START-Register: Nuovi Dati Nazionali

Emilia Antonucci

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

Submitted

ABSTRACT ISTH 2015-Toronto

ANMCO 2015-Roma ESC 2015-Londra

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

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: info@start-register.org

www.anticoagulazione.it

Start-Register Emilia Antonucci Ludovica Migliaccio Serena Zorzi