New developments on the forefront of intermediate-risk pulmonary embolism

 

PULMONARY VASCULAR AND CARDIOVASCULAR NETWORK

Cardiovascular Medicine and Surgery Section

Patients with intermediate-risk pulmonary embolism (IRPE), or those with right ventricular dysfunction without overt hemodynamic instability, represent a heterogenous population with short-term mortality ranging from 2% to 17%.¹ While systemic anticoagulation is the mainstay therapy, select individuals may benefit from more immediate reperfusion. Catheter-based therapies (CBT), including thrombus aspiration, fragmentation, or catheter-directed thrombolysis, have seen rapid uptake over the last decade, with promising retrospective data. Unfortunately, only small, randomized trials exploring surrogate outcomes are available to guide modality and patient selection.²

CHEST

To better define which patients with IRPE are best managed with which therapy, several large-scale randomized controlled trials are underway. PE-TRACT, a study funded by the National Institutes of Health, aims to randomize 500 patients with IRPE to anticoagulation alone vs one of several modalities of CBT with a focus on long-term functional outcomes, including peak oxygen consumption at 3 months and functional class at 1 year. Aspiration thrombectomy with the FlowTriever^® device is being compared with anticoagulation alone in a study of 1,200 patients examining short-term composite end points.

CHEST

While full-dose thrombolysis may decrease the composite outcome of death or hemodynamic deterioration in this population, the benefit is counterbalanced by the risk of significant bleeding. Whether reduced-dose thrombolysis is associated with improved outcomes has been questioned in several small studies. The PEITHO-3 trial plans to randomize 650 patients with IRPE to reduced-dose thrombolytics vs placebo, exploring several outcomes at 30 days. With multiple large trials ongoing, we anticipate important changes to the landscape of IRPE care over the coming years.

References

1. Fernández C, Bova C, Sanchez O, et al. Validation of a model for identification of patients at intermediate to high risk for complications associated with acute symptomatic pulmonary embolism. Chest. 2015;148(1):211-218. doi:10.1378/chest.14-2551

2. Yuriditsky E, Horowitz JM. The role of the PERT in the management and therapeutic decision-making in pulmonary embolism. Eur Heart J Acute Cardiovasc Care. 2022;11(9):693-694. doi:10.1093/ehjacc/zuac102

3. National Library of Medicine (US). A Randomized Trial of Ultrasound-facilitated, Catheter-directed, Thrombolysis Versus Anticoagulation for Acute Intermediate-high Risk Pulmonary Embolism: The Higher-risk Pulmonary Embolism Thrombolysis Study. Updated July 16, 2024. https://clinicaltrials.gov/study/NCT04790370

4. National Library of Medicine (US). PEERLESS II: RCT of FlowTriever vs. Anticoagulation Alone in Pulmonary Embolism. Updated July 17, 2024. https://clinicaltrials.gov/study/NCT06055920

5. National Library of Medicine (US). A Reduced Dose of Thrombolytic Treatment for Patients With Intermediate High-risk Acute Pulmonary Embolism: a Randomized Controled Trial. Updated July 17, 2024. https://clinicaltrials.gov/study/NCT04430569

 

PULMONARY VASCULAR AND CARDIOVASCULAR NETWORK

Cardiovascular Medicine and Surgery Section

Patients with intermediate-risk pulmonary embolism (IRPE), or those with right ventricular dysfunction without overt hemodynamic instability, represent a heterogenous population with short-term mortality ranging from 2% to 17%.¹ While systemic anticoagulation is the mainstay therapy, select individuals may benefit from more immediate reperfusion. Catheter-based therapies (CBT), including thrombus aspiration, fragmentation, or catheter-directed thrombolysis, have seen rapid uptake over the last decade, with promising retrospective data. Unfortunately, only small, randomized trials exploring surrogate outcomes are available to guide modality and patient selection.²

CHEST

To better define which patients with IRPE are best managed with which therapy, several large-scale randomized controlled trials are underway. PE-TRACT, a study funded by the National Institutes of Health, aims to randomize 500 patients with IRPE to anticoagulation alone vs one of several modalities of CBT with a focus on long-term functional outcomes, including peak oxygen consumption at 3 months and functional class at 1 year. Aspiration thrombectomy with the FlowTriever^® device is being compared with anticoagulation alone in a study of 1,200 patients examining short-term composite end points.

CHEST

While full-dose thrombolysis may decrease the composite outcome of death or hemodynamic deterioration in this population, the benefit is counterbalanced by the risk of significant bleeding. Whether reduced-dose thrombolysis is associated with improved outcomes has been questioned in several small studies. The PEITHO-3 trial plans to randomize 650 patients with IRPE to reduced-dose thrombolytics vs placebo, exploring several outcomes at 30 days. With multiple large trials ongoing, we anticipate important changes to the landscape of IRPE care over the coming years.

