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Clinical predictors of adverse outcome in VTE outpatients – the VERITY PUSH (Prospective
Follow-Up Survey in Verity Hospitals) study
Peter Rose, Aidan McManus, Shankaranarayana Paneesha, Nicholas Scriven, Timothy Farren, Sue
Bacon, Roopen Arya, Olatunde Falode, Denise O'Shaughnessy & Tim Nokes for the VERITY
Investigators
Background
• Outpatient VTE treatment with LMWH is now commonplace in the UK
• Factors predictive of VTE recurrence have been reported including age, cancer, immobility and thrombophilic mutations, but there are few data describing risk factors associated with recurrence, or adverse outcome in unselected VTE patients treated in outpatient clinics
PUSH study objectives
• To determine the frequency of major adverse outcomes (death, recurrence of VTE, and bleeding) in patients diagnosed with VTE and treated as outpatients with low molecular weight heparin
• To establish risk factors for adverse outcome after VTE
PUSH study design
Patients negative for VTE
Exclusion algorithms and diagnostic tests
RecurrenceBleedsDeath
Patients with suspected VTE
Consecutive patients with confirmed VTE
Day 0
Day 180
Timeline
VERITY database VERITY PUSH database
Enrolment Follow-up
Day 0
Day 360
Logistic regression
Features of VERITY
• National registry – outpatient VTE treatment
• Full spectrum of VTE – DVT and PE
• Records information on patients presenting with suspected and confirmed VTE
• Expanded data on demographics, presentation, management & outcomes
• Extensive risk factor data
VERITY and PUSH centresVERITY and PUSH centres
PUSH centresPUSH centres
Enrolment (Nov 2008 – Apr 2009)
Seven hospitals enrolled 843 consecutive patients
Study population
• 221 patients were excluded – 75 = no follow-up entry– 50 = no record if treated as an outpatient– 96 = not treated as outpatient
• Final study population n=622
• Patients were followed for up to 388 days (mean duration of 195 days)
Baseline characteristics (risk factors)
RESULTSMajor adverse outcomes
(n=34) (n=16) (n=36)
Major bleed1.2%
Home treatment with LMWH
Levine et al. N Engl J Med. 1996;334:677-81; Koopman et al. N Engl J Med. 1996;334:682-7.
RISK MODELING
1. Major surgery (last 4 weeks) (AND type of major surgery: general/orthopaedic/other)
2. Hormonal risk factor (yes or no)3. Family history 4. Personal history5. History of thrombophilia6. Age (≥50 or ≥70 years on day of diagnosis of VTE) 7. Cancer8. IVDU9. Cancer surgery in last 6 months
Univariate and multivariate logistic regression analyses were conducted to determine if any of the known risk factors predicted for recurrence or adverse outcome.
10. Indwelling catheter11. Metastatic cancer12. New cancer diagnosis after VTE
diagnosis13. Type of VTE (DVT or PE or
DVT+PE)14. High (quantitative) D-dimer at
diagnosis15. Gender
Clinical predictors of adverse outcome in VTE outpatients
• Univariate logistic regression showed that recurrence was related to younger age (<50 years, p=0.007) but to none of the 14 other parameters assessed
• Cancer (p<0.001) and a diagnosis of cancer subsequent to VTE (p=0.037) were predictive of an adverse event
Clinical predictors of adverse outcome in VTE outpatients
• Multivariate logistic regression confirmed these cancer factors were independent predictors of adverse outcome with high odds ratios – Cancer: OR 4.3, 95% CI 2.4–7.5– New cancer: OR 4.3, 95% CI 1.2–15
Clinical predictors of adverse outcome in VTE outpatients
Non-cancer patients
• Restricting the univariate logistic regression analysis to non-cancer outpatients:– age <50 years (p=0.033) was related to the risk of
VTE recurrence– new cancer diagnosis (p=0.007) was a predictor of
adverse outcome
Clinical predictors of adverse outcome in VTE outpatients
‘First event’ VTE
• Restricting the univariate logistic regression analysis to first event VTE outpatients:– age <50 years (p=0.033) was related to the risk of
VTE recurrence– cancer (p<0.001), new cancer diagnosis (p=0.008),
metastatic cancer (p=0.02) and high D-dimer at diagnosis (p=0.023) were all predictors of adverse outcome
Clinical predictors of adverse outcome in VTE outpatients
• ‘First event’ VTE
• Multivariate logistic regression confirmed three factors were independent predictors of adverse outcome with high odds ratios – Cancer: OR 6.3, 95% CI 2.8–14.1– New cancer: OR 13.0, 95% CI 3.0–57.5– High D-dimer: OR 2.7, 95% CI 1.0–6.8
Clinical predictors of adverse outcome in VTE outpatients
Previous history of VTE
• Restricting the univariate logistic regression analysis to outpatients with previous history of VTE:– Cancer (p=0.002) and a hormonal risk factor
(p=0.029) were predictors of adverse outcome
• Cancer was an independent predictor of adverse outcome on multivariate analysis– Cancer: OR 6.9, 95% CI 1.8–27.0)
Clinical implication
From the perspective of routine outpatient treatment of VTE, these results identify cancer as an overriding risk for adverse outcome irrespective of VTE history, and show that high D-dimer at diagnosis is predictive of adverse outcome in patients experiencing a first VTE event.
The VERITY PUSH study was funded by sanofi-aventis