the continuing challenge of venous thromboembolism ... · vte is a leading cause of death worldwide...
TRANSCRIPT
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Satellite Symposium
The Continuing Challenge of Venous Thromboembolism: Insights from the GARFIELD-VTE Registry
ISTH 2017 Congress, Berlin, Germany
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Understanding the global burden: GARFIELD-VTE
Rt Hon Professor the Lord Kakkar
Thrombosis Research Institute and
University College London UK
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Disclosures
Grants and personal fees
Bayer
Personal fees
Boehringer-Ingelheim Pharma, Daiichi Sankyo Europe, Sanofi SA, Janssen Pharma
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Cardiovascular disease is the number one
medical challenge today
• Cardiovascular diseases (CVDs) are responsible for 45% of all mortality in Europe1
– Coronary heart disease
– Cerebrovascular disease
– Other CVD
• Thrombosis is the common underlying mechanism in a quarter of global mortality (MI, ischaemic stroke, PE)2
1. Townsend N et al. Eur Heart J. 2015;36:2696-2705; 2. Wendelboe AM & Raskob GE. Circ Res. 2016;118:1340-1347.
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VTE is a leading cause of death worldwide
150,000 deaths in the USA every year3
VTE is estimated to cause at least 3 million deaths a year worldwide1
>500,000 deaths in Europe every year2
1. ISTH Steering Committee for World Thrombosis Day J Thromb Haemost. 2014;12:1580-1590. 2. Cohen AT et al. Thromb Haemost. 2007;98:756-764;
3. Gould MK et al, 9th ed: ACCP Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 suppl):e227
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Design
Independent academic research initiative
10 878 newly diagnosed VTE patients in 28 countries
Randomised selection of sites representative of national VTE care
settings
Unselected prospective patients enrolled consecutively
Long-term follow-up (minimum of 3 years)
Two sequential cohorts of 5000 patients
Audit requirements
10% of all CRFs monitored against source
documentation
Electronic audit trail for all data modifications
Critical variables subjected to additional audit
Compliant with Declaration of Helsinki
Weitz JI et al, Thromb Haemost 2016;116:1172–1179
Garfield-VTE: A Prospective global disease registry
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Registry features and analyses
10 000 patients recruited at ~420 sites in 28 countriesDescribing economic and societal impact of VTE, nationally and globally
Observational study of unselected patients Documenting routine clinical practice and allowing the full range of clinical evidence to be explored in terms of patient types, clinical settings and outcomes
2 sequential prospective cohortsCapturing temporal trends in treatment of VTE during a time when non-vitamin K antagonist oral anticoagulants are becoming more widely adopted
Sites selected randomly within a carefully assigned distribution of national care settingsDescribing adherence to national and international guidelines
Evaluating physician- and patient-reported outcomesGauging health status and patient treatment satisfaction, and providing unique insights into the quality of life of patients
Follow-up for at least 3 yearsDescribing treatment and outcomes over the long term
Weitz JI et al, Thromb Haemost 2016;116:1172–1179
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Excluded after screening (n=964)
Declined to participate (n=444)
Not meeting protocol-defined
inclusion/exclusion criteria (n=459)
Deceased before consent (n=61)
Assessed for eligibility
(n=11 842)
Enrolled (n=10 878)
Patient population
1 As defined by Bates et al Chest 2012; 141(Suppl): e351S–e418S Date of analyses: 24th April 2017
