START-Register: Nuovi Dati Nazionali
Emilia Antonucci
http://www.start-register.org
9368 patients
6727patients with follow-up
586 patients
230 patients with follow-up
91 patients
Start
laboratorio
November 2015
Total number of Investigators:140
Total number of enrolled patients:
9360
DOACS Patients:
1850
November 2015
Total number of Investigators:140
Enrolled patients 9300*
(54% M - 46%F)
Median age 74 yrs, IQ range 64-84 yrs
Indication to Anticoagulant treatment
Non Valvular AF
Venous Thromboembolism
Atrial Fibrillation
Prosthetic heart valves
Other indications
61.6%
29.1%
2.4%
3.0%
4.0%
Drugs
VKA
77.5%
DOACs
Apixaban
Dabigatran
Rivaroxaban
20.5%
LMWH (chronic)
DOACS shifted from VKA
Median Time of VKA (IQR)
* Analysis performed on 9064 patients
43.1%
24 (8,50) months
408
527
926
2%
Bridging Therapy
LMWH
49%
Fondaparinux
1.0%
November 2015
Characteristics of 9300 patients
Creatinine Clearance*
Age Class
(ml/min x1.73 m2)
All
NVAF
< 65 yrs
2311 (25.5)
732 (13.2)
1232 (46.6)
65-75 yrs
2855 (31.5)
1908 (34.1)
692 (26.2)
>90
60-90
30-59
15-30
<15
> 75 yrs
3898 (43.0)
2944 (52.7)
720 (27.2)
*Cockroft-Gault formula
Patients(%)
VTE
34.6%
18.1%
33.1%
13.6%
0.6%
Follow-up = 9722 pt-yrs
6727 Patients (74.2)
Patients
Fup pt-yrs
VKA (7025)
8430
DOACs (1144)
727
LMWH (161)
122
* Analysis performed on 9064 patients
Major Bleeding events
Number
Rate
Rate
(x 100 pts)
(x 100 pts -yrs)
All
141
2.1
1.52
VKA
113
1.6
1.34
DOACS
27
2.3
3.71
LMWH
1
0.6
0.82
Follow-up
NVAF patients
Number
VKA
DOACS
3365
755
Apixaban (28%)
Dabigatran (35%)
Rivaroxaban (37%)
Median Age, y (IQR)
76 (70,82)
76(71,82)
Males (%)
1840 (55.0)
420 (56.0)
13.0 %
2.0 %
15.0 %
8.1 %
Active cancer
2.9%
2.6%
CrCL 30-60 ml/min
46%
37%
CrCL <30 ml/min
6.5%
-
Past medical history
Previous Stroke/TIA
Previous Major Bleeding
Naive pts (%)
409 (54)
Shifted from VKA (%)
346 (46)
Low dose DAOCs
267 (35)
Follow-up
NVAF patients
Major bleeding events
VKA
DOACS
5632
530
82
2.43; 1.5
24
3.17; 4.5
26
16
44
6
10
8
6*
2**
MB low dose DOACS (%)
-
7 (2.6)
MB naive patients (%)
-
14 (3.4)
MB shifted patients (%)
-
10 (2.9)
Fup (pt-yrs)
Major bleeding
rate: % pt ; x100 pt yrs
Cerebral
Gastrointestinal
Other
Fatal Bleeding
* 5 cerebral; 1 gastrointestinal
**1 cerebral; 1 other
Follow-up
NVAF patients-VKA
Major bleeding events in relation to quality of anticoagulation
Median time (%)
80
p=0.01
60
40
p= 0.01
20
0
without
bleeding
TTR
with
bleeding
without
bleeding
with
bleeding
Time above therapeutic range
Median (IQR) TTR of all patients = 67 (54,77)
Follow-up
NVAF patients
Major bleeding events in relation to renal impairment
4
p= NS
Percentage of events
p=0.01
3
2
1
0
eGFR
>60
VKA
eGFR
15-59
eGFR
>60
eGFR
30-59
DOACs
Follow-up
NVAF patients
Time of major bleeding events
100
Percentage of events
VKA
DOACs
80
60
40
20
0
≤90
90-180 180-365 >365
≤90 90-180 180-365 >365
Follow-up (days)
2 bleeding events occurred in shifted patients, one patients had history of previous bleeding
Follow-up
VTE patients
Number
VKA
DOACS
1521
390
(147 pts LMWH)
Apixaban (5)
Dabigatran (2)
Rivaroxaban (383)
760
337
311
73
297
58
35
-
Median Age, y (IQR)
67 (50,78)
61 (47,63)*
Males (%)
716 (46.9)
220 (56.4)
Thrombophilia
12.6
18.7
Past medical history
Previous Stroke/TIA
Previous Major Bleeding
5.3%
1.9%
4.4%
4.6%
Active cancer
7.8%
2.8%
27.2%
16%
3.7%
-
DVT
DVT/PE
PE
SVT
CrCL 30-60 ml/min
CrCL <30 ml/min
Naive pts (%)
273 (70)
Shifted from VKA (%)
117 (30)
Low dose DAOCs
37 (9.5)
*p=0.001
Follow-up
VTE patients
Major bleeding events
VKA
DOACS
2150
188
20
1.3; 0.93
6
2
12
3
0.76; 1.6
2
1
Fatal Bleeding
1*
-
MB low dose DOACS (%)
-
1 (0.36)
MB naive patients (%)
-
3 (100)
MB shifted patients (%)
