ALL-PARTY PARLIAMENTARY THROMBOSIS GROUP Awareness, Assessment, Management and Prevention APPTG Annual C Confer erence ce 201 2017 #APPTG
PERSPECTIVES FROM
Peter M MacCa Callum um - De Declarations ns • Honoraria – Bayer, Boehringer-Ingelheim, Daiichi-Sankyo • Advisory committees – Daiichi-Sankyo • Sponsorship to attend meetings – Boehringer-Ingelheim, Daiichi-Sankyo
Aims of GARFIELD-VTE • To provide insights into the evolving global patterns of treatment for VTE • To inform the study of aspects of the natural history of VTE: • Rate of early and late VTE recurrence • Incidence of complications of VTE of importance to patients including • Post Thrombotic Syndrome (PTS) • Chronic Thromboembolic Pulmonary Hypertension (CTEPH) • To provide information on: • Adherence to national and international guidelines • Identify good practice as well as treatment deficiencies • Relate patient outcomes to clinical management • To define economic and societal impact of VTE at a regional and global level
Dr Lorenzo G Mantovani Professor the Lord Kakkar Professor Samuel Z Goldhaber Professor Sylvia Haas Professor Alexander G Turpie Professor Henri Bounameaux Professor Walter Ageno Professor Joern Dalsgaard-Nielsen Professor Shinya Goto Professor Jeffrey I Weitz Professor Paolo Prandoni Professor Pantep Angchaisuksiri Dr Sebastian Schellong
Participating countries 10,878 patients in 28 countries AMERICA EUROPE • Argentina • Belgium • Brazil • Czech Republic • Canada • Denmark • Mexico • France • United States of America • Germany Italy • • The Netherlands ASIA & OCEANIA • Russia • Australia • Spain • China • Switzerland • Hong Kong • United Kingdom Japan • • Malaysia AFRICA • South Korea • Taiwan • Egypt • Thailand • South Africa • Turkey • United Arab Emirates
Study Design Design Audit requirements Independent academic research initiative 5% of all CRFs monitored against source 10000 newly diagnosed VTE patients in 28 countries documentation Randomised selection of sites representative of national VTE care Electronic audit trail for all data modifications Critical variables subjected to additional audit settings Unselected prospective patients enrolled consecutively Compliant with Declaration of Helsinki Long-term follow-up (minimum of 3 yrs) Two sequential cohorts of 5000 pateints Weitz JI et al , Thromb Haemost 2016;116:1172–1179
GARFIELD-VTE journey – a review of how far we have come 2016 • First patient in • First GARFIELD-VTE abstracts presented at • Recruitment complete ISTH • Methods paper published 2014 2017
GARFIELD-VTE represents a broad cross-section of VTE patients Variable N=10 677 Female, n (%) 5300 (49.6) Age, years, median (IQR) 60.2 (46.1 to 71.7) Race/Ethnicity 1 , n (%) White 6946 (69.1) Asian 1969 (19.6) Black 465 (4.6) Multi-racial 57 (0.6) Other / Unknown 429 (4.3) / 192 (1.9) Prior episode of VTE, n (%) 1604 (15.0) Active Cancer, n (%) 981 (9.2) History of cancer, n (%) 662 (6.2) 1 Missing n=619 Family history of VTE, n (%) 636 (6.0) Date of analyses: Known thrombophilia, n (%) 306 (2.9) April 2017
GARFIELD-VTE is revealing country differences in characteristics of patients with VTE Variable South Africa (N=416) GLOBAL (N=10 677) Female, n (%) 266 (63.9) 5300 (49.6) Age, years, median (IQR) 49.0 (36.0 to 63.0) 60.2 (46.1 to 71.7) Age range, n (%) < 35 yrs 1345 (12.6) 25.5% pts 93 (22.3) 45.4% pts ≤45 yrs ≤45 yrs 1379 (12.9) 36 to 45 yrs 96 (23.1) 1822 (17.1) 46 to 55 yrs 59 (14.2) 2263 (21.2) 56 to 65 yrs 77 (18.5) 2222 (20.8) 66 to 75 yrs 65 (15.6) 1371 (12.8) 76 to 85 yrs 20 (4.8) 255 (2.6) 86+ yrs 6 (1.4) Acute medical illness 102 (24.5) 594 (5.6) Date of analyses: April 2017
37.5% of patients have at least 1 transient provoking risk factor 1 (within the last 3 months before enrolment) Variable, n (%) N=10 677 Surgery 1333 (12.5) Hospitalization 1277 (12.0) Trauma of the limb 829 (7.8) Acute medical illness 594 (5.6) Long-haul travel 520 (4.9) Pregnancy 2 189 (3.6) Oral contraception 2 527 (9.9) Hormone replacement therapy 2 143 (2.7) 1 As defined by Kearon C, et al. J Thromb Haemost 2016; 14 :1480-3. 2 Calculated as a percentage of women (n=5300) Date of analyses: April 2017
61.7% of VTE patients present with DVT only 70 Proportion of patients, % 61.7% N=10 677 60 50 38.3% 40 30 20 10 0 DVT only (n=6589) PE +/- DVT (n=4088) Date of analyses: 24 th April 2017 DVT includes arm and leg thrombosis, vena cava and atypical sites
