Journal of vascular and interventional radiology : JVIR · 2025
Evaluation of Catheter-Directed Thrombolysis Device Type and Dosing on Treatment Outcomes in Intermediate-Risk Pulmonary Embolism: A PEERLESS Randomized Controlled Trial Post Hoc Analysis.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Gonsalves Carin F, Stortecky Stefan, Horr Samuel, Pappas Orestis, Gandhi Ripal T, Pereira Keith, Giri Jay, Khandhar Sameer J, Azene Ezana M, Elmasri Fakhir, Lindquist Jonathan, Jaber Wissam A
Аннотация
PURPOSE: To assess whether catheter-directed thrombolysis (CDT) treatment heterogeneity in the multicenter PEERLESS randomized controlled trial is associated with differences in pulmonary embolism (PE) clinical outcomes.
MATERIALS AND METHODS: All PEERLESS CDT arm patients were eligible for post hoc analysis, excluding those treated with multiple CDT device types (n = 8), non-tissue plasminogen activator (tPA) thrombolytics (n = 10), or pharmacomechanical CDT (n = 12). Patients were grouped by treatment: ultrasound (US)-assisted thrombolysis or standard CDT (SCDT). Treatment protocols were assessed, and clinical, safety, and quality-of-life outcomes were compared at discharge/7 days, 24 hours, and/or 30 days.
RESULTS: A total of 159 patients treated with US-accelerated CDT and 87 treated with SCDT were included. Longer mean treatment duration (12.4 hours vs 20.8 hours, P < .001), higher mean thrombolytic dose (17.2-mg tPA vs 23.4-mg tPA, P < .001), and more intensive care unit stays >24 hours (57.4% vs 80.5%, P < .001) were identified in the SCDT group. However, in-hospital outcomes were not different, including all-cause mortality (0.0% vs 1.1%, P = .35), intracranial hemorrhage (0.6% vs 0.0%, P = 1.00), major bleeding (5.7% vs 10.3%, P = .20), and clinical deterioration and/or bailout (5.0% vs 5.7%, P = .77). Right ventricular/left ventricular ratio reduction (19.9% vs 23.1%, P = .10) and respirations per minute (20.0 vs 19.9, P = .62) were not statistically significantly different at the 24-hour visit. Pulmonary Embolism Quality of Life (18.5 vs 23.0, P = .18) and EuroQol 5-Dimension 5-Level (0.84 vs 0.81, P = .85) were also not different at the 30-day visit.
CONCLUSIONS: Treatment duration and tPA dose were significantly lower in patients treated with US-accelerated CDT; however, clinical outcomes did not differ significantly between US-accelerated CDT and SCDT. This suggests that the primary analysis of PEERLESS may be generalizable to tPA-based CDT treatment protocols currently in use.
MATERIALS AND METHODS: All PEERLESS CDT arm patients were eligible for post hoc analysis, excluding those treated with multiple CDT device types (n = 8), non-tissue plasminogen activator (tPA) thrombolytics (n = 10), or pharmacomechanical CDT (n = 12). Patients were grouped by treatment: ultrasound (US)-assisted thrombolysis or standard CDT (SCDT). Treatment protocols were assessed, and clinical, safety, and quality-of-life outcomes were compared at discharge/7 days, 24 hours, and/or 30 days.
RESULTS: A total of 159 patients treated with US-accelerated CDT and 87 treated with SCDT were included. Longer mean treatment duration (12.4 hours vs 20.8 hours, P < .001), higher mean thrombolytic dose (17.2-mg tPA vs 23.4-mg tPA, P < .001), and more intensive care unit stays >24 hours (57.4% vs 80.5%, P < .001) were identified in the SCDT group. However, in-hospital outcomes were not different, including all-cause mortality (0.0% vs 1.1%, P = .35), intracranial hemorrhage (0.6% vs 0.0%, P = 1.00), major bleeding (5.7% vs 10.3%, P = .20), and clinical deterioration and/or bailout (5.0% vs 5.7%, P = .77). Right ventricular/left ventricular ratio reduction (19.9% vs 23.1%, P = .10) and respirations per minute (20.0 vs 19.9, P = .62) were not statistically significantly different at the 24-hour visit. Pulmonary Embolism Quality of Life (18.5 vs 23.0, P = .18) and EuroQol 5-Dimension 5-Level (0.84 vs 0.81, P = .85) were also not different at the 30-day visit.
CONCLUSIONS: Treatment duration and tPA dose were significantly lower in patients treated with US-accelerated CDT; however, clinical outcomes did not differ significantly between US-accelerated CDT and SCDT. This suggests that the primary analysis of PEERLESS may be generalizable to tPA-based CDT treatment protocols currently in use.