• Jay N Lozier, Jason M Elinoff, Anthony F Suffredini, Douglas R Rosing, Stanislav Sidenko, Richard M Sherry, Adam R Metwalli, Vandana Sachdev, Robert L Danner, and Richard Chang.
• Office of Tissues and Advanced Therapies, FDA Center for Biologics Evaluation and Research, Silver Spring.
• Blood Coagul. Fibrinolysis. 2018 Dec 1; 29 (8): 701-707.

Abstract: Guidelines-recommend thrombolytic therapy for pulmonary embolism in patients with severe hemodynamic compromise and low risk of bleeding. Thrombolytics in submassive pulmonary embolism have an unfavorable risk/benefit ratio and remain controversial. Based on our experience with extensive, lower extremity thrombi, nine patients with symptomatic, submassive pulmonary embolisms (five medical, four surgical) were treated with low-dose alteplase (<10 mg/day, infused over 6 h per treatment). Alteplase was delivered by pulse spray and/or directed or undirected central venous catheters depending on clot size and location. All patients improved symptomatically and as determined objectively by pulmonary artery pressures and/or imaging, though acute benefits ranged from substantial to modest. One surgical patient required re-exploration for bleeding at the site of a recent retroperitoneal lymph node dissection. This experience may help guide the design of a randomized controlled trial to determine the safety and efficacy of low-dose alteplase for submassive pulmonary embolism.

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