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 2,5 3,0 4,0 5,0 Trombofilia Emorragia INR Range terapeutico

H IL PAZIENTE IN TERAPIA ANTICOAGULANTE ORALE ticket Ogni 2 -3 settimane

Alternativa? IL PAZIENTE IN TERAPIA ANTICOAGULANTE ORALE Coagulometro INR 2.31 Coagulometro portatile TEMPO NECESSARIO 2 MINUTI

I.N.R. 2.5 PRINCIPIO DI FUNZIONAMENTO DEI COAGULOMETRI PORTATILI 1 (capillarita`) I.N.R. 2.5 reagenti rivelatore

I.N.R. 2.5 PRINCIPIO DI FUNZIONAMENTO DEI COAGULOMETRI PORTATILI 2 (particelle magnetiche in rotazione) I.N.R. 2.5 reagenti rivelatore Agitatore magnetico

I.N.R. 2.5 PRINCIPIO DI FUNZIONAMENTO DEI COAGULOMETRI PORTATILI 3 (formazione di un prodotto elettricamente attivo) I.N.R. 2.5 reagenti rivelatore

Monitor vs Laboratorio I.N.R. coefficiente di correlazione = 0,98 DETERMINAZIONI

NUOVA GESTIONE DEL PAZIENTE IN T. A. O 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

case di riposo lungodeg. poliambulat. MMG paziente farmacia INR PC case di riposo PC INR lungodeg. PC INR poliambulat. CENTRO TAO PC INR MMG INR PC paziente INR PC farmacia

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. carl.heneghan@dphpc.ox.ac.uk BACKGROUND: Near-patient testing has made self-monitoring of anticoagulation with warfarin feasible, and several trials have suggested that such monitoring might be equal to or better than standard monitoring. We did a systematic review and meta-analysis of all randomised controlled trials that assessed the effects of self-monitoring or self-management (self-testing and self-dosage) of anticoagulation compared with standard monitoring. METHODS:. Outcomes analysed were: major haemorrhage, thromboembolic events, death, tests in range, minor haemorrhage, frequency of testing, and feasibility of self-monitoring. FINDINGS: We identified 14 randomised trials of self-monitoring: pooled estimates showed significant reductions in thromboembolic events (odds ratio 0.45, 95% CI 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. Patients capable of self-monitoring and self-adjusting therapy have fewer thromboembolic events and lower mortality than those who self-monitor alone. However, self-monitoring is not feasible for all patients, and requires identification and education of suitable candidates FINDINGS: 14 trials of self-monitoring showed significant reductions in thromboembolic events, mortality , and major haemorrhage. Trials of combined self-monitoring and self-adjusted therapy showed significant reductions in thromboembolic events and death. 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 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?  Pazienti con palese inaffidabilità (età del paziente o del familiare, demenza, malattie psichiatriche etc.)  Scarsa “aderenza” del paziente alle istruzioni ricevute  Precedenti complicanze tromboemboliche o emorragiche da “linee guida per l’utilizzo degli strumenti portatili 2002 – FCSA”

ATTIVAZIONE DI UN PROGRAMMA 8 15 22 29 6 13 20 27 3 10 17 24 31 maggio giugno luglio I.N.R. 4 1 2 3 5 schema di dosaggio ATTIVAZIONE DI UN PROGRAMMA dose Se I.N.R. in range Se I.N.R. + elevato di diminuire del % Se I.N.R. + elevato di diminuire del % Se I.N.R. + basso di aumentare del % Se I.N.R. + basso di aumentare del % schemi di dosaggio principi della t.a.o. uso dello strumento schemi di registrazione selezione dei pazienti corsi di addestramento controllo di qualità esterno interfacciamento con il LIS responsabilità costi dello strumento e relativi reagenti Se I.N.R. 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 between self managment and routine care (70% v 68%). Self managed patients with poor control before the study showed an improvement in control that was not seen in the routine care group. Nine patients (2.8/100 patient years) had serious adverse events in the self managed group, compared with seven (2.7/100 patient years) in the routine care arm. 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. 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. chris.gardiner@uchevaluation.co.uk 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 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 management in a specialised hospital anticoagulation clinic. 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 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 in-range 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 self-management 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 self-management group.

COAGULOMETRI PORTATILI 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

ATTIVAZIONE DI UN PROGRAMMA schema di dosaggio 8 15 22 29 6 13 20 27 3 10 17 24 31 maggio giugno luglio I.N.R. 4 1 2 3 5 ATTIVAZIONE DI UN PROGRAMMA schemi di dosaggio dose lun mar mer giov ven sab dom Se I.N.R. in range Se I.N.R. + elevato di diminuire del % Se I.N.R. + elevato di diminuire del % Se I.N.R. + basso di aumentare del % Se I.N.R. + basso di aumentare del % principi della t.a.o. uso dello strumento schemi di registrazione selezione dei pazienti corsi di addestramento controllo di qualità esterno …. ai pazienti in autogestione….. interfacciamento con il LIS responsabilità costi dello strumento e relativi reagenti Se I.N.R. 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

A.I.PA d'ITALIA 2006 Cagliari Bari Lecce Taranto Cosenza Reggio Cal. Palermo Sasari Oristano Latina Frosinone Napoli Avellino Potenza Posillipo Macerata Ortona Avezzano Perugia Rieti L’Aquila Pescara Lanciano Massa C. Firenze Arezzo Siena Ferrara Bologna Chiavari San Vito al T. Lecco Genova Torino Alessandria Parma Mantova Milano Brescia Padova Cremona Pavia Legnano Trento Cles Brianza M. Bergamo Sesto S.G Spilimbergo MI Centro Fatebenefratelli Nord-Niguarda MI Ovest San Paolo San Raffaele Sondalo A.I.PA d'ITALIA 2006

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 ?

Come ?

Da Settembre 2008 ? Quando ? -Scelta dei referenti (infermiere, medici tirocinanti, specializzandi,..) -Formazione dei referenti Da Settembre 2008 ?

MONITORAGGIO DEL PT - INR CON L'AUSILIO DI UN COAGULOMETRO PORTATILE 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 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 . Il coefficiente di correlazione calcolato è risultato pari a 0.88 I.N.R. Conclusioni 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. 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

Buon lavoro