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IVUS-assisted catheter-directed thrombolysis did not enhance thrombus resolution
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The addition of IVUS to a fixed-dose catheter thrombolysis regimen failed to facilitate thrombus resolution in patients with acute iliofemoral deep vein thrombosis in the BERNUTIFUL trial.
The single-center randomized controlled trial included 48 patients with acute iliofemoral DVT and symptoms for less than 2 weeks, 24 of whom underwent IVUS-assisted catheter-directed thrombolysis and 24 of whom received conventional catheter-directed thrombolysis. The mean age of the cohort was 50 years and 52% were women.
EkoSonic MACH4 Endovascular System catheters (EKOS Corp.) were placed in all patients. The system features a control unit, drug-delivery catheters and removable device-containing radiopaque ultrasound transducers, which were turned on only in the group assigned IVUS-assisted catheter-directed thrombolysis. All patients also received continuous infusion of 20 mg recombinant tissue plasminogen for 15 hours. Patients also received an IV bolus of unfractionated heparin (80 U/kg body weight) at the initial presentation, with the exception of those previously treated with heparin, fondaparinux or oral anticoagulants. The unfractionated heparin infusion was administered through a venous access sheath during catheter thrombolysis and adjusted every 6 hours.
The primary endpoint of thrombosis load reduction from baseline to 15 hours according to length-adjusted thrombus score was 55 ± 27% in the IVUS-assisted group vs. 54 ± 27% in the catheter-directed group (P = .91).
Seven patients (29%) in the IVUS-assisted group and 11 (46%) in the catheter-directed group had adjunctive catheter-based thrombus removal therapy. Nineteen patients (80%) in the IVUS-assisted group and 20 (83%) in the catheter-directed group had adjunctive angioplasty and stenting.
Three-month follow-up results indicated that primary venous patency was 100% in the IVUS-assisted group vs. 96% in the catheter-directed group (P = .33). Severity of the post-thrombotic syndrome was similar between the groups; the mean Villalta score was 3 ± 3.9 in the IVUS-assisted group vs. 1.9 ± 1.9 in the catheter-directed group (P = .21).
The rate of treatment complications was 12% in the IVUS-assisted group vs. 8% in the catheter-directed group (P > .99). There were only five treatment-related complications overall. One major bleeding event occurred in the IVUS-assisted group and none in the catheter-directed group.
The researchers concluded that the “in vitro effects of high-frequency (2.2 MHz), low-power (0.5 W) ultrasound, that is, fibrin separation and acoustic streaming, cannot be translated to patients with acute iliofemoral DVT. Given the higher costs of the [ultrasound-assisted] system compared with conventional catheter-directed thrombolysis, our data question the usefulness and particularly the cost effectiveness of adding [IVUS] for the treatment of acute iliofemoral DVT.”
Disclosure: One researcher reports consulting for EKOS Corp. The other researchers report no relevant financial disclosures.
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