https://orcid.org/0000-0002-5076-0177
Abstract
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).
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.
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.
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.