Patients with an objectively confirmed diagnosis of VTE1 (n=10 677)
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ArgentinaBrazilCanadaMexicoUnited States of America
BelgiumCzech RepublicDenmarkFranceGermanyItalyThe NetherlandsRussiaSpainSwitzerlandUnited Kingdom
AustraliaChinaEgyptHong KongJapanMalaysiaSouth AfricaSouth KoreaTaiwanThailandTurkeyUnited Arab Emirates
Participating countries
10 878 patients enrolled in 28 countries
Weitz JI et al, Thromb Haemost 2016;116:1172–1179
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Garfield-VTE: Reflecting multiple care pathways
Post-operative careOutpatients/Primary care
Internal medicine/ ICU Antenatal and peri-
partum care
Oncology
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Care settings
1 Including Haematology and Intensive Care
Variable, n (%) N=10 677
Vascular medicine 4786 (44.8)
Internal medicine1 4632 (43.4)
Cardiology 585 (5.5)
Primary care 398 (3.7)
Emergency medicine 271 (2.5)
Date of analyses: April 2017, Unpublished Data
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The majority of VTE patients present with DVT
only
DVT includes arm and leg thrombosis, vena cava and atypical sites Date of analyses: 24th April 2017, Unpublished Data
61.7%
38.3%
0
10
20
30
40
50
60
70
DVT only (n=6589) PE +/- DVT (n=4088)
Pro
po
rtio
n o
f p
atie
nts
, % N=10 677
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The Registry 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/Ethnicity1, 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)
Family history of VTE, n (%) 636 (6.0)
Known thrombophilia, n (%) 306 (2.9)
1Missing n=619
Date of analyses:
April 2017
Unpublished Data
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37.5% of patients have at least 1 transient provoking risk factor1
(within the last 3 months before enrolment)
Date of analyses: April 2017, Unpublished Data
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)
Pregnancy2 189 (3.6)
Oral contraception2 527 (9.9)
Hormone replacement therapy2 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)
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Treatment within ± 30 days of diagnosis
Thrombolytic: Systemic or catheter-directed Surgical Mechanical: IVC filter, pulmonary embolectomy, thrombectomyCompression: Bandages or stockings Date of analyses: April 2017, Unpublished Data
AC only: 84.3%
Compression only or no therapy: 11.1%
Thrombolytic ± AC3.0%
Surgical/Mechanical ±AC 0.9%
Thrombolytic, Surgical or Mechanical ± AC: 0.6%
Other 4.5%
(N=10 677)
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GARFIELD-VTE is a contemporary treatment registry evaluating a broad-cross section of VTE patients from multiple treatment pathways
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VTE: A chronic disease ̶̶
Implications for extended
duration anticoagulation
Professor Samuel Z Goldhaber, MD
Section Head, Vascular Medicine; Director,
Thrombosis Research Group; Cardiovascular
Division, Brigham and Women’s Hospital;
Harvard Medical School, Boston, MA, USA
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DISCLOSURES
Research Support
BiO2 Medical, Boehringer-Ingelheim, BMS, BTG EKOS, Daiichi, Janssen, NHLBI, Thrombosis Research Institute
Consultant
Agile, Bayer AG, Boehringer-Ingelheim, BMS, Daiichi, Janssen, Portola, Zafgen
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OBJECTIVES
• To obtain at least 3 year follow-up in
GARFIELD-VTE to determine whether VTE is
a chronic illness that warrants extended
duration anticoagulation (beyond 3-6 months)
• This requires tracking recurrent VTE after
anticoagulation is discontinued
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1. VTE is mostly a chronic inflammatory
