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Outpatient Treatment of Acute Pulmonary Embolism

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					Outpatient Treatment of Acute Pulmonary
 Embolism: Review of Published Studies



       Amjad AlMahameed, MD, MPH
              OP Rx of PE with Dalteparin
          (Kovacs MJ, J thromb and Haemoat. 2000;83: 209-11)



•   Prospective cohort study       •   Dalteparin 200 U/kg s/c daily
                                       for a minimum of 5 days until
•   All pts with PE (2/1996-           INR > 1.9 (1st dose given as
    11/1998) unless excluded           soon as possible after PE is
•   158 patients identified, 108       diagnosed, usually w/I 2 hrs)
    managed as OP
                                   •   Warfarin given on day of Dx
•   PE Dx: High prob. V/Q, PA          and continued for 3 months
    gram, spiral CT, DVT (by US
    or venogram) with symptoms     •   3 months f/u for “clinically
    of PE and nonhigh prob V/Q         apparent” recurrence of VTE
                                       and bleeding
•   3 teaching hospitals, Canada
                                   •   Included pts w CA or
                                       hypercoag. (LA)
                                     158 APE patients




                      108 managed                             50 managed
                          as OP                               as inpatient



  27 discharged after 2.5 days         81 managed exclusively
            In house                As OP (Dalteparin to Warfarin)



11 received 2.1     16 2.8 days
 Days of UFH        Of LMWH



         Continue LMWH
       To Coumadin as OP
                                     3 months F/U for recurrent VTE/bleed
                     Folow Up Post Discharge




       INR                    Follow Up Visits        Patients phoned at
  Days 1, 3, and 5           I wk, 1 mo, 3 mos            Least QOD


                           Pts asked to report
                           signs/Sxs of DVT/PE


Recurrent DVT:                          Bleeding:
        US (or venogram)                          Hgb or clinical bleed
                                                 Further eval. per MD
Recurrent PE:                           Mortality:
        V/Q scan (or US legs                     PE-related
        +/- PA gram)                             Non PE-related
    Baseline Characteristics of OP PE patients

                            Outpatient   Early Discharge Total

N                                81            27           108
Mean Age                        56.1          59.4          56.9
Concomitant Symptomatic      23 (28%)       8 (30%)       31 (29%)
DVT
Cancer                        20 (25)        4 (15)        25 (23)
Idiopathic                    39 (48)        16 (59)       45 (42)
V/Q scan                      70 (86)        20 (74)       90 (83)
Spiral Ct                       5 (6)        5 (19)       10 (9.2)
PA gram                         3 (4)         2 (7)        5 (4.6)
DVT with compatible Sxs         3 (4)         0 (0)        3 (2.8)
Hereditary hypercoaguable     10 (12)         2 (7)        12 (11)
State
Lupus Anticoagulant
         Outcome Results for OP Rx of PE

               Outpatient   Early Discharge   Total
                (n 81)           (n 27)
Recurrent        5 (6.2)        1 (3.7)       6 (5.6)
DVT/PE
Minor Bleed      3 (3.7)        2 (7.4)       5 (4.6)

Major Bleed      1 (1.2)        1 (3.7)       2 (1.9)

Deaths           4 (4.9)         0 (0)        4 (3.7)
      OP Rx of PE is Feasible and Safe in a Substantial
                   Proportion of Patients
            (Beer JH et al. J thromb and Haemoat. 2003;1:186-202)



    Low risk (as per Wicki et al) symptomatic PE patients

         No CA                    No CHF                No hypotension



      No hypoxemia              No prior DVT          No concomitant DVT



                             EXCLUSION
•   Contraindications to AC                    •   Drug addiction
•   Rx with warfarin X 24 hrs                  •   Noncompliance
•   Weight > 110 kg                            •   Psychiatric condition
•   CRI (Cr. Cl < 30 ml/min)                   •   Age < 18
•   Thrombocytopenia (< 120k)
     The Bounameaux PE Point Score
                            (The Geneva Risk Score)

      Variable                                                       Point Score


            Cancer                                                             +2
         Heart Failure                                                         +1
             SBP < 90mmHg                                                      +1

          Prior DVT                                                            +1
          Hypoxaemia                                                           +1
                                                 Score of > 2 predicts death
          DVT on US                               recurrent VTE, or major      +1
                                                     bleed at 3 months
Vicki J et.al Thromb Haemost 2000; 84: 548-552
                   Regimen

• Nadroparin calcium (LMWH) 171 IU anti-factor Xa Kg
  for minimum 5-10 days

• Phenoprocoumon until INR 2-3 for 2 consecutive
  days for 6-12 months

• 3 months follow up: recorrent VTE, bleed (major vs.
  minor), and mortality
            255 Patients with Symptomatic PE


