START-Register: Nuovi Dati Nazionali Emilia Antonucci
Feb 14, 2019
http://www.start-register.org
9368 patients 6727patients with follow-up
91 patients
586 patients 230 patients with follow-up
Start laboratorio
Total number of enrolled patients: 9360
DOACS Patients: 1850
November 2015 Total number of Investigators:140
Enrolled patients 9300* (54% M - 46%F)
Indication to Anticoagulant treatment Non Valvular AF 61.6% Venous Thromboembolism 29.1% Atrial Fibrillation 2.4% Prosthetic heart valves 3.0% Other indications 4.0% DOACS shifted from VKA 43.1% Median Time of VKA (IQR) 24 (8,50) months
Drugs VKA 77.5% DOACs 20.5% Apixaban 408 Dabigatran 527 Rivaroxaban 926 LMWH (chronic) 2% Bridging Therapy LMWH 49% Fondaparinux 1.0%
Median age 74 yrs, IQ range 64-84 yrs
* Analysis performed on 9064 patients
November 2015 Total number of Investigators:140
November 2015 Characteristics of 9300 patients
Creatinine Clearance* (ml/min x1.73 m2) >90 34.6% 60-90 18.1% 30-59 33.1% 15-30 13.6% <15 0.6% *Cockroft-Gault formula
Follow-up = 9722 pt-yrs
6727 Patients (74.2)
Patients Fup pt-yrs
VKA (7025) 8430
DOACs (1144) 727
LMWH (161) 122
Major Bleeding events
* Analysis performed on 9064 patients
Number Rate (x 100 pts)
Rate (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
Patients(%)
All NVAF VTE
< 65 yrs 2311 (25.5) 732 (13.2) 1232 (46.6)
65-75 yrs 2855 (31.5) 1908 (34.1) 692 (26.2)
> 75 yrs 3898 (43.0) 2944 (52.7) 720 (27.2)
Age Class
VKA DOACS
Number 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)
Past medical history Previous Stroke/TIA Previous Major Bleeding
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% -
Naive pts (%) 409 (54)
Shifted from VKA (%) 346 (46)
Low dose DAOCs 267 (35)
Follow-up NVAF patients
VKA DOACS
Fup (pt-yrs) 5632 530
Major bleeding rate: % pt ; x100 pt yrs Cerebral Gastrointestinal Other
82 2.43; 1.5
26 16 44
24 3.17; 4.5
6 10 8
Fatal Bleeding 6* 2**
MB low dose DOACS (%) - 7 (2.6)
MB naive patients (%) - 14 (3.4)
MB shifted patients (%) - 10 (2.9)
* 5 cerebral; 1 gastrointestinal **1 cerebral; 1 other
Major bleeding events
Follow-up NVAF patients
Follow-up NVAF patients-VKA
0
20
40
60
80
p= 0.01
Median (IQR) TTR of all patients = 67 (54,77)
Major bleeding events in relation to quality of anticoagulation M
edia
n tim
e (%
)
with bleeding
without bleeding
p=0.01
TTR
with bleeding
without bleeding
Time above therapeutic range
Follow-up NVAF patients
0
1
2
3
4
p= NS
eGFR 15-59
eGFR >60
Major bleeding events in relation to renal impairment Pe
rcen
tage
of e
vent
s
eGFR 30-59
eGFR >60
p=0.01
VKA DOACs
Follow-up NVAF patients
0
20
40
60
80
100
≤90
Time of major bleeding events Pe
rcen
tage
of e
vent
s
VKA DOACs
Follow-up (days)
90-180
180-365
>365
≤90
90-180
180-365
>365
2 bleeding events occurred in shifted patients, one patients had history of previous bleeding
Follow-up VTE patients
VKA DOACS
Number 1521 (147 pts LMWH)
390 Apixaban (5)
Dabigatran (2) Rivaroxaban (383)
DVT DVT/PE PE SVT
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%
CrCL 30-60 ml/min 27.2% 16%
CrCL <30 ml/min 3.7% -
Naive pts (%) 273 (70)
Shifted from VKA (%) 117 (30)
Low dose DAOCs 37 (9.5)
*p=0.001
VKA DOACS
Fup (pt-yrs) 2150 188
Major bleeding rate: % pt; x 100 pt- yrs Cerebral Gastrointestinal Other
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 (%) - -
* gastrointestinal
Major bleeding events
Follow-up VTE patients
Follow-up VTE patients-VKA
0
20
40
60
80
NS
Median (IQR) TTR of all patients = 65 (50-76)
Major bleeding events in relation to quality of anticoagulation M
edia
n tim
e (%
)
with bleeding
without bleeding
NS
TTR
with bleeding
without bleeding
Time above therapeutic range
Follow-up VTE patients
0
1
2
3
4
p= 0.006
eGFR 15-59
eGFR >60
Major bleeding events in relation to renal impairment Pe
rcen
tage
of e
vent
s
eGFR 30-59
eGFR >60
NS
VKA DOACs
0
20
40
60
80
100
≤90
Time of major bleeding events Pe
rcen
tage
of e
vent
s
VKA DOACs
days
90-180
180-365
>365
≤90
90-180
180-365
>365
Follow-up VTE patients
Percentuale del tempo trascorso sotto, entro o sopra il range terapeutico durante l’intero periodo di trattamento in relazione alle classi di score
Submitted
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
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
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
Partecipanti
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
Conclusioni
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
Proposte prossimi lavori….
http://www.start-register.org
Indirizzo mail: [email protected]
www.anticoagulazione.it
Start-Register Emilia Antonucci Ludovica Migliaccio Serena Zorzi