OPTALYSE PE Trial enrolled ~100 patients at 17 centers in Europe and the US and studied USCDT (Ultrasound-facilitated catheter-directed thrombolysis) and varying doses of tPA (4-24mg) over varying durations (2-6h). There was no heparin (anti-coagulation) alone control.
Enrollment criteria included main or proximal lobar pulmonary artery PE, SBP >90 and RV/LV ration >/= 0.9. There were many exclusion criteria. Patients were not further risk stratified using one of the PE intermediate-risk stratification tools (e.g. Bova)
Results showed that RV/LV ratio improved and clot burden (modified Miller score) improved at 48h. There was a 4% major bleeding risk with one ICH.
Take home: This article adds very little to the submassive PE literature. Much like the SEATTLE II and ULTIMA studies, it demonstrates echocardiographic improvement in patients who are poorly risk stratified. It also suggests USCDT is reasonably safe, which has already been reported. The ideal dose of catheter-directed tPA is unknown, but lower doses appear effective.
References
Tapson VF, Sterling K, Jones N, et al. A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism: The OPTALYSE PE Trial.JACC Cardiovasc Interv. 2018 Jul 23;11(14):1401-1410. doi: 10.1016/j.jcin.2018.04.008.