     105/255 Patients Included               150/255 patients excluded




43/105 Outpatient Rx (41%)         62/105 Hospitalized Patients (59%)


                                   54/65 (83%) low
                                                        11/65 (17%) high
                                      risk score
                                                         Risk score (> 2)



No major bleed                                             No major bleed
1 Recurrent PE                                             2 Recurrent PE



        (Beer JH et al. J thromb and Haemoat. 2003;1:186-202)
  Subcutaneous Fondaparinux versus IV
       UFH in the initial Rx of PE
                     NEJM 2003;349:1695-702



• Randomized open-label trial of 2213 pts with APE
• Noninferiority trial (efficacy)
• Minimum 5 days of parenteral AC
• Coumadin ASAP (w/I 72 hrs of AC) and continued for 3
  months
• Efficacy end point: recurrent VTE
• Safety outcome: Major bleeding during the initial Rx period
  and death during the following 3 months
Clinical Outcomes During the Study Period
                       Fondaparinux    UFH
Recurrent VTE
        Initial Rx       14 (1.3%)    19 (1.7%)
        Entire study     42 (3.8%)     56 (5%)
Type of Recurrence
        Fatal PE            16           15
        Non-fatal PE        14           24
        DVT                 12           17

Major Bleed
      Initial Rx         14 (1.3%)    12 (1.1%)
                         22 (2.0%)    26 (2.4%)
      Entire study
Death
        Initial Rx       9 (0.8%)     12 (1.1%)
        Entire study     57 (5.2%)    48 (4.4%)
          Rates of Recurrent VTE and Major
          Bleeding According to Body Weight

Study      Recurrent VTE During the      Major Bleeding During the
Group           3 mos Period                 Initial Rx Period

           <50 kg   50-100 kg   >100kg   <50 kg   50-100 kg   >100kg

Arixtra     5/22     32/945     5/132     0/21     13/939     1/130
           (22.7)     (3.4)     (3.8)      (0)      (1.4)     (0.8)

UFH         4/25     41/948     11/136    1/25     10/931     1/134
            (16)      (4.3)      (8.1)     (4)      (1.1)     (0.7)


                        NEJM 2003;349:1695-702
                         Fundaparinux Group N=1103


 86% were 50-100 kg

                                    1 day(s) of initial Rx on an
   2.4% Cr Cl < 30                       outpatient basis

                                             158 (14.5%)
Study Rx started 5.1 h



Concomitant DVT 38%                                    0/158 (0%. 0.0-2.4)
                             Recurrent VTE: 5/158
                                                        had major bleed
                                (3.2%, 1.0-7.2)
                                                            Or died

      ICU 26%



  Active CA 10.2%
  Outpatient Management of Stable PE:
 Once Daily SC Fondaparinux vs. IV UFH


• Validate risk stratification criteria to predict suitability
  for outpatient Rx of PE
• Evaluate safety and efficacy of fundaparinux for
  outpatient management of PE
• Case series (100 consecutive patients) with PE
• Inclusion: > 18 y/o, objectively confirmed PE (CT, Hi
  Prob V/Q, or + US or venogram with inter. V/Q)
• Stable PE
                   Stable PE

• Hemodynamically stable
• FI O2< 4 L/min
• No ECG criteria for RV strain
• Non-massive PE (radiographically)
• No cardiopulmonary disease
• Negative TnT and BNP
• No moderate or severe RV dysfunction on
  echocardiography (done for selected patients)
               Exclusion Criteria
•   Clinician/patient choice
•   CI for AC
•   Received LMWH, UFH, or Coumadin for > 48 hrs
•   Thrombolysis within 24 hrs
•   Platelets < 100k
• Cr Cl < 30
• Epidural catheters
• Pregnancy
• Weight > 150 kg
• Life expectancy < 6 months
• Associated arterial thrombosis secondary to HIT
Clinical Suspicion for PE


                                                        PE Confirmed (within the past 48 hrs)
    eval for eligibility and Initiate initial Rx
    48 hrs after PE diagnosis to complete
     Can keep patient hospitalized up to




                                                                  Patient Enrolled
              in-house/observe pt




                                                   • Arixtra Rx
                                                   • Can keep in hospital up to 48 hrs
                                                   • Start coumadin ASAP
                                                   • Follow up for 3 mos but AC
                                                     recommended for 6 mos
                                                   • Composite end point of death,
                                                     recurrent symptomatic VTE, and
                                                     major bleed
                                                   • INR: baseline, days 3, 5 and 10
                                                   • Visits: 1 and 3 months

				
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