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March 1, 2002 Medical College of Virginia. Venous Thromboembolism in Rehabilitation Medicine: “the Last Frontier”. Dr. Bill Geerts Sunnybrook & Women’s College HSC University of Toronto. OBJECTIVES. 1. Risks of venous thromboembolism in various

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March 1, 2002

Medical College of Virginia

Venous Thromboembolism in Rehabilitation Medicine:

“the Last Frontier”

Dr. Bill Geerts

Sunnybrook & Women’s College HSC

University of Toronto


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OBJECTIVES

1.Risks of venous thromboembolism in various

patient groups who undergo rehabilitation.

2. Current thromboprophylaxis recommendations

for each of these groups in acute care.

3. Published studies of VTE in rehabilitation settings.

4.Thromboprophylaxisstrategies in rehabilitation.

5. Current treatment of acute VTE.


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Risk of DVT in Hospitalized Patients

Patient group DVT prevalence

Medical patients 10-20 %

Major gyne/urol/gen surgery 15-40 %

Neurosurgery 15-40 %

Stroke 20-50 %

Critical care patients 15-80 %

Hip/knee surgery 40-60 %

Major trauma 40-80 %

Spinal cord injury 60-80 %

Rehabilitation low-high


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6th American College of Chest Physicians Consensus Conference

on Antithrombotic Therapy

Prevention of Venous Thromboembolism

Chest January 2001 Supplement


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Mechanical Prophylaxis Conference

  • Graduated compression stockings

  • Intermittent pneumatic compression

  • Venous foot pump


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Mechanical Prophylaxis Conference

ADVANTAGES

DISADVANTAGES

  • no bleeding

  • efficacious in moderate

  • risk patients


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Mechanical Prophylaxis Conference

ADVANTAGES

DISADVANTAGES

  • no bleeding

  • efficacious in moderate

  • risk patients

  • limited efficacy data

  • no data related to

  • routine use

  • cumbersome

  • poor compliance

  • may  mobilization

  • no long-term use data

  • no mortality data

  • cost


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Pharmacologic Prophylaxis Conference

  • Low dose heparin

  • Adjusted-dose heparin

  • Low molecular weight heparin

  • Danaparoid

  • Hirudin

  • Pentasaccharide

  • Oral thrombin inhibitors: ximelagatran

  • Warfarin


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Pharmacologic Prophylaxis Conference

ADVANTAGES

DISADVANTAGES

  • proven efficacy

  • (RRR 60-80%)

  • broad spectrum of pts

  • N > 100,000

  • multiple agents

  • ease of use

  • high compliance

  • no monitoring (except OAC)

  • demonstrated cost-effectiveness

  • mortality reduction


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Pharmacologic Prophylaxis Conference

ADVANTAGES

DISADVANTAGES

  • proven efficacy

  • (RRR 60-80%)

  • broad spectrum of pts

  • N > 100,000

  • multiple agents

  • ease of use

  • high compliance

  • no monitoring (except OAC)

  • demonstrated cost-effectiveness

  • mortality reduction

  • bleeding - GS 0.1%

  • - ortho 1%

  • cost (low  high)


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Orthopedic Conference

Surgery

Hip arthroplasty

Knee arthroplasty

Hip fracture surgery


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HIP ARTHROPLASTY - PROPHYLAXIS Conference

  • prospective trials with mandatory venography

No. of No. of Risk

Regimen Trials Patients DVT Red’n

Control/placebo

Grad comp stockings

Aspirin

Low dose heparin

Warfarin

Int pneum compress

LMW heparin

Hirudin

12

4

6

11

13

7

30

3

626

290

473

1016

1828

423

6216

1172

54 %

42 %

40 %

30 %

22 %

20 %

16 %

16 %

---

23 %

26 %

45 %

59 %

63 %

70 %

70 %

ACCP CONSENSUS GUIDELINES - CHEST (2001)


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Elective hip replacement Conference

Recommended:

LMWH started 12 hr before surgery, 1A

12-24 hr after surgery, or 4-6 hr after

surgery at half the usual high dose

or

 Warfarin (INR 2-3) 1A

Alternative:

 adjusted-dose heparin to aPTT > ULN 2A

Not recommended: aspirin, LDH, IPC alone

6th ACCP Consensus Conference on Antithrombotic Therapy


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KNEE ARTHROPLASTY - PROPHYLAXIS Conference

  • prospective trials with mandatory venography

No. of No. of Risk

Regimen Trials Patients DVT Red’n

Placebo

Aspirin

Warfarin

Low dose heparin

LMW heparin

Int pneum compress

6

6

9

2

13

4

199

443

1294

236

1740

110

64 %

56 %

47 %

43 %

31 %

28 %

---

13 %

27 %

33 %

52 %

56 %

ACCP CONSENSUS GUIDELINES - CHEST (2001)


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Elective knee replacement Conference

Recommended:

LMWH 1A

or

Warfarin (INR 2-3) 1A

Alternative:

 optimal use of IPC 1B

Not recommended: aspirin, LDH1C+

6th ACCP Consensus Conference on Antithrombotic Therapy


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HIP FRACTURE - PROPHYLAXIS Conference

  • prospective trials with mandatory venography

No. of No. of Risk

Regimen Studies Patients DVT Red’n

---

29 %

44 %

44 %

48 %

Control/placebo

Aspirin

Low dose heparin

LMW heparin

Warfarin

9

3

2

5

5

381

171

59

437

239

48 %

34 %

27 %

27 %

24 %

ACCP CONSENSUS GUIDELINES - CHEST (2001)


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Hip fracture surgery Conference

Recommended:

LMWH 1B

or

 Warfarin (INR 2-3) 1B

Alternative:

 Low dose heparin 2B

Not recommended: aspirin 2A

6th ACCP Consensus Conference on Antithrombotic Therapy


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NEED FOR POST-DISCHARGE PROPHYLAXIS Conference

placebo

THR

R

LMWH

LMWH

(or warfarin)

discharge

day 6-14

venogram

day 30-35

In-hosp

In-hosp + 3-4 weeks post-discharge


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In-hospital vs Post-discharge LMWH After THR Conference

DVT Proximal DVT

Author, year

Bergqvist, 1996

Planes, 1996

Dahl, 1997

Spiro, 1997

Lassen, 1998

Hull, 2000*

COMBINED

Patients

223

173

218

435

215

533

1797

Placebo

37 %

19 %

32 %

23 %

12 %

37 %

27 %

LMWH

18 %

7 %

19 %

8 %

4 %

20 %

14 %

Placebo

24 %

8 %

13 %

13 %

5 %

9 %

12 %

LMWH

7 %

6 %

9 %

3 %

1 %

3 %

4 %

* In-hospital prophylaxis with warfarin.

6th ACCP Consensus Conference on Antithrombotic Therapy


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Extended Duration Prophylaxis: Symptomatic VTE Conference

Eikelboom - Lancet (2001)


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Trauma Conference


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MAJOR TRAUMA PATIENTS ARE Conference

THE HIGHEST RISK GROUP

FOR THROMBOSIS


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Sunnybrook VTE in Trauma Study - 1 Conference

  • ISS > 9; no prophylaxis given

  • Prospective; routine bilateral venography

  • N = 443; mean age 39; ISS 27

DVT PROX DVT

All patients 58 % 16 %

Major injuries:

Face/ chest / abdomen 50 % 15 %

Head 54 % 20 %

Spine 62 % 27 %

L.E. Ortho 69 % 24 %

Geerts - NEJM (1994)


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Major Trauma Conference

Recommended:

 Prophylaxis should be used if possible

 LMWH as soon as considered safe 1A

With high bleeding risk:

 initial mechanical prophylaxis (IPC, 1C

ES) until LMWH safe

High TE risk + suboptimal prophylaxis:

 consider screen with DUS 1C

IVC Filter:

 not for prophylaxis 1C

6th ACCP Consensus Conference on Antithrombotic Therapy


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Spinal Cord Injury Conference


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ACUTE SPINAL CORD INJURY: LDH + EPC vs LMWH Conference

