Download AVAIL ME first set of analysis

Audit of Venous Thromboembolism
Management in Middle East Hospitals
AVAIL ME Project
Elham Mir,MD MPH
Medical Affairs Clinical Operation Head
Sanofi Iran
MMM October 2008
1
Study Design
Multinational, observational, cross sectional audit.
Trial location
MECA
Treatment
This is an observational audit therefore there are no restrictions on
pharmacological and other treatments. The protocol will not interfere
with participant’s management.
Assessment Schedule
The patient files will be assessed during a single visit during the predefined audit periods.
2
Objectives
Primary:
- Impact of educational program on management of patients at risk of
VTE, comparing data at baseline, and after 6 months of an educational
program.
Secondary:
- to define factors driving prophylaxis decision in medical and surgical
patients
- to compare prescriptions modalities v/s hospitals protocols or
local/international guidelines
- Proportion of at risk hospitalized patients who received effective types
of VTE prophylaxis
3
Audit Population
All patients hospitalized during the day of the audit
Inclusion Criteria
- Medical patients 40 years of age or older admitted for treatment of
serious acute medical illness
- Surgical patients 18 years of age or older undergoing an operation
which required general or local anaesthesia lasting at least 45’
Exclusion Criteria
- Missing hospital chart
- Age less than 18 and underwent a major operation
- Patients admitted for treatment of DVT or PE
- Patients who refused to give consent to participate in this audit
4
AVAIL ME Extension Article Journal of Thrombosis and
Hoemostasis
5
Patients per hospital
Wave 1 patients (n=1084)
Wave 2 patients (n=1219)
Baghiatollah
61
51
Bank Melli
27
50
Shohada Tajrish
61
37
Emam Reza
56
57
Erfan
65
40
Ghaem
86
79
Imam Hosseiny
35
94
Imam Khomeiny
54
71
Laleh
58
67
Loghman
39
67
Masih Daneshvari
61
66
Modaress
48
67
Oromiyeh
67
60
Poorsina
78
87
Rassoul Akram
89
72
Shahid Sadooghi
73
74
Shariati
45
73
Shiraz
0
32
Sina
31
75
Chamran
15
0
Saadi
31
0
Hospital
6
Surgical vs Medical Patients
( Wave1: N=1084; wave 2: N =1219)
Wave 1
Wave 2
98.3%
36.40
%
63.60
%
35.30
%
Medical
Surgical
Medical
Surgical
64.70
%
7
Patients risk factors
MMM October 2008
8
Patients in medical wards who met ACCP risk criteria
(Wave 1: n=395; Wave 2: n=430)
VTE risk According to ACCP/ CAPRINI
Wave 1
Wave 2
4.80%
95.20%
4.70%
At risk
Not at risk
95.30%
At risk
Not at risk
9
Patients in surgical wards who met ACCP risk criteria
(Wave 1: n=689; Wave 2: n=789)
VTE risk According to ACCP/ CAPRINI
Wave 1
Wave 2
19.90%
20.50%
At risk
Not at risk
At risk
Not at risk
79.50%
80.10%
10
Patient demographics
Wave 1
Wave 2
Medical
(N=395)
Surgical
(N=689)
Medical
Surgical
(N=430)
(N=789)
187(47.3%)
268(38.9%)
184(42.8%)
335(42.5%)
<=40 years
24(6.1%)
294(42.7%)
