COmparison of Methods for thromboembolic risk assessment with clinical Perceptions and AwareneSS in real life Surgical and Medical patients COMPASS study

1
COmparison of Methods for thromboembolic risk
assessment with clinical Perceptions and
AwareneSS in real life Surgical and Medical
patients COMPASS study

• Prevalence of risk factors for VTE in
  hospitalized medical and surgical patients

2
Unmet needs for VTE risk stratification

• The identification of hospitalized patients at
  VTE risk is a major chalenge since it will
  protect from underuse or misuse of
  thromboprophylaxis.
• Most of the available risk assessment models
  (RAM) have been constructed on a disease or
  surgical act based approach
• RAMs include the most relevant risk factors for
  VTE in order to stratify hospitalized patients to
  three risk levels (low, moderate and high).
• However they do not take into account the most
  frequent VTE risk factors as well as risk factors
  related to bleeding or other comorbidities that
  might influence treating physicians decision
  making in real-life clinical practice.

3
COMPASSAim

• The primary aim of the COMPASS registry was to
  evaluate the prevalence of the known risk factors
  for VTE and bleeding described in the literature
  in real-life surgical and medical patients which
  are hospitalised in different medical or surgical
  departments.

4
COMPASS Patients

• COMPASS a prospective multicenter
  cross-sectional observational study
• Conducted in 8 hospitals (7 in Greece and one in
  France)
• All patients aged gt40 years hospitalised for
  serious medical disease
• Inpatients aged gt18 years admitted due to a
  surgical condition requiring operation and
  hospitalisation for a period exceeding three days
  were included in the study
• Patients and their treating physicians were
  interviewed with standardised questionnaire
  including all VTE risk factors described in
  literature (120 items)
• Patients charts were also analysed

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COMPASS Methods

• Patients were assessed on the third day of
  hospitalisation.
• Main exclusion criteria
• Patients not giving informed consent
• Patients receiving anticoagulant treatment for
  any reason
• Patients hospitalised in order to undergo
  diagnostic tests without need for further
  therapeutic intervention were excluded from the
  study.