  • Randomized trial in 27 acute spinal cord units

  • C2-T12 SCI ASIA A, B, or C (motor nonfunctional)

Acute Phase Rehab Phase

No VTE

Heparin + IPC Heparin 5000 U Q8H

5000 U Q8H

R

VTE

Enoxaparin Enoxaparin 40 mg once daily

30 mg Q12H

No VTE

2 weeks

bilateral venography

+ DUS

8 weeks

DUS


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SCI Multicenter Trial: Conference

Rehabilitation Phase (Weeks 2-8)

  • Patients who completed Acute Phase without VTE

  • Routine DUS at start of Rehab Phase + 6 weeks later

Heparin Enoxaparin

5000 Q8H 40 mg QD

No. 60 59

New VTE 22% 8%

DVT 18% 7%

PE 3%* 2%

Major bleeding 1 0

* 1 fatal


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Acute Spinal Cord Injury Conference

Recommended:

 LMWH 1B

If anticoagulants C/I early after injury:

 IPC and ES  LMWH2B

Possible alternative:

 IPC/ES + LMWH/LDH 2B

Not recommended:

 LDH, ES, IPC alone 1C

Rehabilitation phase:

 continue LMWH or warfarin (INR2-3) 1C

6th ACCP Consensus Conference on Antithrombotic Therapy


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Stroke Conference


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Ischemic Stroke Conference

Recommended:

 LDH, LWMH, danaparoid 1A

If anticoagulants contraindicated:

 ES or IPC 1C+

6th ACCP Consensus Conference on Antithrombotic Therapy



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VTE IN REHABILITATION: PROBLEMS Conference

1. Scanty, poor quality data - ??? risk

2. Huge patient variability: underlying conditions, time

in acute care, pre-rehab prophylaxis, duration of rehab

3. Some patients have DVT on admission

4. Symptoms/signs: nonspecific, reduced communication

5. Risk often prolonged

6. Often no diagnostic testing on site

7. ? Higher threshold for Dx  larger thrombi/emboli

8. Resource utilization: transportation, diagnostic tests,

two hosp beds, interrupts/prolongs rehab, drug costs


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GENERAL REHABILITATION Conference

Prophylaxis

prior to rehab

Author,

year

Method

of Dx

When

screened

Prox

DVT

No.

DVT

Halvorsen,

1985a

Katz,

1995

NS

70 %

(various)

FgLS 

veno

IPG 

DUS

NS

on adm

(< 6 mos)

150

301

18%

---

NS

1%


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STROKE REHABILITATION Conference

Prophylaxis

prior to rehab

Method

of Dx

When

screened

Prox

DVT

Author, yr

No.

DVT

Cope, 73

Miyamoto, 80

Sioson, 88

Desmukh, 91

Oczkowski, 92

Pambianco, 95

Harvey, 96

NS

NS

21%

NS

35 %

NS

some

veno

FgLS

IPG

DUS

IPG

DUS

DUS

on adm

10-14 d

45 d

21 d

81 d

on adm

25 d

42

141

98

123

93

421

105

40 %

28 %

---

18 %

---

14 %

13 %

NS

NS

33 %

NS

12 %

NS

NS


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TRAUMATIC BRAIN INJURY REHABILITATION Conference

Prophylaxis

prior to rehab

Author,

year

Method

of Dx

When

screened

Prox

DVT

No.

DVT

Cifu,

1996

Meythaler,

1996

All (LDH or IPC)

none

DUS

DUS

On adm

(4-29 d)

On adm

(< 4 mos)

82

116

18%

NS

14 %

8 %


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SPINAL CORD INJURY REHAB Conference

Prophylaxis

prior to rehab

Author,

year

Method

of Dx

When

screened

Prox

DVT

No.