57(13.3%)
345(43.7%)
41-59 years
172(43.5%)
229(33.2%)
187(43.5%)
275(34.9%)
60-74 years
124(31.4%)
108(15.7%)
106(24.7%)
128(16.2%)
75 years +
75(19%)
58(8.4%)
80(18.6%)
41(5.2%)
20(5.1%)
105(26.6%)
69(17.5%)
28(7.1%)
2(0.5%)
14(2.0%)
141(20.5%)
111(16.1%)
36(5.2%)
4(0.5%)
10(2.3%)
99(23%)
69(16%)
35(8.1%)
3(0.7%)
Characteristic
Female sex
Age
BMI (kg/m2)
Underweight (<18.5)
Normal (18.5-25)
Overweight (25.1-30)
Obese(30.1-40)
Morbid(>40)
14(1.8%)
153(19.4%)
125(15.8%)
37(4.7%)
11
3(0.4%)
Caprini risk categories
(Blue=Wave 1; Orange=Wave 2)
50.00%
43.0%
45.00%
41.6%
40.00%
35.00%
30.00%
27.40% 25.70%
25.00%
20.00%
15.00%
14.80% 14.50%
16.80%
16.20%
10.00%
5.00%
0.00%
Low risk
Moderate risk
High risk
Very high risk 12
Total Population at VTE risk split medical/surgical
Risk category 
Low risk
Moderate risk
High risk
Very High
N=160
N=176
N=297
N=451
Medical patients
19(4.8%)
44(11.1%)
106(26.8%)
226(57.2%)
Surgical patients
141(20.5%)
132(19.2%)
191(27.7%)
225(32.7%)
Risk category 
Low risk
Moderate risk
High risk
Very High
N=177
N=205
N=313
N=524
Medical patients
20(4.7%)
52(12.1%)
125(29.1%)
233(54.2%)
Surgical patients
157(19.9%)
153(19.4%)
188(23.8%)
291(36.9%)
Wave 1
Wave 2
P<0.001 for wave 1 and wave 2
13
Medical patients: reason for Hospitalization (1)
Wave 1
Wave 2
N=395
%
N=430
%
Renal disease
Other medical condition
Acute respiratory disease (non infectious)
Malignancy (active)
Acute pulmonary infection
84
33
66
45
37
21.3%
8.4%
16.7%
11.4%
9.4%
94
62
60
59
48
21.9%
14.4%
14%
13.7%
11.2%
GI / Hepatobiliary
50
12.7%
45
10.5%
Infectious disease (non respiratory)
24
6.1%
34
7.9%
Ischemic stroke
20
5.1%
31
7.2%
Heart failure (NYHA class III/IV)
24
6.1%
26
6%
Diagnosis
14
Medical patients: reason for Hospitalization (2)
Wave 1
Wave 2
N=395
%
N=430
%
Other cardiovascular disease
Endocrine / metabolic
18
17
4.6%
4.3%
25
22
5.8%
5.1%
Hematological diseases
5
1.3%
13
3%
Rheumatologic or inflammatory
7
1.8%
13
3%
Neurological (excluding stroke)
Urinary tract infection
11
2
2.8%
0.5%
12
7
2.8%
1.6%
Hemorrhagic stroke
6
1.5%
4
0.9%
Diagnosis
15
Surgical Patients: type of surgery (1)
Wave 1
Surgery
Other surgery
Orthopedic trauma
Hip fracture
Gynecologic surgery
Hepatobiliary surgery
Colon / small bowel surgery
Gastric surgery
Urologic surgery
Knee replacement
Hip replacement
Thoracic surgery
Wave 2
N=689
%
N=789
%
178
162
27
23
51
58
35
25
13
11
34
25.8%
23.5%
3.9%
3.3%
7.4%
8.4%
5.1%
3.6%
1.9%
1.6%
4.9%
233
138
55
50
42
34
34
30
26
25
25
29.5%
17.5%
7.0%
6.3%
5.3%
4.3%
4.3%
3.8%
3.3%
3.2%
3.2%
16
Surgical Patients: type of surgery (2)
Wave 1
Wave 2
N=689
%
N=789
%
Obstetric surgery
Rectosigmoid surgery
Vascular surgery
Curative arthroscopy
18
20
14
8
2.6%
2.9%
2.0%
1.2%
21
17
14
9
2.7%
2.2%
1.8%
1.1%
Surgery minimally invasive
76
11%
93
11.8%
Open surgery
613
89%
696
92.2%
Was surgery for cancer?
