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November 16, 2011

posted Nov 14, 2011, 7:37 AM by Bonni Stahl   [ updated Nov 16, 2011, 3:49 PM by David de Gijsel ]

Outpatient vs Inpatient treatment for patients with acute pulmonary Embolism: an international, open label, randomized non inferiority trial. Lancet July 2, 2011.

      Inspired by an inpatient experience, Jason expertly presented a recent article from the Lancet that was designed as a non-inferiority comparison of "inpatient" vs "outpatient" (patients discharged from the ED within 24hrs of admission and managed with home nursing visits) management of confirmed pulmonary embolism in low risk patients. A prior RTC attempted to show this but did not effectively limit the analysis to low risk patients and was stopped early due to increased mortality.
      This study was conducted in Switzerland, France, Belgium and the USA in a largely white population and because of the criteria used to determine a low risk patient, largely excluded patients over age 60 and patients with malignancy. The study also excluded anyone that the providers felt had barriers to follow up. Out of the 1557 patients that presented to the ED with confirmed PE 787 patients did not meet criteria for "low risk" and ultimately 344 patients were randomized.
      Interestingly the average hospital stay in the group admitted for management was 3.9 days vs 0.5 days in the outpatient management group. There was no significant difference between the INR goals achieved in the two groups (at goal @ 50% of the time). Recurrent thrombosis was seen in only 1 of the outpatients at 90 days (the primary endpoint) vs none in the inpatient group. THIS IS SIGNIFICANTLY NON-INFERIOR. 2 intramuscular hematomas where found in the outpatient group and 1 episode of vaginal bleeding occurred at day 50 in the outpatient group. No major bleeding events (a secondary outcome) occurred in the inpatient group. The bleeding risk was non-inferior only if calculated in the per-protocol analysis.

Our consensus was that this study suggests that ED discharge for a LOW RISK patient presenting with PE was possible, although it is unclear if there is an increase in bleeding risk from this analysis.