SELF - TEST e SELF - MANAGEMENT
CON COAGULOMETRI PORTATILI
Dott. Alessandro Porcu
Consiglio Nazionale FEDER-A.I.P.A.
Hotel Royal Santina
Roma 17 Maggio 2008
IL PAZIENTE IN TERAPIA
ANTICOAGULANTE ORALE
fibrillazione atriale
infarto del miocardio
trombosi arteriose
trombosi venose
ictus cerebrale
trombofilia
protesi valvolari cardiache
IL PAZIENTE IN TERAPIA
ANTICOAGULANTE ORALE
farmaci impiegati non possono essere
somministrati secondo una dose fissa
e’ necessario eseguire periodicamente il Tempo
di Protrombina - INR al fine di misurare il loro
effetto
l’effetto non deve essere né eccessivo (rischio
emorragico) né scarso (scarsa protezione dalla
trombosi)
IL PAZIENTE IN TERAPIA
ANTICOAGULANTE ORALE
1
1,5
Trombofilia
2,5
3,0
4,0
Range terapeutico
INR
5,0
Emorragia
IL PAZIENTE IN TERAPIA
ANTICOAGULANTE ORALE
ticket
Ogni 2 -3 settimane
anticoagulante
Alternativa?
IL PAZIENTE IN TERAPIA
ANTICOAGULANTE
ORALE
Coagulometro
portatile
TEMPO NECESSARIO 2 MINUTI
PRINCIPIO DI FUNZIONAMENTO DEI
COAGULOMETRI PORTATILI 1
(capillarita`)
I.N.R.
2.5
reagenti
rivelatore
PRINCIPIO DI FUNZIONAMENTO DEI
COAGULOMETRI PORTATILI 2
(particelle magnetiche in rotazione)
I.N.R.
2.5
reagenti
rivelatore
Agitatore
magnetico
PRINCIPIO DI FUNZIONAMENTO DEI
COAGULOMETRI PORTATILI 3
(formazione di un prodotto
elettricamente attivo)
I.N.R.
2.5
reagenti
rivelatore
Monitor vs Laboratorio
8
7
6
I.N.R.
5
laboratorio
4
monitor
3
2
1
coefficiente di
correlazione = 0,98
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
DETERMINAZIONI
NUOVA GESTIONE DEL PAZIENTE IN T.A.O.
CON L’AUSILIO DEI COAGULOMETRI
PORTATILI
SELF -TEST: automonitoraggio del PT-INR
SELF -MANAGEMENT: automonitoraggio e
autoprescrizione della terapia = GESTIONE
COMPLETA
PC
PC
PC
INR
INR
INR
lungodeg.
case di riposo
poliambulat.
PC
CENTRO
TAO
INR
PC
MMG
INR
PC
paziente
farmacia
INR
INR
Lancet. 2006 Feb 4;367(9508):404-11.
Self-monitoring of oral anticoagulation: a systematic review and meta-analysis.
Heneghan C, Alonso-Coello P, Garcia-Alamino JM, Perera R, Meats E, Glasziou P.
Department of Primary Health Care, Centre for Evidence Based Medicine, University of Oxford, Rosemary Rue Building,
Headington, Oxford, UK. [email protected]
FINDINGS: 14 trials of self-monitoring showed significant
reductions in thromboembolic events, mortality , and
BACKGROUND: Near-patient testing has made self-monitoring of anticoagulation with
major
haemorrhage.
Trials
of combined
self-monitoring
warfarin feasible,
and several trials
have suggested
that such monitoring
might be equal to or
better
than standard monitoring.
We showed
did a systematic
review and
meta-analysis of all
and self-adjusted
therapy
significant
reductions
randomised controlled trials that assessed the effects of self-monitoring or self-management
in
thromboembolic
and compared
death. with
11 standard
trials reported
(self-testing
and self-dosage) ofevents
anticoagulation
monitoring.
METHODS:. Outcomes analysed were: major haemorrhage, thromboembolic events, death, tests in range, minor haemorrhage,
improvements
inofthe
mean proportion of international
frequency of testing, and feasibility
self-monitoring.