References

1. Fernández C, Bova C, Sanchez O, et al. Validation of a model for identification of patients at intermediate to high risk for complications associated with acute symptomatic pulmonary embolism. Chest. 2015;148(1):211-218. doi:10.1378/chest.14-2551

2. Yuriditsky E, Horowitz JM. The role of the PERT in the management and therapeutic decision-making in pulmonary embolism. Eur Heart J Acute Cardiovasc Care. 2022;11(9):693-694. doi:10.1093/ehjacc/zuac102

3. National Library of Medicine (US). A Randomized Trial of Ultrasound-facilitated, Catheter-directed, Thrombolysis Versus Anticoagulation for Acute Intermediate-high Risk Pulmonary Embolism: The Higher-risk Pulmonary Embolism Thrombolysis Study. Updated July 16, 2024. https://clinicaltrials.gov/study/NCT04790370

4. National Library of Medicine (US). PEERLESS II: RCT of FlowTriever vs. Anticoagulation Alone in Pulmonary Embolism. Updated July 17, 2024. https://clinicaltrials.gov/study/NCT06055920

5. National Library of Medicine (US). A Reduced Dose of Thrombolytic Treatment for Patients With Intermediate High-risk Acute Pulmonary Embolism: a Randomized Controled Trial. Updated July 17, 2024. https://clinicaltrials.gov/study/NCT04430569

 

PULMONARY VASCULAR AND CARDIOVASCULAR NETWORK

Cardiovascular Medicine and Surgery Section

Patients with intermediate-risk pulmonary embolism (IRPE), or those with right ventricular dysfunction without overt hemodynamic instability, represent a heterogenous population with short-term mortality ranging from 2% to 17%.¹ While systemic anticoagulation is the mainstay therapy, select individuals may benefit from more immediate reperfusion. Catheter-based therapies (CBT), including thrombus aspiration, fragmentation, or catheter-directed thrombolysis, have seen rapid uptake over the last decade, with promising retrospective data. Unfortunately, only small, randomized trials exploring surrogate outcomes are available to guide modality and patient selection.²

CHEST

To better define which patients with IRPE are best managed with which therapy, several large-scale randomized controlled trials are underway. PE-TRACT, a study funded by the National Institutes of Health, aims to randomize 500 patients with IRPE to anticoagulation alone vs one of several modalities of CBT with a focus on long-term functional outcomes, including peak oxygen consumption at 3 months and functional class at 1 year. Aspiration thrombectomy with the FlowTriever^® device is being compared with anticoagulation alone in a study of 1,200 patients examining short-term composite end points.

CHEST

While full-dose thrombolysis may decrease the composite outcome of death or hemodynamic deterioration in this population, the benefit is counterbalanced by the risk of significant bleeding. Whether reduced-dose thrombolysis is associated with improved outcomes has been questioned in several small studies. The PEITHO-3 trial plans to randomize 650 patients with IRPE to reduced-dose thrombolytics vs placebo, exploring several outcomes at 30 days. With multiple large trials ongoing, we anticipate important changes to the landscape of IRPE care over the coming years.

References

1. Fernández C, Bova C, Sanchez O, et al. Validation of a model for identification of patients at intermediate to high risk for complications associated with acute symptomatic pulmonary embolism. Chest. 2015;148(1):211-218. doi:10.1378/chest.14-2551

2. Yuriditsky E, Horowitz JM. The role of the PERT in the management and therapeutic decision-making in pulmonary embolism. Eur Heart J Acute Cardiovasc Care. 2022;11(9):693-694. doi:10.1093/ehjacc/zuac102

3. National Library of Medicine (US). A Randomized Trial of Ultrasound-facilitated, Catheter-directed, Thrombolysis Versus Anticoagulation for Acute Intermediate-high Risk Pulmonary Embolism: The Higher-risk Pulmonary Embolism Thrombolysis Study. Updated July 16, 2024. https://clinicaltrials.gov/study/NCT04790370

4. National Library of Medicine (US). PEERLESS II: RCT of FlowTriever vs. Anticoagulation Alone in Pulmonary Embolism. Updated July 17, 2024. https://clinicaltrials.gov/study/NCT06055920

5. National Library of Medicine (US). A Reduced Dose of Thrombolytic Treatment for Patients With Intermediate High-risk Acute Pulmonary Embolism: a Randomized Controled Trial. Updated July 17, 2024. https://clinicaltrials.gov/study/NCT04430569