disease, like MI or diabetes mellitus
2. VTE does not disappear after 3 months of
anticoagulation
3. VTE lurks sub-clinically, waiting to recur
4. VTE requires lifelong attention to risk factor
reduction with heart-healthy lifestyles
(exercise, nutrition) and medication
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UK: RECURRENT VTE
(Martinez C. Thromb Haemost 2014; 112: 255-263)
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D-DIMER DISAPPOINTS re:
EXCLUDING RECURRENT VTE
Unprovoked VTE; 5 months warfarin;
Average 2.2 years follow-up (N=319)
Gender Negative D-
dimer:
Recurrence
Positive D-dimer:
Recurrence
Men 8% per year 16% per year
Women 5% per year 10% per year
(Kearon C. Ann Intern Med 2015; 162: 27-34)
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PADIS-PE: 6 vs 24 MONTHS
OF WARFARIN
373 PE patients
Goals
1) prevent recurrent PE after additional
18 months of warfarin compared with
6-month group, and to
2) compare recurrent PE rates in both
groups, 2 years after completing
warfarin therapy in all patients
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PADIS-PE: 6 vs 24 MONTHS
OF WARFARIN
(PADIS-PE. JAMA 2015; 314: 31-40)
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PADIS-PE: 6 vs 24 MONTHS
OF WARFARIN• Benefit of 18 additional months of
warfarin is not maintained following
cessation of warfarin
• The group in which extended warfarin is
completed develops new PE at a rate
twice as high as the group that never
had extended warfarin, suggesting a
rebound effect(PADIS-PE. JAMA 2015; 314: 31-40)
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VKA Era: LONG vs SHORT-TERM
VKA FOR VTE - 80% Reduction in
Recurrence (N=3,716)
(Middeldorp S. JAMA 2015; 314: 72-73)
X 3.4 more major bleeds
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CHEST ACCP GUIDELINES 2016:
DURATION OF RX
• If unprovoked with low to moderate bleeding risk, we suggest extended anticoagulant therapy (no scheduled stop date) over 3 months of therapy (Grade 2B)
• If provoked by surgery or a nonsurgical transient risk factor, anticoagulate for 3 months (Grade 1B)
(CHEST 2016; 149: 315-352)
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EINSTEIN CHOICE:
LONG-TERM PREVENTION OF
RECURRENT VTE
(Weitz JI. Thromb Haemost 2015; 114: 645-650)
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Both Rivaroxaban Doses Reduced Recurrent VTE Rates with
Similar Risk of Bleeding versus ASA Efficacy
(Weitz JI. NEJM 2017; 376: 1211-1222)
0
1
2
4
5
3
Days‡
ASA 100 mg od
Rivaroxaban 20 mg odRivaroxaban 10 mg od
1 30 60 90 120 150 180 210 240 270 300 330 360
Cu
mu
lati
ve
in
cid
en
ce
(%
)
Rivaroxaban 20 mg vs ASA
(0.5%) vs (0.3%)
HR=2.01 (95% CI 0.50–8.04),
p=0.32
Rivaroxaban 10 mg vs ASA
(0.4%) vs (0.3%)
HR=1.64 (95% CI 0.39–6.84),
p=0.50
Major bleeding
ASA 100 mg od
Rivaroxaban 20 mg od
Rivaroxaban 10 mg od
Days
0
1
2
3
4
5C
um
ula
tive
in
cid
en
ce
(%
)
1 30 60 90 120 150 180 210 240 270 300 330 367
Riva 20 mg
vs ASA
(1.5%) vs
(4.4%)
HR=0.34
(95% CI
0.20–0.59),
p<0.001
Riva 10 mg
vs ASA
(1.2%) vs
(4.4%)
HR=0.26 ,
p<0.001
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RECURRENT VTE:
PROVOKED vs UNPROVOKED
Riva 20
mg
Riva 10 mg ASA 100
mg
Provoked 1.4% 0.9% 3.6%
Unprovoked 1.8% 1.5% 5.6%
(Weitz JI. NEJM 2017; 376: 1211-1222)
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SPECIAL CONTRIBUTIONS OF
EINSTEIN CHOICE
• Largest Extension Study ever of VTE (N=3,396
randomized patients)
• Largest Extension Study ever of Provoked VTE
(N=1,976; 59%)
• Rivaroxaban: equally effective in recurrent VTE risk
reduction (70%) in both provoked/ unprovoked VTE
(Weitz JI. NEJM 2017; 376: 1211-1222)
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EXTENDED THERAPY: WHEN?