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COMPASS patients
n Mean age (min - max) Malese/Females
All patients 806 66 (18-100) 406/400
Medical Patients 414 71 (40-100) 210/204
Surgical Patients 392 60 (18-92) 196/196
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COMPASS Causes of hospitalisation in medical
patients
Causes of hospitalisation Frequency Percentage
Infection 174 42,03
Ischemic Stroke 60 14,49
Cancer 56 13,53
Gastro-intestinal disease 38 9,18
Acute pulmonary disease 16 3,86
Anemia 13 3,14
Cardiovascular disease 13 3,14
Renal disease 11 2,66
Diabetes 7 1,69
Rhumatological disease 5 1,21
Hematological disease 3 0,72
Other 18 4,35
Total 414 100
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COMPASS Causes of hospitalisation in surgical
patients
Cuases of hospitalisation Frequency Percentage
Vascular disease 86 21,94
Cancer 76 19,39
Orthopedic and trauma surgery 56 14,29
Gastro-intestinal disease 49 12,50
Acute infection 31 7,91
Minor surgery 29 7,40
Obésité/affection Obesity/Metabolic disease 21 5,36
Urological disease 9 2,30
Gynecological disease 7 1,79
Post-op compications 6 1,53
Others 22 5,64
Total 392 100
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Frequency of thromboprophylaxis
n Patients receiving thromboprophylaxis (n) Patients receiving thromboprophylaxis ()
All Compass Patients 806 594 73,7
Medical patients 414 256 61,84
Surgical patients 392 338 86,22
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Type of thromboprophylaxis
LMWH UFH Vitamin K antagonists
All Compass patients(n806) 72,58 (585) 1,36 (11) 0 (0)
Medical pts (n414) 58,94 (244) 1,69 (7) 0 (0)
Surgical pts (n392) 86,99 (341) 1,02 (4) 0 (0)
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Predicted duration of thromboprophylaxis
Durée moyenne estimée (min-max)
All Compass pts (n806) 16 d (5-105)
Medical pts(n414) 11 d (5-90)
Surgical pts (n392) 19 d (5-105)
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Monitoring of platelet count
date de contrôle des plaquettes Frequency of platelet monitoring Frequency of platelet monitoring
date de contrôle des plaquettes In global sample (n806) In patients treated with LMWHs (n585)
Before treatment initiation (Baseline) 529 (65) 486 (83)
Between D3 and D8 after treatment initiation 689 (86) 430 (73)
Other date after treatment initiation 308 (39) 291 (50)
The most recent date 481 (60) 431 (75)
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COMPASSFrequency of VTE and bleeding risk
factors in hospitalised medical and surgical
patients
plt0,05
14
Risk Assessment model for VTE in surgical
patients according to the ACCP
Group Risk factor classification score Risk level
A Minor surgery without additional RF and agelt 40ys   1 low
A Minor surgery with additional risk factor and age 40 60 ys   1 low
B Major risk factor without any additional RF 2 moderate
C Major surgery with additional risk factors 3 high
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Classification of surgical patients to VTE risk
according to ACCP
Risk level (ACCP) Frequency (n392)
low 92 23,47
moderate 122 31,12
high 178 45,41
76,53 of patients are classified as moderate or
high risk 87 of patients received prophylaxis
with LMWH
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Classification of medical patients according to
ACCP RAM
Groupe Facteurs de risque score Risk level
A Hospitalisation for heart insufficiency, or serious pulmonary disease .   1 low
B Prolonged immobilisation and at least one additional RF 2 moderate
C Prolonged immobilisation and at least one additional RF Active Cancer or Personal history of VTE or Sepsis or Acute neurological disease Inflammatory bowel disease 3 high
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COMPASS RAM for medical patients
Groupe COMPASS risk factors Score
a Cancer actif   10
a Chirurgie liée à un cancer récent   10
a Infection sévère ou sepsis   10
a Médicaments thrombogeniques   10
b Hospitalisation récente (3 mois maximum) pour maladie médicale 2
b Intervention chirurgicale non liée à un cancer 2
c Insuffisance cardiaque (NYHA class I ou II, III, IV) 1
c Affection Pulmonaire Obstructive 1
c Maladie pulmonaire avec détérioration 1
c Maladie auto-immune avec détérioration 1
c Maladie intestinale inflammatoire 1
d Hyper-coagulation 2
d antécédents personnels de MTEV 2
d antécédents familiale de MTEV 2
e Paralysie du membre inférieure 1
e Accident Ischémique cérébral et paralysie 1
e Hémorragie récente 1
f Varices 1
f Athérosclérose 1
f Opération chirurgicale mineure 1
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Classification of medical patients according to
ACCP ad COMPASS RAM
Risk levels ACCP (n414) COMPASS (n414)
low 44,44 (184) 21,98 (91)
moderate 11,59 (48) 10,14 (42)
high 43,96 (182) 67,87 (281)
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Comparison of classification of medical patients
wt risk levels according to COMPASS and ACCP RAM
High Risk ACCP Moderate risk ACCP Low Risk ACCP
High risk Compass 134 (32,37 ) 33 (7,97 ) 114 (27,54 )
Moderate risk Compass 19 (4,59 ) 13 (3,14 ) 10 (2,42 )
Low risk Compass 29 (7 ) 2 (0,48 ) 60 (14,49 )
20
Prophylaxis administration and risk level
according to ACCP and COMPASS RAM
ACCP Compass
High risk without prophylaxis 58 (14) 88 (21,26)
Moderate risk without prophylaxis 15 (3,62) 22 (5,31)
Low risk with prophylaxis 99 (23,91) 43 (10,39)
60 of medical patients received prophylaxis with
LMWH
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COMPASSConlusion

• COMPASS is the first registry that provides key
  data on the prevalence of all known VTE and
  bleeding risk factors in real life medical and
  surgical patients hospitalised in two countries
  of European Union
• The analysis of the data shows that in addition
  to risk steming from the disease or surgical act
  both medical and surgical patients share common
  VTE risk factors
• The careful analysis of the most frequent and
  relevant VTE risk factors will allow the
  derivation of a practical VTE and bleeding risk
  assessment model taken into account these factors
•  

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Prospective COmparison of Methods for
thromboembolic risk assessment with clinical
Perceptions and AwareneSS in real life Cancer
patients.

• COMPASS Cancer

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Background

• the identification of cancer patients at VTE risk
  and the optimization of thromboprophylaxis is a
  puzzling exercise
• VTE risk may vary according
• to patient grounds,
• to cancer evolution,
• histological type and stage of cancer
• Type and intensity of chemotherapy and other
  adjuvant treatments
• drawbacks for the application of pharmacological
  thromboprophylaxis
• thrombocytopenia or thrombocytopathia due to the
  myelotoxic effect of chemotherapy
• other acquired coagulopathies related to cancer
  (i.e. consumption coagulopathy or liver
  impairment, acquired von Willebrand disease...)

