Figures
- FIGURE 1
a) Prognostic stratification of acute pulmonary embolism (PE). Information from [4]. b) Proposed algorithm for catheter-directed therapies (CDT) in high-risk and intermediate-high risk PE. Reproduced and modified from [13] with permission. PESI: pulmonary embolism severity index; sPESI: simplified pulmonary embolism severity index; RV: right ventricular; TTE: transthoracic echocardiogram; CTPA: computed tomography pulmonary angiography; UFH: unfractionated heparin; LMWH: low-molecular weight heparin; ECMO: extracorporeal membrane oxygenation; DOAC: direct oral anticoagulant. GBP
Tables
- TABLE 1
Summary of studies using catheter-directed therapies (CDT) in patients with acute pulmonary embolism (PE)
Trial name Year Sample Size Population Intervention Control Primary outcome Efficacy Safety Randomised controlled trials testing the efficacy and safety of different modes of catheter-directed thrombolysis ULTIMA [14] 2014 59 Intermediate–high risk USAT, EkoSonic Endovascular System (10 mg per 15 h) Anticoagulation monotherapy Change in 24-h TTE-based RV/LV ratio. Mean RV/LV ratio was reduced 1.28 to 0.99 at 24 h (p<0.001) in USAT group versus 1.20 to 1.17 at 24 h (p=0.31) in heparin group At 90 days, there was one death (control), no major bleeding, four minor bleeding episodes (three in the USAT group and one in the heparin group; p=0.61) OPTALYSE PE [16] 2018 100 Intermediate risk USAT, EkoSonic Endovascular System (4 mg per 2 h) (arm 1) USAT, EkoSonic System
(4 mg per 4 h) (arm 2)
(6 mg per 6 h) (arm 3)
(12 mg per 6 h) (arm 4)Change in the 48-h CT-based RV/LV ratio Mean RV/LV diameter ratio:
Arm 1: 0.40 (24.0%)
Arm 2: 0.35 (22.6%)
Arm 3: 0.42 (26.3%)
Arm 4: 0.48 (25.5%)Major bleeding event rates:
Arm 1: 0%
Arm 2: 3.7%
Arm 3: 3.6%
Arm 4: 11.1%SUNSET-sPE [17] 2021 81 Intermediate risk (submassive) USAT, EkoSonic Endovascular System (8 mg per 8 h) cCDT, UniFuse (AngioDynamics) or
Cragg-McNamara (Medtronic)
(8 mg per 8 h)Change in the 48-h CT-based thrombus burden No significant difference in mean thrombus burden.
Mean reduction in RV/LV ratio (p=0.01):
USAT: 0.37
cCDT: 0.59Major bleeds: intervention four versus control zero CANARY [20] 2022 94 Intermediate-high risk cCDT, Cragg-McNamara (Medtronic) (12 mg per 24 h) Anticoagulation monotherapy Proportion of patients with a TTE-based RV/LV ratio >0.9 at a 3-month follow-up 4.3% in the cCDT group and 12.8% in the anticoagulation monotherapy group (p=0.24)
Median RV/LV ratio at 3-month follow-up (p=0.01):
cCDT: 0.7
Anticoagulation monotherapy: 0.8One case of nonfatal major gastrointestinal bleeding occurred in the cCDT group HI-PEITHO (NCT04790370) [21] 406 Intermediate–high risk with additional criteria of severity USAT, EkoSonic Endovascular System (9 mg per 7 h) Parenteral anticoagulation monotherapy Composite of PE-related mortality, PE recurrence or cardiorespiratory decompensation or collapse, within 7 days of randomisation Ongoing Ongoing BETULA (NCT03854266) [24] 60 Intermediate–high risk cCDT, Unifuse (AngioDynamics) (4 mg per 2 h) Unfractionated heparin monotherapy Improvement in RV/LV ratio at 24 h Recruiting Recruiting PE-TRACT (NCT05591118) [22] 500 Intermediate risk CDT consisting of mechanical thrombectomy or cCDT Anticoagulation monotherapy Peak oxygen consumption at a 3-month follow-up Ongoing Ongoing PEERLESS (NCT05111613) [25] 550 Intermediate–high risk without absolute contraindication of thrombolysis Mechanical thrombectomy, FlowTriever System cCDT (any commercially available CDT system) Composite clinical end-point of all-cause mortality, ICH, major bleeding, clinical deterioration, ICU admission, and ICU length of stay during hospitalisation Recruiting Recruiting STORM-PE (NCT05684796) [26] 100 Intermediate–high risk Mechanical aspiration, Indigo Aspiration System Anticoagulation monotherapy Change in the 48-h CT-based RV/LV ratio Recruiting Recruiting STRATIFY (NCT04088292) [27] 210 Intermediate–high risk USAT (20 mg per 6 h) Anticoagulation monotherapy Reduction in Miller score 48–96 h post-randomisation Recruiting Recruiting Peripheral Systemic Thrombolysis Versus Catheter Directed Thrombolysis for Submassive PE (NCT03581877) [28] 2023 31 Intermediate risk Peripheral low-dose thrombolysis (24 mg per 12 h) USAT, EkoSonic Endovascular System (24 mg per 12 h) Change in the 48-h TTE-based RV/LV ratio Completed Completed Registry of prospective studies testing the efficacy and safety of different modes of catheter-directed thrombolysis SEATTLE II [15] 2015 150 Massive (n=31)
