title: Risk factors for major bleeding in the SEATTLE II trial.
abstract: Ultrasound-facilitated, catheter-directed, low-dose fibrinolysis minimizes the risk of intracranial bleeding compared with systemic full-dose fibrinolytic therapy for pulmonary embolism (PE). However, major bleeding is nevertheless a potential complication. We analyzed the 150-patient SEATTLE II trial of submassive and massive PE patients to describe those who suffered major bleeding events following ultrasound-facilitated, catheter-directed, low-dose fibrinolysis and to identify risk factors for bleeding. Major bleeding was defined as GUSTO severe/life-threatening or moderate bleeds within 72 hours of initiation of the procedure. Of the 15 patients with major bleeding, four (26.6%) developed access site-related bleeding. Multiple venous access attempts were more frequent in the major bleeding group (27.6% vs 3.6%; p<0.001). All patients with major bleeding had femoral vein access for device delivery. Patients who developed major bleeding had a longer intensive care stay (6.8 days vs 4.7 days; p=0.004) and longer hospital stay (12.9 days vs 8.4 days; p=0.004). The frequency of inferior vena cava filter placement was 40% in patients with major bleeding compared with 13% in those without major bleeding ( p=0.02). Massive PE (adjusted odds ratio 3.6; 95% confidence interval 1.01-12.9; p=0.049) and multiple venous access attempts (adjusted odds ratio 10.09; 95% confidence interval 1.98-51.46; p=0.005) were independently associated with an increased risk of major bleeding. In conclusion, strategies for improving venous access should be implemented to reduce the risk of major bleeding associated with ultrasound-facilitated, catheter-directed, low-dose fibrinolysis. ClinicalTrials.gov Identifier: NCT01513759; EKOS Corporation 10.13039/100006522.
authors.affiliation: 1 Vascular Medicine Division, Hartford Hospital, Hartford, CT, USA.
authors.forename: Immad
authors.initials: I
authors.lastname: Sadiq
authors.affiliation: 2 Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Samuel Z
authors.initials: SZ
authors.lastname: Goldhaber
authors.affiliation: 3 Fred Hutchinson Cancer Center, Seattle, WA, USA.
authors.forename: Ping-Yu
authors.initials: PY
authors.lastname: Liu
authors.affiliation: 2 Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Gregory
authors.initials: G
authors.lastname: Piazza
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002406:Catheterization, Peripheral / Q000009:adverse effects*; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D006470:Hemorrhage / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D011655:Pulmonary Embolism / Q000175:diagnosis / Q000188:drug therapy*; D011677:Punctures; D018570:Risk Assessment; D012307:Risk Factors; D015912:Thrombolytic Therapy / Q000009:adverse effects*; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D014481:United States / Q000453:epidemiology; D016306:Vena Cava Filters / Q000009:adverse effects
chemical_list: D005343:Fibrinolytic Agents
keywords: bleeding; catheter-directed therapy; fibrinolysis; pulmonary embolism; right ventricular function; risk factors