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DVT Prophylaxis in Medical Patients. Rog Kyle, MD MUSC 6/5/12. Review risks for developing DVT and bleeding from DVT prophylaxis Review current recommendations for inpatient DVT prophylaxis (AT9) Review different pharmacologic and mechanical methods for DVT prophylaxis

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slide2

Review risks for developing DVT and bleeding from DVT prophylaxis

  • Review current recommendations for inpatient DVT prophylaxis (AT9)
  • Review different pharmacologic and mechanical methods for DVT prophylaxis
  • Examine recent controversies in DVT prophylaxis
risk for dvt
Risk for DVT
  • Historical baseline
    • 0.8% DVT
    • 0.4% PE
    • Not used by ACCP 2012
  • Hospitalization in general associated with 8X VTE risk and 25% of all VTE
  • 50-75% of all in hospital VTE events are on medical services
risk for dvt1
Risk for DVT
  • Important to remember that most RCT’s looking at DVT prophylaxis used asymptomatic DVT detected by venography.
    • Start as calf DVT
    • Reduction in asymptomatic parallels reduction in symptomatic DVT
    • Does not mean that the relative effects of asymptomatic and symptomatic events will be similar (particularly PE)
    • Bleeding? - there are no published data addressing the relationship between wound or joint bleeding and either wound infection or long-term joint function
  • Net benefit (non-fatal) – PE, DVT, GI bleed, periop bleed)
    • Prevention ≈ complication
    • Fatal events are rare
risk for dvt2
Risk for DVT
  • AT9
  • Critically ill vs. non-critical
  • In non-critical
    • RAM’s (risk assessment model) suffer from prospective validation, among other problems
    • ACCP 2012 guidelines utilize the “Padua Prediction Score”
risk for dvt3
Risk for DVT
  • Critically ill vs. non-critical
  • In non-critical
    • RAM’s (risk assessment model) suffer from prospective validation, among other problems
    • ACCP 2012 guidelines utilize the “Padua Prediction Score”
    • High Risk ≥ 4
padua prediction score
Padua Prediction Score
  • Journal of Thrombosis and Haemostasis 2010; 8: 2450–2457
  • Prospective cohort study, 1180 pts. (medical) followed to 90 days after d/c
  • Assessed
    • Whether pts could be assigned to high or low risk by a RAM
    • Whether prophylaxis worked (TID heparin, LMWH, fondaparinux) in either group
      • Risk level was blinded to the treating MD
      • Use of prophylaxis left up to the treating MD
    • Excluded bleeding, plts < 100K, CrCl < 30
padua prediction score1
Padua Prediction Score
  • 40 % high risk, 60% low risk
  • 40% of the high risk received DVT prophylaxis and 7.3% of the low risk
  • Only investigated symptomaticpts for DVT/PE
padua prediction score2
Padua Prediction Score
  • 40 % high risk, 60% low risk
  • 40% of the high risk received DVT prophylaxis and 7.3% of the low risk
  • Only investigated symptomatic pts for DVT/PE
  • Highly significant (P < 0.001, HR 0.13)
  • Of the 4 in the high risk/treated 3 occurred after d/c
bleeding risk from prophylaxis
Bleeding Risk from Prophylaxis
  • ACCP 2012 choose 0.4% major bleeding risk
    • From the control arms of DVT prophylaxis trials
    • IMPROVE trial
bleeding risk from prophylaxis1
Bleeding Risk from Prophylaxis
  • ACCP 2012 choose 0.4% major bleeding risk
    • From the control arms of DVT prophylaxis trials
    • IMPROVE trial – risk model “too complex” and “not validated”
slide16
AT9
  • 2.3. For acutely ill hospitalized medical patients at increased risk of thrombosis, we recommend anticoagulant thromboprophylaxis with low molecular- weight heparin [LMWH], low-dose unfractionated heparin (LDUH) bid, LDUH tid, or fondaparinux (Grade 1B) .
slide17
AT9
  • 2.4. For acutely ill hospitalized medical patients at low risk of thrombosis, we recommend against the use of pharmacologic prophylaxis or mechanical prophylaxis (Grade 1B) .
lduh vs lmwh
LDUH vs. LMWH
  • No difference in DVT, PE, overall mortality or HIT (one trial)
  • No cost difference
  • Minimally less major bleeds for LMWH (5/1000)
bid vs tid lduh
BID vs. TID LDUH
  • The low quality evidence from these indirect comparisons provides no compelling evidence that LDUH TID dosing, compared with BID dosing, reduces VTE or causes more bleeding
slide21

