LA GESTIONE DEL PAZIENTE LA GESTIONE DEL PAZIENTE CON FIBRILLAZIONE ATRIALE
Convegno Associazione G. Dossetti g“Le Malattie Cardiovascolari : dalla Fase Acuta alla
Prevenzione, l’Accesso alle Terapie nell’Era pdel Risanamento Economico”
Roma, 4 Ottobre 2011
Giuseppe Di Pasquale Unità Operativa di CardiologiaOspedale Maggiore, Bologna
www.escardio.org/guidelines
www.escardio.org/guidelines
1
CHADS2 ScoreCHADS2 Score
Risk Factor SCORE
CHF / LV dysfunction 1CHF / LV dysfunction 1
Hypertension 1Hypertension 1
Age > 75 years 1g y
Diabetes mellitus 1
Stroke / TIA 2
Gage BF et al. JAMA 2001; 285: 2864-70
CHADSCHADS22 Score: Validation for Predicting StrokeScore: Validation for Predicting Stroke
US National Registry of AFUS National Registry of AF - AFI schemeCHADS index
18.21820
%
N= 1733 pts (65-95 yrs)- SPAF scheme
CHADS2 index
12.512141618
ke R
ate
5 9
8.58
1012
ed S
trok
1.9 2.84.0
5.9
246
Adjus
te
02
0 1 2 3 4 5 6(n= 120) (n= 463) (n= 523) (n= 337) (n= 220) (n= 65) (n= 5) CHADS2 Score(n= 120) (n= 463) (n= 523) (n= 337) (n= 220) (n= 65) (n= 5) CHADS2 Score
1 point: recent CHF, hypertension, age > 75 years, diabetes mellitus2 points: prior stroke or TIA Gage BF et al. JAMA 2001; 285: 2864-70
CHADSCHADS22 Score: Validation for Predicting StrokeScore: Validation for Predicting Stroke
US National Registry of AFUS National Registry of AF - AFI schemeCHADS index
18.21820
%
N= 1733 pts (65-95 yrs)- SPAF scheme
CHADS2 index
12.512141618
ke R
ate
5 9
8.58
1012
ed S
trok
1.9 2.84.0
5.9
246
Adjus
te
02
0 1 2 3 4 5 6(n= 120) (n= 463) (n= 523) (n= 337) (n= 220) (n= 65) (n= 5) CHADS2 Score(n= 120) (n= 463) (n= 523) (n= 337) (n= 220) (n= 65) (n= 5) CHADS2 Score
1 point: recent CHF, hypertension, age > 75 years, diabetes mellitus2 points: prior stroke or TIA
Gage BF et al,. JAMA 2001; 285: 2864-70
CHA2DS2 - VASc Score2 2
Risk Factor ScoreRisk Factor ScoreCongestive heart failure / LV dysfunction 1Hypertension 1Hypertension 1Age ≥ 75 y 2Diabetes mellitus 1Diabetes mellitus 1Stroke / TIA / systemic embolism 2Vascular disease Vascular disease (prior myocardial infarction, peripheral artery disease or aortic plaque) 1Age 65 74 y 1Age 65 - 74 y 1Sex category (ie female gender) 1
Lip GYH et al. Chest 2010;137(2): 263-72
CHA2DS2 - VASc Score: Validation for Predicting Stroke
The Euro Heart Survey on AF
Adjusted StrokeRate %
11,112 N = 1.084 pts (age 66±15 years)Rate %
88
10
3,93 2 3,64
6
0 0,61,6 1,9
3,2 3,6
2
4
00
0N=103
1N=162
2N=184
3N=203
4N=208
5N=95
6N=57
7N=25
8N=9
• 1 point: CHF/LV dysfunction, Hypertension, Diabetes , Vascular disease, Age 65-74 y, Sex category
• 2 points: Age ≥ 75 y, Stroke/TIA/TE Lip G et al. Chest 2010;137:263-72
www.escardio.org/guidelines
Bleeding RiskBleeding RiskBleeding RiskBleeding Risk
an assessment of bleeding risk should be … an assessment of bleeding risk should be part of the patient assessment before starting
anticoagulation…
ESC AF GUIDELINES 2010ESC AF GUIDELINES 2010
HAS-BLED Bleeding Risk Score
