Thrombolytic Therapy in Treatment in Patients with Pulmonary Embolism not High-risk: SIRENA Registry Data

Aim. To study the features of the use of thrombolytic therapy (TLT) in normotensive patients with pulmonary embolism (PE) in real clinical practice in Russian hospitals.

Material and Methods. From 04/1 5/2018 to 04/15/2019 patients hospitalized with a diagnosis of PE consistently were included in the Russian multicenter observational prospective register "SIRENA” (RusSIan REgistry of pulmoNAry embolism).

Results. For 12 months in the registry was included 609 patients with a lifetime confirmed diagnosis of PE. TLT was performed in 152 patients with PE (25.0%), of which only 51 (33.8%) were indicated as "high risk" (shock or hypotension). In 101 not high risk patients, the indications for TLT were: severe shortness of breath/respiratory failure - 19 (18.8%), massive venous thrombosis - 7 (6.9%), signs of massive/submassive PE - 10 (9.9%), intermediate-high risk - 14 (13.9%), suspicion of acute coronary syndrome with ST segment elevation - 3 (2.9%), high pulmonary hypertension -2 (2.0%). The other 46 (45.5%) non-high-risk patients had no clear indication of the reasons for TLT in their medical history. To study the features of management of patients with not high-risk PE who received TLT (group 1), a selection of pairs of patients from the "SIRENA” registry, comparable in gender and age, in a ratio of 1:1 of patients with not high-risk PE who did not perform TLT (group 2). Hospital mortality was 4 (4%) patients in the TLT group and 6 (5.9%) patients in group 2 (р=0,748). Logistic regression analysis showed that floating blood clot in the veins of the lower extremities, syncopes in the debut of PE, respiratory rate over 22 per minute were independent clinical factors that significantly influence the doctor's decision to perform thrombolysis, and probability of completion TLT decreased in the presence of a history of bleeding, chronic kidney disease, surgery in the previous 12 months, increase in the size of the right atrium on EchoCG (statistical significance of the model x2=51.574; p<0.001). The development of bleeding during hospitalization was recorded only in 10 (9.9%) patients of group 1, including severe (3 stage on the BARC scale) in 2 patients. Patients without TLT more often developed an acute heart failure (25.9% vs. 8.5%, p=0.043).

Conclusion. In real clinical practice, there is a high frequency of TLT in patients with not high-risk PE. Floating blood clot in the veins of the lower extremities, syncope in the debut of PE, respiratory rate over 22 per minute were independent clinical factors that significantly influence the doctor's decision to perform thrombolysis.

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