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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.