H 1 point HypertensionA 1 or 2 points Abnormal renal and liver functionA 1 or 2 points Abnormal renal and liver functionS 1 StrokeB 1 BleedingB 1 BleedingL 1 Labile INRsE 1 Eldery (e.g. age > 65 years)D 1 or 2 points Drugs or alcoholp g
Maximum 9 pointsPisters R et al. Chest 2010
a u 9 po ts
NET CLINICAL BENEFIT OF ORAL ANTICOAGULANT TREATMENT IN ATRIAL FIBRILLATION
Bleeding Thromboembolism
Antithrombotic Therapy for AFibStroke Risk ReductionStroke Risk Reduction
Treatment TreatmentBetter Worse
Warfarin vs.Placebo/Control 6 Trials
n = 2,900-64%
Antiplatelet drugs 8 Trials19%vs. Placebo n = 4,876-19%
100%100% 50%50% 00 -- 50%50%Hart RG et al. Ann Intern Med 2007; 146: 857
Limiti della terapia con antagonisti della Vitamina K
Risposta non prevedibile Frequentiprevedibile
La terapia con antagonisti
qaggiustamenti della
doseFinestra di
t tt t t tt antagonisti della vitamina
K presenta Numerose interazioni
alimentari
trattamento stretta(INR range 2-3)
Monitoraggioroutinario dei fattoridella coagulazione
diversi limiti che ne
rendono
Numerose interazionicon altri farmaci
Lente insorgenza/termine
Resistenza al Warfarin
rendono difficoltoso l’impiego
d’azionep g
nella pratica clinica
1. Ansell J, et al. Chest 2008;133;160S-198S; 2. Umer Ushman MH, et al. J Interv Card Electrophysiol 2008; 22:129-137; Nutescu EA, et al. Cardiol Clin 2008; 26:169-187.
Limiti della Terapia Anticoagulante Orale
Conseguenze nella FA
U i ifi ti di i ti FA i hi diU i ifi ti di i ti FA i hi di
Conseguenze nella FA
Un significativo numero di pazienti con FA a rischio distroke non riceve la TAOUn significativo numero di pazienti con FA a rischio distroke non riceve la TAO
• Underuse of OAC for high risk AF patients was found in most of the 54 studies (1998-2008) was found in most of the 54 studies (1998 2008)
• Over two third of studies of AF patients with prior stroke/TIAreported treatment levels of under 60% of eligible patients
Most studies based on CHADS score • Most studies based on CHADS2 score reported OAC treatment levels of high risk subjects below 70%
Patients with AF and prior stroke/TIA: OAC treatment levels as a proportion of patients eligible for OAC
Ogilvie IM et al. Am J Med 2010;123:638-45
Steering Committee
Giuseppe Di Pasquale (Chairman ANMCO), Giovanni Mathieu (Chairman pp q ( ), (FADOI), Francesco Chiarella, Fabrizio Colombo, Michele Gulizia,
Gualberto Gussoni, Carlo Nozzoli, Domenico Panuccio, Salvatore Pirelli, M i S h ill Gi i V M i Z i B iMarino Scherillo, Giorgio Vescovo, Massimo Zoni Berisso
Setting of the Study
360 Participating Centers360 Participating Centers7148 enrolled patients
164C di l
196Cardiology
DepartmentsCardiology ward
Internal Medicine Dept.Hospital without cardiologyHospital with cardiology wardCardiology ward
Cardiology ward and Cath LabCardiology ward with Cath Lab
Hospital with cardiology wardHospital with cardiology ward and Cath Lab (with or without CCH)and CCH CCH)
From each Center:Duration of the enrollment 4 weeks
A T AF Baseline Characteristics
Clinical SettingClinical SettingTotal
(n. 7148)Cardiology
