Moderate Pulmonary Embolism Treated With Thrombolysis - MOPETT

Description:

The goal of the trial was to evaluate treatment with low-dose thrombolytic therapy compared with usual care among patients with hemodynamically stable moderate pulmonary embolism (PE).

Hypothesis:

Thrombolysis will reduce the rate of pulmonary hypertension.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients with PE and any two of the following:
    - Chest pain
    - Tachypnea
    - Tachycardia
    - Dyspnea
    - Jugular venous distention
    - Cough
    - Oxygen desaturation

    Number of enrollees: 121
    Duration of follow-up: 28 months
    Mean patient age: 58 years
    Percentage female: 54%

Exclusions:

  • Blood pressure ≥200/100 mm Hg
  • Surgery or major trauma in the last 2 weeks
  • Brain mass
  • Intracranial hemorrhage, subdural hematoma, or neurological surgery within the last year
  • Gastrointestinal bleed requiring transfusion within the last 2 months
  • Need for full-dose thrombolysis

Primary Endpoints:

  • Pulmonary hypertension

Secondary Endpoints:

  • Recurrent PE plus pulmonary hypertension
  • In-hospital bleeding
  • Hospital duration

Drug/Procedures Used:

Patients with hemodynamically stable PE were randomized to tissue plasminogen activator (t-PA) 10 mg in 1 minute, then 40 mg in 2 hours (n = 61) versus control (n = 60).

Patients <50 kg received t-PA at a total dose of 0.5 mg/kg: 10 mg in 1 minute, then the remainder in 2 hours.

Concomitant Medications:

Enoxaparin 1 mg/kg twice daily not to exceed 80 mg per dose

Principal Findings:

Overall, 121 patients were randomized. The mean age was 58 years, 54% were women, mean weight was 84 kg, and 38% had diabetes. B-type natriuretic peptide (BNP) or troponin I was elevated in 66%, 20% had right ventricular enlargement, and 5% had right ventricular hypokinesis.

In the thrombolytic therapy group, the initial pulmonary systolic pressure was 50 mm Hg and 28 mm Hg at study end. In the standard therapy group, the initial pulmonary systolic pressure was 51 mm Hg and 43 mm Hg at study end.

The primary outcome of pulmonary hypertension at 28 months occurred in 16% of the thrombolytic group versus 57% of the standard therapy group (p < 0.001).

Recurrent PE plus pulmonary hypertension: 16% versus 63% (p < 0.001), recurrent PE: 0% versus 5% (p = 0.08), mortality: 1.6% versus 5% (p = 0.30), hospital stay: 2.2 days versus 4.9 days (p < 0.001), in-hospital bleeding: 0 versus 0, respectively.

Interpretation:

Among patients with hemodynamically stable PE, the use of low-dose thrombolytic therapy is feasible. Currently, full-dose thrombolytic therapy is recommended for large PE that results in hemodynamic instability. This is a small trial; therefore, larger confirmatory studies would be needed before this therapy could be widely advocated.

References:

Presented by Dr. Mohsen Sharifi at ACC.12 & ACC-i2 with TCT, Chicago, IL, March 27, 2012.

Clinical Topics: Arrhythmias and Clinical EP, Dyslipidemia, Heart Failure and Cardiomyopathies, Pulmonary Hypertension and Venous Thromboembolism, Vascular Medicine, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Lipid Metabolism, Heart Failure and Cardiac Biomarkers, Pulmonary Hypertension

Keywords: Thrombolytic Therapy, Follow-Up Studies, Pulmonary Embolism, Human Rights, Blood Pressure, Hypertrophy, Right Ventricular, Fibrinolytic Agents, Dyspnea, Tachycardia, Troponin I, Chest Pain, Tachypnea, Hypertension, Pulmonary, Oxygen, Tissue Plasminogen Activator, Cough, Diabetes Mellitus, Natriuretic Peptide, Brain


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