BACKGROUND: Whether to continue oral anticoagulant therapy beyond 6 months after an "unprovoked" venous thromboembolism is controversial. We sought to determine clinical predictors to identify patients who are at low risk of recurrent venous thromboembolism who could safely discontinue oral anticoagulants. METHODS: In a multicentre prospective cohort study, 646 participants with a first, unprovoked major venous thromboembolism were enrolled over a 4-year period. Of these, 600 participants completed a mean 18-month follow-up in September 2006. We collected data for 69 potential predictors of recurrent venous thromboembolism while patients were taking oral anticoagulation therapy (5-7 months after initiation). During follow-up after discontinuing oral anticoagulation therapy, all episodes of suspected recurrent venous thromboembolism were independently adjudicated. We performed a multivariable analysis of predictor variables (p < 0.10) with high interobserver reliability to derive a clinical decision rule. RESULTS: We identified 91 confirmed episodes of recurrent venous thromboembolism during follow-up after discontinuing oral anticoagulation therapy (annual risk 9.3%, 95% CI 7.7%-11.3%). Men had a 13.7% (95% CI 10.8%-17.0%) annual risk. There was no combination of clinical predictors that satisfied our criteria for identifying a low-risk subgroup of men. Fifty-two percent of women had 0 or 1 of the following characteristics: hyperpigmentation, edema or redness of either leg; D-dimer > or = 250 microg/L while taking warfarin; body mass index > or = 30 kg/m(2); or age > or = 65 years. These women had an annual risk of 1.6% (95% CI 0.3%-4.6%). Women who had 2 or more of these findings had an annual risk of 14.1% (95% CI 10.9%-17.3%). INTERPRETATION:Women with 0 or 1 risk factor may safelydiscontinue oral anticoagulant therapy after 6 months of therapy following a first unprovoked venous thromboembolism. This criterion does not apply to men.
RCT Entities:
BACKGROUND: Whether to continue oral anticoagulant therapy beyond 6 months after an "unprovoked" venous thromboembolism is controversial. We sought to determine clinical predictors to identify patients who are at low risk of recurrent venous thromboembolism who could safely discontinue oral anticoagulants. METHODS: In a multicentre prospective cohort study, 646 participants with a first, unprovoked major venous thromboembolism were enrolled over a 4-year period. Of these, 600 participants completed a mean 18-month follow-up in September 2006. We collected data for 69 potential predictors of recurrent venous thromboembolism while patients were taking oral anticoagulation therapy (5-7 months after initiation). During follow-up after discontinuing oral anticoagulation therapy, all episodes of suspected recurrent venous thromboembolism were independently adjudicated. We performed a multivariable analysis of predictor variables (p < 0.10) with high interobserver reliability to derive a clinical decision rule. RESULTS: We identified 91 confirmed episodes of recurrent venous thromboembolism during follow-up after discontinuing oral anticoagulation therapy (annual risk 9.3%, 95% CI 7.7%-11.3%). Men had a 13.7% (95% CI 10.8%-17.0%) annual risk. There was no combination of clinical predictors that satisfied our criteria for identifying a low-risk subgroup of men. Fifty-two percent of women had 0 or 1 of the following characteristics: hyperpigmentation, edema or redness of either leg; D-dimer > or = 250 microg/L while taking warfarin; body mass index > or = 30 kg/m(2); or age > or = 65 years. These women had an annual risk of 1.6% (95% CI 0.3%-4.6%). Women who had 2 or more of these findings had an annual risk of 14.1% (95% CI 10.9%-17.3%). INTERPRETATION:Women with 0 or 1 risk factor may safely discontinue oral anticoagulant therapy after 6 months of therapy following a first unprovoked venous thromboembolism. This criterion does not apply to men.
Authors: Paolo Prandoni; Anthonie W A Lensing; Martin H Prins; Enrico Bernardi; Antonio Marchiori; Paola Bagatella; Michela Frulla; Laura Mosena; Daniela Tormene; Andrea Piccioli; Paolo Simioni; Antonio Girolami Journal: Ann Intern Med Date: 2002-12-17 Impact factor: 25.391
Authors: G Agnelli; P Prandoni; M G Santamaria; P Bagatella; A Iorio; M Bazzan; M Moia; G Guazzaloca; A Bertoldi; C Tomasi; G Scannapieco; W Ageno Journal: N Engl J Med Date: 2001-07-19 Impact factor: 91.245
Authors: P A Kyrle; E Minar; M Hirschl; C Bialonczyk; M Stain; B Schneider; A Weltermann; W Speiser; K Lechner; S Eichinger Journal: N Engl J Med Date: 2000-08-17 Impact factor: 91.245
Authors: L Pinede; J Ninet; P Duhaut; S Chabaud; S Demolombe-Rague; I Durieu; P Nony; C Sanson; J P Boissel Journal: Circulation Date: 2001-05-22 Impact factor: 29.690
Authors: Paul M Ridker; Samuel Z Goldhaber; Ellie Danielson; Yves Rosenberg; Charles S Eby; Steven R Deitcher; Mary Cushman; Stephan Moll; Craig M Kessler; C Gregory Elliott; Rolf Paulson; Turnly Wong; Kenneth A Bauer; Bruce A Schwartz; Joseph P Miletich; Henri Bounameaux; Robert J Glynn Journal: N Engl J Med Date: 2003-02-24 Impact factor: 91.245
Authors: Giancarlo Agnelli; Paolo Prandoni; Cecilia Becattini; Mauro Silingardi; Maria Rita Taliani; Maddalena Miccio; Davide Imberti; Renzo Poggio; Walter Ageno; Enrico Pogliani; Fernando Porro; Pietro Zonzin Journal: Ann Intern Med Date: 2003-07-01 Impact factor: 25.391
Authors: Clive Kearon; Elie A Akl; Anthony J Comerota; Paolo Prandoni; Henri Bounameaux; Samuel Z Goldhaber; Michael E Nelson; Philip S Wells; Michael K Gould; Francesco Dentali; Mark Crowther; Susan R Kahn Journal: Chest Date: 2012-02 Impact factor: 9.410