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Catheter-directed thrombolysis (CDT) in the treatment of acute pulmonary embolism (PE) aims to reduce bleeding complications while maintaining efficacy compared to systemic fibrinolysis. While studies have shown CDT to have superior hemodynamic outcomes compared to systemic anticoagulation alone, bleeding events occur at higher frequencies. To date, few studies have explored factors contributing to higher bleeding risk in this unique population. A better understanding of these factors is crucial in order to select the right population for CDT.
From January 2012 to December 2016, 93 patients with submassive or massive PE were treated with CDT using the EkoSonic Endovascular System (EKOS, Bothell, WA, USA) were identified. Data was collected on demographics, co-morbidities, procedural characteristics, and bleeding risk factors. HAS-BLED scores were calculated on all patients. The primary outcome was any bleeding event during the hospitalization following CDT. Bleeding events were defined by any episode fulfilling the Bleeding Academic Research Consortium bleeding definition and were scored according to this definition.
25 bleeding events occurred (Type 1 – 10, Type 2 – 8, Type 3a – 3, Type 3b – 2, Type 4 – 2). HAS-BLED scores were not significantly different between the bleeding and non-bleeding groups (1.72 vs 1.71, p=0.921). Likewise the rate of hypertension, renal disease, liver disease, stroke, prior major bleeding, cancer, alcohol abuse, anti-platelet use, non-steroidal anti-inflammatory drug use, and steroid use were similar between the two groups. Factors seen more frequently in the bleeding group but lacking statistical significance included older age, lack of ultrasound use when establishing access, common femoral vein access site, and higher total tissue plasminogen (tPA) dose. Bolus doses of tPA were significantly higher in the bleeding group (5.60mg vs 3.80mg, p=0.028).
In patients with acute PE treated with CDT, higher tPA bolus dose is associated with increased risk of bleeding. HAS-BLED scores and other known bleeding risk factors are not predictive of bleeding in this population.
ENDOVASCULAR: Peripheral Vascular Disease and Intervention