1) GARFIELD-VTE will provide “real world data” on
whether extended anticoagulation therapy for
VTE should be the default, unless risk of
recurrence is very low or bleeding risk is very
high
2) GARFIELD-VTE bridges randomized pivotal trial
data with “real world” considerations
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Anticoagulation strategies –
from initial treatment to
6 months therapy
Professor Sylvia Haas Formerly Klinikum re. der Isar, Technical University
of Munich, Munich, Germany
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Disclosures
• Scientific Advisory Board member
Bayer AG, Bristol-Myers Squibb, Daiichi-Sankyo, Sanofi
• Received honoraria from
Aspen, Bayer Healthcare, Bristol-Myers Squibb, Daiichi-Sankyo, Pfizer
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VTE: Disease Phases and Conventional Anticoagulation Treatment Strategies
*With re-assessment of the individual benefit–risk at periodic intervals
Disease phases
Intermediate
Acute
Long term
Types and intensity of conventional anticoagulation treatmentUFH, LMWH, fondaparinux
At least 5 days
Initial, parenteral therapeutic dose
VKA INR 2.0–3.0 or 1.5–1.9
>3 months/years/indefinite*
At least 3 months
VKA INR 2.0–3.0
Long-term maintenance anticoagulation/secondary prevention
Early maintenance/secondary prevention
Kearon C et al. Chest 2008;133;454S–545S. ESC Textbook of Cardiovascular Medicine, 2nd edn, 2009; chapter 37 Schellong et al. pp. 1348–1349
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Trial name Initial treatment with heparin/
fondaparinux
Treatment duration (months)
Long-term treatment regimen
Rivaroxaban
EINSTEIN DVT No 3, 6 or 12 od
EINSTEIN PE No 3, 6 or 12 od
Dabigatran
RE-COVER Yes 6 bid
RE-COVER II Yes 6 bid
Apixaban
AMPLIFY No 6 bid
Edoxaban
Hokusai-VTE Yes 3–12 od
Four oral DOACs have become available...
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Aim
• To describe initial and longer term anticoagulation (AC)
treatment patterns of patients prospectively enrolled
from May 2014 to January 2017
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Excluded after screening (n=964)
Declined to participate (n=444)
Not meeting protocol-defined
inclusion/exclusion criteria (n=459)
Deceased before consent (n=61)
Assessed for eligibility
(n=11 842)
Enrolled with an objectively confirmed diagnosis of VTE1
(n=10 677)
Patient population
1 As defined by Bates et al. Chest 2012; 141(Suppl): e351S–e418S Date of analyses: 24th April 2017, Unpublished Data
Sub-set analysis of patients initiated on
AC trx ONLY + 30 days of diagnosis (n=9111)
Excluded from analysis Receiving thrombolytic or surgical intervention (n=448)
Undefined or no AC treatment; combined oral AC within
+ 30 days of diagnosis (n=1118)
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Treatment patterns of AC therapy within ± 30 days of diagnosis
0
20
40
60
80
100
Pro
po
rtio
n o
f p
atie
nts
, %
N=9111
VKA Only (5.3%)
DOACS only (25.9%)
Parenteral +DOACs (25.0%)
Parenteral +VKA (29.2%)
Parenteral only (14.6%)
Date of analyses: 24th April 2017, Unpublished Data
% Patients on Parenteral AC
(n=6268)
Low molecular weight heparin 89.0%
Unfractionated heparin 13.0%
Fondaparinux 4.0%
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Initial AC treatment patterns ─ by year of enrolment
14.3 14.9
31.627.3
25.1 2523.3
27.9
5.7 5
0
10
20
30
40
2014-2015 (n=4092) 2016-2017 (n=5019)
% P
atie
nts
Parenteral alone Parenteral + VKA Parenteral +DOACs DOACS only VKA only
Date of analyses: 24th April 2017, Unpublished Data
- 4,3 % + 4,6 %
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AC treatment patterns ─ by geographic region
0
10
20
30
40
Europe (n=5333) Asia (n=1395) North America (n=852) Other Countries(n=1531)
% P
atie
nts
Parenteral alone Parenteral + VKAs Parenteral +DOACs DOACs only VKAs only