FINDINGS: We identified 14 randomised trials of self-monitoring: pooled estimates showed significant reductions in
normalisation
inCIrange
thromboembolic events (odds ratios
ratio 0.45, 95%
0.30-0.68), all-cause mortality (0.61, 0.38-0.98), and major haemorrhage (0.65,
0.42-0.99). Trials of combined self-monitoring and self-adjusted therapy showed significant reductions in thromboembolic events
(0.27, 0.12-0.59) and death (0.37, 0.16-0.85), but not major haemorrhage (0.93, 0.42-2.05). No difference was noted in minor
haemorrhage. 11 trials reported improvements in the mean proportion of international normalisation ratios in range.
INTERPRETATION: Self-management improves the
quality
of oral anticoagulation.. However, self-monitoring
INTERPRETATION: Self-management improves the quality of oral anticoagulation.
is
not feasible
all patients,
requires
identification
Patients
capable of for
self-monitoring
and and
self-adjusting
therapy
have fewer
thromboembolic
events
lower mortality
than those who self-monitor alone.
and education
ofand
suitable
candidates
However, self-monitoring is not feasible for all patients, and requires identification
and education of suitable candidates
PER CHI ’ E’ INDICATO L’USO
DEL COAGULOMETRO PORTATILE?
Pazienti in T.A.O. stabilizzata
Pazienti in T.A.O. a tempo indeterminato o a
vita
Pazienti confinati a casa o residenti in zone poco
accessibili
Pazienti per i quali il prelievo venoso è
difficoltoso
Pazienti con attività lavorativa che li porta ad
assenze frequenti o prolungate
da “linee guida per l’utilizzo degli strumenti portatili 2002 – FCSA”
A CHI INVECE E’ SCONSIGLIATO
L’USO DEL COAGULOMETRO PORTATILE?
con palese inaffidabilità (età del
 Pazienti
paziente o del familiare, demenza, malattie
psichiatriche etc.)
“aderenza” del paziente alle istruzioni
 Scarsa
ricevute
complicanze tromboemboliche o
 Precedenti
emorragiche
da “linee guida per l’utilizzo degli strumenti portatili 2002 – FCSA”
I.N.R.
schema
dose dose di
dosedosaggio
dose dose dose dose
ATTIVAZIONE
DI
UN PROGRAMMA
schemi di dosaggio
5
4
Se I.N.R. in range
principi della t.a.o.
3
Se I.N.R. + elevato di
diminuire del %
selezione dei pazienti
Se I.N.R. + elevato di
diminuire del %
corsi di addestramento
Se I.N.R. + basso di
aumentare del %
2
uso dello strumento
1
schemi di registrazione
controllo di qualità esterno
Se I.N.R. + basso di
aumentare del %
1 8 15 22 interfacciamento
29 6 13 20 27con3 il 10
LIS 17 24 31
maggio
giugno
responsabilità
luglio
dello
strumento
e relativi reagenti
Se I.N.R. costi
più
basso
di ___
o più alto di ___ telefonare al centro tao
BMJ 2005;331:1057 (5 November),
Self management of oral anticoagulation: randomised trial
D A Fitzmaurice, professor of primary care1,
1
Department of Primary Care, University of Birmingham, Birmingham, 2 Health Services Management Centre, Birmingham B15 2RT
Objective To determine the clinical effectiveness of self management compared with routine
care in patients on long term oral anticoagulants.
Participants 617 patients aged over 18 and receiving warfarin randomised to intervention (n = 337) and routine care (n =
from 2470 invited; 193/337 (57%) completed the 12 month intervention.
Intervention Intervention patients used a point of care device to measure international normalised ratio twice a week and a
simple dosing chart to interpret their dose of warfarin.
Main outcome measure Percentage of time spent within the therapeutic range of international normalised ratio.
Results No significant differences were found in percentage of time in the therapeutic range
Conclusion:
With
self management is
between self managment
andappropriate
routine care (70% vtraining,
68%).
Self
patients with
poora control
beforeproportion
the study showedof
an patients
improvementreceiving
in control
safemanaged
and reliable
for
sizeable
that was not seen in the routine care group.
oral
anticoagulation
treatment.
mayevents
improve
themanaged
time group,
spent
Nine patients
(2.8/100 patient years)
had serious It
adverse
in the self
compared
with seven (2.7/100
patient
in the routine
careinitially
arm.
the therapeutic
range
foryears)
patients
with
poor control.
Conclusion: With appropriate training, self management is safe and reliable for a
sizeable proportion of patients receiving oral anticoagulation treatment. It may
improve the time spent the therapeutic range for patients with initially poor control.
