Medical Patients – VTE Prevention

Dale W. Bratzler, DO, MPHProfessor and Associate Dean, College of Public Health

Professor of Medicine, College of MedicineChief Quality Officer – OU Physicians Group

University of Oklahoma Health Sciences Center

August 3, 2012

During 2007–2009, an estimated annual average of 547,596 adult hospitalizations occurred for which a discharge diagnosis of VTE was recorded;

348,558 of these hospitalizations had a discharge diagnosis of DVT, and 277,549 had a discharge diagnosis of PE. A total of 78,511 had both discharge

diagnoses.

MMWR. 2012; 61:401-4.

VTE in Medical Patients

Medical patients account for:

- 80% of fatal PE in hospitals

- 60% of symptomatic VTE in hospitals

No prophylaxis + routine screening for DVT:

DVT 10-20% (greater in stroke)

Proximal DVT 4-5%

Burden of VTE in Hospital PatientsWhy are medical patients so important?

VTE riskper patient

Examples: SCI THR, TKR other surgery medical patients maj trauma

100%

25%

75%

50%

ACP Meta-Analysis of VTE Prophylaxis in Medical Patients: Summary

1. In medical patients, anticoagulant prophylaxis reduced PE but not total mortality or symptomatic DVT with more bleeding events (but not more major bleeding).

2. In acute stroke patients, anticoagulant prophylaxis did not reduce total mortality, PE or symptomatic DVT but increased major bleeding (but not all bleeding).

3. In medical + acute stroke patients, anticoagulant prophylaxis reduced PE but not total mortality (p=0.056) or symptomatic DVT with increased major and all bleeding.

4. No difference in any outcomes for LDH vs LMWH.

Lederle – Ann Intern Med 2011;155:602

ACP VTE Prophylaxis in Medical Patients: Recommendations

1. Assess risk of VTE and bleeding before starting prophylaxis i.e. individual risk assessment [strong recommendation; moderate quality evidence]

2. Use anticoagulant prophylaxis (heparin, LMWH, fonda) unless bleeding risk outweighs likely benefit [strong recommendation; moderate quality evidence]

3. Don’t use graduated compression stockings [strong recommendation; moderate quality evidence]

4. ACP does not support use of performance measures in medical patients that promote universal prophylaxis regardless of risk

Qaseem – Ann Intern Med 2011;155:625

ACP Meta-Analysis of VTE Prophylaxis in Medical Patients: Limitations -1

1. Asked a question for which the answer was already known (Lederle, 1998, 2006; Dentali 2007; Wein 2007; etc).

2. Combined very different patient groups (GIM, ICU, ischemic stroke, palliative care) to get greater power BUT…

3. Expanding the sample increases heterogeneity not truth.

4. More than ½ of the included studies used prophylaxis options (agent or dose) we don’t use (17/32 trials).

5. Many studies followed patients for only 7-30 days.Lederle – Ann Intern Med 2011;155:602

Symptomatic VTE in Medical Patients

Meta-analysis of RCTs of anticoagulant vs no prophylaxis 9 studies with 19,958 medical patients

Outcome No prophylaxis Prophylaxis RR [95% CI] NNT

PE 49/10043 20/9915 0.43 [0.26-0.71] 345

Fatal PE 39/9823 14/9687 0.38 [0.21-0.69] 400

Sympt DVT 21/2587 10/2619 0.47 [0.22-1.00]

Death 165/3679 158/3676 0.97 [0.77-1.21]

Maj Bleed 19/4304 25/4301 1.32 [0.73-2.37]

