TY - JOUR
T1 - Recurrent venous thromboembolism and bleeding with extended anticoagulation
T2 - the VTE-PREDICT risk score
AU - De Winter, Maria A.
AU - Büller, Harry R.
AU - Carrier, Marc
AU - Cohen, Alexander T.
AU - Hansen, John Bjarne
AU - Kaasjager, Karin A.H.
AU - Kakkar, Ajay K.
AU - Middeldorp, Saskia
AU - Raskob, Gary E.
AU - Sørensen, Henrik T.
AU - Visseren, Frank L.J.
AU - Wells, Philip S.
AU - Dorresteijn, Jannick A.N.
AU - Nijkeuter, Mathilde
AU - Braekkan, Sigrid K.
AU - Burggraaf, Louise
AU - Cannegieter, Suzanne C.
AU - Farjat, Alfredo
AU - Pap, Akos Ferenc
AU - Goldhaber, Samuel
AU - Grosso, Michael
AU - Horváth-Puhó, Erzsebet
AU - Lensing, Anthonie W.A.
AU - Pieper, Karen
AU - Schulman, Sam
AU - Shi, Minggao
AU - Virdone, Saverio
N1 - Publisher Copyright:
© 2023 The Author(s). Published by Oxford University Press on behalf of the European Society of Cardiology.
PY - 2023/4/7
Y1 - 2023/4/7
N2 - Aims: Deciding to stop or continue anticoagulation for venous thromboembolism (VTE) after initial treatment is challenging, as individual risks of recurrence and bleeding are heterogeneous. The present study aimed to develop and externally validate models for predicting 5-year risks of recurrence and bleeding in patients with VTE without cancer who completed at least 3 months of initial treatment, which can be used to estimate individual absolute benefits and harms of extended anticoagulation. Methods and results: Competing risk-adjusted models were derived to predict recurrent VTE and clinically relevant bleeding (non-major and major) using 14 readily available patient characteristics. The models were derived from combined individual patient data from the Bleeding Risk Study, Hokusai-VTE, PREFER-VTE, RE-MEDY, and RE-SONATE (n = 15,141, 220 recurrences, 189 bleeding events). External validity was assessed in the Danish VTE cohort, EINSTEIN-CHOICE, GARFIELD-VTE, MEGA, and Tromsø studies (n = 59 257, 2283 recurrences, 3335 bleeding events). Absolute treatment effects were estimated by combining the models with hazard ratios from trials and meta-analyses. External validation in different settings showed agreement between predicted and observed risks up to 5 years, with C-statistics ranging from 0.48-0.71 (recurrence) and 0.61-0.68 (bleeding). In the Danish VTE cohort, 5-year risks ranged from 4% to 19% for recurrent VTE and 1% -19% for bleeding. Conclusion: The VTE-PREDICT risk score can be applied to estimate the effect of extended anticoagulant treatment for individual patients with VTE and to support shared decision-making.
AB - Aims: Deciding to stop or continue anticoagulation for venous thromboembolism (VTE) after initial treatment is challenging, as individual risks of recurrence and bleeding are heterogeneous. The present study aimed to develop and externally validate models for predicting 5-year risks of recurrence and bleeding in patients with VTE without cancer who completed at least 3 months of initial treatment, which can be used to estimate individual absolute benefits and harms of extended anticoagulation. Methods and results: Competing risk-adjusted models were derived to predict recurrent VTE and clinically relevant bleeding (non-major and major) using 14 readily available patient characteristics. The models were derived from combined individual patient data from the Bleeding Risk Study, Hokusai-VTE, PREFER-VTE, RE-MEDY, and RE-SONATE (n = 15,141, 220 recurrences, 189 bleeding events). External validity was assessed in the Danish VTE cohort, EINSTEIN-CHOICE, GARFIELD-VTE, MEGA, and Tromsø studies (n = 59 257, 2283 recurrences, 3335 bleeding events). Absolute treatment effects were estimated by combining the models with hazard ratios from trials and meta-analyses. External validation in different settings showed agreement between predicted and observed risks up to 5 years, with C-statistics ranging from 0.48-0.71 (recurrence) and 0.61-0.68 (bleeding). In the Danish VTE cohort, 5-year risks ranged from 4% to 19% for recurrent VTE and 1% -19% for bleeding. Conclusion: The VTE-PREDICT risk score can be applied to estimate the effect of extended anticoagulant treatment for individual patients with VTE and to support shared decision-making.
KW - Anticoagulants
KW - Haemorrhage
KW - Prediction model
KW - Recurrence
KW - Risk
KW - Venous thromboembolism
UR - http://www.scopus.com/inward/record.url?scp=85152488637&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehac776
DO - 10.1093/eurheartj/ehac776
M3 - Article
C2 - 36648242
SN - 0195-668X
VL - 44
SP - 1231
EP - 1244
JO - European heart journal
JF - European heart journal
IS - 14
ER -