DVT

Jarrell,

1983

Yelnik,

1991

Gunduz,

1993

LDH

91%

all

none

FgLS

+ IPG

veno

veno

veno

NS

on adm

(45 d)

80 d

27 d

209

127

87

30

65 %

23 %

14 %

53 %

NS

NS

NS

28 %


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VTE in Rehabilitation Conference

The best strategy is

optimal prophylaxis

in the acute care setting


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PROPHYLAXIS OPTIONS IN REHAB Conference

1. Mobilization

2. Physiotherapy

3. Low dose heparin

4. Low molecular weight heparins

5. Warfarin


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PREVENTING VTE in REHAB: PRINCIPLES Conference

  • Appropriate prophylaxis MUST start in acute care

  • Written policy (care pathway)

  • Simple, universal

  • Routine prophylaxis for highrisk patients (SCI,

  • hip and knee surgery, orthopedic trauma)

  • No prophylaxis (or individual decision) for lower

  • risk patients (stroke, head injury, amputation, burn)

  • No routine screening for DVT


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Strategies to facilitate effective, safe, efficient, and cost-effective thromboprophylaxis in rehab settings

  • Written, “approved” and used protocols

  • Pharmacy involvement

  • Point of care INR testing

  • Greater use of LMWH if LOS < 2 weeks

  • “Education” of referring centers


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REHAB PROPHYLAXIS SUMMARY cost-effective thromboprophylaxis in rehab settings

Patient Group

Spinal cord injury

LE orthop trauma

THR

TKR

Hip fracture

Others

Duration

Until discharge

Until discharge

2-4 wks postop

(~ til discharge)

  • Method

  • Warfarin

  • (INR 2-3)

  • Warfarin

  • (INR 2-3)

  • LMWH

  • Warfarin

  • (INR 2-3)

  • None

  • Individualize


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? Post-rehab Prophylaxis cost-effective thromboprophylaxis in rehab settings

Almost never


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Treatment of VTE in Rehabilitation cost-effective thromboprophylaxis in rehab settings


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Treatment of Venous Thromboembolism: cost-effective thromboprophylaxis in rehab settings

S/C Low Molecular Weight Heparin

is Preferred over IV Heparin

1. At least as efficacious

2. Safer:  bleeding

 HIT

3. Reduced all-cause mortality

4. Cheaper

5. No lab monitoring

6. Most can be treated as out-patients


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Treatment of DVT/PE cost-effective thromboprophylaxis in rehab settings

LMWH S/C

Oral Anticoagulation (INR 2.0 - 3.0)

5-7 d

3 mos-indefinite

  • Subcutaneous LMWH:

  • dalteparin (Fragmin) 100 U/kg BID or 200 U/kg QD

  • enoxaparin (Lovenox) 1 mg/kg BID or 1.5 mg/kg QD

  • nadroparin (Fraxiparine) 86 U/kg BID

  • tinzaparin (Innohep) 175 U/kg QD

  • No lab monitoring or dosage adjustment


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INDICATIONS FOR PROLONGED LMWH THERAPY cost-effective thromboprophylaxis in rehab settings

1. Pregnancy

2. Uncontrolled malignancy

3. High risk of bleeding

4. Warfarin failure

5. Major chemotherapy

6. INR monitoring difficult

- poor venous access

- geographic inaccessibility

- unstable values

7. Need for recurrent invasive procedures

8. PATIENT PREFERENCE


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Indications for an IVC Filter cost-effective thromboprophylaxis in rehab settings

Recent PROXIMAL DVT PLUS:

1. Absolute C/I to full anticoagulation

2. Untreatable, major bleeding on anticoag

NOT for: PE without proximal DVT

Minor bleeding

Minor/moderate surgery

Primary prophylaxis

“Recurrent” VTE/failure of Rx


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Vitamin K: Routes & Doses cost-effective thromboprophylaxis in rehab settings

IM  NEVER

SC  RARELY (only if NPO)

IV  1 mg for MINOR bleeding

10 mg for MAJOR bleeding

PO  ROUTE OF CHOICE

INR < 9 1 mg

INR > 9 2.5-5 mg

FFP  Only if major bleeding, surgery

imminent


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Duration of Anticoagulation cost-effective thromboprophylaxis in rehab settings

1. RISK FACTOR RESOLUTION

2. NUMBER OF EPISODES OF VTE

3. THROMBOEMBOLISM RESOLUTION

4. BLEEDING RISK

5. PATIENT PREFERENCE

INDIVIDUALIZE


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Discussion cost-effective thromboprophylaxis in rehab settings