Date of analyses: 24th April 20171 Other is defined as: Argentina, Australia, Brazil, Egypt, Mexico, South Africa and United Arab Emirates
1
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Initial AC treatment patterns ─ by VTE site
1315.6
29.9 28.8
33.5
19.819.1
30
4.5 5.8
0
10
20
30
40
PE/DVT (n=3468) DVT alone* (n=5643)
% P
atie
nts
Parenteral alone Parenteral + VKA Parenteral +DOACs DOACS only VKA only
Date of analyses: 24th April 2017*DVT includes arm and leg thrombosis, vena cava and atypical sites
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24.5
13.8
20.3
30.0
23.225.2
21.4
26.3
10.6
4.8
0.0
10.0
20.0
30.0
40.0
Before diagnosis (day -30 to -1) After diagnosis (day 0-30) (n=8951)
% P
atie
nts
Parenteral alone Parenteral + VKA Parenteral +DOACs DOACS only VKA only
Date of analyses: 24th April 2017, Unpublished Data
Initial AC treatment patterns ─ before and after diagnosis
n=738 n=8373
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Date of analyses: 24th April 2017, Unpublished Data
From initial anticoagulation to secondary prevention and beyond
AC treatment within ± 30 days and on day 90 and day 180
0
10
20
30
40
50
60
Peri-diagnosis On day 90 On day 180
% P
atie
nts
Parenteral alone
Parenteral + VKA
Parenteral +DOACs
DOACS only
VKA only
No Treatment
Died
N=9111
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Conclusions• Geographic variations of AC treatment patterns may reflect cultural
differences, but also reimbursement of DOACs
• The variation of AC treatment patterns over time is less than originallyexpected because momentum in DOACs prescribing had already taken hold when GARFIELD-VTE started
• A higher percentage of parenteral + DOAC is prescribed in patients with PE/DVT than in patients with DVT only
• Clear shift from conventional parenteral + VKA treatment in the first 30 days towards DOACs in the following 5 months
DOACs becoming new standard of care for chronic anticoagulation?Date of analyses: 24th April 2017, Unpublished Data
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Cancer Associated Thrombosis
in Everyday Practice
Professor Jeffrey I. Weitz
McMaster University and Thrombosis and
Atherosclerosis Research Institute,
Hamilton, Canada
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DisclosuresResearch Support/P.I.
Canadian Institutes of Health Research, Heart and Stroke Foundation, Canadian Fund for Innovation
ConsultantBayer AG, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Pfizer, Portola, Ionis Pharmaceuticals, Janssen, Merck, Novartis
Scientific Advisory BoardBayer AG, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Pfizer, Portola, Ionis Pharmaceuticals, Janssen, Servier
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Introduction
• 20% of VTE cases are associated with active cancer / history of cancer
• VTE is the second leading cause of death in cancer patients
• VTE in cancer patients increases hospitalization, delays cancer treatment and increases healthcare costs
Date of analyses: 24th April 2017
Heit, Arch Intern Med, 2003; Sorensen, N Engl J Med, 2000; Chew, Arch Intern Med, 2006; Khorana, J Thromb Haemost, 2007
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Aims
• To compare the clinical characteristics of patients with a confirmed diagnosis of VTE in patients with active cancer, a history of cancer or no cancer
• To describe the initial anticoagulant treatment patterns over the initial 30 days after diagnosis
Date of analyses: 24th April 2017, Unpublished Data
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Excluded after screening (n=964)
Declined to participate (n=444)
Not meeting protocol-defined
inclusion/exclusion criteria (n=459)
Deceased before consent (n=61)
Assessed for eligibility
(n=11 842)
Enrolled with an objectively confirmed diagnosis of VTE1
(n=10 677)
Patient population
1 As defined by Bates et al. Chest 2012; 141(Suppl): e351S–e418S Date of analyses: 24th April 2017, Unpublished Data