Diagnosti tic I c Investigati tion / / Assessment t for DV DVT 95.3 100 90 Confirmatory diagnostic 80 Other investigation Proportion of patients, % 70 60 50 40 25.7 30 20 5.5 10 4.6 1.5 0.4 0.2 0 Compression Vein CT scan Contrast venography MRV Impedence D-dimer assay Pre-test probability scores ultrasonography plethysmography CT, Computed tomography; MRV, magnetic resonance venography; Date of analyses: 24 th April 2017 Patients may have received more than one test and so the values are not mutually exclusive
Diagnosti tic I c Investigati tion / / Assessment t for PE 100 91.8 Confirmatory diagnostic 90 Other investigation 80 Proportion of patients (%) 70 60 50 40 30 16.3 20 14.2 10.4 10 0.2 0 Any CT Ventilation perfusion scan MRA Biomarkers including D- Echocardiography* dimer MRA, magnetic resonance angiography; *Transthoracic and/or Transoesophageal Date of analyses: 24 th April 2017 Patients may have received more than one test and so the values are not mutually exclusive
AC treatment patterns ─ by geographic region Parenteral alone Parenteral + VKAs Parenteral +DOACs DOACs only VKAs only 40 30 % Patients 20 10 0 1 Europe (n=5333) Asia (n=1395) North America (n=852) Other Countries (n=1531) 1 Other is defined as: Argentina, Australia, Brazil, Egypt, Mexico, South Africa and United Arab Emirates Date of analyses: 24 th April 2017
Geographic variations in AC prescribing, e.g. Australia North America Europe Australia (n=852) (n=5333) (n=356) Parenteral AC Only 12.7 14.2 10.5 VKA + Parenteral AC 31.6 28.2 9.2 VKA Only 2.5 3.4 1.3 DOACS Only 16.8 26.3 43.1 53.3% 54.2% 79.0% DOACS + Parenteral 36.5 27.9 35.9 Date of analyses: 24 th April 2017
From i initial a anticoagul ulation t on to secondar ndary p prevention a n and d beyond A ond AC treatment w within in ± 30 30 days a and on on d day y 90 a 90 and d day 180 180 60.0 N=9111 50.0 Parenteral alone 40.0 Parenteral + VKA % Patients Parenteral +DOACs DOACS only 30.0 VKA only No Treatment 20.0 Died 10.0 0.0 Peri-diagnosis On day 90 On day 180 Date of analyses: 24 th April 2017
Global Enrolment : By Country Total Enrolled= 10,878 1000 884 900 800 718 705 704 700 640 624 608 562 600 555 536 500 431 416 358 400 349 343 327 314 300 246 245 229 226 224 183 200 150 122 102 61 100 18 0
GARFIELD-VTE - 20 sites in the UK • 16 sites in England • 2 sites in Scotland • 1 site in Northern Ireland NHS Ayshire and Arran • 1 site in Wales Ulster
Patient Population from UK Excluded after screening, n=200 Assessed for eligibility Declined to participate Not meeting protocol-defined n=1084 inclusion/exclusion criteria Deceased before consent Enrolled n=884 Patients with objectively confirmed diagnosis of VTE 1 n=865 Date of analyses: 24 th April 2017 1 As defined by Bates et al Chest 2012; 141(Suppl) : e351S–e418S
Site of VTE 70 64.2 Europe UK 59 60 Proportion of patients, % 50 41 40 35.8 30 20 10 0 DVT only PE +/- DVT Date of analyses: 24 th April 2017 DVT includes arm and leg thrombosis, vena cava and atypical sites
Site of DVT 100 4.4 5.6 90 80 Upper limb Lower limb 70 60 50 95.6 94.4 40 30 20 10 0 Europe UK Date of analyses: 24 th April 2017
Baseline Demographics Variable UK (N=865) Europe (N=5123) Tobacco use, n (%) 365 (47.4) 2063 (41.8) Current or ex-smoker Body mass index, median (IQR) 29.1 (25.3 to 33.4) 27.4 (24.5 to 31.2) Body mass index, n (%) Underweight 57 (1.2) 3(0.5) Normal 1307 (27.3) 122 (22.1) Overweight 1919 (40.2) 175 (31.8) Obese I (30.0-34.9 kg/cm 2 ) 962 (20.1) 137 (24.9) Obese II (35.0 to 39.9 kg/cm 2 ) 372 (7.8) 65 (11.8) Obese III (40 kg/cm 2 or greater) 162 (3.4) 49 (8.9) Date of analyses: April 2017
Transient provoking risk factor 1 (within the last 3 months before enrolment) Variable, n (%) UK (N=865) Europe (N=5123) Surgery 100 (11.6) 565 (10.9) Hospitalization 72 (8.3) 529 (10.2) Trauma of the limb 80 (9.2) 425 (8.2) Acute medical illness 39 (4.5) 267 (5.2) Long-haul travel 88 (10.2) 251 (4.8) Pregnancy 2 8 (0.9) 72 (1.4) Oral contraception 2 22 (2.5) 300 (5.8) Hormone replacement therapy 2 12 (1.4) 86 (1.7) 1 As defined by Kearon C, et al. J Thromb Haemost 2016; 14 :1480-3. Date of analyses: April 2017 2 Calculated as a percentage of women
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