Questions


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6th ACCP Consensus Conference on Antithrombotic Therapy cost-effective thromboprophylaxis in rehab settings

Chest Supplement January 2001

Prevention of Venous Thromboembolism

Bill Geerts, chair

John Heit

Patrick Clagett

Graham Pineo

Cliff Colwell

Fred Anderson

Brownell Wheeler


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ACCP CONSENSUS CONFERENCES ON ANTITHROMBOTIC THERAPY cost-effective thromboprophylaxis in rehab settings

Chest 1986, 1989, 1992,

1995, 1998, 2001, 2003


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Pulmonary Embolism in UK Hospitals cost-effective thromboprophylaxis in rehab settings

  • 0.9 % of pts admitted to hospital DIE from PE

  • < 1/2 of high risk pts had any prophylaxis

  • 400 deaths/yr could be saved by prophylaxis

  • £ 33-82 million/yr COST SAVINGS with more

  • appropriate use of prophylaxis

Office of Health Economics (1996)


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Making Health Care Safer: A Critical cost-effective thromboprophylaxis in rehab settings

Analysis of Patient Safety Practices

  • UCSF-Stanford Evidence-Based Practice Center report for

  • Agency for Healthcare Research and Quality, US DOHHR

  • systematic review of practices to improve patient safety

  • rank practices according to strength of evidence supporting

  • more widespread implementation

No. 1 = “Appropriate use of prophylaxis to prevent venous

thromboembolism in patients at risk”

Shojania (2001)


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Rationale for Prophylaxis cost-effective thromboprophylaxis in rehab settings

  • high incidence of VTE

  • associated mortality and morbidity

  • cost of diagnosis and treatment

  • treatment-related complications

OPPORTUNITY TO:

1. Improve patient outcomes, AND

2. Reduce costs


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VTE Prevalence after THR or TKR Surgery, cost-effective thromboprophylaxis in rehab settings

or Surgery for Hip Fracture

Deep Vein Thrombosis*

Total, % Proximal, %

45-57 23-36

40-84 9-20

36-60 17-36

Pulmonary Embolism

Total, % Fatal, %

0.7-30 0.1-0.4

1.8-7 0.2-0.7

4.3-24 3.6-12.9

Procedure

THR

TKR

Hip fracture surgery

* DVT rates among control/placebo groups in RCTs using routine venography

6th ACCP Consensus Conference on Antithrombotic Therapy


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HIP ARTHROPLASTY cost-effective thromboprophylaxis in rehab settings

1000 patients undergoing THA

Without Prophylaxis:

500 develop DVT

166 have symptomatic DVT

100 develop symptomatic nonfatal PE

20 die due to PE

Paiement - Am J Surg (1991)


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DVT after THR cost-effective thromboprophylaxis in rehab settings

  • 289 patients prophylaxed with GCS + SCD

  • Ipsilateral duplex ultrasound 5 days postop

Proximal DVT

Overall

Anesthetic - general

- regional

Age > 75

< 75

Age > 75 + GA

6 %

11 %

4 %

16 %

3 %

26 %

Woolson - JBJS (1996)


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Warfarin vs Dalteparin in THR cost-effective thromboprophylaxis in rehab settings

  • 580 patients; bilateral contrast venography

Warfarin Dalteparin P

INR 2.5 5000 U daily

Patients

DVT

Proximal DVT

Major bleeding

Op site bleeding

Transfused - OR day

- D 1 - 8

190

26 %

8 %

1 %

1 %

65 %

44 %

192

15 %

5 %

2 %

4 %

69 %

68 %

0.006

NS

NS0.03

NS

0.004

Francis - JBJS (1997)


Slide61 l.jpg

Prevention of DVT After THR Surgery* cost-effective thromboprophylaxis in rehab settings

Combined

Enrollment

626

290

473

1016

1828

423

6216

1172

293

Total DVT

Prevalence RRR

54 % ---

42 % 23 %

40 % 26 %

30 % 45 %

22 % 59 %

20 % 63 %

16 % 70 %

16 % 70 %

14 % 74 %

Proximal DVT

Prevalence RRR

27 % --

26 % 4 %

11 % 57 %

19 % 27 %

5 % 80 %

14 % 48 %

6 % 78 %

4 % 85 %

10 % 62 %

Prophylaxis Regimen

Control/placebo

Elastic stockings

Aspirin

Low dose heparin

Adjusted-dose warfarin

IPC

LMWHRecombinant hirudin

Adjusted-dose heparin

No. of

Trials

12

4

6

11

13

7

30

3

4

* Pooled DVT rates using routine contrast venography.

