Catheter-directed thrombolysis for PE confers less bleeding vs. mechanical thrombectomy
Click Here to Manage Email Alerts
Key takeaways:
- Catheter-directed thrombolysis was linked to less major bleeding than mechanical thrombectomy in patients with pulmonary embolism.
- There were no differences in length of stay, death or 30-day readmission.
SAN FRANCISCO — In the REAL-PE study of a real-world population of patients with pulmonary embolism, catheter-directed thrombolysis was associated with reduced risk for major bleeding compared with mechanical thrombectomy.
For REAL-PE, the researchers analyzed information from Truveta, a data and analytics company that provides electronic health record data including lab values, comorbidities, images, demographics and clinical outcomes, as well as information about the performance of specific medical devices. The data included more than 82 million patients from 16 U.S. health systems, of whom 2,259 patients were treated with ultrasound-assisted catheter-directed thrombolysis (EKOS Endovascular System, Boston Scientific) or mechanical thrombectomy (FlowTriever System, Inari Medical) from 2009 to May 2023. The results were presented at TCT 2023 and simultaneously published in the Journal of the Society for Cardiovascular Angiography and Interventions.
“Over the last few years, we have had an incredibly rapid explosion of advanced therapies [for PE]. The use of these therapies has run ahead of a lot of the data that we have,” Peter Monteleone, MD, interventional cardiologist at the University of Texas at Austin Dell School of Medicine, Ascension Texas Cardiovascular in Austin, who presented the data, told Healio. “We have some single-arm trials, and we are waiting on the large-scale randomized controlled trials that will probably take a few more years to come. And so what we have here is the ability to get near real-time data about the actual patient experience with pulmonary embolism therapies to help guide decision-making that’s being made today by clinicians taking care of patients with PE. We are able to look not at a selected, highly controlled cohort, but ... at every patient that has been treated with one of these device-based therapies during this time interval.”
All patients were included in the primary analysis and 1,798 were included in the contemporary analysis of those who had procedures from 2018 to May 2023. The catheter-directed thrombolysis group was 43.4% women, and 55.6% were aged 60 years or older. The mechanical thrombectomy group was 47.8% women, and 63.5% were aged 60 years or older.
In the contemporary analysis, more patients in the catheter-directed thrombolysis group had been treated with a direct oral anticoagulant within 30 days of the procedure compared with the mechanical thrombectomy group, but there were no other differences in anticoagulant use.
In both the primary and contemporary analyses, the catheter-directed thrombolysis group had lower rates of 7-day transfusion, hemoglobin reduction of more than 2 g/dL and hemoglobin reduction of more than 5 g/dL (P < .0001 for all), according to the researchers.
In-hospital major bleeding by International Society on Thrombosis and Haemostasis (ISTH) criteria was lower in the catheter-directed thrombolysis group compared with the mechanical thrombectomy group in the primary analysis (12.4% vs. 17.3%; P = .0018) and the contemporary analysis (11% vs. 17.2%; P = .0002), and the same was true for major bleeding by Bleeding Academic Research Consortium (BARC) 3b criteria (primary analysis, 11.8% vs. 15.4%; P = .019; contemporary analysis, 10.6% vs. 15.4%; P = .0024), Monteleone and colleagues found.
In both analyses, there were no differences between the groups in post-procedure length of stay, 30-day readmission or in-hospital mortality.
In multiple logistic regression analyses, mechanical thrombectomy was associated with major bleeding in the primary cohort by ISTH criteria (OR = 1.367; 95% CI, 1.075-1.737), in the contemporary cohort by ISTH criteria (OR = 1.608; 95% CI, 1.234-2.095) and in the contemporary cohort by BARC 3b criteria (OR = 1.763; 95% CI, 1.397-2.225) and trended toward being associated with major bleeding in the primary cohort by BARC 3b criteria (OR = 1.232; 95% CI, 0.961-1.579).
“What’s special about the dataset is that we are getting a chance to look into the health records of these patients. We are not looking just at billed outcomes,” Monteleone told Healio. “By every definition, there is a decrease in bleeding associated with EKOS use vs. mechanical thrombectomy.”
The data have the potential to impact real-world clinical practice, he said.
“I’m an interventional cardiologist that does a lot of pulmonary embolism therapies. I will selectively utilize EKOS and mechanical thrombectomy,” Monteleone told Healio. “This is the type of data that really lets us optimize and refine our decision-making about when to use these devices. In addition to the bleeding risk that we saw, we also saw by medical coding and billing a decreased incidence of intracranial hemorrhage associated with EKOS as opposed to mechanical thrombectomy. That’s a very new finding and we have never had the chance to see that data before. [And] we now know that there is no real difference in length of stay in the actual patient experience. We know that there is this major bleeding benefit signal with EKOS, and so as we are deciding what’s our standard of care therapies for most patients, this really informs that decision for the first time.”
Reference:
Perspective
Back to Top
Going back to the initial studies of systemic and catheter-directed thrombolysis, we have observed a small but hazardous rate of intracranial bleeding with tissue plasminogen activator (tPA). The thought has been that if we can perform a procedure that is purely mechanical, not involving tPA, then maybe we can eliminate or obviate that rate of intracranial hemorrhage or brain bleeding. This study is interesting because it shows that there are bleeding hazards introduced with mechanical thrombectomy that also have to be taken into account. The issue is not as clear cut as we had thought. Therefore, the biggest takeaway message is that determining which technology is best for the patient at hand is going to depend upon other factors such as assessment of their particular risk profile.
We know that we need a lot more information and data. This study had an innovative design because it used EHR data across millions of patients and was able to assess patient-level data. But there is inherent bias in the way patients are treated in the real world. The bleeding rates are higher across both technology groups compared to prior trial data, so we need to blend the real-world data with rigorous, scientific, randomized controlled data to come up with the best plan going forward. Fortunately, several studies on the horizon will attempt to answer some of these questions. The message I take is that there are bleeding hazards with both technologies. Those particular bleeding risks need to be assessed and be balanced with information about each individual patient.
I would caution that it is premature to interpret this data as definitively supporting the use of one technology over the other. These data bring to light that there are other kinds of bleeding hazards beyond intracranial hemorrhage, including blood loss from the actual procedure. We have not traditionally thought of those bleeding risks as clinically important compared to intracranial hemorrhage, however the true clinical relevance will need to be ascertained. Ultimately, the study needs to be interpreted as a thought-provoking, hypothesis-generating analysis that can lead to more definitive studies.
Collapse
Monteleone P, et al. Endovascular spotlight 3: Featured clinical science with live case. Presented at: TCT Scientific Symposium; Oct. 23-26, 2023; San Francisco (hybrid meeting).
Read more about
Click Here to Manage Email Alerts