Chest 2007;131;507-516

“BID heparin dosing causes fewer major bleeding episodes, while TID dosing appears to offer somewhat better efficacy in preventing clinically relevant VTE events”

slide22

Chest2011;140;374-381

“Moderate-quality evidence suggests that subcutaneous UFH bid and UFH tid do not differ in effect on DVT, PE, major bleeding, and mortality”

gcs vs ipc s vs vfp s
GCS vs. IPC’s vs. VFP’s
  • GCS
    • Conflicting data, thigh high probably better than knee high (CLOTS I, II trials)
    • Surgical, stroke pts
    • Most studies screened for asymptomatic DVT
  • IPC/VFP
    • No studies in hospitalized medical pts
    • Less DVT (sx’c) but no mortality or PE benefit in surgical pts
gcs vs ipc s vs vfp s1
GCS vs. IPC’s vs. VFP’s
  • …the compelling evidence of a decrease in fatal PE that exists for anticoagulants and for aspirin does not exist for mechanical methods
mechanical compression vs heparin
Mechanical Compression vs. Heparin
  • No studies in hospitalized medical pts
  • Surgical pts – no difference in DVT, PE (except subgroup of LMWH vs. compression – less DVT); less bleeding with compression
mechanical compression heparinoids vs h eparinoids alone
Mechanical Compression + Heparinoids vs. Heparinoids Alone
  • Surgical pts
    • IPC’s + pharm trended better than pharm alone
    • GCS + pharm better than pharm alone but more skin complications
slide27
But…
  • Surgical studies looking at IPC functioning found them working or applied properly in only 20 - 50% of pts.
extended duration dvt prophylaxis
Extended Duration DVT Prophylaxis
  • Approximately 70% of DVT’s in medical pts occur in the out patient setting
  • Over half of these pts had been hospitalized within the past 3 months, and 2/3’s of these within 1 month
  • MEDENOX RTC - N Engl J Med 1999;341: 793-800
    • RTC
    • 40/20 lovenox vs. placebo
    • 3 mos f/u
extended duration dvt prophylaxis1
Extended Duration DVT Prophylaxis
  • Approximately 70% of DVT’s in medical pts occur in the out patient setting
  • Over half of these pts had been hospitalized within the past 3 months, and 2/3’s of these within 1 month
  • MEDENOX RTC - N Engl J Med 1999;341: 793-800
  • EXCLAIM - Ann Intern Med. 2010;153:8-18
    • 40 lovenox for 28 days after initial therapy in hosp
exclaim
EXCLAIM
  • Only RTC of extended DVT prophylaxis (LMWH) in medical pts (in-hospital and 28 days post-d/c)
    • Reduced overall DVT (sym and asym)
      • Level 1 mobility (bed rest)
      • > 75 y.o.
      • female
    • No difference fatal PE
    • No difference in overall mortality and 4 ICB’s (one fatal) in LMWH group (none in placebo)
    • Overall, 5/1000 fewer sx’c DVT’s, 4/1000 major bleeds
  • AT9 – not recommended
slide33
ASA
  • Studies in medical pts – 9 trials, 555 pts – all antiplatelet drugs
  • Small number of events (DVT’s)
  • Asymptomatic/symptomatic, proximal/distal
  • US/fibrinogen labeling/venography
  • Up to 8 wks of drug, bleeding events not reported
slide34
ASA
  • Pooling 9 trials
    • 35% reduction in asymptomatic DVT
    • No effect on PE rate
    • Bleeding not reported
slide35
ASA
  • PEP Trial - Lancet 2000; 355: 1295–302
    • 13,000 + orthopts (hip fx)
    • 160 mg ASA vs. placebo (+ “any other thromboprophylaxis thought necessary”) for 35 days
    • 35 days post hip fracture surg, THA, TKA
      • Less DVT’s – sym and asym
      • Less PE’s – fatal and non-fatal
      • No overall mortality benefit
      • No difference in fatal bleeding (some increase in surg site bleeds)
slide37
ASA
  • PEP Trial - Lancet 2000; 355: 1295–302
    • 13,000 + orthopts (hip fx)
    • 160 mg ASA vs. placebo (+ “any other thromboprophylaxis thought necessary”) for 35 days
    • 35 days post hip fracture surg, THA, TKA
      • Less DVT’s – sym and asym
      • Less PE’s – fatal and non-fatal
      • No overall mortality benefit
      • No difference in fatal bleeding (some increase in surg site bleeds)
  • “…there is now good evidence for considering aspirin routinely in a wide range of surgical and medical groups at high risk of venous thromboembolism”
slide38
AT9
  • “Based on the low quality of available evidence…no recommendation could be made”
  • There have been no studies of antiplatelet therapy compared with antithrombotic therapy (pharm or mech) to prevent VTE in acutely ill medical patients
slide40

