Picking up where we left off w/ last week’s intern report, I thought I’d add a brief synopsis of the data on thrombolysis in sub-massive PE, thanks to Esteban for bringing the case to report.
#MOPETT trial: This is the “clot burden” trial. Patients w/ PE dx on CT angio w/ involvement of at least 70% of lung areas received thrombolysis compared to just anti-coagulation. Only 121 patients but some significant findings. Followup was long, about 2.5 years, primary outcome was development of pulm htn. At various times of follow-up the estimated PA pressure on echo was about 10-15 mmHg higher in the anti-coag only group (mostly LMWH like enox) compared to the tPA group, which finished w/ a normal avg PA pressure. There were no differences in bleeding rates which is obviously different from the ot her big trial below, but remember small sample size, based on the other rates observed you would only expect about 0-1 major bleeding events in a n=60 group of tPA (they did use half dose tPA for what it’s worth). No mortality difference, but again, smaller sample size.
#PEITHO trial: This is the echo + troponin study for sub-massive PE, not clot burden. Much larger, about 1000 patients randomized to heparin alone vs tPA+heparin, shorter f/u, only 30 days. There was a significantly reduced incidence of shock but no mortality benefit. This study did have a higher incidence of major bleeding, including intracranial bleeds, (2% vs 0.2% treatment:heparin groups), in the tPA cohort, though no excess mortality.
#Cochrane review: in 2015 A cochrane review was published pooling 18 RCTs but overall the grading of the studies was low quality mostly due to heterogeneity in the definition of sub-massive PE, there was a trend towards mortality benefit in TPA but less than a ringing endorsement.