Ultrasound-assisted catheter-directed thrombolysis versus surgical pulmonary embolectomy for intermediate-high or high-risk pulmonary embolism: a randomized phase II non-inferiority trial.
Autor: | Stortecky S; Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland., Barco S; Department of Angiology, University Hospital Zurich, Zurich, Switzerland.; Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Mainz, Germany., Windecker S; Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland., Heg D; CTU Bern, University of Bern, Bern, Switzerland., Kadner A; Department of Cardiac Surgery, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland., Englberger L; Department of Cardiac Surgery, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.; Department of Cardiac Surgery, Hirslanden Clinic Aarau, Aarau, Switzerland., Kucher N; Department of Angiology, University Hospital Zurich, Zurich, Switzerland.; Department of Angiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. |
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Jazyk: | angličtina |
Zdroj: | European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery [Eur J Cardiothorac Surg] 2024 Jul 01; Vol. 66 (1). |
DOI: | 10.1093/ejcts/ezae252 |
Abstrakt: | Objectives: We hypothesized that ultrasound-assisted thrombolysis (USAT) is non-inferior to surgical pulmonary embolectomy (SPE) to improve right ventricular (RV) function in patients with acute pulmonary embolism (PE). Methods: In a single-centre, non-inferiority trial, we randomly assigned 27 patients with intermediate-high or high-risk acute PE to undergo either USAT or SPE stratified by PE risk. Primary and secondary outcomes were the baseline-to-72-h difference in right-to-left ventricular (RV/LV) ratio and the Qanadli pulmonary occlusion score, respectively, by contrast-enhanced chest-computed tomography assessed by a blinded CoreLab. Results: The trial was prematurely terminated due to slow enrolment. Mean age was 62.6 (SD 12.4) years, 26% were women, and 15% had high-risk PE. Mean change in RV/LV ratio was -0.34 (95% CI -0.50 to -0.18) in the USAT and -0.53 (95% CI -0.68 to -0.38) in the SPE group (mean difference: 0.152; 95% CI 0.032-0.271; Pnon-inferiority = 0.80; Psuperiority = 0.013). Mean change in Qanadli pulmonary occlusion score was -7.23 (95% CI -9.58 to -4.88) in the USAT and -11.36 (95% CI -15.27 to -7.44) in the SPE group (mean difference: 5.00; 95% CI 0.44-9.56, P = 0.032). Clinical and functional outcomes were similar between the 2 groups up to 12 months. Conclusions: In patients with intermediate-high and high-risk acute PE, USAT was not non-inferior when compared with SPE in reducing RV/LV ratio within the first 72 h. In a post hoc superiority analysis, SPE resulted in greater improvement of RV overload and reduction of thrombus burden. (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.) |
Databáze: | MEDLINE |
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