney disease increases the risk of stroke, bleeding, and all-cause death in AF patients
Olesen et al. N Engl J Med 2012;367:625–35.
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Xa inhibitors are eliminated from the body via multiple routes
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NAO vs Warfarin nei pazienti con IR moderataMAJOR BLEEDING
Novel Oral Anticoagulants in Patients With Renal Insufficiency: A Meta-analysis of Randomized Trials. Partha Sardar et al, Can. J Cardiol. 2014; Aug, 30: 888-97.
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NAO vs Warfarin nei pazienti con IR moderataSTROKE OR SE
Novel Oral Anticoagulants in Patients With Renal Insufficiency: A Meta-analysis of Randomized Trials. Partha Sardar et al, Can. J Cardiol. 2014; Aug, 30: 888-97.
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Raccomandazioni dell’ESC nei pazienti con IR
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Raccomandazioni dell’EHRA nei pazienti con IR (2015)
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Cambiamento della GFR in pt con D110, D150 o Warfarin
0
-1
-2
-3
-4
Chan
ge fr
om B
asel
ine
30 6 9 12 15 18 21 3024 27
Months
DE 110mg bid DE 150mg bid Warfarin*
*p< 0.005 vs warfarin
**
Available patients
3 months 6 months 12 months 24 months 30 months
DE 110mg bid 5130 5000 4686 3368 1672DE 150mg bid 5171 5005 4696 3434 1685Warfarin 5243 5146 4895 3519 1703
Michael Böhm, ESC 2014, Barcelona, 30 Aug - 3 Sep 2014
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Schurgers et al,Blood 109 (2007): 2823-2831
Brodsky et al,Kidney Int 109 (2011): 181-189
Price et al,Arterioscler Thromb Vasc Biol 18 (1998): 1400-1407
Krüger et al,Arterioscler Thromb Vasc Biol 33 (2013): 2618-2624
Backgroun: Vitamin K-Antagonists Induce Vascular Damage
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NOA in patients with valvular atrial fibrillation
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Updated EHRA Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with NVAF: Heidbuchel, August 31, 2015
Definition of non valvular atrial fibrillation (NVAF)
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NAO in numeri….
• 180000 pz nei trials
• Oltre 18 milioni di pz trattati nel mondo
• 6200 articoli - studi clinici (PUBMED)
• Almeno 300000 pz nei registri
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Real world data
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Due importanti problemi nell’interpretazione dei dati
provenienti dal mondo reale (registri e studi osservazionali)
• Selection bias
• Prescrizione inappropriata
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Primary findings for dabigatran are based on analysis of both 75 mg and 150 mg together without stratification by dose. Warfarin is the reference group. CI
= confidence interval; HR = hazard ratio; MI = myocardial infarction; Available at: www.fda.gov/Drugs/DrugSafety/ucm396470.htm (accessed May
2014)
Incidence rate per 1000 person-years Adjusted HR
(95% CI)Dabigatran Warfarin
Ischaemic stroke 11.3 13.9 0.80 (0.67-0.96)
Intracranial haemorrhage
3.3 9.6 0.34 (0.26-0.46)
Major gastrointestinal bleeding
34.2 26.5 1.28 (1.14-1.44)
Acute myocardial infarction
15.7 16.9 0.92 (0.78-1.08)
Mortality 32.6 37.8 0.86 (0.77-0.96)
Dabigatran was associated with a lower risk of ischaemic stroke, intracranial haemorrhage and death than warfarin.
Risk of MI was similar for dabigatran and warfarin.
Medicare analysis: resultsMedicare analysis: results
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Primary findings for dabigatran are based on analysis of both 75 mg and 150 mg together without stratification by dose. Warfarin is the reference group. CI
= confidence interval; HR = hazard ratio; MI = myocardial infarction; Available at: www.fda.gov/Drugs/DrugSafety/ucm396470.htm (accessed May
2014)
Incidence rate per 1000 person-years Adjusted HR
(95% CI)Dabigatran Warfarin
Ischaemic stroke 11.3 13.9 0.80 (0.67-0.96)
Intracranial haemorrhage
3.3 9.6 0.34 (0.26-0.46)
Major gastrointestinal bleeding
34.2 26.5 1.28 (1.14-1.44)
Acute myocardial infarction
15.7 16.9 0.92 (0.78-1.08)
Mortality 32.6 37.8 0.86 (0.77-0.96)
Dabigatran was associated with a lower risk of ischaemic stroke, intracranial haemorrhage and death than warfarin.
