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

Employee No relevant conflicts of interest to declare

Consultant No relevant conflicts of interest to declare

Major Stockholder No relevant conflicts of interest to declare

Speakers Bureau No relevant conflicts of interest to declare

Honoraria Sanofi-aventis

Scientific Advisory Board No relevant conflicts of interest to declare

In compliance with ACCME policy, ASH requires the following disclosures to the session audience:

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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

0

5000

10000

15000

20000

25000

30000

35000

40000

45000

50000

55000

60000

2002/01 2002/09 2003/05 2004/01 2004/09 2005/05 2006/01 2006/09

Time

No

. of

pat

ien

ts

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 patientIdentifying at-risk patient

Counselling at-risk Counselling at-risk patientpatient

PrescribingPrescribingthromboprophylaxisthromboprophylaxis

Venous thromboembolism risk score

Kucher, N. et al. N Engl J Med 2005;352:969-977

Risk score for VTE

Kucher, N. et al. N Engl J Med 2005;352:969-977

Risk score for VTE

Kucher, N. et al. N Engl J Med 2005;352:969-977

Clinical Feature Score

Active cancer (treatment ongoing or within 6 months or palliative) 3

Personal history of VTE 3

Thrombophilia 3

Recent major surgery 2

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;352:969-977

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 sex 896 (48%) 2385 (62%)

Age ≥ 75 433 (23%) 912 (24%)

Medical illness/ immobility

203 (11%) 374 (10%)

Recent surgery 229 (12%) 494 (13%)

Cancer 224 (12%) 148 (4%)

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

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10

20

30

40

50

60

70

80%

pat

ien

ts w

ith

VT

E

0,1 2,3 4,5 6,7 >7

Risk score

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

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10

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40

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80

% p

atie

nts

wit

h V

TE

<4 >/=4

Risk score

P<0.01

VTE patients – RISK SCORE 0,1

0 20 40 60 80 100

Medical

Surgical

>75

Obesity

Cancer

Thrombophilia

Hormone

VTE history

% of patients

VTE patients – RISK SCORE 2,3

0 20 40 60 80 100

Medical

Surgical

>75

Obesity

Cancer

Thrombophilia

Hormone

VTE history

% of patients

VTE patients – RISK SCORE 4,5

0 20 40 60 80 100

Medical

Surgical

>75

Obesity

Cancer

Thrombophilia

Hormone

VTE history

% of patients

VTE patients – RISK SCORE 6,7

0 20 40 60 80 100

Medical

Surgical

>75

Obesity

Cancer

Thrombophilia

Hormone

VTE history

% of patients

VTE patients – RISK SCORE >7

0 20 40 60 80 100

Medical

Surgical

>75

Obesity

Cancer

Thrombophilia

Hormone

VTE history

% of patients

Risk score threshold in VTE patients – medical and surgical

0 20 40 60 80 100

>/=4

<4

Ris

k sc

ore

% of patients

Medical Surgical

Thromboprophylaxis & risk score – medical & surgical

01020304050607080

% r

ecei

ved

p'la

xis

0,1 2,3 4,5 6,7 >7

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<0.01

• 71% 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.