6th ACCP Consensus Conference on Antithrombotic Therapy


Slide62 l.jpg

Prevention of DVT After TKR Surgery* cost-effective thromboprophylaxis in rehab settings

Combined

Enrollment

199

145

443

1294

236

172

1740

110

Total DVT

Prevalence RRR

64 % ---

61 % 6 %

56 % 13 %

47 % 27 %

43 % 33 %

41 % 37 %

31 % 52 %

28 % 56 %

Proximal DVT

Prevalence RRR

15 % --

17 % --

9 % 42 %

10 % 35 %

11 % 25 %

2 % 85 %

6 % 63 %

7 % 52 %

Prophylaxis Regimen

Control/placebo

Elastic stockings

Aspirin

Warfarin

Low dose heparin

Venous foot pump

LMWH

Int. Pneum. Compr.

No. of

Trials

6

2

6

9

2

4

13

4

* Pooled DVT rates using routine contrast venography.

6th ACCP Consensus Conference on Antithrombotic Therapy


Slide63 l.jpg

Prevention of DVT After Surgery for Hip Fracture* cost-effective thromboprophylaxis in rehab settings

Prophylaxis Regimen

Control/placebo

Aspirin

Low dose heparin

LMWH/heparinoidWarfarin

Combined

Enrollment

381

171

59

437

239

(95 % CI)

(43-53)

(27-42)

(16-40)

(23-31)

(19-30)

No. of

Trials

9

3

2

5

5

Relative Risk

Reduction

- -

29 %

44 %

44 %

48 %

DVT

48 %

34 %

27 %

27 %

24 %

* Pooled total DVT rates in RCTs using routine contrast venography.

6th ACCP Consensus Conference on Antithrombotic Therapy


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249 cost-effective thromboprophylaxis in rehab settings

257

1142

842

1516

1494

588

This concept has been challenged by 4 prospective studies based on symptomatic VTE after in-hospital prophylaxis for THR or TKR

Sympt

DVT

Fatal PE

Duration,d

Therapy

Procedure

n

Robinson

THR

W

9.8

1.2%

0

1997

TKR

W

9.8

0.6%

0

Leclerc

THR

LM

9.0

4.3%

0

1998

TKR

LM

9.0

3.9%

0.4%

Colwell

THR

LM

7.5

3.6%

0.1%

1999

THR

W

7.0

3.7%

0.1%

Heit 2000

THR

LM

7.3

2.0%

0

ACCP - Chest (2001)

W, warfarin; LM, low molecular weight heparin


Extended duration prophylaxis venography l.jpg
Extended Duration Prophylaxis: cost-effective thromboprophylaxis in rehab settingsVenography

Eikelboom - Lancet (2001)


Risk reduction of clinical vte l.jpg

1 cost-effective thromboprophylaxis in rehab settings

.1

.2

5

10

Risk reduction of clinical VTE

Expt Ctrl Peto OR Weight Peto OR Study n/N n/N (95% CI Fixed) % (95% CI Fixed)

Bergqvist 2/191 10/131 19.7 0.26 (0.08, 0.79)

Dahl 4/117 6/110 16.6 0.62 (0.17, 2.18)

Helt 7/607 10/588 26.6 0.66 (0.26, 1.78)

Hull 4/291 9/133 10.2 0.58 (0.12, 2.91)

Lassen 2/140 9/141 8.5 0.57 (0.11,6.92)

Planes 3/90 7/88 16.9 0.49 (0.12, 1.52)