Br J Haematol. 2006 Mar;132(5):598-603.
A randomised control trial of patient self-management of oral anticoagulation compared with patient
self-testing.
Gardiner C, Williams K, Longair I, Mackie IJ, Machin SJ, Cohen H.
Department of Haematology, University College London Hospitals, London, UK. [email protected]
Several studies suggest that patient self-management (PSM) may improve the quality of oral
anticoagulation therapy as measured by time spent within the international normalised ratio (INR)
target range.
We performed a prospective randomised control trial to determine whether the improvement in quality of
treatment afforded by PSM is greater than that achieved by patient self-testing (PST) alone.
A total of 104 of 800 eligible patients aged 22-88 years (median = 59.8), attending our hospital anticoagulant
clinic and receiving long-term warfarin for >8 months agreed to participate. Patients were randomised to PSM
(n = 55) or PST (n = 49).
Both groups measured their INR using the CoaguChek S every 2 weeks or more frequently if required, for a
period of 6 months. Seventy-seven of 104 (74%) patients completed the study (PSM = 41 and PST = 36).
The 'drop out' rates for both groups were similar.
There was no significant difference between the percentage time in target therapeutic range for PSM (69.9%)
and PST (71.8%).
Both groups combined PSM and PST showed a
significant improvement over the previous 6 months.
The quality of warfarin control in both PST and PSM may
be superior to that achieved by conventional
Both groups combined showed
significant improvement
over the previous
6 months
management
in a a specialised
hospital
anticoagulation
The quality of warfarin control in both PSTclinic.
and PSM may be superior to that achieved by
conventional management in a specialised hospital anticoagulation clinic.
VANTAGGI DELL’UTILIZZO DEL
COAGULOMETRO A DOMICILIO
Mancata perdita di ore lavorative
(e di tempo libero) per il paziente
Miglioramento del tempo trascorso in range
Diminuzione di eventi avversi
Soddisfazione del paziente
Comparing Self-Management of Oral Anticoagulant Therapy with Clinic Management
A Randomized Trial
Bárbara Menéndez-Jándula, MD;
4 January 2005 | Volume 142 Issue 1 | Pages 1-10
Background: Control of oral anticoagulant treatment has been reported to be suboptimal, but previous studies suggest
that patient self-management improves control.
Objective: To compare the quality of control and the clinical outcomes of oral anticoagulant treatment in self-managed
patients versus patients following conventional management.
Design: Randomized, controlled trial.
Setting: University-affiliated hospital in Spain.
Patients: 737 patients with indications for anticoagulant treatment.
Intervention: The self-management group (n = 368) received simple instructions for using a portable coagulometer
weekly and self-adjusting treatment dose. The conventional management group (n = 369) received usual care in an
anticoagulation clinic (monthly measurement and control of international normalized ratio [INR], managed by hematologists).
Measurements: Percentage of INR values within the target range and major related complications.
Results: The median follow-up period was 11.8 months (range, 0.3 to 16.9 months). The unadjusted percentages of inrange INRs were 58.6% in the self-management group and 55.6% in the conventional management group (difference, 3.0
percentage points [95% CI, 0.4 to 5.4 percentage points]). Twenty-seven patients (7.3%) in the conventional management
group and 8 (2.2%) in the self-management group had major complications related to anticoagulant treatment. The
unadjusted risk difference for major complications between groups was 5.1 percentage points (exact 95% CI, 1.7 to 8.5
percentage points). Fewer patients had minor hemorrhages in the self-management group (14.9%) than in the conventional
management group (36.4%). Fifteen patients (4.1%) in the conventional management group and 6 (1.6%) in the selfmanagement group died (unadjusted risk difference, 2.5 percentage points [exact 95% CI, 0.0 to 5.1 percentage points]).
Limitations: The trial was performed at only 1 center and was not blinded. The dropout rate in the intervention group
was 21%.
Conclusions: Compared with conventional management by an anticoagulation clinic, self-management of oral
anticoagulant treatment achieved a similar level of control. Of note, major complications and minor hemorrhages were less
common in the self-management group.
Conclusions: Compared with conventional
management by an anticoagulation clinic,
self-management of oral anticoagulant
treatment achieved a similar level of control. Of
note, major complications and minor
hemorrhages were less common in the selfmanagement group.
