Large bore mechanical thrombectomy reduces adverse outcomes in high-risk PE patients

LARGE BORE MECHANICAL thrombectomy with the FlowTriever system (Inari Medical) in patients with high-risk pulmonary embolism (PE) was associated with a significantly lower occurrence of meaningful in-hospital adverse clinical outcomes compared to other contemporary treatments, data presented at the American College of Cardiology (ACC) 2023 Scientific Sessions (4–6 March, New Orleans, USA) indicate.

These were among the results of the FLAME study, a prospective, non-randomised study of interventional treatment in high-risk PE, a patient population with a historical mortality rate of 25-50%, which were presented at ACC 2023 by Mitchell Silver (OhioHealth Heart and Vascular, Mansfield, USA).

The study collected data on patients treated with the FlowTriever and on those treated with other therapies in a context arm. The primary endpoint measured a composite of meaningful in-hospital clinical outcomes, including mortality, major bleeding, clinical deterioration, and escalation to an alternate therapy.

Silver reported that FLAME was stopped early after meeting the pre-specified interim the FlowTriever arm, in which a mortality rate of 1.9% was recorded, compared to 29.5% in the context arm. In all, the composite primary endpoint occurred in 17% of patients in the FlowTriever arm, compared to 63.9% in the context arm.

“The remarkably low mortality seen with FlowTriever demonstrates the benefit of rapidly identifying PE patients and getting them to an interventionalist for assessment,”

Silver was quoted as saying in a press release issued shortly after the presentation of the results at ACC 2023. “It is time for our hospital systems to develop standardised care pathways for PE, similar to what has been done in other major cardiovascular diseases such as heart attack and stroke.”

“High-risk PE persists as one of the deadliest cardiovascular diseases,” James Horowitz (NYU Grossman School of Medicine, New York, USA), FLAME national principal investigator was also quoted as saying in the same release. “Outcomes have remained unchanged for decades. The FLAME data show that [the] FlowTriever is an important new treatment option that offers a dramatic improvement in survival.” well in a medically complex patient cohort for long-term treatment of PAD. The HAV is designed to be available off-the-shelf, has the potential for a regenerative capacity and low infection risk, all of which are particularly important in this patient group.”

The HAV has been evaluated in eight clinical studies in the USA, Europe, and Israel.

New VOYAGER PAD analysis confirms consistent benefit of low-dose rivaroxaban plus aspirin following lower extremity revascularisation

Data from a new prespecified analysis of the phase three VOYAGER PAD clinical trial show that low-dose rivaroxaban plus aspirin resulted in a 33% reduction in acute limb ischaemia and a 15% reduction in major adverse limb and cardiovascular events, with or without dual antiplatelet therapy (DAPT). The data were presented at the American College of Cardiology’s 72nd annual scientific session (ACC; 4–6 March, New Orleans, USA).

THE NEW FINDINGS REINFORCE THE benefits of the Xarelto (rivaroxaban; Janssen Pharmaceutical Companies of Johnson & Johnson) vascular dose (2.5mg twice daily plus aspirin 100mg once daily) over standard of care (aspirin alone), demonstrating consistent benefit at 30 days, 90 days and up to three years following lower extremity revascularisation in patients with peripheral arterial disease (PAD).

“These data demonstrate an evolution in the medical therapy of patients undergoing lower extremity revascularisation for symptomatic [PAD],” said Marc P Bonaca (University of Colorado Anschutz Medical Campus, Aurora, USA), lead study author of the VOYAGER PAD analysis. “We hope these data assist clinicians in understanding how to implement antithrombotic therapy in practice and overall support initiation of rivaroxaban in the first days after revascularisation regardless of whether or not DAPT is utilised.”

Those treated with Xarelto plus aspirin after lower extremity revascularisation saw a 33% reduction in acute limb ischaemia, with a trend toward greater benefit observed early (≤30 days hazard ratio [HR]=0.45; 95% confidence interval [CI] 0.24–0.85) vs. late (>90 days HR=0.75; 95% CI 0.60–0.95).

Xarelto plus aspirin was more effective than antiplatelet therapy alone in preventing acute limb ischaemia after lower extremity revascularisation (Kaplan-Meier estimate from 0 to 90 days 1.02% vs. 2.10%, respectively, and 4.3% and 5.7% from 91 days to three years). The hazard ratio for the rate of thrombolysis in myocardial infarction (TIMI) major bleeding at 0 to 90 days was 2.01 (range 0.9–4.47) and from days 91 up to three years was 1.28 (range 0.82–1.99), neither of which were statistically significant.