Standard Versus Ultrasound-Assisted Thrombolysis for Submassive Pulmonary Embolism - SUNSET sPE

Jun 28, 2021
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC; Neil Keshvani, MD
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Published:
06/21/2021
Date Updated:
06/28/2021
Original Posted Date:
06/28/2021
References

Contribution To Literature:

The SUNSET sPE trial showed that, among patients with submassive PE, there were no differences in pulmonary arterial thrombus reduction between standard catheter-directed thrombolysis or ultrasound-assisted catheter-directed thrombolysis.

Description:

The goal of the trial was to assess whether ultrasound-assisted catheter-directed thrombolysis was more effective than standard catheter-directed thrombolysis for patients with submassive pulmonary embolism (PE).

Study Design

Among patients with submassive PE being considered for catheter-directed thrombolysis, patients were randomized in 1:1 single-blind fashion to undergo ultrasound-assisted thrombolysis (n = 40) or standard catheter-directed thrombolysis (n = 41). Both arms had similar recommendations for dosing and duration of tissue plasminogen activator (tPA).

  • Total screened: 92
  • Total number of enrollees: 81
  • Duration of follow-up: 12 months
  • Mean patient age: 53 years
  • Percentage female: 47%

Inclusion criteria:

  • Right ventricular (RV) strain as diagnosed by RV-to-left ventricular (LV) diameter ratio >1 by computed tomography (CT) angiography or transthoracic echocardiography (TTE) and/or elevated troponin or B-type natriuretic peptide
  • Absence of circulatory shock—persistent hypotension or requirement for vasoactive medications

Exclusion criteria:

  • Symptoms >14 days
  • Increased bleeding risk (prior intracranial hemorrhage, ischemic stroke within 3 months, active bleeding, recent surgery or trauma)

Other salient features/characteristics:

  • 64% with acute deep vein thrombosis on presentation
  • Baseline RV/LV ration on CT: 1.62
  • Mean pulmonary artery systolic/diastolic pressure: 56/25 mm Hg
  • Mean total tPA dose: 19 ± 7 mg
  • Mean total time of tPA: 14 ± 6 hours

Principal Findings:

The primary endpoint, thrombus load reduction on CT using the Miller scoring system, for ultrasound-assisted versus standard catheter-directed thrombolysis, was 21% vs. 22% (p = 0.77).

Secondary outcomes (for ultrasound-assisted vs. standard catheter-directed thrombolysis):

  • Change in RV/LV diameter ratio after lytic therapy: 0.37 vs. 0.59 (p = 0.01)
  • Intensive care unit stay: 4.1 vs. 2.4 days (p = 0.23)
  • Major bleeding: 2 events vs. 0 events

Interpretation:

The results of this trial indicate that among patients undergoing catheter-directed thrombolysis for submassive PE, there was no difference in thrombus reduction between standard catheter-directed thrombolysis or ultrasound-assisted thrombolysis. Both procedures had improvement in RV function, but ultrasound-assisted thrombolysis had lesser improvement in RV/LV ratio. Overall catheter-directed thrombolysis in this trial was safe, with only 2.5% overall major bleeding rate.

It does not appear that the addition of ultrasound, which is thought to enhance lytic effect, improves thrombus removal or clinical outcomes. Given the cost of ultrasound-assisted catheters is significantly higher than standard multi-hole catheters, their routine use for catheter-directed thrombolysis may need reconsideration. However, the study was powered to detect an improvement of ≥50% in the ultrasound group, and a smaller difference may not have been detected given the small sample size. Future studies could also consider assessment of thrombus clearance utilizing shorter duration or dose of alteplase (tPA) infusion given a recent study, OPTA-LYSE PE, demonstrated efficacy of ultrasound-assisted thrombolysis with shorter lysis time.

References:

Avgerinos ED, Jaber W, Lacomis J, et al. Randomized Trial Comparing Standard Versus Ultrasound-Assisted Thrombolysis for Submassive Pulmonary Embolism: The SUNSET sPE Trial. JACC Cardiovasc Interv 2021;14:1364-73.

Editorial Comment: Sista AK. Is it Time to Sunset Ultrasound-Assisted Catheter-Directed Thrombolysis for Submassive PE? JACC Cardiovasc Interv 2021;14:1374-75.

Clinical Topics: Anticoagulation Management, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Vascular Medicine, Lipid Metabolism, Interventions and Imaging, Interventions and Vascular Medicine, Angiography, Echocardiography/Ultrasound, Nuclear Imaging

Keywords: Angiography, Anticoagulants, Catheters, Cost-Benefit Analysis, Diagnostic Imaging, Echocardiography, Hypotension, Intensive Care Units, Natriuretic Peptide, Brain, Pulmonary Embolism, Secondary Prevention, Thrombolytic Therapy, Thrombosis, Tissue Plasminogen Activator, Troponin, Ultrasonography, Vascular Diseases


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