Large meta-analysis

  • Randomized trials including medical patients or strokes
  • Heparin, LMWH, mechanical prophylaxis
  • 40 unique trials; 52,000 pts
  • Medical and stroke pts, no surg/trauma/OB
slide41

Trials

    • Heparin vs no heparin (1)
    • LMWH vs no LMWH (2)
    • LMWH vs UFH (3)
    • Mechanical vs no mechanical (4)
  • Outcomes
    • Death (primary); PE, major bleeding (secondary) (1, 2, 3)
    • Death (4)
slide42

Results

    • no significant effect of prophylaxis on mortality (there was a trend in favor of heparin prophylaxis (P=0.056)
    • Heparin vs no heparin
      • 3 less PE’s, 9 more bleeds (4 major)/1000 pts
    • LMWH vs heparin
      • No difference in outcomes
    • No improved outcomes with mechanical prophylaxis in stroke
  • Conclusion
    • Reduced PE, no change total mortality, increased bleeding (heparin, LMWH) (stroke and medical pts)
    • Therefore, no net clinical benefit
slide43

Raised numerous questions

    • Which are the preferred outcomes (PE vs bleed)
    • Use of surrogate outcomes – asymptomatic DVT?
      • Most PE not preceded by symptomatic DVT
      • Asymptomatic PE’s? No studies screen with CT
    • Editorial comments
      • JC’s recommendation for DVT proph only excludes children and pts hospitalized < 2 days
slide44

N Engl J Med 2011;365:2463-72

N Engl J Med 2011;365:2463-72

lmwh in medical patients
LMWH in Medical Patients
  • Double blind, randomized, placebo controlled
  • LMWH vs. placebo, all pts received elastic stockings with graduated compression
    • China, India, Korea, Malaysia, Mexico, the Philippines, and Tunisia
  • 8300+ pts
  • Primary outcome – death at 30 days
  • Secondary outcomes
    • Death at 0-14 days, 0-90 days rate of cardiopulm death 14, 30, 90 days and sudden death or PE 14, 30, 90 days
slide50

Conclusion

    • No reduction in the rate of death from any cause among hospitalized, acutely ill medical patients with the addition of lovenox
  • Counterintuitive?
    • Pharm prophylaxis reduces DVT (including asympt DVT) in acutely ill medical pts by > 45%
    • Assumed that DVT’s in medical pts are the same as surgical – distal to proximal progression (we know that proximal DVT in medical pts has higher risk of PE than distal
references
References
  • Kahn et al. Prevention of VTE in Nonsurgical Patients : Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012;141;e195S-e226S
  • Barbar et al. A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score. Journal of Thrombosis and Haemostasis, 8: 2450–2457
  • Decousus et al. Factors at Admission Associated With Bleeding Risk in Medical Patients. Chest. 2011; 139(1):69-79
  • King et al. Twice vs Three Times Daily Heparin Dosing for Thromboembolism Prophylaxis in the General Medical Population. Chest 2007;131;507-516
  • Phung et al. Dosing Frequency of Unfractionated Heparin Thromboprophylaxis. Chest 2011;140;374-381
  • CLOTS Trial Collaboration. Thigh-Length Versus Below-Knee Stockings for Deep Venous Thrombosis Prophylaxis After Stroke. Ann Intern Med. 2010;153:553-562.
  • Samama et al. A Comparison of Enoxaparin with Placebo for the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients. N Engl J Med 1999;341:793-800.
  • Hull et al. Extended-Duration Venous Thromboembolism Prophylaxis in Acutely Ill Medical Patients With Recently Reduced Mobility. Ann Intern Med. 2010;153:8-18.
  • Pulmonary Embolism Prevention (PEP) Trial Collaborative Group. Prevention of pulmonary embolism and deep vein thrombosis with low dose aspirin: Pulmonary Embolism Prevention (PEP) trial. Lancet 2000; 355: 1295–302
  • Lederle et al. Venous Thromboembolism Prophylaxis in Hospitalized Medical Patients and Those With Stroke: A Background Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2011;155:602-615
  • Kakkar et al. Low-Molecular-Weight Heparin and Mortality in Acutely Ill Medical Patients. N Engl J Med 2011;365:2463-72.