Randomized Trial Comparing Standard Versus Ultrasound-Assisted Thrombolysis for Submassive Pulmonary Embolism: The SUNSET sPE Trial

Published on Jun 28, 2021in Jacc-cardiovascular Interventions8.432
· DOI :10.1016/J.JCIN.2021.04.049
Efthymios D. Avgerinos22
Estimated H-index: 22
(University of Pittsburgh),
Wissam Jaber15
Estimated H-index: 15
(Emory University)
+ 7 AuthorsRabih A. Chaer37
Estimated H-index: 37
(University of Pittsburgh)
OBJECTIVES The aim of this trial was to determine whether ultrasound-assisted thrombolysis (USAT) is superior to standard catheter-directed thrombolysis (SCDT) in pulmonary arterial thrombus reduction for patients with submassive pulmonary embolism (sPE). BACKGROUND Catheter-directed therapy has been increasingly used in sPE and massive pulmonary embolism as a decompensation prevention and potentially lifesaving procedure. It is unproved whether USAT is superior to SCDT using traditional multiple-side-hole catheters in the treatment of patients with pulmonary embolism. METHODS Adults with sPE were enrolled. Participants were randomized 1:1 to USAT or SCDT. The primary outcome was 48-hour clearance of pulmonary thrombus assessed by pre- and postprocedural computed tomographic angiography using a refined Miller score. Secondary outcomes included improvement in right ventricular-to-left ventricular ratio, intensive care unit and hospital stay, bleeding, and adverse events up to 90 days. RESULTS Eighty-one patients with acute sPE were randomized and were available for analysis. The mean total dose of alteplase for USAT was 19 ± 7 mg and for SCDT was 18 ± 7 mg (P = 0.53), infused over 14 ± 6 and 14 ± 5 hours, respectively (P = 0.99). In the USAT group, the mean raw pulmonary arterial thrombus score was reduced from 31 ± 4 at baseline to 22 ± 7 (P < 0.001). In the SCDT group, the score was reduced from 33 ± 4 to 23 ± 7 (P < 0.001). There was no significant difference in mean thrombus score reduction between the 2 groups (P = 0.76). The mean reduction in right ventricular/left ventricular ratio from baseline (1.54 ± 0.30 for USAT, 1.69 ± 0.44 for SCDT) to 48 hours was 0.37 ± 0.34 in the USAT group and 0.59 ± 0.42 in the SCDT group (P = 0.01). Major bleeding (1 stroke and 1 vaginal bleed requiring transfusion) occurred in 2 patients, both in the USAT group. CONCLUSIONS In the SUNSET sPE (Standard vs. Ultrasound-Assisted Catheter Thrombolysis for Submassive Pulmonary Embolism) trial, patients undergoing USAT had similar pulmonary arterial thrombus reduction compared with those undergoing SCDT, using comparable mean lytic doses and durations of lysis.
📖 Papers frequently viewed together
7 Citations
22 Citations
#1Sorcha AllenH-Index: 2
Last. Yevgeniy BrailovskyH-Index: 5
view all 14 authors...
1 CitationsSource
#1Paul D. Stein (MSU: Michigan State University)H-Index: 93
#2Fadi Matta (MSU: Michigan State University)H-Index: 32
Last. Mary J. Hughes (MSU: Michigan State University)H-Index: 13
view all 3 authors...
ABSTRACT Treatment of submassive (intermediate-risk) pulmonary embolism (PE), defined as hemodynamically stable with right ventricular (RV) dysfunction, showed lower in-hospital all-cause mortality with intravenous thrombolytic therapy than with anticoagulants, but at an increased risk of major bleeding. The present investigation was performed to test whether catheter-directed thrombolysis reduces mortality without increasing bleeding in submassive PE. This was a retrospective cohort study based...
1 CitationsSource
#1Sebastian Beyer (BIDMC: Beth Israel Deaconess Medical Center)H-Index: 15
#2Colby Shanafelt (BIDMC: Beth Israel Deaconess Medical Center)H-Index: 1
Last. Brett J. Carroll (BIDMC: Beth Israel Deaconess Medical Center)H-Index: 7
view all 9 authors...
