Risk of Fatal Pulmonary Embolism after Stopping Anticoagulant Therapy in Patients with Venous Thromboembolism
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Slide 1 :
The Risk of Fatal Pulmonary Embolism after Stopping Anticoagulant Therapy in Patients with Venous Thromboembolism James Douketis MD1 Chu Shu Gu MSc2 Sam Schulman MD, PhD1,3 Angelo Ghirarduzzi MD4 Vittorio Pengo MD5 Paolo Prandoni MD, PhD6 Depts. of Medicine1 and Clin. Epidemiology2, McMaster University, Hamilton, Canada; Dept. of Hematology, Karolinska University Hospital3, Stockholm, Sweden; Dept. of Medicine, Angiology Unit, Arcispedale Santa Maria Nuova, Reggio Emilia4; Dept. of Vascular Sciences5; Dept. of Medical-Surgical Sciences, Thromboembolism Unit, University of Padua6, Italy
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Background and Rationale In patients with VTE in whom stopping anticoagulants is being considered…risk of fatal PE after treatment stopped is unclear Risk for PE-related death can be expressed as… annual risk for fatal PE risk that recurrent disease will be fatal (case-fatality) Reliable estimates of these prognostic indices relevant… annual risk for fatal PE may influence decisions about stopping anticoagulation…depending on ‘comfort level’ case-fatality measures clinical impact of disease recurrence…weighed against the case-fatality of bleeding if anticoagulation continued
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Study Objectives In patients with 1st VTE after anticoagulant therapy stopped, to provide reliable/precise estimates of: annual risk for fatal PE case-fatality of disease recurrence To assess these outcomes according to… - clinical presentation: DVT, PE or both - disease etiology: idiopathic, secondary events per 100 patient-yrs of follow-up fatal PE ÷ (fatal PE + non-fatal DVT/PE)
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Study Design Prospective cohort study identified inception cohort of patients with 1st VTE who stopped anticoagulant therapy inception cohort derived from 2 sources: Italian prospective cohort study of 1st VTE: all patients Prandoni P, et al. Haematologica 2007;92:199-205 2) DURAC trial (6-months vs. 6-weeks VKA treatment for 1st VTE) long-term follow-up: 6-month group only Schulman S, et al. J Thromb Haemost 2006;4:734-42
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Inception Cohort Characteristics Consecutive patients presenting with 1st symptomatic lower limb DVT, PE or both referred by primary care physicians DVT and PE confirmed by objective diagnostic testing Anticoagulant therapy 5-10 days heparin =3 months VKA (INR: 2.0-3.0) Patient exclusions (require indefinite VKA therapy): cancer permanent immobility high-risk thrombophilia
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Patient Follow-up and Study Outcomes Patient follow-up Italian cohort: until study completed or for up to 120 months after anticoagulation stopped DURAC: for up to 120 months after anticoagulation stopped Study outcomes non-fatal recurrent DVT or PE death fatal PE all outcomes independently adjudicated cause of death based on autopsy findings, medical records, and national death registry (DURAC)
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Classification of Fatal PE ‘definite/probable’ fatal PE definite: confirmed at autopsy probable: anteceded in the immediate period before death by confirmed non-fatal DVT or PE ‘any’ fatal PE: definite/probable and possible fatal PE possible: sudden death of undetermined etiology that could not be explained by a disease or condition other than PE
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Schematic of Inception Cohort Diagnosis of VTE Start of Inception Cohort End of Cohort Follow-up non-fatal VTE death end of study f/u VKA therapy After VKA therapy stopped
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Results: Inception Cohort at Baseline Patient demographics 2,052 (1,628 from Italian cohort; 424 from DURAC) mean age (range) 62 (16-96) female sex 1,082 (53%) Initial presentation DVT (159 with distal DVT) 1,450 (71%) PE 310 (15%) DVT + PE 292 (14%) (1,121 patients had thrombophilia testing, 295 [14%] had abnormality) Duration of anticoagulation (months) 3 540 (33%) 95% receive >3-6 817 (50%) 3-12 months >6-12 191 (12%) VKA therapy >12 80 (5%) (mean = 6m)
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Results: Inception Cohort Follow-up Duration of follow-up (months) after anticoagulation stopped ?12 211 (10%) >12 - 24 335 (16%) >24 - 48 517 (25%) >48 - 72 434 (21%) >72 555 (27%) mean follow-up 54 months Clinical outcomes 501 (24%) patients had recurrent non-fatal VTE 278 (14%) patients died - 27 possible fatal PE - 18 definite/probable fatal PE Patients lost to follow-up 44 (2%) patients resumed anticoagulation for reason(s) other than recurrent VTE or could not be contacted
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Results: Incidence of Fatal PE
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Results: Case-fatality of Recurrent VTE
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Time Course of Any Fatal PE after Stopping Anticoagulation According to Disease Presentation* *Annual rate of fatal PE constant over time when assessed for any fatal PE (P = 0.18) and definite/probable fatal PE (P = 0.13).
