Head-to-head: Surgical embolectomy versus ultrasound-assisted thrombolysis in high-risk pulmonary embolism

Surgical pulmonary embolectomy (SPE) yielded better health outcomes than ultrasound-assisted thrombolysis (USAT) in patients with intermediate-high or high-risk pulmonary embolism in the phase 2 SPECIAL trial.

“To date, no randomised trials have been conducted comparing USAT and SPE as reperfusion strategies in patients with intermediate-high or high-risk pulmonary embolism,” said Dr Stefan Stortecky (University of Bern, Switzerland) [1]. The single-centre, randomised-controlled, non-inferiority, phase 2 SPECIAL trial investigated this matter. The primary endpoint was the difference in right to left ventricular dimension ratio (RV/LV ratio), assessed by contrast-enhanced chest CT from baseline to 72 hours. “The trial was ended prematurely due to the difficulty of enrolling patients in the emerging era of less-invasive endovascular techniques,” added Dr Stortecky. Thus, the trial included 27 instead of the planned 60 participants.

Both treatment options resulted in significant mean changes in RV/LV ratio from baseline to 72 hours: for USAT 1.43 to 1.09 (P<0.001) and for SPE 1.47 to 0.94 (P<0.001). However, USAT was not non-inferior to SPE (mean change 0.34 vs 0.53; P_{non-inferiority}=0.80). In addition, the P-value for superiority was 0.013 in favour of the SPE arm. Other endpoints, such as the Qanadli Obstruction Index and the total number of fully and partially occluded segments also indicated that SPE led to better treatment results than USAT.

Finally, there were no significant differences in safety outcomes, including the rate of recurrent VTE (SPE vs USAT, 14% vs 0%) and any bleeding (SPE vs USAT, 14% vs 23%). No deaths or strokes were reported in the current trial.

Dr Sahil Parikh (Columbia University Irving Medical Center, NY, USA) commented that there are several catheter-based treatment options effective in reducing the RV/LV ratio in 2023 and that the remaining role of SPE in this era still needs to be determined. “We see a movement towards mechanical thrombectomy and because this approach delivers more rapid clinical improvement, it offers the opportunity to avoid thrombolytics and may result in less need for an ICU stay,” he decided.

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   1. Stortecky S, et al. Ultrasound-assisted catheter-directed thrombolysis versus surgical pulmonary embolectomy for intermediate-high or high-risk pulmonary embolism: a randomised phase 2 non-inferiority study. FS07, AHA Scientific Sessions 2023, 11–13 November, Philadelphia, PA, USA.

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Posted on 29 January, 202428 March, 2024