VANTAGGI DEI
COAGULOMETRI PORTATILI
 AFFIDABILITA’
 QUALITA’ DEL DATO (controlli di qualita’)
 PRECISIONE
 TEMPI BREVI DI ESECUZIONE (2 min.)
COAGULOMETRI PORTATILI
Classic trip to clinic; 1-1.5hrs
schema
di
dosaggio
I.N.R.
ATTIVAZIONE
DIdosaggio
UN PROGRAMMA
schemi di
5
4
principi della t.a.o.
selezione dei pazienti
3
Se I.N.R. in range
uso dello strumento
corsi di addestramento
2
Se I.N.R. + elevato
schemi di registrazione
di diminuire del %
1
controllo
di
qualità
esterno
Se I.N.R. + elevato
dose
lun
dose
mar
dose
mer
dose
giov
dose
ven
dose
sab
dose
dom
…. ai pazienti in
con il LIS
Se I.N.R.
+ bassointerfacciamento
di
autogestione…..
aumentare del %
di
diminuire del %
1 8 15 22 29 6 13 20 27 3 10 17 24 31
Se I.N.R. + basso di
aumentare
del %responsabilità
maggio
giugno
luglio
dello
strumento
e relativi reagenti
Se I.N.R. costi
più
basso
di ___
o più alto di ___ telefonare al centro tao
PROGETTO FEDER- A.I.P.A.
Confronto su larga scala di un
coagulometro portatile
Dott. Alessandro Porcu
Roma 17 Maggio 2008
Sondalo
Cles
Brianza M.
Trento
San Vito al T.
Bergamo
Brescia
Sesto S.G
Legnano
Padova Spilimbergo
Milano
Cremona Mantova
Torino
Pavia
Parma
Ferrara
Lecco
Alessandria
MI Centro
Genova
Bologna
Chiavari
Fatebenefratelli
Nord-Niguarda
Massa C.
Firenze
Perugia
Rieti
San Raffaele
Avezzano
Pescara
L’Aquila
Latina
San Paolo
Ortona
Siena
Lanciano
Frosinone
Napoli
Sasari
MI Ovest
Macerata
Arezzo
Napoli
Posillipo
Oristano
Avellino
Bari
Potenza
Lecce
Taranto
Cosenza
Cagliari
Reggio Cal.
Palermo
ROCHE diagnostics :
1 Coag-chek per ogni sezione AIPA
+ 100 strisce reattive
1) Perché?
2) Quali pazienti ?
3) Come ?
4) Quando?
Perché?
Avere conferma su larga scala relativa
alla efficienza del Coagulometro portatile.
Quali pazienti ?
Tutti i pazienti di età
- tra 18 anni e 80 anni;
50 % maschi
50% femmine
- in TAO da almeno 30 giorni
Come ?
…... Li …..
…. 2008
Città :
Provincia:
Nome :
Regione :
Cognome:
Da quanto tempo in
T
Coumadin :
M
F
Età:
-
Sintrom 1 mg :
Sintrom 4 mg :
Fibrillazione Atriale :
Malattie Valvolari cardiache :
Protesi Valvolari Meccaniche :
Cardiomiopatia dilatativa :
Protesi Valvolari Biologiche :
Arteriopatia cerebrali :
TVP/Embolia Polmonare :
Prevenzione del TEV:
Infarto Miocardico Acuto :
Sindrome da Antic-antifosf. :
Range terapeutico :
INR
Coagulometro portatile :
INR
Laboratorio Centrale :
Il Referente A.I.P.A. :
Come ?
Modulo per Referente AIPA per uso Coagulometro
Nome ………………….
AIPA di ……………….
Cognome……………………..
Regione …………………………….
Tipo e modello del Coagulometro utilizzato presso il Laboratorio Centrale:
………………………………………
controllo qualità……………….
Coagu-Chek : controllo qualità al 1° giorno: alto
basso
Ultimo giorno: alto
basso
Sesso:  M  F
Età:
anni
Regione di residenza:
Comune di residenza:
Provincia di:
1. Da quanto tempo si trova in terapia con farmaci anticoagulanti orali?
 < 30 gg
 da 30 gg a 6 mesi
 > 6 mesi
2.
Farmaco anticoagulante orale attualmente utilizzato:
 COUMADIN
 SINTROM 1mg
 SINTROM 4mg
3.






4.



5.
Per quale patologia?