Risk of MI was similar for dabigatran and warfarin.
Medicare analysis: resultsMedicare analysis: results
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Primary findings for dabigatran are based on analysis of both 75 mg and 150 mg together without stratification by dose. Warfarin is the reference group. CI
= confidence interval; HR = hazard ratio; MI = myocardial infarction; Available at: www.fda.gov/Drugs/DrugSafety/ucm396470.htm (accessed May
2014)
Incidence rate per 1000 person-years Adjusted HR
(95% CI)Dabigatran Warfarin
Ischaemic stroke 11.3 13.9 0.80 (0.67-0.96)
Intracranial haemorrhage
3.3 9.6 0.34 (0.26-0.46)
Major gastrointestinal bleeding
34.2 26.5 1.28 (1.14-1.44)
Acute myocardial infarction
15.7 16.9 0.92 (0.78-1.08)
Mortality 32.6 37.8 0.86 (0.77-0.96)
Dabigatran was associated with a lower risk of ischaemic stroke, intracranial haemorrhage and death than warfarin.
Risk of MI was similar for dabigatran and warfarin.
Medicare analysis: resultsMedicare analysis: results
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Primary findings for dabigatran are based on analysis of both 75 mg and 150 mg together without stratification by dose. Warfarin is the reference group. CI
= confidence interval; HR = hazard ratio; MI = myocardial infarction; Available at: www.fda.gov/Drugs/DrugSafety/ucm396470.htm (accessed May
2014)
Incidence rate per 1000 person-years Adjusted HR
(95% CI)Dabigatran Warfarin
Ischaemic stroke 11.3 13.9 0.80 (0.67-0.96)
Intracranial haemorrhage
3.3 9.6 0.34 (0.26-0.46)
Major gastrointestinal bleeding
34.2 26.5 1.28 (1.14-1.44)
Acute myocardial infarction
15.7 16.9 0.92 (0.78-1.08)
Mortality 32.6 37.8 0.86 (0.77-0.96)
Dabigatran was associated with a lower risk of ischaemic stroke, intracranial haemorrhage and death than warfarin.
Risk of MI was similar for dabigatran and warfarin.
Medicare analysis: resultsMedicare analysis: results
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Global Registry on Long-Term Oral Antithrombotic Treatment in AF Patients
• Collection of data on dabigatran in countries/regions and globally• Increase knowledge on AF patients, treatment patterns, and outcome events
in a real-world setting• Involvement of up to 2200 physicians worldwide: GPs, cardiologists,
neurologists, internists, geriatricians, etc – hospital based or private practice
up to 56 000 patients
2200 sites
up to 50 countries
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Comparison of Main Outcomes: XANTUS versus ROCKET AF
CHADS2 Prior stroke#
ROCKET AF1 3.5 55%
XANTUS2 2.0 19%
#Includes prior stroke, SE or TIA; *Events per 100 patient-years
1. Patel MR et al, N Engl J Med 2011;365:883–891; 2. Camm AJ et al, Eur Heart J 2015; doi: 10.1093/eurheartj/ehv466
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ROCKET AF1 mean CHADS2-Score 3.5
n=7,111
Eve
nt r
ate
(%/y
ear
)
*Major bleeding definitions according to ISTH; # modified ISTH definition (additionally included surgical revision from bleeding)**Major bleeding was defined by the Cunningham algorithm3
#55th ASH Meeting 2013, Oral presentation, Abstract 213, https://ash.confex.com/ash/2013/webprogram/Paper58333.html1. Patel MR et al. N Engl J Med 2011; 365(10):883–891; 2. Beyer—Westendorf et al. Blood 2014;124(6); 955-962; 3. Peacok ESC 2015; 4. Camm et al Eur Heart J 2015; 5. Tamayo et al. Clin Cardiol 2015
n=1,200
Major Bleeding Rates with Rivaroxaban:Low and consistent in clinical trial and real life setting
Dresden NOAC Registry2
mean CHADS2-Score 2.4#
US DoD PMSS3
mean CHADS2-Score 2.25
n=39,052
2.9
3,6
2.93.1
XANTUS4
mean CHADS2-Score 2.1
n=6,784
2.1
Data on more than 54.000 rivaroxaban treated patients
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Conclusions
• The efficacy and major bleeding results of NOA vs. warfarin were consistent
• NOA have benefits over warfarin that are maintained irrespective of age
• NOA have benefits over warfarin that are maintained irrespective of renal function
• NOA real world data are consistent
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