MIAMI BEACH – Rheolytic pharmacomechanical thrombectomy used in combination with adjunctive therapies is safe and effective for the endovascular treatment of upper- and lower-extremity deep vein thrombosis, according to interim findings from a prospective multicenter registry.
Treatment time was reduced from more than 2 days with other catheter-directed thrombolysis approaches to less than 24 hours with rheolytic pharmacomechanical thrombectomy, Dr. Robert Lookstein reported at the International Symposium on Endovascular Therapy 2013.
He based that conclusion on findings in 371 voluntary registry participants treated at 35 centers across the United States as part of the PEARL I and II registries of patients treated using Bayer HealthCare’s MEDRAD AngioJet catheter.
Dr. Robert A. Lookstein
The thrombectomy procedure fragments the thrombus and aspirates it. The mean catheter-directed thrombolysis drip time was 17 hours, compared with 48 hours in the Venous Registry (Radiology 1999;211:39-49) and 58 hours in the CaVenT Registry (Lancet 2012;379:31-8), he said.
Substantial or complete lysis was achieved in more than 90% of 1,346 vessel segments treated. At 6 months’ follow-up, 86% of patients remained free of thrombosis, and at 12 months 81% remained free of thrombosis, reported Dr. Lookstein, chief of interventional radiology at Mount Sinai Medical Center, New York.
The PEARL I Registry included patients followed for 3 months to document symptomatic improvement; PEARL II is an ongoing phase II study that follows patients to 12-month outcomes. Patients included in the interim analysis of the phase II data were 214 men and 157 women with a mean age of 52 years. Most (322) had lower-extremity DVT, 256 reported symptoms of less than 14 days’ duration, and 130 had previous DVT, suggesting that "this is not as isolated an acute systematic event as once thought," Dr. Lookstein said.
Most patients (86%) received two or more therapies, including a stent in 116 cases, an inferior vena cava filter in 84 cases, catheter-directed thrombolytics in 216 cases, and other thrombectomy in 19 cases.
Bleeding requiring transfusion was the most frequent adverse event, occurring in 2.2% of patients, and hematoma was the second most frequent (1.3%).
These findings from a "real-world" registry suggest that rheolytic thrombectomy is a "transformative technology" that will enable fast, effective, minimally invasive therapy for more DVT patients, Dr. Lookstein said.
Dr. Lookstein disclosed that he is a consultant for Bayer HealthCare, which is the maker of the AngioJet system and the sponsor of the PEARL registries.