Dentali – Ann Intern Med 2007;146:278

Meta-analysis of Thromboprophylaxis in Medical Patients

No Prophylaxis vs Anticoagulant Prophylaxis

No RelOutcome Trials Patients Prophy Prophy Risk p

DVT 22 8,333 11.0% > 4.9% 0.45 <0.001

PE 19 39,762 1.0% > 0.6% 0.48 <0.001

Mortality 20 42,960 7.5% 7.3% 0.95 0.15

Bleeding 16 40,031 1.7% < 3.8% 1.71 <0.001

Wein – Arch Intern Med 2007;167:1476

Meta-analysis of Thromboprophylaxis in Medical Patients

Low Dose Heparin vs Low Molecular Weight Heparin

Outcome Trials Patients LDH LMWH Rel Risk p

DVT 9 4,421 5.4% > 3.7% 0.68 0.004

PE 7 4,231 0.6% 0.3% 0.65 0.36

Mortality 10 4,881 2.9% 3.3% 1.14 0.46

Total Bldg 9 4,715 3.3% 2.7% 0.83 0.26

Major Bldg 7 4,497 1.8% 1.4% 0.78 0.29

platelets 3 2,574 0.5% 0.1% 0.29 0.13

Wein – Arch Intern Med 2007;167:1476

RCTs of Medical Prophylaxis with LMWH/LDH

Lederle – Am J Med 2006;119:54

All-cause mortality

ACP Meta-Analysis of VTE Prophylaxis in Medical Patients: Limitations - 2

6. Inappropriate to use total mortality at 120 days as the primary outcome:a) Only 3/40 trials used it as the primary outcome b) 3 trials didn’t even report death as an outcomec) All-cause deaths have nothing to do with VTEd) Prophylaxis given for 5-14 days - ? relevance of all-cause death at120 days

7. Did not assess for symptomatic VTE (also problematic with the studies included).

8. Clinical VTE outcomes (symptomatic VTE, fatal PE) are underestimated in studies with a routine screening test for asymptomatic DVT.

Lederle – Ann Intern Med 2011;155:602

6.0 Medical Patients

6.0.1 For acutely ill medical patients admitted to hospital with congestive heart failure or severe respiratory disease, or who are confined to bed and have one or more additional risk factors, including active cancer, previous VTE, sepsis, acute neurological disease, or inflammatory bowel disease, we recommend prophylaxis with LMWH [Grade 1A], LDUH [Grade 1A], or fondaparinux [Grade 1A].

6.0.2 For medical patients with risk factors for VTE, and in whom there is a contraindication to anticoagulant prophylaxis, we recommend the optimal use of mechanical prophylaxis with GCS or IPC [Grade 1A].

8th ACCP Guidelines on Antithrombotic Therapy

ACCP 9th EditionGeneral Overview

• For acutely ill hospitalized medical patients at increased risk of thrombosis, we recommend anticoagulant thromboprophylaxis with LMWH, LDUH, or fondaparinux (Grade 1B)– Mechanical prophylaxis (GCS or IPC) if bleeding or

high risk for bleeding• Similar recommendation for critically ill

patients

Prophylaxis Use in Medical Patients1,894 medical patients in 29 hospitals in 6 provinces

Khan – Thromb Res 2007;119:145

90%Prophylaxis Prophylaxis Recommended indicated given prophylaxis

23% 15%

100%

75%

50%

25%

0

Knowledge-care gap

Appropriate use

Thromboprophylaxis in Medical Patients

Acute medical illness with: CHF respiratory decompensation stroke bedrest + active cancer, prior VTE, sepsis, IBD

1. Individual decision

2. Daily reassessment

Prophylaxis indicated

LMWHHeparin 5,000 U bid (or tid)

Anticoagulant prophylaxis contraindicated

mechanical prophylaxis - Grad compr stockings - Int pneumatic compr anticoag when C/I gone

No

Yes

Is Prophylaxis Perfect?

Surgery Type

Cases (VTE event)

N/D (%)*ControlsN/D (%)*

All Procedures 72/116 (62.1) 83/116 (71.6)Orthopedic surgery 55/63 (87.3) 55/63 (87.3) Knee Replacement 28/31 (90.3) 23/25 (92.0) Hip Replacement 17/20 (85.0) 24/26 (92.3)General Surgery 13/34 (38.2) 17/31 (54.8)Urologic Surgery 0/8 (0) 2/7 (28.6)Thoracic Surgery 2/5 (40.0) 5/8 (62.5)Lower extremity amputation 2/6 (33.3) 4/7 (57.1)

Boraecki AM, et al. Jt Comm J Qual Patient Saf. 2012; 38:348-57.

*Appropriate pharmacologic prophylaxis.

Other Findings

• Underuse of prophylaxis for patients with malignancy

• Clinicians often failed to document reasons for lack of pharmacoprophylaxis (medicolegal issue)

• Some reasons documented for failure to use pharmacoprophylaxis are questionable (e.g., epidural use

• Higher rates of “mechanical prophylaxis only” in cases

Group name: Hospital Quality ShareGroup home page: http://groups.google.com/group/hospital-quality-shareGroup email address hospital-quality-share@googlegroups.com

dale-bratzler@ouhsc.edu