Abstract Background There are increased options to deliver thrombolytic treatment for acute, high-risk pulmonary embolism (PE). The goals of this study were to examine practice patterns of systemic thrombolysis and catheter-directed thrombolysis (CDT) and to compare outcomes after CDT with ultrasound facilitation (CDT-US) and CDT alone. Methods We analyzed adults >18 years of age with hospitalizations associated with acute PE and thrombolysis in the 2016 Nationwide Readmissions Database. We iden...
8 CitationsSource
#1Jay GiriH-Index: 29
#2Akhilesh K. SistaH-Index: 11
Last. Vascular BiologyH-Index: 8
view all 12 authors...
Pulmonary embolism (PE) represents the third leading cause of cardiovascular mortality. The technological landscape for management of acute intermediate- and high-risk PE is rapidly evolving. Two i...
63 CitationsSource
#1Efthymios D. Avgerinos (University of Pittsburgh)H-Index: 22
#2Rabih A. Chaer (University of Pittsburgh)H-Index: 37
1 CitationsSource
#1Belinda Rivera-Lebron (University of Pittsburgh)H-Index: 8
#2Michael C. McDaniel (Emory University)H-Index: 21
Last. Richard N. Channick (UCLA: University of California, Los Angeles)H-Index: 59
view all 34 authors...
Pulmonary embolism (PE) is a life-threatening condition and a leading cause of morbidity and mortality. There have been many advances in the field of PE in the last few years, requiring a careful a...
49 CitationsSource
#1Thomas Tu (Baptist Health)H-Index: 1
#2Catalin Toma (University of Pittsburgh)H-Index: 24
Last. Flare InvestigatorsH-Index: 1
view all 19 authors...
Abstract Objectives The aim of this study was to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, California) in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE). Background Catheter-directed thrombolysis has been shown to improve right ventricular (RV) function in patients with PE. However, catheter-directed thrombolysis increases bleeding risk and many patients with PE have rel...
77 CitationsSource
#1Edward L. Gayou (The Ohio State University Wexner Medical Center)H-Index: 1
#1Edward L Gayou (The Ohio State University Wexner Medical Center)H-Index: 1
Last. Luciano M. Prevedello (The Ohio State University Wexner Medical Center)H-Index: 24
view all 7 authors...
Abstract Purpose To evaluate changes in the use of catheter-directed therapy (CDT) for pulmonary embolism (PE) treatment with attention to primary operator specialty in the Medicare population. Methods Using a 5% national sample of Medicare claims data from 2004 to 2016, all claims associated with PE were identified. The annual volume of 2 billable CDT services—arterial mechanical thrombectomy and transcatheter arterial infusion for thrombolysis—were determined to evaluate changes in CDT use and...
10 CitationsSource
#1Gaurav Rao (Hofstra University)H-Index: 4
#2Hai Xu (Hofstra University)H-Index: 1
Last. Mitchell D. Weinberg (Hofstra University)H-Index: 8
view all 11 authors...
Both catheter-directed thrombolysis (CDT) and ultrasound-assisted thrombolysis (USAT) are novel treatment modalities for patients presenting with acute pulmonary embolism (PE). The objective of this study was to compare clinical and quality-of-life (QOL) outcomes for patients undergoing either treatment modality. We retrospectively studied 70 consecutive patients treated with either CDT or USAT over 3 years at a multicenter health system. The primary clinical efficacy endpoint was right ventricu...
19 CitationsSource
#1Daniel P. Rothschild (Beaumont Health)H-Index: 4
#2James A. Goldstein (Oakland University)H-Index: 53
Last. Terry R. Bowers (Oakland University)H-Index: 2
view all 4 authors...
Ultrasound-accelerated thrombolysis (USAT) is advocated in pulmonary embolism (PE) based on the hypothesis that adjunctive ultrasound provides superior clinical efficacy compared to standard catheter-directed thrombolysis (CDT). This retrospective study was designed to compare outcomes between the two modalities. We analyzed patients with computed tomography-diagnosed PE at our institution treated with either USAT or standard CDT. Efficacy parameters assessed included invasive pulmonary artery s...
20 CitationsSource
Cited By1