APEX-AV Trial Evaluates AngioDynamics’ AlphaVac F18⁸⁵ Mechanical Thrombectomy System to Treat PE

May 3, 2024—The safety and efficacy results from the APEX-AV trial of acute pulmonary embolism (PE) extraction with the AlphaVac F18⁸⁵ aspiration system (AngioDynamics, Inc.) demonstrated that catheter-directed mechanical thrombectomy is safe and effective in patients with acute intermediate-risk PE with significant improvement in the right ventricle (RV) function and minimal major adverse events.

The APEX-AV trial is a prospective, single-arm, multicenter investigational device exemption trial. The study is led by William Brent Keeling, MD, who is Associate Professor at the Emory School of Medicine in Atlanta, Georgia.

The study findings were presented at SCAI 2024, the Society for Cardiovascular Angiography & Interventions scientific sessions held May 2-4 in Long Beach, California.

According to the SCAI press release, the APEX-AV study’s primary efficacy endpoint was a change in the RV-to–left ventricle (RV/LV) ratio from baseline to 48 hours postprocedure on core lab–adjudicated CT angiography. The primary safety endpoint was a composite of 48 hours postprocedure major adverse events (ie, device-related death, major bleeding, and device-related serious adverse events).

Among the 122 patients treated at 25 sites in the United States, the average reduction in the RV/LV ratio was 0.45 with a 35.5% mean percentage reduction in the overall clot burden from the baseline at 48 hours postprocedure.

Five patients had major adverse events within the 48-hour visit and no death was reported. Finally, procedural times were short with a mean procedural time of 37.2 ± 17.7 minutes, stated the press release.

“Pulmonary emboli can be extremely dangerous and require effective and prompt action,” commented Dr. Keeling in the SCAI press release. “Catheter-directed mechanical thrombectomy using a new aspiration system can achieve excellent thrombus removal with a wonderful safety profile, thus enabling more tools in our armamentarium for the treatment of acute PE.”