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Moderate Pulmonary Embolism Treated With Thrombolysis (from the “MOPETT” Trial)

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The role of low-dose thrombolysis in the reduction of pulmonary artery pressure in moderate pulmonary embolism (PE) has not been investigated. Because the lungs are very sensitive to thrombolysis, we postulated that effective and safe thrombolysis might be achieved by a lower dose of tissue plasminogen activator. The purpose of the present study was to evaluate the role of this “safe dose” thrombolysis in the reduction of pulmonary artery pressure in moderate PE. During a 22-month period, 121 patients with moderate PE were randomized to receive a “safe dose” of tissue plasminogen activator plus anticoagulation (thrombolysis group [TG], n = 61 patients) or anticoagulation alone (control group [CG], n = 60). The primary end points consisted of pulmonary hypertension and the composite end point of pulmonary hypertension and recurrent PE at 28 months. Pulmonary hypertension and the composite end point developed in 9 of 58 patients (16%) in the TG and 32 of 56 patients (57%) in the CG (p <0.001) and 9 of 58 patients (16%) in the TG and 35 of 56 patients (63%) in the CG (p <0.001), respectively. The secondary end points were total mortality, the duration of hospital stay, bleeding at the index hospitalization, recurrent PE, and the combination of mortality and recurrent PE. The duration of hospitalization was 2.2 ± 0.5 days in the TG and 4.9 ± 0.8 days in the CG (p <0.001). The combination of death plus recurrent PE was 1 (1.6%) in TG and 6 (10%) in the CG (p = 0.0489). No bleeding occurred in any group, and despite a positive trend in favor of a “safe dose” thrombolysis, no significant difference was noted in the rate of individual outcomes of death and recurrent PE when assessed independently. In conclusion, the results from the present prospective randomized trial suggests that “safe dose” thrombolysis is safe and effective in the treatment of moderate PE, with a significant immediate reduction in the pulmonary artery pressure that was maintained at 28 months.

Section snippets

Methods

The Moderate Pulmonary Embolism Treated with Thrombolysis trial was a prospective, controlled, randomized, single-center open study that enrolled 121 adult patients with symptomatic “moderate” PE. All patients provided written informed consent, and the institutional review board approved the study protocol.

Adult patients presenting with signs and symptoms suggestive of PE plus imaging documentation on computed tomographic angiography or ventilation/perfusion scanning were potentially eligible

Results

During a 22-month period from May 2008, 178 patients with PE were considered for enrollment in the present study. The patient flow is shown in Figure 2. Ultimately, 121 patients were randomized. The randomization process occurred after the inclusion and exclusion criteria were satisfied, and the patients had provided written informed consent. After evaluation of the patient, the study investigator placed a telephone call to the study center, and, by opening of sealed envelopes, randomization to

Discussion

The results have demonstrated that “safe dose” tPA is safe and effective in the treatment of moderate PE, leading to a significant early reduction in the pulmonary artery systolic pressure that was maintained through the intermediate term. This finding is consistent with the few published reports in this area. Only 4 reports have addressed the effects of pulmonary artery pressure changes after thrombolysis from a total of 257 patients10, 11, 12, 13 with PE. The largest of these was a

Disclosures

The authors have disclosed no conflicts of interest.

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