-
-
Fup (pt-yrs)
Major bleeding
rate: % pt; x 100 pt- yrs
Cerebral
Gastrointestinal
Other
* gastrointestinal
Follow-up
VTE patients-VKA
Major bleeding events in relation to quality of anticoagulation
Median time (%)
80
NS
60
40
NS
20
0
without
bleeding
TTR
with
bleeding
without
bleeding
with
bleeding
Time above therapeutic range
Median (IQR) TTR of all patients = 65 (50-76)
Follow-up
VTE patients
Major bleeding events in relation to renal impairment
4
Percentage of events
p= 0.006
3
NS
2
1
0
eGFR
>60
VKA
eGFR
15-59
eGFR
>60
eGFR
30-59
DOACs
Follow-up
VTE patients
Time of major bleeding events
Percentage of events
100
80
60
40
20
0
≤90 90-180 180-365 >365
≤90 90-180 180-365 >365
VKA
days
DOACs
ABSTRACT
ISTH 2015-Toronto
ANMCO 2015-Roma
ESC 2015-Londra
Submitted
Submitted
Percentuale del tempo trascorso sotto, entro o sopra il range terapeutico
durante l’intero periodo di trattamento in relazione alle classi di score
Submitted
Percentuale del tempo trascorso sotto, entro o sopra il range terapeutico nei
primi tre mesi di trattamento in relazione alle classi di score
Submitted
Comparison between results obtained in
patients in relation to SAME-TTR
score groups
Nei pazienti con score ≥2 prima di iniziare la terapia anticoagulante, la qualità della
conduzione della terapia era peggiore rispetto ai pazienti con score 0-1
Submitted
Partecipanti Attivi
Giuliana Guazzaloca-Bologna
Sophie Testa, Oriana Paoletti-Cremona
Vittorio Pengo-Padova
Daniela Poli , Rossella Marcucci-Firenze
Anna Falanga, Teresa Lerede-Bergamo
Antonietta Piana, Francesco Cibecchini-Genova
Lucia Ruocco-Pisa
Giuliana Martini, Giovanni Scovoli- Brescia
Simona Pedrini, Federica Bertola-Brescia
Serena Rupoli-Ancona
Claudio Vasselli-Roma
Lucilla Masciocco, Angelo Benvenuto-Lucera (FG)
Andrea Toma, Pietro Barbera-Arzignano (Vicenza)
Eugenio Bucherini-Faenza
Antonio Insana-Moncalieri (TO)
Carmelo Paparo-Chieri (TO)
Paola Casasco-Tortona (AL)
Giovanni Nante-Padova
Giuseppe Boriani-Bologna
Salvatore Bradamante-Taranto
Giuseppe Malcangi Bari
Catello Mangione-Galatina (LE)
Walter Ageno-Varese
Nicola Lucio Liberato-Pavia
Alberto Tosetto-Vicenza
Domenico Lione-Brindisi
Maria Lombardi-Parma
Rosella Sangiorgio-Lecco
Vincenzo Oriana-Reggio Calabria
Enrica Agostinelli-Treviglio (Bg)
Maddalena Loredana Zighetti- Milano
Paolo Gresele-Perugia
Giuseppe Meduri-Reggio Calabria
AOU-Careggi
Piera Sivera-Torino
AOU Careggi- Firenze
UO Cardiologia-Reggio Emilia
Partecipanti
Luciano Crippa-Milano
Giacomo Lucarelli- Acquaviva delle Fonti (Ba)
Vincenza Rossi-Cosenza
Samantha Pasca-Udine
Carla Lombardo-Mazara del Vallo
Paolo Manotti-Regggio Emilia
Azienda Ospedaliera Mugello-Firenze
Vanessa Roldan-Spagna
Conclusioni
Stabile il numero dei partecipanti attivi, quasi tutti centri FCSA
Uno score per identificare i pazienti che avrebbero una cattiva
conduzione della TAO nei primi tre mesi e che gioverebbero
di un trattamento con NAO (FA o TEV)
Aumento del rischio emorragico nei primi tre mesi di terapia nei
pazienti in trattamento con NAO
Importanza della funzione renale per emorragie in NAO per
TEV
Proposte prossimi lavori….
Dentali
Studio Emorragie Cerebrali: pazienti fibrillanti con evento durante
trattamento con AVK shiftati a NAO
Pengo
Valutazione dei pazienti con fibrillazione atriale a basso rischio
tromboembolico: motivi del trattamento e analisi complicanze
Poli
Differenze di genere nella qualità della terapia con AVK
Palareti
Rischio emorragico primi 3 mesi di terapia (AVK o NAO); entità, fattori di
rischio
www.anticoagulazione.it
http://www.start-register.org
Start-Register
Emilia Antonucci
Ludovica Migliaccio
Serena Zorzi
Indirizzo mail: [email protected]