Total (95% CI) 22/1370 39/1192 100.0 0.50 (0.30, 0.83)

Favours treatment

Favours control

Cohen - Thromb Haemost (2001)


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Orthopedic Surgery - Other Issues cost-effective thromboprophylaxis in rehab settings

Duration of Prophylaxis:

Uncertain, but at least 7-10 days

 Extended, out-of-hospital LMWH may reduce

clinically-important VTE and is recommended

at least for high-risk patients

Pre-discharge Screening:

 Routine DUS not recommended

1A

1A

1A

6th ACCP Consensus Conference on Antithrombotic Therapy


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Symptomatic VTE After In-hospital Prophylaxis cost-effective thromboprophylaxis in rehab settings

Duration of

Prophylaxis

9.8 d

9.8 d

9.0 d

9.0 d

7.5 d

7.0 d

7.3 d

Sympt.

VTE, (%)

6 (1.2)

3 (0.6)

49 (4.3)

33 (3.9)

55 (3.6)

56 (3.7)

11 (1.9)

Fatal PE,

(%)

0

1 (0.2)

0

3 (0.4)

2 (0.1)

2 (0.1)

3 (0.5)

Author, year

Robinson, 1997

Leclerc, 1998

Colwell, 1999

Heit, 2000

Operation

THR

TKR

THR

TKR

THR

THR

THR/TKR

No.

506

518

1,142

842

1,516

1,495

588

Prophylaxis

warfarin

warfarin

LMWH

LMWH

LMWH

warfarin

LMWH

6th Consensus Conference on Antithrombotic Therapy


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Clinical Outcomes After THA cost-effective thromboprophylaxis in rehab settings

  • Patients: elective, unilateral, primary THA

  • Design: 156 centers, unblinded RCT

  • Interventions: enoxaparin 30 mg BID postop

  • warfarin INR 2-3 pre- or postop

}

in hospital

(x = 7.3 d)

No.

Symptomatic VTE (OR ---> 3 mos)

In-hospital

Discharge ---> 3 mos

Fatal PE

Bleeding - all

- major

Warfarin* Enoxaparin

1495 1516

3.7 % 3.6 %

1.1 % 0.3 % p=0.008

2.6 % 3.4 %

2 2

7.4 % 10.0 % p=0.01

0.5 % 1.2 % p=0.06

* only 35 % had INR >2 by day 7 Colwell - JBJS (1999)


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  • Extended duration of prophylaxis for cost-effective thromboprophylaxis in rehab settings

    30 – 42 days reduced symptomatic VTE: 1.3 % vs 3.3 %, OR: 0.38,

    95% CI: 0.24 – 0.61, NNT = 50

  • Asymptomatic venographic DVT also significantly reduced:9.6 % vs 19.6 %, OR: 0.49,

    95% CI: 0.36 – 0.63, NNT = 10

  • Major bleeding: similar in extended prophylaxis as in placebo and untreated groups


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Eikelboom - Lancet (2001)


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Conclusions sympt.

  • There is good evidence that prolonged prophylaxis reduces asymptomatic DVT

  • Also good evidence that prolonged prophylaxis reduces symptomatic VTE

  • Unable to identify the patients at risk for late VTE

  • A 2 % rate for (preventable) symptomatic VTE is excessive in view of the high frequency of major orthopedic surgery


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Duration of Prophylaxis after sympt.

Major Orthopedic Surgery

Optimal duration after THR/TKR uncertain

Recommendations:

at least 7-10 days 1A

 extended out-of-hospital prophylaxis 2A

may reduce clinically important VTE

and is recommended at least for high-

risk patients

6th ACCP Consensus Conference on Antithrombotic Therapy


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Incidence of DVT in Trauma Patients (No Prophylaxis) sympt.