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Background

• 5 to 7 of cancer patients suffer symptomatic
  VTE of approximately
• similar or greater than that reported in
  hospitalized or postoperative patients for whom
  VTE prophylaxis has been shown to be highly
  effective.

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COMPASS CancerAims

• Primary aim
• prospective evaluation of the 4Ts RAM, the
  Khorana RAM and the established RAMs (i.e.
  Caprini and ACCP) to predict symptomatic or
  objectively diagnosed VTE in hospitalised
  patients and ambulatory/outpatients with cancer.
• Secondary aim
• evaluation of the actual level of awareness of
  oncologists for VTE risk and the actual
  perception on the use of thromboprophylaxis. This
  information will be used as baseline for
  comparing the efficacy of eventual future
  initiatives in order to optimize VTE prophylaxis
  in cancer patients.

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COMPASS Cancer Centers
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COMPASS-Cancer histology or localisation

• types of cancer
• gynaecological
• lung
• gastrointestinal
• pancreatic breast
• hematological

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COMPASS-Cancer studied population

• Expected 6 months cumulative incidence of
  symptomatic VTE
• 3,3 for ovarian cancer,
• 1,4 for lung cancer,
• 0,9 for breast cancer

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COMPASS-Cancer studied population
Surgical pts (n 1000)
Medical pts (n2500) at distance from any
surgical intervention, receivinge the indicated
chemotherapy, or targeted treatment or
combination of any of these treatments with
radiotherapy.
Control group 500 acutely ill medical patient
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COMPASS-Cancerend-points

• symptomatic and objectively diagnosed VTE
  episodes (DVT and/or PE).
• symptomatic and documented arterial thrombosis
  (ischemic stroke, acute coronary syndrome or
  other site)
• superficial venous thrombosis
• central catheter thrombosis
• thrombosis in rare localizations
• all cause mortality
• combined clinical end-point (symptomatic VTE,
  arterial thrombosis superficial venous
  thrombosis, central catheter thrombosis,
  thrombosis in rare localizations)
• Severe bleeding (according to the definition
  given by the ISTH)

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COMPASS-Cancerinclusion criteria

• consecutive newly diagnosed out-patients with
  histologically confirmed ovarian, lung or breast
  cancer (OR OTHER according to PROMETHEE Centers)
  before any treatment administration
• consecutive out-patients with ovarian, lung or
  breast cancer, hospitalised in one day clinics
  for daily administration of anticancer treatment
• consecutive patients with ovarian, lung or breast
  cancer hospitalized for administration of
  anticancer treatment
• patients receiving anticancer treatment should
  have a perspective to receive at least 2 cycles
  of this treatment
• acutely ill patients hospitalized for at least 2
  days for acute medical disease other than cancer
  (control group)
• Patients with known cardiovascular disease
  receiving treatment with antiplatelet agents
  (aspirin, clopidogrel or prasugrel or combination
  of aspirin and clopidogrel or prasugrel) will not
  be excluded from the study

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COMPASS-Cancerexclusion criteria

• agelt 18 years
• pregnant or lactating women
• any kind of anticoagulant treatment (vitamin K
  antagonists, or rivaroxaban or dabigatran or
  unfractionated heparin or low molecular weight
  heparin of fondaparinux) for any indication until
  one moth before the interview
• For the non surgical pts any kind of surgery
  during the last 3 months prior inclusion

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COMPASS-CancerData recruitment and follow-up
Local Investigator
Data entry in the web-site data base
Telephone interview, or out-patient interview,
or analysis of medical records
CRF for patient
3 months
6 months
3 months
CRF for treating physician
Laboratory data
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COMPASS-Cancerschedule

• 750 patients per center (?)
• Interim analysis of the data will be done when
  recruitment of patients will reach 25, 50 and
  75 of the total size
• In three months after the end of the study final
  data analysis and report of the study will be
  completed

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COMPASS-CancerPublication policy

• GG and IE will sign as first and last and
  corresponding authors in at least two major
  publications. All members of the national
  PROMETHEE boards (national and local
  investigators and their assistants) will
  participate in these two publications
• In addition to the scheduled central
  publications, articles and abstracts for
  international or national congresses will be
  produced by PROMETHEE members using data from the
  COMPASS-Cancer data base after information of the
  steering committee
• The coordinating center and the steering
  committee will be responsible for the data
  management and the quality control of the data
  collection
• Statistical analysis of the data regarding the
  endpoints of the study described above will be
  done by a biostatistitian based in the
  coordinating center
• All data will be available for the members of
  PROMETHEE network for additional analysis and all
  additional publications will be done after the
  authorisation of the steering committee.