Fibrillazione Atriale
Protesi Valvolari Meccaniche
Protesi Valvolari Biologiche
TVP / Embolia Polmonare
Infarto Miocardio Acuto
Altro
Indicare il range terapeutico
anticoagulazione (INR):
1,5 – 2
2–3
>3
Indicare i risultati del test:
INR Coagulometro portatile:
INR Laboratorio Centrale:





Malattie Valvolari Cardiache
Cardiomiopatia dilatativa
Arteriopatie cerebrali
Prevenzione del TEV
Sindrome da Antic-antifosf.
in cui deve essere compreso il suo livello di
Quando ?
-Scelta dei referenti
(infermiere, medici tirocinanti,
specializzandi,..)
-Formazione dei referenti
Da Settembre 2008 ?
Porcu A., Porcu A., Lochi M.F., Pasciu D., Mulas R., Porcu P.P., Sanna M.
Laboratorio Analisi Chimico Cliniche e Microbiologia - Ospedale Oncologico “A. Businco” - CAGLIARI
Clinical indications for oral anticoagulant therapy (OAT) have increased steadily during the past few years. In addition to
patients with TVP, ictus and cardiac valves prothesis, for which OAT is a standard therapy, it has been shown that other
categories, such as patients with chronic atrial fibrillation, can also benefit from this type of treatment.
As a consequence, the number of patients taking OAT has also increased (over 600,000 in Italy) and is predicted to
further increase in the coming years. The health care system must therefore meet an increased public demand for the
management of these patients, in terms of both space and time.
To this end, a relevant improvement has been the introduction of a new technique to test PT-INR on whole blood, which
can be performed with a portable coagulometer at patient’s home. Numerous studies have confirmed that results
obtained with this technique are comparable to those of a standard hospital-based laboratory.
The aim of the present study was to verify the reliability of one such instrument, Coag-Check from Roche, and to
compare its performance to that of a standard automated method routinely used in our laboratory (CA-6000 from Dade
Behring).
Scopo del lavoro.
Scopo di questo lavoro è verificare se, un coagulometro portatile,
il Coag - Check della Ditta Roche, fornisca dei risultati del tempo di
Protombina espressa in I.N.R., sovrapponibili a quelli ottenuti utilizzando lo
strumento in dotazione al nostro Laboratorio, il CA- 6000 della Ditta Dade
Behring
Materiali e metodi
Per questo studio sono stati arruolati 76 pazienti in Terapia
Anticoagulante Orale, 41 maschi e 35 femmine (grafico 1), di età
compresa fra i 40 e i 68 anni, afferenti al nostro Centro FCSA n.
141.
Su questi pazienti è stato effettuato il controllo del PT-INR: col
metodo standardizzato di Laboratorio (utilizzando plasma citratato
0.129 M) e col coagulometro portatile utilizzando sangue intero da
prelievo capillare
m as chi
53%
fe m m ine
47%
Grafico 1
Risultati
I valori ottenuti con lo strumento di Laboratorio hanno un intervallo
di lettura che va da 1.00 a 6.88, mentre le misurazioni ottenute col
Coag- Check vanno da 0.8 a 5.9. La media dei valori è risultata di 3.19 per
il CA- 6000 e di 3.01 per il Coag- Check .
8
Il coefficiente di correlazione calcolato è risultato pari a 0.88
7
6
5
I.N.
R.
4
3
2
Conclusioni
1
75
73
71
69
67
65
63
61
59
57
55
53
51
49
47
45
43
41
39
37
35
33
31
29
27
25
23
21
19
17
15
13
9
11
7
5
3
1
0
In blu i risultati ottenuti con il CA- 6000
in rosso i risultati ottenuti col Coag- Check .
Grafico 2
Bibl. Reliability of a point of care coagulation monitor for inr determinations. Slavec et alt. Euromedilab 2001 S331
si ringraziano, la sig.ra Saba B., la sig.ra Barbarossa E., il sig. Deiana A. e il Sig. Pilloni G. per la preziosa collaborazione
Il Coag- Check è uno strumento che fornisce risultati sovrapponibili
a quelli ottenuti in Laboratorio. Tuttavia sono state notate delle
discordanze quando i valori del PT- INR sono maggiori o uguali a 5
(vedi grafico 2). I dati dunque suggeriscono che per questi valori è
raccomandabile un controllo eseguito in un Laboratorio di
riferimento.