REAL-PE highlights disparities in pulmonary embolism care
Data from the REAL-PE study suggest that there are inequities in care in how patients are treated for pulmonary embolism (PE).[1] Researchers also found that mechanical thrombectomy had higher rates of bleeding than ultrasound-assisted catheter-directed thrombolysis (USCDT).
To get more detailed insights into the study’s findings, Cardiovascular Business spoke with Sahil Parikh, MD, director of endovascular services at New York-Presbyterian Columbia University Irving Medical Center and associate professor of medicine at Columbia University.
The REAL-PE study analyzed data from over 2,000 patients treated with catheter-directed therapies for PE, utilizing real-world electronic health records (EHRs) from the Truveta database. This extensive database consolidates patient records from 27 health systems across the United States, covering approximately 120 million records.
The study looked specifically at differences in the use of MT compared to USCDT. Parikh said they found about 400,000 PE diagnoses in the dataset and he was surprised that only around 2,000 included the newer, advanced therapies compared to systemic based fibrinolytic drugs to dissolve the clots.
Health disparities identified in REAL-PE
Treatment selection disparities were evident in the data as to who was treated with more advanced therapy. More men than women were treated with MT compared to USCDT.
Black patients were also less likely to receive device-based therapies than non-Black patients.
"The data may point to some implicit biases in the allocation of treatment of patients with advanced therapies, but whether in fact that's true or not will remain to be seen. But we've seen similar trends with respect to other advanced therapies for valvular heart disease, complex coronary intervention, as well as peripheral vascular intervention. So these disparities in care are things that need to be better understood and then obviously eradicated to the extent possible," Parikh said.
He said there was not a clear indication if costs and insurance coverage were determining factors in how patients were treated, so further research needs to answer these questions. He added the data also did not show the geographic distribution of these patients.
Thrombectomy linked to high bleeding risks
One of the big surprises was that, contrary to popular belief, the study found a higher incidence of bleeding complications with mechanical thrombectomy compared to USCDT. This was despite the fact the USCDT uses fibrinolytic drugs to dissolve the clots. Bleeding was measured by hemoglobin drops in the EHRs. This finding was unexpected and suggests that MT may not always be the safer option.
"We identified that there was increased hazard of bleeding as measured by hemoglobin drops in the EHR after patients who received mechanical thrombectomy with the Inari device versus catheter directed thrombolysis using the Ekos device. That was contrary to our hypothesis, that lytic therapy would increase bleeding hazard. To our surprise, we saw that there was actually greater hemoglobin drop with large poor venous access related thrombectomy, suggesting that clinicians should take pause when selecting therapies and should individualize the based on individual bleeding characteristics of patients," Parikh emphasized.
Women and non-Black patients exhibited higher rates of bleeding post-procedure. This aligns with similar trends observed in percutaneous coronary intervention and peripheral vascular intervention registries.
Challenges and future directions for PE research
The study underscores the challenges of ensuring equitable healthcare access and the importance of comprehensive data to inform clinical decisions. Parikh pointed out that geographic, socio-economic and ethno-demographic factors could influence these disparities, suggesting a need for more granular data analysis in future studies.
Prospective clinical trials are ongoing to further investigate the efficacy and safety of different PE treatments. The insights from the REAL-PE study pave the way for more inclusive and diverse research that could lead to improved clinical outcomes and reduced disparities in PE care.
Find more insights from the PI or the REAL-PE trial Peter Monteleone, MD — Interventional cardiology sees growing role in pulmonary embolism interventions.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com