What is the PE-TRACT Study?

The PE-TRACT study includes patients who have been diagnosed with a pulmonary embolism (blood clots in their lungs). The study is designed to identify the best way to treat pulmonary embolism, specifically when there is a large amount of clot but the patient’s blood pressure is stable. While this condition is sometimes life-threatening, both of the treatment approaches in this study work well to help people survive. Less is known about which treatment helps people do better in terms of breathing, heart function, and ability to exercise over time.

Our Approach

Treatment for pulmonary embolism involves one of two standard approaches:

  • One standard approach is to try to dissolve or remove the clot using catheter-directed therapy (CDT). This procedure is done by inserting a thin plastic tube (catheter) into a vein, typically in the groin or neck. The catheter is guided toward the blood clots in the lungs using x-ray. Then, a clot- dissolving medicine or a vacuum can be used to dissolve or suck out the clot. Exactly how this is performed is determined by the doctor doing the procedure. Patients treated with CDT will also take blood thinner medicine (anticoagulation).
  • The other standard approach is not to have CDT and to take a blood- thinner medicine (anticoagulation) alone.

The goal of the PE-TRACT study is to compare these two standard approaches to treatment. Both CDT and anticoagulation alone have been shown to work effectively to treat patients in the hospital. However, it is unknown which approach works better or worse, especially regarding patients’ ability to exercise and do other activities over the long term.

Why is the Study Important?

Pulmonary embolism (PE) afflicts 300,000–600,000 Americans/year, causes 100,000 deaths/year, and results in profound disability in many survivors. PE is classified into three risk groups in order of increasing mortality: low-risk, submassive, and massive. While the treatment for low-risk and massive PE is fairly clear, the optimal treatment for submassive PE (25% of PE) is uncertain. This study will determine whether adding an innovative, image-guided thrombus-removal technology (catheter-directed therapy) to standard anticoagulant therapy improves cardiopulmonary physiology and functional status in patients with submassive PE.

PE-TRACT will be the first large multi-center randomized trial of CDT for PE. It will create an enduring PE clinical trial network and apply innovative trial methodology to the endovascular field. If the trial finds CDT to be effective and safe, it will transform clinical practice and improve cardiopulmonary health in many thousands of patients. If CDT proves to be ineffective or unsafe, patients can be spared the risks, inconvenience, and cost of an invasive procedure. Hence, either study outcome will improve public health and define submassive PE treatment.

Total Number of Expected Participants

The PE-TRACT study is expected to include about 500 patients and will last for approximately 6 years.

Interim efficacy analyses will begin when 250 patients are randomized and then after every additional 50 patients are randomized, which approximately corresponds to interim analyses every 7 months. Stopping criteria for the interim analyses are pre-defined. The DSMB will also review safety data (i.e., frequency of SAEs), and based on an overall assessment of risk and benefit, the DSMB can recommend premature stopping of the study after any of these analyses.