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Outpatient Treatment of Acute Pulmonary Embolism: Review of Published Studies

Outpatient Treatment of Acute Pulmonary Embolism: Review of Published Studies. Amjad AlMahameed, MD, MPH. Prospective cohort study All pts with PE (2/1996-11/1998) unless excluded 158 patients identified, 108 managed as OP

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Outpatient Treatment of Acute Pulmonary Embolism: Review of Published Studies

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  1. Outpatient Treatment of Acute Pulmonary Embolism: Review of Published Studies Amjad AlMahameed, MD, MPH

  2. Prospective cohort study All pts with PE (2/1996-11/1998) unless excluded 158 patients identified, 108 managed as OP PE Dx: High prob. V/Q, PA gram, spiral CT, DVT (by US or venogram) with symptoms of PE and nonhigh prob V/Q 3 teaching hospitals, Canada Dalteparin 200 U/kg s/c daily for a minimum of 5 days until INR > 1.9 (1st dose given as soon as possible after PE is diagnosed, usually w/I 2 hrs) Warfarin given on day of Dx and continued for 3 months 3 months f/u for “clinically apparent” recurrence of VTE and bleeding Included pts w CA or hypercoag. (LA) OP Rx of PE with Dalteparin(Kovacs MJ, J thromb and Haemoat. 2000;83: 209-11)

  3. 158 APE patients 108 managed as OP 50 managed as inpatient 27 discharged after 2.5 days In house 81 managed exclusively As OP (Dalteparin to Warfarin) 11 received 2.1 Days of UFH 16 2.8 days Of LMWH Continue LMWH To Coumadin as OP 3 months F/U for recurrent VTE/bleed

  4. Folow Up Post Discharge INR Days 1, 3, and 5 Follow Up Visits I wk, 1 mo, 3 mos Patients phoned at Least QOD Pts asked to report signs/Sxs of DVT/PE Recurrent DVT: US (or venogram) Recurrent PE: V/Q scan (or US legs +/- PA gram) Bleeding:  Hgb or clinical bleed Further eval. per MD Mortality: PE-related Non PE-related

  5. Baseline Characteristics of OP PE patients

  6. Outcome Results for OP Rx of PE

  7. No CA No CHF No hypotension No hypoxemia No prior DVT No concomitant DVT 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 EXCLUSION • Drug addiction • Noncompliance • Psychiatric condition • Age < 18 • Contraindications to AC • Rx with warfarin X 24 hrs • Weight > 110 kg • CRI (Cr. Cl < 30 ml/min) • Thrombocytopenia (< 120k)

  8. The Bounameaux PE Point Score (The Geneva Risk Score) Cancer +2 SBP < 90mmHg +1 Score of > 2 predicts death recurrent VTE, or major bleed at 3 months Vicki J et.al Thromb Haemost 2000; 84: 548-552

  9. 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

  10. 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 risk score 11/65 (17%) high Risk score (> 2) No major bleed 1 Recurrent PE No major bleed 2 Recurrent PE (Beer JH et al. J thromb and Haemoat. 2003;1:186-202)

  11. Subcutaneous Fondaparinux versus IV UFH in the initial Rx of PENEJM 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

  12. Clinical Outcomes During the Study Period

  13. Rates of Recurrent VTE and Major Bleeding According to Body Weight NEJM 2003;349:1695-702

  14. Fundaparinux Group N=1103 86% were 50-100 kg 1 day(s) of initial Rx on an outpatient basis 158 (14.5%) 2.4% Cr Cl < 30 Study Rx started 5.1 h Concomitant DVT 38% Recurrent VTE: 5/158 (3.2%, 1.0-7.2) 0/158 (0%. 0.0-2.4) had major bleed Or died ICU 26% Active CA 10.2%

  15. 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

  16. 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)

  17. 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

  18. Clinical Suspicion for PE PE Confirmed (within the past 48 hrs) Patient Enrolled • 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 Can keep patient hospitalized up to 48 hrs after PE diagnosis to complete eval for eligibility and Initiate initial Rx in-house/observe pt

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