Submassive (n=119)USAT, EkoSonic Endovascular System (24 mg per 24 h) Change in the 48-h CT-based RV/LV ratio Mean RV/LV ratio decreased from 1.55 to 1.13 at 48 h (p<0.0001). One GUSTO severe bleed; 16 GUSTO moderate bleed KNOCKOUT PE Registry [29] 2018 1480 Intermediate–high risk or high risk USAT, EkoSonic Endovascular System Change in 24–48 h TTE-based RV/LV ratio
Persistence of pulmonary hypertensionOngoing Ongoing PERFECT [30] 2015 101 Massive (n=28)
Submassive (n=73)Massive PE: catheter-directed mechanical or pharmaco-mechanical thrombectomy
Submassive PE: catheter-directed thrombolysis (UniFuse, EkoSonic or pig tail)Clinical success was defined as: stabilisation of haemodynamic, improvement in pulmonary hypertension and/or right heart strain, and survival to hospital discharge Clinical success:
Massive PE: 85.7% (95% CI 67.3–96.0%)
Submassive PE: 97.3% (95% CI 90.5–99.7%)No major haemorrhages and no haemorrhagic strokes FLARE [31] 2019 106 Intermediate–high risk Mechanical thrombectomy, FlowTriever System (Inari) Change in the 48-h CT-based RV/LV ratio Mean RV/LV ratio 1.53 reduced to 1.15 at 48 h Four patients (3.8%) experienced six major adverse events EXTRACT-PE [32] 2021 119 Submassive PE Mechanical aspiration, IndigoVac (Penumbra) Change in the 48-h CT-based RV/LV ratio Mean RV/LV ratio reduction was 0.43 (95% CI 0.38–0.47; p<0.0001) at 48 h Two (1.7%) patients experienced three major adverse events FLAME [18] 2023 115 High-risk PE Mechanical thrombectomy, FlowTriever System (Inari) Context arm Composite incidence of all-cause mortality, clinical deterioration, bailout, and major bleeding at 45 days FlowTriever: 17%
Context arm: 63.9%FLASH interim results registry [33] 2022 250 Intermediate–risk (n=233)
High risk (n= 17)Mechanical thrombectomy, FlowTriever System (Inari) Composite of MAEs: device-related death, major bleeding, and intraprocedural device- or procedure-related adverse events at 48 h MAEs: three (1.2%), all of which were major bleeds that resolved without sequelae
All-cause mortality was 0.4% at 30 days, with a single death that was unrelated to PEFLASH 6 months [34] 2023 799 High risk (n=64)
Intermediate–high risk (n=616)
Intermediate–low risk or unclassified (n=119)Mechanical thrombectomy, FlowTriever System (Inari) Evaluate RV function, MMRCD, 6MWT distances, and PE QoL scores at 6 months Normal RV function increased from 15.1% to 95.1% (p<0.0001)
MMRCD score improved from 3.0 to 0.0 (p<0.0001)
6MWT distances increased from 180 m to 398 m (p <0.001)Prevalence of site-reported chronic thromboembolic pulmonary hypertension was 1.0% and chronic thromboembolic disease was 1.9% FLASH full cohort [19] 2023 800 High risk (n=63)
Intermediate–high risk (n=614)Mechanical thrombectomy, FlowTriever System (Inari) Composite of MAE: device-related death, major bleeding, device- or procedure-related adverse events MAEs: 1.8%
All-cause mortality was 0.3% at 48-h follow-up and 0.8% at 30-day follow-up, with no device-related deathsRV: right ventricular; LV: left ventricular; TTE: transthoracic echocardiogram; CT: computed tomography; cCDT: combined catheter-directed treatment (fibrinolysis and thrombectomy); GUSTO: Global Use of Streptokinase and t-PA for Occluded Coronary Arteries; ICH: intracerebral haemorrhage; ICU: intensive care unit; MAE: major adverse events; MMRCD: modified Medical Research Council dyspnoea scores; 6MWT: 6-min walk test; QoL: quality of life.
Vol 19 Issue 3
Table of Contents
When should we involve interventional radiology in the management of acute pulmonary embolism?