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Time Course of Any Fatal PE after Stopping Anticoagulation According to Disease Etiology* *Annual rate of fatal PE constant over time when assessed for any fatal PE (P = 0.18) and definite/probable fatal PE (P = 0.13).
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Potential Study Limitations ‘the duration of anticoagulation was not standardized…’ pre-specified regression analyses found duration of anticoagulation did not affect incidence of fatal PE after treatment stopped (HR = 1.00; 95% CI: 0.94-1.07) ‘you included 159 lower risk patients with distal DVT…’ post hoc analysis showed annual risk (95% CI) for definite/prob. fatal PE comparable in patients with distal DVT (0.18; 0.03-0.58) and proximal DVT (0.19; 0.11-0.30) ‘you cannot combine patients from 2 different study designs…’ post hoc analysis showed annual risk (95% CI) for definite/prob. fatal PE comparable from Italian cohort (0.17; 0.09-0.30) and DURAC (0.25; 0.11-0.50)
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Potential Clinical Implications Low rate of fatal PE after stopping anticoagulation may provide reassurance to clinicians and patients about the safety of stopping treatment. Case-fatality of recurrent VTE (~6%) and case-fatality of bleeding (~9%) may inform decisions about risks of stopping vs. continuing anticoagulation. …however, also consider: risk/clinical impact of non-fatal sequelae of recurrent VTE (post-thrombotic syndrome, pulmonary hypertension) patient values/preferences for duration of anticoagulation
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Study Conclusions We studied an inception cohort of ~2,000 patients who received ~6 months anticoagulation and had ~4.5 yrs follow-up Findings pertain to patients with a first symptomatic VTE who stop anticoagulation… Risk of death from PE estimated at 0.19/100 to 0.49/100 person-years 0.19% - 0.49% per year Case-fatality of recurrent VTE estimated at 4% to 9%
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Acknowledgments and Disclosures Thank you to Dr. Richard H. White (University of California, Davis) and Dr. Frederick A. Spencer (McMaster University) for reviewing this work. Thank you to Dr. Paolo Prandoni and Dr. Sam Schulman for kindly providing access to their study databases. This was a non-funded study. There are no disclosures or potential conflicts of interest.
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Risk Factors for Any Fatal PE Putative Risk Factor Univariable Analysis Multivariable Analysis HR (95% CI) HR (95% CI) Age (10-yr increments) 2.1 (1.6-2.8) 2.1 (1.6-2.8) Sex (vs. female) 1.3 (0.7-2.3) n/a Disease etiology (vs. secondary) 3.1 (1.5-6.2) 2.4 (1.2-4.9) VKA duration (1-month increments) 1.0 (0.9-1.1) n/a Disease presentation (vs. PE) - DVT alone 1.1 (0.5-2.5) n/a - DVT + PE 0.9 (0.3-2.5) n/a Source study type (vs. RCT) 0.5 (0.2-1.2) n/a
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