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Aspiration mechanical thrombectomy meets safety, efficacy endpoints for acute PE
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LAS VEGAS — In the EXTRACT-PE trial, an aspiration mechanical thrombectomy device was safe and effective among patients with acute pulmonary embolism, researchers reported at VIVA 19.
The device (Indigo Aspiration System, Penumbra) met its primary efficacy endpoint of reduction in right ventricular/left ventricular ratio at 48 hours (baseline, 1.47; 48 hours, 1.04; difference, 0.43; 95% CI, 0.38-0.47; percentage reduction, 27.3%; P < .0001) and its primary safety endpoint of a 1.7% rate of 48-hour major adverse events, Akhilesh Sista, MD, FSIR, FAHA, chief of vascular and interventional radiology at NYU Langone School of Medicine and vice chair of the Interventional Therapies for Acute Pulmonary Embolism guidelines from the American Heart Association, said during a presentation.
Nearly all patients (98.3%) did not require thrombolytic drugs, Sista said.
“The positive results of the EXTRACT-PE trial, the first prospective safety and efficacy study of the Indigo Aspiration System, are a step forward in building needed clinical evidence around catheter-based embolectomy in patients with acute pulmonary embolism,” Sista, principal investigator of EXTRACT-PE, said in a press release. “New AHA guidelines state that catheter-based embolectomy may have an important role in severe PE, but that more study is needed. EXTRACT-PE is an important first step in determining how and when we should employ promising and innovative catheter-based technologies such as the Indigo Aspiration device.”
The 119 patients (mean age, 60 years; 45% women) enrolled in the single-arm study also experienced a mean reduction in systolic pulmonary artery pressure during the procedure (reduction, 4.7 mm Hg; 95% CI, 3-6.4), according to the researchers.
In the modified intention-to-treat cohort, which excluded patients who received tissue plasminogen activator or an adjunctive intervention to reduce clot burden, the primary efficacy endpoint was similar to the intention-to-treat cohort (baseline RV/LV ratio, 1.46; 48 hours, 1.04; difference, 0.42; 95% CI, 0.37-0.46; percentage reduction, 26.9%; P < .0001), Sista said.
He said there were two patients with safety events at 48 hours; one patient had groin access-site bleeding and one patient had hemoptysis and died 11 hours after the procedure from sustained ventricular tachycardia.
At 30 days, 2.5% of patients had died (all unrelated to the device) and 1.7% had device-related serious adverse events, Sista said.
Most safety and efficacy results were similar to those seen in trials of other devices to treat acute PE, but bleeding rates were lower than in most of the other studies and time of device in the patient was lower than in all of them, he said.
“From a pulmonologist’s perspective, the results of the EXTRACT-PE trial are another important dataset that help broaden the mechanical treatment options for patients with pulmonary embolism,” Victor F. Tapson, MD, pulmonary critical care specialist at Cedars-Sinai and EXTRACT-PE steering committee member, said in the release. “The safety profile of the Indigo System and the low rate of bleeding events, combined with the significant reduction in RV/LV ratio seen in the EXTRACT-PE trial, can positively impact the emerging field of acute pulmonary embolism intervention.” – by Erik Swain
Reference:
Sista A, et al. Late-Breaking Clinical Trials. Presented at: VIVA 19; Nov. 4-7, 2019; Las Vegas.
Disclosure: The study was funded by Penumbra. Sista reports he received research grants from Penumbra administered through the New York University School of Medicine.