Half-dose rt-PA plus LMWH significantly reduced death or hemodynamic decompensation at 7 and 30 days compared with LMWH alone in submassive pulmonary embolism (p=0.028 and p=0.009, respectively).
Observational (n=76)
Open-label
No
Does half-dose rt-PA plus LMWH reduce death or hemodynamic decompensation in patients with submassive pulmonary embolism compared to LMWH alone?
Half-dose rt-PA combined with LMWH significantly reduces death or hemodynamic decompensation at 7 and 30 days in patients with submassive PE without increasing bleeding risk compared to LMWH alone.
p-value: p=0.028 (7 days), 0.009 (30 days)
The role of thrombolysis in submassive pulmonary embolism (PE) is controversial due to the high risk of hemorrhage. This study aimed to evaluate the role of half-dose tissue-type plasminogen activator (rt-PA) in preventing death/hemodynamic decompensation in submassive (intermediate-risk) PE without increasing the risk of bleeding. In a prospective, non-randomized, open-label, single-center trial, we compared 50 mg rt-PA plus low molecular weight heparin (LMWH) with LMWH in submassive (intermediate-risk) PE. Eligible cases had confirmed pulmonary hypertension on echocardiography, and/or right ventricular cavity expansion and/or interventricular septal deviation on echocardiography, and/or right to left ventricular ratio equal to or greater than 0.9 mm on CT angiography. The primary outcome was death or hemodynamic decompensation within 7 and 30 days after treatment was given. The primary safety outcome was major extracranial bleeding or hemorrhagic stroke within 7 days. Seventy-six patients were included in the study. Total death/hemodynamic decompensation in the first 7 and 30 days was significantly less in the half-dose rt-PA group than in the LMWH group (p=0.028 and p=0.009, respectively). No significant differences were found between the two groups in terms of recurrent embolism and pulmonary hypertension at 6-month follow-up (p=1.000 and p=0.778). There was no intracranial hemorrhage in any of the patients. There were no statistically significant differences between the two groups in terms of major or minor bleeding complications. This trial showed half-dose rt-PA treatment in submassive (intermediate-risk) PE prevented death/hemodynamic decompensation in the first 7-day and 30-day period compared with LMWH treatment without increasing the risk of bleeding.
Yılmaz et al. (Mon,) conducted a observational in Submassive (intermediate-risk) pulmonary embolism (n=76). tissue-type plasminogen activator (rt-PA) plus low molecular weight heparin (LMWH) vs. LMWH alone was evaluated on Death or hemodynamic decompensation within 7 and 30 days (p=0.028 (7 days), 0.009 (30 days)). Half-dose rt-PA plus LMWH significantly reduced death or hemodynamic decompensation at 7 and 30 days compared with LMWH alone in submassive pulmonary embolism (p=0.028 and p=0.009, respectively).