(n. 3862)Internal Medicine
(n. 3286) p
Females, % 47.0 43.4 51.3 <.0001Age >75 years, % 56.8 44.6 71.3 <.0001Age (years) median 77 74 80Age (years), median[IQR]
77[70-83]
74[66-80]
80[74-86] <.0001
BMI >25, % 61.9 67.1 55.9 <.0001SBP (mmHg), mean±SD 130±18 130±17 130±19 0.16
A T AF Antithrombotic Treatments in
non valvular AF (4.845 pts)
OACNone Other ATT
A T AF Risk of non prescription of OAC by age
A T AF Prescription of OAC by CHADS2
p=0.024(non valvular AF, 4845 pts)
CHADSCHADS2
A T AF Prescription of OAC by CHA2DS2-VASc
p=0.012
(non valvular AF, 4845 pts)
CHA2DS2-VASc
Limiti della Terapia Anticoagulante Orale
Conseguenze nella FA
U i ifi ti di i ti FA i hi diU i ifi ti di i ti FA i hi di
Conseguenze nella FA
Un significativo numero di pazienti con FA a rischio distroke non riceve la TAOUn significativo numero di pazienti con FA a rischio distroke non riceve la TAO
L’intensità della scoagulazione è spesso al di fuori delrange terapeutico (INR 2 0 3 0)L’intensità della scoagulazione è spesso al di fuori delrange terapeutico (INR 2 0 3 0)range terapeutico (INR 2.0 – 3.0)range terapeutico (INR 2.0 – 3.0)
Anticoagulation with Anticoagulation with WarfarinWarfarinI t it Oft O t id th T t RIntensity Often Outside the Target Range
International Study of Anticoagulation Management
100
International Study of Anticoagulation Management
Ran
ge
80
100
INR<2 INR 2–3 INR >3
n Ta
rget
40
60
% T
ime
in
20
40
%
0
U S Canada France Italy Spain
Ansell J, et al. J Thromb Thrombolysis 2007; 23: 83.
U.S. Canada France Italy Spain
% di permanenza in range INR in real life in Italiain Italia
Descrizione della distribuzione delle percentuali di controllo dell’INRDescrizione della distribuzione delle percentuali di controllo dell’INR
Range INR VKAPrecedente media mediana (p25 - p75)
% INR < 2 No 33.4% 28.8% (15.4% - 47.9%)
% INR < 2 Si 25.3% 20.0% (7.7% - 36.4%)
% INR in [2,3] No 49.7% 50.0% (33.3% - 66.7%)
% INR in [2,3] Si 56.8% 58.3% (42.5% - 73.1%)% INR in [2,3] Si 56.8% 58.3% (42.5% 73.1%)
% INR> 3 No 16.9% 13.3% (0.0% - 25.0%)
% INR> 3 Si 17.9% 14.3% (4.0% - 26.7%)
31Anticoagulation control and treatment coverage in vitamin K antagonists-treated patients: in vitamin K antagonists-treated patients:
An administrative databases analysis in a large Italian population
60%
70%
,3]
30%
40%
50%
NR
in r
ange
[2,
0%
10%
20%
30%
% I
0%0-9 10-19 20-29 30-39 40-49 50-59 60-69 70-79 80-89 >90
% Adherence with VKA treatment
Degli Esposti L et al 2011
Naive patients Established patients
Anticoagulation control and treatment coverage in vitamin K antagonists-treated patients: an administrative databases analysis in a large Italian population (L Degli Esposti et al, 20110411)
Degli Esposti L et al. 2011
The Promise of New Anticoagulants
New Anticoagulants•Coagulation • Drug
g
cascade
•Initiation •TF/VIIaTissue factor Tissue factor pathway inhibitors:pathway inhibitors:
•IXa
•IX•X NAPc2NAPc2
•Propagation
•VIIa•IXa
•Xa
Indirect: fondaparinux, Indirect: fondaparinux, idraparinuxidraparinux
•Va
•II
