Clinical Conversation in Interventional Cardiology - Updates from ACC.25 on PE: New Data From the REAL-PE II and OPTALYSE 3D Studies-REAL-PE II Manuscript

REAL-PE II Manuscript

Pdf Summary

A study conducted by Peter P. Monteleone, MD, from the University of Texas at Austin, assessed the safety and efficacy of two treatment methods for pulmonary embolism (PE): ultrasound-assisted catheter-directed thrombolysis (USCDT) and mechanical thrombectomy (MT). The study used de-identified electronic health records from Truveta to analyze 30-day readmission rates and 7-day safety events for patients treated with either method from July 2021 to May 2024.<br /><br />The analysis included 2,261 patients and employed propensity score matching to compare the risk of major bleeding, inpatient mortality, and 30-day readmission between the two groups. Results indicated that patients treated with MT experienced a higher likelihood of major bleeding (according to ISTH and BARC3b definitions) and were more likely to be readmitted within 30 days. Specifically, the odds ratios for major bleeding were 1.69 for ISTH and 1.66 for BARC3b, while the odds ratio for 30-day readmission was 2.77 for MT-treated patients, signifying an elevated risk compared to the USCDT group.<br /><br />The study found no significant difference in inpatient mortality risks between MT and USCDT. Demographic differences were noted, with MT patients tending to be older and more likely to have a history of cancer. The results remained consistent across different matching methods used in the sensitivity analysis.<br /><br />The study underscores a greater risk associated with MT for major bleeding and readmission, challenging prior assumptions about the safety of catheter-based PE treatments. The findings help refine the understanding of treatment risks and inform clinical decisions regarding PE management. The study was sponsored by Boston Scientific, with author disclosures of affiliations with several companies related to medical devices and therapies.

Keywords

pulmonary embolism

ultrasound-assisted catheter-directed thrombolysis

mechanical thrombectomy

safety and efficacy

major bleeding

30-day readmission

propensity score matching

inpatient mortality

Boston Scientific

treatment risks