the continuing challenge of venous thromboembolism ......gould mk et al, 9th ed: accp evidence-based...

Satellite Symposium

The Continuing Challenge of Venous Thromboembolism: Insights from the GARFIELD-VTE Registry

ISTH 2017 Congress, Berlin, Germany

Understanding the global burden: GARFIELD-VTE

Rt Hon Professor the Lord Kakkar

Thrombosis Research Institute and

University College London UK

Disclosures

Grants and personal fees

Bayer

Personal fees

Boehringer-Ingelheim Pharma, Daiichi Sankyo Europe, Sanofi SA, Janssen Pharma

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.

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

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

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


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)

ArgentinaBrazilCanadaMexicoUnited States of America

BelgiumCzech RepublicDenmarkFranceGermanyItalyThe NetherlandsRussiaSpainSwitzerlandUnited Kingdom

AustraliaChinaEgyptHong KongJapanMalaysiaSouth AfricaSouth KoreaTaiwanThailandTurkeyUnited Arab Emirates

Participating countries

10 878 patients enrolled in 28 countries


Garfield-VTE: Reflecting multiple care pathways

Post-operative careOutpatients/Primary care

Internal medicine/ ICU Antenatal and peri-

partum care

Oncology

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

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

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

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

37.5% of patients have at least 1 transient provoking risk factor1

(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)

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)

Treatment within ± 30 days of diagnosis

Thrombolytic: Systemic or catheter-directed Surgical Mechanical: IVC filter, pulmonary embolectomy, thrombectomyCompression: Bandages or stockings


AC only: 84.3%

Compression only or no therapy: 11.1%

Thrombolytic ± AC3.0%

Surgical/Mechanical ± AC0.9%

Thrombolytic, Surgical or Mechanical ± AC: 0.6%

Other 4.5%

(N=10 677)

GARFIELD-VTE is a contemporary treatment registry evaluating a broad-cross section of VTE patients from multiple treatment pathways

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

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

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

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

UK: RECURRENT VTE

(Martinez C. Thromb Haemost 2014; 112: 255-263)

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)

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


OF WARFARIN

(PADIS-PE. JAMA 2015; 314: 31-40)


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)

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

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)

EINSTEIN CHOICE:

LONG-TERM PREVENTION OF

RECURRENT VTE

(Weitz JI. Thromb Haemost 2015; 114: 645-650)

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

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)

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)

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

Anticoagulation strategies –

from initial treatment to

6 months therapy

Professor Sylvia Haas Formerly Klinikum re. der Isar, Technical University

of Munich, Munich, Germany

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

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

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...

Aim

• To describe initial and longer term anticoagulation (AC)

treatment patterns of patients prospectively enrolled

from May 2014 to January 2017







(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

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)

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

% Patients on Parenteral AC

(n=6268)

Low molecular weight heparin 89.0%

Unfractionated heparin 13.0%

Fondaparinux 4.0%

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


- 4,3 % + 4,6 %

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

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


Date of analyses: 24th April 2017*DVT includes arm and leg thrombosis, vena cava and atypical sites

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



Initial AC treatment patterns ─ before and after diagnosis

n=621 n=8951


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

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

Cancer Associated Thrombosis

in Everyday Practice

Professor Jeffrey I. Weitz

McMaster University and Thrombosis and

Atherosclerosis Research Institute,

Hamilton, Canada

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

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


Heit, Arch Intern Med, 2003; Sorensen, N Engl J Med, 2000; Chew, Arch Intern Med, 2006; Khorana, J Thromb Haemost, 2007

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








(n=11 842)

Enrolled with an objectively confirmed diagnosis of VTE1

(n=10 677)

Patient population


History of cancer

(n=662; 6.2%)

No cancer

(n=9034; 84.6%)

Active cancer

(n=981; 9.2%)

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

Site of pulmonary arterial branch involvement


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

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

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

http://globocan.iarc.fr/Pages/fact_sheets_population.aspx

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


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

Outcomes in the Real World

Professor Alexander G G Turpie

McMaster University, Hamilton, Canada

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

Introduction

• Garfield VTE is a global prospective observational study of the management of VTE patients

• GARFIELD VTE evaluates the rates and nature of VTE recurrence, major bleeding and all-cause mortality up to 36 months of follow-up

Aim

• To describe the baseline characteristics of patients and outcomes over 6 months after an objectively confirmed diagnosis of VTE

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







(n=11 842)

Enrolled with an objectively

confirmed diagnosis of VTE1 (n=10 677)

Patient population


Subset analyses of patients with 6 months follow-up

(n=10 315)

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)


Outcomes in the first month and over the following

2 ─ 6 months after diagnosis of VTE


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)

Causes of death over 6 months after VTE

n %

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 460 100.0Date of analyses: 24th April 2017

A new diagnosis of cancer

• A new diagnosis of cancer was made in 195

patients over the first 6 months after VTE

Equivalent to a rate of 4.1 (3.6 to 4.8) events per

100 person-years


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


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 occurs 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 occur at rate of 4.1 per 100 person-years

• Fatal bleed is a rare event

Panel Discussion

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

the continuing challenge of venous thromboembolism ......gould mk et al, 9th ed: accp evidence-based...

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