122
17.7%
101
12.8%
Surgery
17
Risk factors for VTE (1)
Risk factor
No risk factor
Long term immobility
Active cancer (diagnosed/treated within 6 months)
Obesity
Acute infection
Chronic heart failure
Central venous catheter
Chronic pulmonary disease
Cancer therapy (hormonal, chemotherapy)
Acute respiratory failure
Recent ischemic stroke
Wave 1
Wave 2
N=1084
45.5%
16.9%
17%
11.8%
9.1%
8.5%
5.7%
8.7%
4.4%
6.1%
4.4%
N=1219
43%
18.2%
15.4%
12.1%
11.2%
8.4%
7.2%
7.2%
6.5%
5.2%
4.8%
18
Risk factors for VTE (2)
Risk factor
Acute inflammatory disorder
Previous venous thromboembolism
Pregnancy within 3 months/post partum
Contraceptives / HRT
Varicose veins / venous insufficiency
Thrombophilia
Previous superficial venous thrombosis
Wave 1
Wave 2
N=1084
N=1219
1.9%
1.3%
1.9%
3.1%
1.6%
0.3%
2.6%
1.7%
1.5%
1.2%
1.2%
0.7%
0.4%
0.1%
19
VTE risk management
MMM October 2008
20
Patients who received any VTE prevention (1)
Risk category
Wave 1
Low risk
N=160
Moderate risk
N=176
High risk
N=297
Very High
N=451
Overall
N=1084
0
89.2%
85.2%
78.3%
70.4%
Any VTE prevention*
28.1%
36.4%
46.1%
60.1%
47.7%
Any drug prophylaxis*
27.5%
34.1%
44.8%
55.9%
45.1%
Any mechanical prophylaxis*
0.6%
2.3%
4%
10%
5.8%
Guidelines applied*, **
70.6%
4.5%
33.3%
34.1%
34.5%
Guidelines applied*, +
70.6%
4.5%
30.3%
26.2%
30.4%
Low risk
N=177
Moderate risk
N=205
High risk
N=313
Very High
N=524
Overall
N=1219
0
85.4%
86.6%
83.2%
72.4%
Any VTE prevention*
39.5%
55.1%
60.1%
78.6%
64.2%
Any drug prophylaxis*
38.4%
48.8%
55.3%
75.8%
60.5%
Any mechanical prophylaxis
4.6%
12.2%
8.6%
10.1%
9.3%
Guidelines applied*, **
54.8%
13.7%
42.2%
55.3%
44.9%
Guidelines applied*, +
54.8%
13.2%
36.4%
48.3%
40.3%
Eligible for prophylaxis*
Risk category
Wave 2
Eligible for prophylaxis*
*p<0.001 for differences between risk classes; ** Guidelines were applied with certainty regarding
dosing and respect of contraindication; + Taking duration additionally
21
Patients who received VTE prevention (2)
Wave 1
Low risk
N=160
Moderate
risk N=176
High risk
N=297
Very High
N=451
Overall
N=1084
Medical
19
44
106
226
395
Any drug*
0
22.7%
40.6%
49.1%
41.5%
94.7%
2.3%
20.8%
20.8%
22.3%
141
132
191
225
689
Any drug*
31.2%
37.9%
47.1%
62.7%
47.2%
Guidelines application*, **
67.4%
5.3%
35.6%
31.6%
35%
Low risk
N=177
Moderate
risk N=205
High risk
N=313
Very High
N=524
Overall
N=1219
20
52
125
233
430
Any drug*
35%
61.5%
53.6%
68.2%
61.6%
Guidelines application*,**
30%
7.7%
25.6%
33%
27.7%
Surgical
157
153
188
291
789
38.9%
44.4%
56.4%
81.8%
59.9%
58%
15%
43.6%
60.5%
47.1%
Risk category
Guidelines application*,**
Surgical
Wave 2
Risk category
Medical
Any drug‡
Guidelines application‡, **
*P<0.001; **taking duration, dosing and contraindication respect; ‡ p<0.01
22
Details of management
Management
Low risk N=160
Moderate risk N=176
High risk N=297
Very High N=451
Overall N=1084
21.9%
24.4%
27.9%
35%
29.4%
UFH*
5.6%
9.7%
17.5%
22.4%
16.5%
VKA
0
0
1.3%
1.6%
1%
Fondaparinux
0
0
0
0.2%
0.1%
Other anticoagulant*
0
0
1.3%
1.8%
1.1%
Low risk N=177
Moderate risk N=205
High risk N=313
Very High N=524
Overall N=1219
30.5%
35.6%
39%
55.5%
44.3%
7.9%
10.2%
12.8%
13%
11.7%
VKA**
0
0.5%
1%
2.7%
1.5%
Fondaparinux
0
0
0
0
0
0.6%
3.4%
3.2%
7.8%
4.8%
LMWH*
Management
LMWH*
UFH
Other anticoagulant*
*p<0.001; **p<0.05
23
Safety issues
MMM October 2008
24
Contraindication for prophylaxis
Medical
N=395
Surgical
N=689
All patients
N=1084
No contraindications to thromboprophylaxis
82.3%
93%
89.1%
High risk of bleeding
11.1%
4.4%
6.8%
Acute infectious endocarditis
0
0.1%
0.1%
Hypersensitivity to heparin/LMWH
0
0.1%
0.1%
Current therapeutic LMWH/UFH/VKA
2.3%
0.7%
1.3%
