Efficacy and Safety of Thrombolytic Therapy in Acute Submassive Pulmonary Embolism: Follow-Up Study

Abstract

BackgroundThrombolysis in acute submassive pulmonary embolism (PE) remains controversial. So we studied impact of thrombolytic therapy in acute submassive PE in terms of mortality, hemodynamic status, improvement in right ventricular function, and safety in terms of major and minor bleeding.MethodA single-center, prospective, randomized study of 86 patients was conducted at LPS Institute of Cardiology, G.S.V.M. Medical College, Kanpur, India. Patients received thrombolysis (single bolus of tenecteplase) with unfractionated heparin (UFH, group I) or placebo with UFH (group II).ResultMean age of patients was 54.35 ± 12.8 years with male dominance (M:F = 70%:30%). Smoking was the most common risk factor seen in 29% of all patients, followed by recent history of immobilization (25%), history of surgery or major trauma within past 1 month (15%), dyslipidemia (10%) and diabetes mellitus (10%). Dyspnea was the most common symptom in 80% of all patients, followed by chest pain in 55% and syncope in 6%. Primary efficacy outcome occurred significantly better in group I vs. group II (4.5% vs. 20%; P = 0.04), and significant difference was also found in hemodynamic decompensation (4.5% vs. 20%; P = 0.04), the fall in mean pulmonary artery systolic pressure (PASP) (28.8% vs. 22.5%; P = 0.03), improvement in right ventricular (RV) function (70% vs. 40%; P = 0.001) and mean hospital stay (8.1 ± 2.5 vs. 11.1 ± 2.14 days; P = 0.001). There was no difference in mortality and major bleeding as safety outcome but increased minor bleeding occurred in group I patients (16% vs. 12%; P = 0.04).ConclusionPatients with acute submassive PE do not derive overall mortality benefit, recurrent PE and rehospitalization with thrombolytic therapy but had improved clinical outcome in form of decrease in hemodynamic decompensation, mean hospital stay, PASP and improvement of RV function with similar risk of major bleed but at cost of increased minor bleeding.

Catheter‐directed therapy for submassive pulmonary embolism after unsuccessful systemic thrombolysis

“… 3 Submassive PE is associated with high mortality and adverse short-term outcomes, and therefore effective and safe treatment must be provided promptly. 4 The management of patients with submassive PE depends on the clinical presentation and risk classification. By the 2014 European Society of Cardiology (ESC) criteria, our patient had intermediate to high risk of PE.…”

The Role of Thrombolytic Therapy for Patients with a Submassive Pulmonary Embolism

“…The treatment group then received a weight-adjusted bolus dose of tenecteplase. The control group received the same volume of placebo (normal saline), followed by a maintenance dose of heparin [ 11 ].…”

“…There was also a significant difference between mean hospital stay in the tenecteplase group at 8.1 days versus the placebo group at 11.1 days (p = 0.001). Lastly, there was a statistically significant improvement in right ventricular function between both groups (p = .001) with 70% from the tenecteplase arm experiencing improvement in right ventricular function while 40% experienced an improvement in the placebo arm (p = 0.001) [ 11 ].…”

Thrombolytic therapy in submassive pulmonary embolism

“…However, in the results section they have written that 52% (n = 16) of the subjects presented with shock at admission or within 48 h following admission. It is not clear how many patients presented with massive PE; 8 or 16?The authors concluded that thrombolytic therapy can be considered for patients with both massive and submassive PE, However, the value of thrombolysis in acute submassive PE remains controversial in the current studies 2, 3. In a recent article, Desai and colleagues evaluated 3253 PE patients with hemodynamically stable right-sided heart failure 2 .…”

“…There was no significant difference in mortality between hemodynamically stable PE patients with right ventricular dysfunction who received thrombolytic agents compared with those who did not 2 . In another single-center, prospective, randomized study of 86 patients with submassive PE, patients were divided into two groups: group I patients received thrombolysis (single bolus of tenecteplase) with unfractionated heparin and group II patients received placebo with unfractionated heparin 3 . In this study, Sinha et al found that patients with acute submassive PE do not derive overall mortality benefit, recurrent PE and rehospitalization with thrombolytic therapy 3 .…”