VKA treatment and bleeding rate of patients aged older than

DECLARATION OF CONFLICT OF INTEREST
• None to declare
Bleeding risk in very old patients
on VKA treatment:
Results from the prospective
collaborative EPICA Study
(Elderly Patients followed by Italian Centres of Anticoagulation)
D Poli, E Antonucci, S Testa, A Tosetto,
W Ageno, G Palareti
on behalf of the ad hoc Study group of FCSA
Poli D et al. Circulation, 2011
Background and aim of the study
The increasing number of very old patients on treatment
with vitamin K antagonists (VKAs) requires a better
knowledge of the risks associated with this treatment in
elderly.
We performed a prospective collaborative study among
Centres affiliated to the Italian Federation of
Anticoagulation Clinics – FCSA-, to assess the adverse
events of VKAs in patients who started treatment after
80 years of age.
Partecipating Centres
Daniela Poli, Thrombosis Centre Department of Heart and Vessels, AOU-Careggi, Florence
Umberto Carini, Grosseto Misericordia Hospital – Cardiovascular Medicine Grosseto
Antonio Ciampa, AORN SG Moscati, UOSS "Thrombosis Centre" Avellino
Paolo Da Col, Sanitary Service Regione Friuli Venezia Giulia, Thrombosis Centre Trieste
Loreto Galbo, Cervello Hospital, Laboratory Service Palermo
Antonio Insana, S. Croce Hospital, Dept Clinical Pathology Moncalieri (TO)
Giovanni Nante, University of Padova Dept of Medical and Surgical Science, Padova
Domenico Restifo, AO Desio-Vimercate, Thrombosis Centre Vimercate
Roberto Cappelli Hospital of Siena Thrombosis Centre Siena
Eugenio Lucherini Civic Hospital Angiology Unit Ravenna
Francesco Orlandini Civic Hospital S. Andrea Dept Internal Medicine 1 La Spezia
Fabio Pini Civic Hospital "Villa Marina" Thrombosis Centre Piombino
Antonietta Piana University of Genova Dept of Internal Medicine Genova
Alessandro Porcu ASL n° 8 Cagliari Thrombosis Centre Cagliari
Lucia Ruocco Cisanello Hospital Thrombosis Centre Pisa
Eros Tiraferri Hospital of Rimini Thrombosis Centre Rimini
Leonardo Di Gennaro Catholic University School of Medicine Haemostasis Research Center Roma
Anna Falanga Ospedali Riuniti of Bergamo Department of Oncology/Hematology Bergamo
Pietro Falco Hospice San Marco Thrombosis Centre Latina
Marco Valerio Grasso Lastaria Hospital UOC Internal Medicine Lucera (FG)
Francesco Marongiu University of Cagliari Department of Medical Sciences "Mario Aresu Cagliari
Simona Pedrini Hospital of Brescia Laboratory Service Brescia
Pasquale Pignatelli Sapienza University Department of Experimental Medicine Rome
Anna Rita Scortechini Umberto 1° Hopsital Haematology Clinic Ancon
Sophie Testa, A O Istituti Ospitalieri of Cremona, Haemostasis and Thrombosis Centre Cremona
Walter Ageno University of Insubria, Dept of Clinical Medicine Varese
Gualtiero Palareti, University Hospital of Bologna, Angiology and Blood Coagulation Bologna
Geographic distribution of partecipating Centres
13 Centers (48%)
North
9 Centers (33%)
Centre
5 Centers (19%)
South
Methods
Patients ≥80 years suffering from atrial fibrillation (AF) or
venous thromboembolism (VTE) were prospectively
followed-up from the start of treatment.
Clinical characteristics of patients, quality of anticoagulation
and adverse events occurring during follow-up were
recorded.
.
Clinical Characteristics of patients
N
4093
Males n (%)
1762 (43)
Median (IQR) age
84 (80-102)
Follow-up period (years)
9603
Mean follow-up period (years) (SD)
2.35 ±2.1
Indication for VKA treatment (%)
Atrial fibrillation
3015 (73.7)
Venous thrombembolism
1078 (26.3)
.
Characteristics of patients
History of major bleeding (%)
114 (2.9)
History of falls (%)
151 (4.2)
N. of drugs associated (≥3) (%)
2367 (62.5)
creatinine clearance ≤30 mL/min (*) (%) 251 (10.1)
creatinine clearance ≤50 mL/min (*) (%)
1500 (60.6)
Quality of anticoagulation (IQR)
Time in therapeutic range %
62 (49-75)
Time above therapeutic range %
11 (5-18)
Time below the therapeutic range %
24 (13-35)
Characteristics of patients in relation to
indication for treatment
Total Number of enrolled patients:
4093
AF
VTE
Males (%)
1361(45.1)
401 (37.2)
Median Age (IQR)
83(80-102)
84(80-98)
Follow-up period (years)
7620
1981
Mean follow-up (years)
2.5±2.1
1.8±1.9
TTR (IQR)
63(50-75)
59.5(46-73)
p value
ns
0.000
.
Bleeding events
Distribution of bleeding events in relation to indication
to VKA treatment
Risk Factors Associated With Bleeding Events:
Univariate Analysis
Risk Factors Associated With Bleeding Events:
Competing-Risk Regression Analysis
CONCLUSIONS
History of prior major bleeding event, active
cancer and history of falls are risk factors
associated with bleeding risk.
Among very old patients on VKA treatment we
observed a higher rate of bleeding among VTE
patients in comparison to AF patients.
However, the rate of bleeding events is acceptably
low, probably due to the good quality of
anticoagulation recorded.