AI Article Synopsis
- The KNOCOUT PE registry investigated the safety and efficacy of ultrasound-facilitated catheter-directed thrombolysis (USCDT) for treating acute pulmonary embolism (PE) in a diverse patient population across 64 sites worldwide.
- Among 489 patients treated with USCDT, the study found a low incidence of major bleeding (1.6%) and a low mortality rate (1.0%) within 30 days, while patients also reported improvements in their quality of life over 12 months.
- The findings support the use of USCDT with reduced doses of the thrombolytic agent alteplase (r-tPA), suggesting it can be done safely and effectively for patients at intermediate-high and high risk for
Article Abstract
Background: Prior clinical trials have demonstrated the efficacy of ultrasound-facilitated catheter-directed thrombolysis (USCDT) for the treatment of acute intermediate-risk pulmonary embolism (PE) using reduced thrombolytic doses and shorter infusion durations. However, utilization and safety of such strategies in broader PE populations remain unclear. The KNOCOUT PE (The EKoSoNic Registry of the Treatment and Clinical Outcomes of Patients With Pulmonary Embolism) registry is a multicenter international registry designed to study the treatment of acute PE with USCDT, with focus on safety outcomes.
Methods: The KNOCOUT PE prospective cohort included 489 patients (64 sites internationally) with acute intermediate-high or high-risk PE treated with USCDT between March 2018 and June 2020. Principal safety outcomes were independently adjudicated International Society on Thrombosis and Haemostasis major bleeding at 72 hours post-treatment and mortality within 12 months of treatment. Additional outcomes included change in right ventricular/left ventricular ratio and quality of life measures over 12 months.
Results: Mean alteplase (r-tPA [recombinant tissue-type plasminogen activator]) infusion duration was 10.5 hours. Mean total r-tPA dose was 18.1 mg, with 31.0% of patients receiving ≤12 mg. Major bleeding events within 72 hours occurred in 1.6% (8/489) of patients. One patient experienced worsening of a preexisting subdural hematoma after USCDT and therapeutic anticoagulation, which ultimately required surgery. All-cause mortality at 30 days was 1.0% (5/489). Improvement in PE quality of life score was observed with a 41.1% (243/489, 49.7%) and 44.2% (153/489, 31.3%) mean relative reduction by 3 and 12 months, respectively.
Conclusions: In a prospective observational cohort study of patients with intermediate-high and high-risk PE undergoing USCDT, mean r-tPA dose was 18 mg, and the rates of major bleeding and mortality were low.
Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03426124.
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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10942169 | PMC |
| http://dx.doi.org/10.1161/CIRCINTERVENTIONS.123.013448 | DOI Listing |
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