Journal Summary

A randomized, double-blind, placebo-controlled trial was conducted to compare the effects of tenecteplase and heparin vs placebo and heparin in patients with a non-massive (intermediate-risk) pulmonary embolism (PE). A non-massive PE is defined by hemodynamic stability with evidence of right heart strain on echo and myocardial injury, as indicated by an elevation of troponin I or T. 1006 patients were enrolled at 76 sites in 13 coutries, 506 in the tenecteplase group and 499 in the placebo group. Patients who were assigned to undergo fibrinolysis received a single weight-based IV bolus of tenecteplase. The primary outcome was a clinical composite of death from any cause or hemodynamic decompensation within 7 days after randomization. The secondary outcomes included confirmed symptomatic recurrence of PE within 7 days, death within 30 days, and major adverse events within 30 days.

• The primary efficacy outcome occurred in 13 patients (2.6%) in the tenecteplase group abd 28 (5.6%) in the placebo group – 6 patients in the tenecteplase group and 9 in the placebo group died between randomization and day 7 while hemodynamic decompensation or collapse occurred in 8 patients in the tenecteplase group and 25 in the placebo group
• 8 patients in the tenectplase group required mechanical ventilation vs 15 in the placebo group and more patients in the placebo group underwent open-label rescue fibrinolysis
• By day 30 after randomization, 12 patients in the tenectplase group and 16 patients in the placebo group had died
• Major bleeding events were recording in 58 patients in the tenectplase group and 12 in the placebo group
• According to previous studies, increasing age and the presence of coexisting conditions have been associated with a higher risk of bleeding complication

The study concluded that while there was a decreased risk of all-cause mortality with the administration of tenecteplase in patients with sub-massive PE there was also a significant increase in the risk of major bleeding events. It is therefore recommended that while fibrinolytic therapy may be used in the setting of an intermediate-risk PE, it should be done with extreme caution and close monitoring.

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