Previous heparin induced thrombocytopenia
0.8%
0.3%
0.5%
Medical
N=430
Surgical
N=789
All patients
N=1219
No contraindications to thromboprophylaxis
84.7%
94.8%
91.2%
High risk of bleeding
10.2%
3.9%
6.2%
Acute infectious endocarditis
0
0.1%
0.1%
Hypersensitivity to heparin/LMWH
0
0
0
0.7%
0.3%
0.4%
0
0.1%
0.1%
Reason for CI (wave 1)
Reason for CI (wave 2)
Current therapeutic LMWH/UFH/VKA
Previous heparin induced thrombocytopenia
25
Risk factors for bleeding
Medical
N=395
Surgical
N=689
All patients
N=1084
No risk factors for bleeding upon admission
73.4%
90.9%
84.5%
Significant renal impairment
8.1%
1.2%
3.7%
Low platelet count (<100,000 per ml)
10.9%
2%
5.3%
Active gastrointestinal bleeding
3.8%
1.2%
2.1%
Incracranial haemorrhage
1.5%
2%
1.8%
Known bleeding disorder (congenital or acquired)
2.5%
0.7%
1.4%
Hepatic impairment (clinically relevant)
2.8%
0
1%
Oesophageal varices
0.8%
0.1%
0.4%
Medical
N=430
Surgical
N=789
All patients
N=1219
No risk factors for bleeding upon admission
79.3%
93.5%
88.5%
Significant renal impairment
6.7%
1.1%
3.1%
4%
0.5%
1.7%
Active gastrointestinal bleeding
3.3%
0.9%
1.7%
Incracranial haemorrhage
0.7%
2.3%
1.7%
3%
0.1%
1.1%
1.6%
0.1%
0.7%
Risk for bleeding (wave 1)
Risk for bleeding (wave 1)
Low platelet count (<100,000 per ml)
Known bleeding disorder (congenital or acquired)
Hepatic impairment (clinically relevant)
26
Contraindications to VTE prophylaxis
Detail (Wave 1)
Medical
Surgical
All patients
N=395
N=689
N=1084
Should not be given drug
prophylaxis
26.1%
9.4%
15.5%
Should not be given
mechanical prophylaxis
18.5%
4.6%
9.7%
Medical
Surgical
All patients
N=430
N=789
N=1219
Should not be given drug
prophylaxis
24.4%
9.4%
14.7%
Should not be given
mechanical prophylaxis
14.7%
5.3%
8.6%
Detail (Wave 2)
27
Safety data of the population that prohibit VTE
prophylaxis
Wave 1
Contra Indication to anticoagulation
Contraindication to mechanical prophylaxis
Number
% receiving anticoagulation
168
61(36.3%)
Number
% receiving mechanical prophylaxis
105
7(6.7%)
Number
% receiving anticoagulation
179
73(40.8%)
Number
% receiving mechanical prophylaxis
105
9(8.6%)
Wave 2
Contra Indication to anticoagulation
Contraindication to mechanical prophylaxis
28
In summary…
MMM October 2008
29
Patients at risk for VTE and receiving ACCP
recommended prophylaxis
Wave 2
Wave 1
N=1084
924(85.2 %) at Risk
for VTE
161(17.4%)
have CI to
VTE
prophylaxis
N=1219
160(14.8%)
do not need
prophylaxis
1042(85.5 %) at Risk
for VTE
160(15.4%)
have CI to
VTE
prophylaxis
763(82.6%)
eligible for
prophylaxis
45(28.1%)
received
prophylaxis
195(25.6%) received ACCP
Recommended prophylaxis
respecting duration
882(84.6%)
eligible for
prophylaxis
602(68.3%) received
drug prophylaxis
389(51%) received drug
prophylaxis
56(34.8%)
received
prophylaxis
177(14.5%)
do not need
prophylaxis
68(42.5%)
received
prophylaxis
70(39.5%)
received
prophylaxis
361(40.9%) received ACCP
Recommended prophylaxis
respecting duration
30
Concordance between theory and practice
Theory
Practice
Should not receive
VTE drug prophylaxis
Should receive VTE
drug prophylaxis
Total
Did not receive VTE drug
prophylaxis
221(68.8%)
374(49%)
595(54.9%)
Received VTE drug
prophylaxis
100(31.2%)
389(51%)
489(45.1%)
Total (Wave 1)
321(100%)
763(100%)
1084(100%)
Theory
Practice
Should not receive
VTE drug prophylaxis
Should receive VTE
drug prophylaxis
Total
Did not receive VTE drug
prophylaxis
201(59.6%)
280(31.7%)
481(39.5%)
Received VTE drug
prophylaxis
136(40.4%)
602(68.3%)
738(60.5%)
Total (wave 2)
337(100%)
882(100%)
1219(100%)
Wave 1: Kappa=0.159; p<0.001 - Wave 2: Kappa = 0.246 ; p-value <0.001
31
Thank You
MMM October 2008
32