History of cancer
(n=662; 6.2%)
No cancer
(n=9034; 84.6%)
Active cancer
(n=981; 9.2%)
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Baseline demographics
Active cancer
(n=981)
History of cancer
(n=662)
No cancer
(n=9034)
Female, n (%) 510 (52.0) 361 (54.5) 4429 (49.0)
Age at diagnosis, median (IQR) 64.5 (55.7 to 72.9) 68.9 (61.0 to 76.8) 58.6 (44.3 to 70.7)
Prior VTE, n % 83 (8.5) 123 (18.6) 1398 (15.5)
At least one provoking factor for VTE*, n (%)
337 (34.4) 232 (35.0) 3439 (38.1)
DVT only : PE ± DVT, n (%) 60.6 : 39.4 57.4 : 42.6 62.2 : 37.8
*Provoking factor in past 3 months: Surgery trauma of lower limb, Acute medical illness, Hospitalization Long-haul travelling , pregnancy, oral contraception or hormone replacement therapy (women) Date of analyses: 24th April 2017, Unpublished Data
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Site of pulmonary arterial branch involvement
Date of analyses: 24th April 2017
Unpublished Data
29.1 27.7 29.9
27.3 32.3 29.4
35.1 32.3 30.8
8.6 7.8 9.9
0
10
20
30
40
50
60
70
80
90
100
Active cancer(n=385)
History of cancer(n=282)
No cancer(n=3397)
Pro
po
rtio
n o
f p
atie
nts
, %
Subsegmental
Segmental
Lobar
Main
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Regional variation in the proportion of VTE patients
with cancer
6.1
19.012.7
7.56.4 6.3 7.2 4.9
87.5
74.780.1
87.6
0102030405060708090
100
Europe (n=5988) Asia (n=1820) North America(n=1090)
Other Countries(n=1779)
% P
atie
nts
Active cancer History of cancer No cancer
1 Other is defined as: Argentina, Australia, Brazil, Egypt, Mexico, South Africa and United Arab Emirates Date of analyses: 24th April 2017
Unpublished Data
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Top 5 most common sites of cancer in VTE patients
Rank
GARFIELD-VTE registry GLOBOCAN Reference group
500 events in 471 men
526 events in 510 women
1026 events in 981 patients
Men Women Overall
1st Lung18.8%
Gynaecological21.1%
Lung14.7%
Lung Breast Breast
2nd Prostate14.0%
Breast18.3%
Gynaecological10.8%
Prostate Colorectal Prostate
3rd Colorectal13.4%
Lung10.8%
Colorectal10.8%
Colorectal Cervical Lung
4th Urological10.2%
Lymphoma9.9%
Breast9.6%
Stomach Lung Colorectal
5th Lymphoma8.8%
Colorectal8.4%
Lymphoma9.4%
Liver Uterus Cervix
http://globocan.iarc.fr/Pages/fact_sheets_population.aspx
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Anticoagulation over first 30 days after diagnosis
56.1
14.4 14.612.5
2.4
15.9
29.626.9
23.1
4.5
9.2
31.7
26.127.9
5.1
0
10
20
30
40
50
60
Parenteral Parenteral + VKA Parenteral +DOACs
DOACs only VKA only
% P
atie
nts
Active cancer History of cancer No cancer
Date of analyses: 24th April 2017, Unpublished Data
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Conclusions• Most common sites of cancer associated with thrombosis are:
• lung (in men) • gynaecological (in women) • lung and gynaecological (overall)
• Patients with active cancer are more likely to receive parenteral anticoagulants and less likely to receive DOACs or VKAs than patients with a history of cancer or without cancer
• DOACS are used in 27% of patients
Date of analyses: 24th April 2017, Unpublished Data
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Outcomes in the Real World
Professor Alexander G G Turpie
McMaster University, Hamilton, Canada
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Disclosures
Consultant and/or Honoraria
Bayer AG, Boehringer-Ingelheim, Bristol-Myers Squibb,
Johnson and Johnson, Sanofi-Aventis, Takeda, Portola
Speakers Bureau
Janssen, Pfizer, GSK
Scientific Advisory BoardBayer AG, Johnson and Johnson
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Introduction
• Garfield VTE is a global prospective observational study of the management of VTE patients
• GARFIELD VTE will evaluate the rates and nature of VTE recurrence, major bleeding and all-cause mortality up to 36 months of follow-up
