Prospective Multicenter International Registry of Ultrasound-Facilitated Catheter-Directed Thrombolysis in Intermediate-High and High-Risk Pulmonary Embolism (KNOCOUT PE)

Author:

Sterling Keith M.1ORCID,Goldhaber Samuel Z.2ORCID,Sharp Andrew S.P.3ORCID,Kucher Nils4ORCID,Jones Noah5,Maholic Robert6,Meneveau Nicolas7ORCID,Zlotnick David8,Sayfo Sameh9,Konstantinides Stavros V.10ORCID,Piazza Gregory2ORCID

Affiliation:

1. Inova Alexandria Hospital, VA (K.M.S.).

2. Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (S.Z.G., G.P.).

3. University Hospital of Wales and Cardiff University, United Kingdom (A.S.P.S.).

4. University Clinic of Angiology, University Hospital Zurich, Switzerland (N.K.).

5. Mount Carmel Health System, Columbus, OH (N.J.).

6. University of Pittsburgh Medical Center Hamot, Erie, PA (R.M.).

7. CHU Besancon, France (N.M.).

8. University at Buffalo/Great Lakes Cardiovascular, NY (D.Z.).

9. Baylor Scott and White The Heart Hospital Plano, TX (S.S.).

10. Center for Thrombosis and Hemostasis, University Medical Center Mainz, Germany (S.V.K.).

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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