Epidemiologia delle complicanze emorragiche da AVK e aspirina nella popolazione generale

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Mariano Belli
6 anni fa
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1 Convegno Nazionale FCSA, Bologna 7-9 Novembre 2013 Epidemiologia delle complicanze emorragiche da AVK e aspirina nella popolazione generale Gualtiero Palareti Bologna

2 Rates of bleeds during VKAs in prospective studies Fatal % Major % Minor %

3 Reported rates of bleeding in patients treated with anticoagulants vary widely in clinical studies. Differences in: classification of bleeding events designs of studies

4 Annual rates of major bleeds with VKAs (pts with AF)

5 Designs of studies Clinical trials: highly selected pts (low risk profile, highly compliant, less co-morbidities) Observational studies: more reliable results for safety, especially if prospective, consecutive pts, non-selected, first-time takers of ACs (Inception-cohort)

6 Blood 2008 Case-control study in 993 pts who required hospitalization for bleeding during VKAs 40% of them had at least one exclusion criterion They had a 2.9-fold increased risk of bleeding; higher when more exclusion criteria were present VKAs are often prescribed to patients who would not have qualified for clinical trials; these are at higher risk of bleeding

7 Rates of major bleeds with warfarin in recent trials with NOACs Trial Indication VKA arm % ICH % TTR % mean Author, year RE-LY AF Connolly, 2009 ROCKET AF Patel, 2010 ARISTOTLE AF Granger, 2011 RECOVER VTE 1.9 NA 60 Schulman, 2009 EINSTEIN VTE 1.2 NA 57.7 Bauersachs, 2010 AMPLIFY VTE Agnelli, 2013 HOKUSAI VTE Buller, 2013

8 TTR = 71%, below 14%, above 15% (Poli et al., JACC 2009)

9 Major determinants of OAT-induced bleeding Treatment-associated Target INR values Actual INR values Quality of anticoagulation control Length of OAT Services provided and surveillance Person-dependent Age History of past bleeding Co-morbid conditions Underlying pathologic lesions

10 Risk of bleeding when antiplatelet agents are added to VKAs

11 Flaker et al., SPORTIF trial, Am Heart J 2006

12 HANSEN et al., Arch Intern Med 2010 a cohort study using nation-wide registries to identify all Danish pts surviving first-time hospitalization for AF between January 1997, and December 2006, and their posthospital therapy of warfarin, aspirin, clopidogrel, and combinations of these drugs. ( pts) Dual warfarin and clopidogrel therapy and triple therapy carried a more than 3-fold higher risk than did warfarin monotherapy.

13 Bleeding with ASA

15 (from Serebruany et al Am J Hematol 2004;75:40)

De Berardis et al., JAMA 2012 A population-based cohort study, using administrative data from 4.1 million citizens in 12 local health authorities in Puglia, Italy.

16 De Berardis et al., JAMA 2012 A population-based cohort study, using administrative data from 4.1 million citizens in 12 local health authorities in Puglia, Italy. incidence of major gastrointestinal and intracranial bleeding individuals being treated with low-dose aspirin and matched controls without aspirin use During a follow-up of 5.7 years the incidence rate of bleeding was: 5.58 (95% CI, ) per 1000 pt/y for aspirin users 3.60 (95% CI, ) per 1000 pt/y for those without aspirin use (incidence rate ratio [IRR], 1.55; 95% CI, ).

17 Conditions associated with > bleeding: age >75 years, females, renal function impairment, anaemia, history of bleeding, low body weight. From Gresele; Blood Transfusion 2013

18 ASA for primary prevention

19 (From Patrono et al., NEJM 2005)

20 (From Patrono et al., NEJM 2005)

21 Direct comparisons between Anticoagulants and ASA

22 Lancet 2007 Results from the BAFTA study: 973 pts with AF > 75 y, randomized to Warfarin (2-3 INR) or Aspirin (75 mg oid) (Mant et al., Lancet 2007) Stroke = 1 8% warfarin vs 3 8% ASA, RR 0 48, p=0 003; Bleeding = 1 4% warfarin vs 1 6% ASA, RR 0 87;

23 2012 Primary outcomes = 7.47 %pt-y in warfarin 7.93 %pt-y in aspirin Warfarin vs aspirin = < ischemic stroke (0.72 %pt-y vs %pt-y HR 0.52; P = 0.005) = > major hemorrhage 1.78 % pt-y vs 0.87 (P<0.001) = no difference in ICHs (0.27 % pt-y vs 0.22, ns)

24 2011

25 Treatment of patients with AF in clinical practice

26 T&H 2011 The risk of bleeding, HR: 1.0 (VKA;reference), 0.93 (ASA), 1.64 (VKA+ASA), and 0.84 (no treatment)

27 Inter J Cardiol 2012 Among the 4845 patients with nonvalvular AF= OAC was prescribed in 55.5% (64.2% CARD and 46.3% MED, p<0.0001), antiplatelets in 35.8% No therapy in 8.7%.

29 CAF-BO: Ictus o EIC in paz con FA nei PS dell area di Bologna durante 6 mesi (prospettico, osservazionale) - Popolazione definita nell area vasta di Bologna (735, a.; 148,159 >70 a.) - La rete dei P.S. copre tutta questa popolazione - La rete Centri TAO copre la grande maggioranza dei pazienti anticoagulati dell area di Bologna

30 AF patients, characteristics and antithrombotic treatment at the presentation with an event (CAF-BO study; Palareti et al, submitted) Treatment Ischemic events N=178 n. (%) ICH N=20 n. (%) VKAs INR value at the event In range < 2.0 > (17.4) 13 (41.9) 16 (51.6) 2 (6.5) 13 (65) 11 (84.6) 0 2 (15.4) Antiplatelet drugs 107 (60.1) 6 (30) LMWH 1 (5) NO treatment. (%) 40 (22.5) 0 Formerly treated with VKAs 32 (18.0) 0

31 Pts CAF-BO Study: Different treatments in relation to age (Palareti et al, submitted) Age (AA)

32 CAF-BO study: modeling analysis of the expected number of subjects > 70 y. affected by AF and of events (148,159 >70 a) Expected subjects with AF aged > 70 y (estimated prevalence of AF of 7%) - Monitored by NACs - Not included in NACs 10, Ischemic events during the 6 months - Monitored in NACs - Not included in NACs Intracranial hemorrhages - Monitored in NACs - Not included in NACs 23 (0.57 % y) 134 (12.0% y) ARR 11.4% y, RRR 95% y P< (0.30% y) 8 (0.71% y) ARR 0.41%y RRR 57.7%y P=

33 Quali messaggi dal CAF-BO La maggior parte dei pazienti con eventi ischemici ricevono ASA L ASA non è efficace ed ha rischio emorragico Molti non sanno di avere FA, o non vengono trattati Il controllo degli AVK potrebbe migliorare, evitando valore < 2 INR

34 Cosa fare Uno screening attivo per FA nella popolazione a rischio (apparecchi per PA con segnalazione di FA) Convincere il paz circa il rischio se FA Terapia anticoagulante No ASA Scegliere l anticoagulante + giusto

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