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Aim
• To describe the baseline characteristics of patients and outcomes over 6 months after an objectively confirmed diagnosis of VTE
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Methods
• Data on outcomes were collected through review of clinical records and analyzed from the date of enrollment into the study
• Clinical outcomes analysed included: All-cause mortality, recurrent VTE, major bleed, myocardial infarction and stroke/TIA
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Excluded after screening (n=964)
Declined to participate (n=444)
Not meeting protocol-defined
inclusion/exclusion criteria (n=459)
Deceased before consent (n=61)
Assessed for eligibility
(n=11 842)
Enrolled with an objectively
confirmed diagnosis of VTE1 (n=10 677)
Patient population
1 As defined by Bates et al. Chest 2012; 141(Suppl): e351S–e418S Date of analyses: 24th April 2017
Unpublished Data
Subset analyses of patients with 6 months follow-up
(n=10 315)
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0-6 month outcomes
Events Person-time Event rate
per 100 person-years (95% CI)
Primary endpoints
All-cause mortality 460 4764.8 9.7 (8.8 to 10.6)
Recurrent VTE 169 4727.9 3.6 (3.1 to 4.2)
Major bleed 106 4725.6 2.2 (1.9 to 2.7)
Secondary endpoints
Any bleed 622 4585.8 13.6 (12.5 to 14.7)
Myocardial infarction 42 4754.6 0.9 (0.7 to 1.2)
Stroke/TIA 38 4757.6 0.8 (0.6 to 1.1)
Date of analyses: 24th April 2017,
Unpublished Data
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Outcomes in the first month and over the following
2 ─ 6 months after diagnosis of VTE
Date of analyses: 24th April 2017, Unpublished Data
Month 0-1 Months 2 - 6
Events Rate per 100 person year (95% CI)
Events Rate per 100 person year (95% CI)
Primary endpoints
All-cause mortality 108 13.0 (10.7 to 15.6) 352 7.4 (6.7 to 8.2)
Major bleed 46 5.5 (4.2 to 7.4) 60 1.3 (1.0 to 1.7)
Recurrent VTE 35 4.2 (3.0 to 5.9) 134 2.9 (2.4 to 3.4)
Secondary endpoints
Any bleed 239 29.0 (25.6 to 32.9) 383 8.4 (7.6 to 9.3)
Myocardial infarction 11 1.3 (0.7 to 2.4) 31 0.7 (0.5 to 0.9)
Stroke/TIA 9 1.1 (0.6 to 2.1) 29 0.6 (0.4 to 0.9)
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Causes of death over 6 months after VTEn %
Cancer-related 250 54.3
Cardiac 32 7.0
VTE-related events (including
PE)22
4.8
Bleed 15 3.3
Stroke 5 1.1
Other 82 17.8
Unknown 54 11.7
Total 460 100.0
Date of analyses: 24th April 2017, Unpublished Data
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A new diagnosis of cancer
• A new diagnosis of cancer was made in 195
patients in the first 6 months after VTE
diagnosis
Equivalent to a rate of 4.1 (3.6 to 4.8) events per
100 person-years
Date of analyses: 24th April 2017, Unpublished Data
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Characteristics of bleeding
• 106 of 622 (17.0%) bleeds were reported by the investigator to be
major bleed
• 90 of 622 (14.5%) patients required transfusion
• 15 of 622 (2.4%) bleeds were fatal
Date of analyses: 24th April 2017, Unpublished Data
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Conclusions
• Adverse outcomes at 6 months of follow-up of VTE treatment:
• All-cause mortality (9.7 per 100 person-years)
• VTE recurrence (3.6 per 100 person-years)
• Major bleed (2.2 per 100 person-years)
• Myocardial infarction occurred at a rate of 0.9 per 100 person-years
and stroke at a rate of 0.8 per 100 person-years
• New diagnoses of cancer occurred at rate of 4.1 per 100 person-
years
• Fatal bleeding is a rare event
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Panel Discussion
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ACKNOWLEDGEMENTSWe thank the physicians, nurses and patients
involved in the GARFIELD-VTE registry
SAS programming support and editorial assistance was provided by the Thrombosis Research Institute,
London, UK