LE Prox

Author, yr Patients No . Fracture DVT DVT

NS

8 %

NS

32 %

18 %

4 %

Injuries  bedrest > 3 weeks

Tibial fractures

Tibial fractures

Multisystem trauma, bedrest > 10 d

Major trauma, ISS > 9

Isolated LE # Rx’d surgically

42

76

14

38

349

102

29 %

45 %

57 %

63 %

58 %

28 %

Freeark, 1967

Hjelmstedt, 1968

Nylander, 1972

Kudsk, 1989

Geerts, 1994

Abelseth, 1996

33 %

100 %

100 %

55 %

52 %

100 %

6th ACCP Consensus Conference on Antithrombotic Therapy


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Randomized Studies of DVT Prevention after Acute SCI sympt.

Regimen Author, yr Endpoints DVT, No. (%)

Low-dose heparin Green, 1988

Green, 1990

Geerts, 1996

IPC Green, 1982

Adjusted-dose heparin Green, 1988

LMWH Green, 1990

Geerts, 1996

Combinations Green, 1982

(IPC, ASA, dipyridamole)

9/29 (31)

5/19 (26)

10/15 (67)

6/15 (40)

2/29 ( 7)

0/16 ( 0)

4/8 (50)

3/12 (25)

IPG

IPG, DUSVenography

FgLS/IPG

IPG

IPG, DUS

Venography

FgLS/IPG

6th ACCP Consensus Conference on Antithrombotic Therapy


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DVT in Patients with Acute SCI - No Prophylaxis sympt.

No. of

Patients

10

18

9

8

9

26

DVT

90 %

72 %

100 %

48 %

67 %

81 %

Proximal DVT

NS

17 %

NS NS NS

35 %

Author, year

Brach, 1977

Rossi, 1980

Myllynen, 1985

Merli, 1988

Petaja, 1989

Geerts, 1994

Endpoint

FgLS/IPG

FgLS

FgLS

FgLS/IPG

FgLS

Venography

6th ACCP Consensus Conference on Antithrombotic Therapy


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SCI Multicenter Trial: sympt.

Acute Treatment Phase (Weeks 0-2)

  • Routine venography and DUS day 14 + 3; blinded interpretation

Heparin 5000 Q8H Enoxaparin

+ IPC 30 mg BID

No. rand/completed 246/48 230/58

VTE 63% 66%

DVT 46% 60%

Proximal DVT 7% 9%

PE 10% 3%

Major VTE (pDVT+PE) 16% 12%

Major bleeding 5% 3%


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RISK OF SYMPTOMATIC VTE AFTER SCI sympt.

A. age-matched controls

B. no prophylaxis

C. prophylaxis

RISK

B

C

A

1 2

years

1 2 3 4 5 6

weeks


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Cost-effectiveness of Prophylaxis sympt.

  • 1000 patients undergoing THA

Strategy

Observation only

Warfarin

Warfarin + duplex scan

Warfarin X 12 wks

Fatal PE

20.0

4.0

0.3

0.15

Charges (US $)

$ 774,000

394,000

616,000

595,000

Paiement - Am J Surg (1991)


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VTE in Stroke sympt.

  • Prospective studies

  • No prophylaxis

  • Routine screening for DVT (17/18 used FgLS)

Studies 18

Patients 749

DVT 49 %

Prox DVT 11 % (17/152)

PE 6 % (10/174)

Fatal PE 4 % (12/270)


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Prevention of DVT in Ischemic Stroke sympt.

Trials Patients DVT RRR

---

56 %

58 %

82 %

8

5

3

4

55 %

24 %

23 %

10 %

Control

Low dose heparin

LMWH

Danaparoid

346

364

158

203

Geerts (6th ACCP) - Chest (2001)


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Risk Factors for VTE in Stroke sympt.

Degree of paralysis

Age

YES

Level of consciousness

NO

Improvement in weakness

Previous VTE

Varicose veins

Obesity

UNKNOWN


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DVT Treatment: UFH or LMWH? sympt.

  • meta-analysis of RCTs

  • adjusted UFH vs fixed-dose S/C LMWH

  • 11 studies, 3674 patients

UFH

5.4 %

6.8 %

1.9 %

LMWH

4.6 %

5.0 %

1.1 %

RRR

15 %

27 %

42 %

P

> 0.2

0.02

0.47

NNT

114

61

164

Recurrent VTE

All cause mortality

Major bleeding

Gould - AIM (1999)