Direct Oral: rivaroxaban, Direct Oral: rivaroxaban, apixaban, edoxabanapixaban, edoxaban
•Thrombin activity•IIa
Direct Parenteral: Direct Parenteral: bivalirudinbivalirudinDirect Oral: ximelagatran, Direct Oral: ximelagatran,
•Fibrinogen •Fibrin dabigatran, AZD0837dabigatran, AZD0837
Atrial Fibrillation Phase 3 Study TimelinesPhase 3 Study Timelines
Rivaroxaban Edoxaban
ROCKET AFPublished
August 2011
ROCKET AFPublished
August 2011 RE-LY
P bli h d 2009RE-LY
P bli h d 2009
Dabigatran ENGAGE AF TIMI 48
Study ongoingExpected 2012
ENGAGE AF TIMI 48Study ongoingExpected 2012August 2011 August 2011 Published 2009Published 2009 Expected 2012Expected 2012
2009 2010 2011 2012
AVERROESPublished
AVERROESPublished
ARISTOTLEPublished
ARISTOTLEPublishedPublished
February 2011Published
February 2011Published
August 2011Published
August 2011
Apixaban
1
2
ESC Guidelines 2010
SCELTA DI STRATEGIE NELLA FA
CARDIOVERSIONE+
PROFILASSI AA
CARDIOVERSIONE+
PROFILASSI AA
CONTROLLO FC+
TAO
CONTROLLO FC+
TAOPROFILASSI AAPROFILASSI AA TAOTAO
Efficacia ?Efficacia ?Sicurezza ?Sicurezza ?
Q lità di it ?Q lità di it ?Qualità di vita ?Qualità di vita ?Preferenze del paziente ?Preferenze del paziente ?
A T AF Therapeutic Strategies
Total (7148 pts) Cardiology (3862 pts)
27.4%21.2%39 8%
16.6%
51 4%
39.8%
43.6%
p<.0001
51.4%
12.9%12.9%26.6%
Rh th t l
60.5%
Rhythm control
UnknownRate control Internal Medicine (3286 pts)
Decision on Rate and Rhythm Control in Patients With Persistent AFin Patients With Persistent AF
Rhythm control strategy
60
70
80
67%
Pts with AF symptomsPts without
40
50
60
53% 48%
67%
44%
AF symptoms
20
3044%
0
10
E H t S AF G AFNET Euro Heart Survey AF Eur Heart J 2006;27:3018-26
German AFNET Europace 2009;11:423-34
Rhythm control Rhythm control Left atrial catheter ablation
Catheter Ablation for AFibCatheter Ablation for AFib
LassoLassoLassoLasso
AblatAblat AblatAblat
LAO RAO
Catheter Ablation for AF
1999, 1999, Left COMPARTIMENTALIZATIONLeft COMPARTIMENTALIZATIONLeft COMPARTIMENTALIZATIONLeft COMPARTIMENTALIZATION
2000, 2000, CPVA CPVA –– OSTIAL AblationOSTIAL Ablation
2003, 2003, CPVA CPVA –– ModifiedModified
2001, 2001, CPVA CPVA –– JUNCTION Ablation JUNCTION Ablation
Underuse of Non-Pharmacological Treatment
Adherence to Guidelines for AF ManagementThe SITAF StudyThe SITAF Study
Bottoni N et al. Europace 2010;12:1070-77
1
2
3
ESC Guidelines 2010
To evaluate whether in patients withTo evaluate whether in patients with previous AF episodes treated with
the best recommended therapies the addition of valsartan can prevent AFaddition of valsartan can prevent AF
recurrence
Time to first recurrence of AF(n 1442)(n. 1442)
Valsartan: 371/722 (51.4%)Placebo: 375/720 (52.1%)
Adjusted* HR 0.9996%CI 0.85-1.15P value 0 84P value 0.84
* The 96%CI was calculated by Cox proportional hazards model adjusted for ACE-I, amiodarone use, cardioversion, PAD, CAD
27 Settembre 2011, Ore 11.00Sala Caduti di Nassirya
Senato della RepubblicaPiazza Madama 11 RomaPiazza Madama, 11 Roma
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