VIVA

VIVA

Source:

Sista A, et al. Late-Breaking Clinical Trials. Presented at: VIVA 21; Oct. 4-7, 2021; Las Vegas (hybrid meeting).

Disclosures: The study was funded by Thrombolex. Sista reports receiving prior research funding from the NIH and Penumbra.
October 14, 2021
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Pharmacomechanical catheter-directed thrombolysis shows promise in PE

Source:

Sista A, et al. Late-Breaking Clinical Trials. Presented at: VIVA 21; Oct. 4-7, 2021; Las Vegas (hybrid meeting).

Disclosures: The study was funded by Thrombolex. Sista reports receiving prior research funding from the NIH and Penumbra.
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Pharmacomechanical catheter-directed thrombolysis using an endovascular catheter was preliminarily safe and effective in patients with pulmonary embolism, according to interim results of the RESCUE trial presented at VIVA 21.

Akhilesh K. Sista

“Systemic thrombolysis is associated with improved mortality and hemodynamic decompensation in patients with intermediate-risk PE, and catheter-directed thrombolysis improves right ventricular function faster than anticoagulation at 24 hours,” Akhilesh K. Sista, MD, FSIR, FAHA, section chief of vascular interventional radiology and associate professor of radiology at NYU Grossman School of Medicine, said during a presentation. “Most of the devices used to perform CDT are not designed for use in large vessels like pulmonary arteries. Pharmacomechanical CDT with the Bashir Endovascular Catheter (Thrombolex) has shown promising early results.”

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Sista and colleagues conducted a prospective, multicenter, single-arm study of the catheter in 62 patients (mean age, 59 years; 71% men) with intermediate-risk acute PE (90% with high intermediate-risk PE). All patients had PE symptoms for 14 days or less, a filling defect in at least one main or lobar pulmonary artery and a RV/left ventricular end diastolic diameter ratio of at least 0.9.

The primary efficacy endpoint was reduction in RV/LV ratio at 48 hours, and the interim analysis of 60 evaluable patients required a P value of < .0038 to be significant. The primary safety endpoint was major bleeding and device-related adverse events at 72 hours.

At 48 hours, RV/LV ratio was reduced by 0.52 (95% CI, 0.42-0.62) or 32.1%, and the P value of < .0001 met statistical significance, Sista said, noting the reduction was comparable to those seen in PE trials with other devices that used core-lab-reported data.

All patients achieved procedural success, and there were no cases of major bleeding or device-related adverse events at 72 hours, he said.

He also said 4.8% of patients had non-device-related serious adverse events at 30 days, and the mean length of hospital stay was 3 days.

The Refined Modified Miller Index, a measure of thrombus burden, was reduced by 8.4 at 48 hours (95% CI, 7.34-9.5; P < .0001; relative reduction, 36.3%), Sista said. This reduction was larger than those seen in PE trials with other devices that used core-lab-reported data, he said.

“What’s interesting about the signal we’re getting from this trial is that for middle-of-the-road dosage and duration, there’s a favorable amount of thrombus clearance with this device, which is something we would like to explore in the full analysis and with future trials of this catheter,” Sista said.