Evaluating the Performance of a Previously Reported Risk Score to Predict Venous Thromboembolism: A VERITY Registry Study Denise O'Shaughnessy, Peter Rose, Fran Pressley, Nicholas Scriven, Tim Farren, Tim Nokes, and Roopen Arya for the VERITY Investigators

Disclosures for Dr. Roopen Arya Presentation includes discussion of the following off-label use of a drug or medical device: N/A Research Support/P.I.Sanofi-aventis EmployeeNo relevant conflicts of interest to declare ConsultantNo relevant conflicts of interest to declare Major StockholderNo relevant conflicts of interest to declare Speakers BureauNo relevant conflicts of interest to declare HonorariaSanofi-aventis Scientific Advisory BoardNo relevant conflicts of interest to declare In compliance with ACCME policy, ASH requires the following disclosures to the session audience: 48 th ASH Annual Meeting ♦ Orlando, Florida

What is VERITY? A UK, multi-centre observational registry of clinical management practices & patient outcomes in the treatment of venous thromboembolism (VTE).

What is VERITY? Launched December 2001 in 39 NHS centre Now has ~80 NHS centres in the UK Independent Steering Committee

Current data - patient numbers Total entries 58,737 DVT 11,893 PE 849 No VTE 45,793

91 Study Sites in 14 Countries

Unique Features of VERITY National registry – outpatient VTE treatment Full spectrum of VTE – DVT and PE Records information on patients presenting with suspected VTE Expanded data on demographics, presentation, management & outcomes Annual analysis of data

Objective To evaluate a simple score for estimating risk of VTE using a registry (VERITY) of patients presenting to hospital with suspected VTE.

Why the need for risk assessment? Identifying at-risk patient Counselling at-risk patient Prescribingthromboprophylaxis

Venous thromboembolism risk score Kucher, N. et al. N Engl J Med 2005;352:

Risk score for VTE Kucher, N. et al. N Engl J Med 2005;352:

Risk score for VTE Kucher, N. et al. N Engl J Med 2005;352: Clinical FeatureScore Active cancer (treatment ongoing or within 6 months or palliative)3 Personal history of VTE3 Thrombophilia3 Recent major surgery2 Advanced age (≥ 75 years)1 Obesity (BMI >29)1 Bed rest (medical inpatient/immobilized >3d in last 4 wks/paralysis)1 Hormonal therapy (OCP/HRT)1

Risk score for VTE The computer program alerted physicians to the increased risk for VTE and more than doubled the rate of prophylaxis (14.5% to 33.5%) Overall rate of VTE at 90 days was reduced by 41% Kucher, N. et al. N Engl J Med 2005;352:

Risk score analysis using VERITY Retrospective analysis of risk score in VERITY population aiming to validate this as a decision aid to enable use of thromboprophylaxis. Risk score applied to complete population (VTE +ve and VTE –ve patients) Examine risk factor profiles in our patients and reveal existing levels of thromboprophylaxis.

Patient Cohort 27,179 - presented with suspected VTE 6,124 - had a positive diagnosis of DVT, PE or both All 8 risk factors known for 5,692 cases 1872 with VTE (31% of VTE cases) 3820 VTE-negative cases (24% of not VTE cases)

Baseline characteristics VTE cohort (n=1872) Control cohort (n=3820) Female sex896 (48%)2385 (62%) Age ≥ (23%)912 (24%) Medical illness/ immobility 203 (11%)374 (10%) Recent surgery229 (12%)494 (13%) Cancer224 (12%)148 (4%)

Final diagnosis of VTE and risk score (n=5,692)

Final diagnosis of VTE and risk score threshold (n=5,692) P<0.01

VTE patients – RISK SCORE 0,1

VTE patients – RISK SCORE 2,3

VTE patients – RISK SCORE 4,5

VTE patients – RISK SCORE 6,7

VTE patients – RISK SCORE >7

Risk score threshold in VTE patients – medical and surgical

Thromboprophylaxis & risk score – medical & surgical

Results – risk score & VTE An increasing risk score was associated with linear rise in confirmed VTE 51% of patients with a risk score ≥4 were diagnosed with VTE –significantly higher than risk score <4 26% vs. 51%; p< % of patients with a risk score >7 were diagnosed with VTE

Results – risk score & prophylaxis Significantly more medical patients with a risk score ≥4 received VTE prophylaxis –Medical patients – 22% (<4) vs. 33% (≥4), p=0.02 Risk score did not seem to influence prophylaxis provision in surgical patients –Surgical patients – 34% (<4) vs. 32% (≥4)

Conclusion Confirmed utility of risk scoring system in defining those at risk for VTE in VERITY cohort. Cases of suspected VTE managed in community rather than hospitalised patient population. Retrospective analysis of risk factor profile and thromboprophylaxis behaviour. Further refinement of such scoring systems to increase the accuracy of VTE prediction might be valuable.