Study Shows Potential of Ethicon's Evarrest Patch for Aortic Reconstruction Surgery

March 10, 2015—Ethicon announced that positive new data from the phase II study for the Evarrest fibrin sealant patch were presented at the Houston Aortic Symposium in Houston, Texas. The study compared the use of two human fibrinogen- and thrombin-containing fibrin sealant patch products, the Evarrest versus the TachoSil patch (Baxter International Inc.), with the current standard of care method. The current standard of care for controlling anastomotic suture line bleeding in aortic reconstruction surgery includes manual compression with or without a topical absorbable hemostat.

In the study, > 92% of patients treated with the device during aortic reconstruction surgery achieved hemostasis on the first attempt within 3 minutes and maintained hemostasis throughout the duration of the surgery. By comparison, this result was achieved in 33% of patients treated with the TachoSil patch and 46% of patients treated with the standard of care, manual compression with or without an additional topical absorbable hemostat.

Despite the small sample in this study of 42 patients, Evarrest demonstrated a significant difference in efficacy versus the two comparator arms of the trial. These findings demonstrate the potential of Evarrest as an adjunctive hemostatic agent in this challenging setting, stated the company.

According to Ethicon, this three-arm, randomized multicenter phase II clinical study enrolled 42 patients who were randomized and treated during procedures involving elective repair of aortic aneurysm or aortic dissection. Patient age ranged from 29 to 83 years. Thirty-three patients were men, and nine were women.

The target bleeding site was defined as the first synthetic aortic graft anastomotic site with suture line bleeding that did not respond to 30 seconds of manual compression, requiring adjunctive treatment. The site was identified and treated while patients were still on cardiopulmonary bypass and before heparin reversal. During the surgery, treatment in all study arms was applied with 3 minutes of continuous firm manual compression. After application, hemostasis was assessed at 3, 6, and 10 minutes and up through immediately before initiation of final chest wall closure.

The company advised that no safety signals were identified during the study. No patients treated with Evarrest experienced adverse events that were potentially related to rebleeding at the target bleeding site or reported as thrombotic events. Two patients treated with TachoSil had postprocedural hemorrhagic events potentially related to rebleeding at the target site.

In the company’s announcement, study investigator Sina L. Moainie, MD, commented, “These findings demonstrate the potential clinical usefulness of the Evarrest fibrin sealant patch when surgically repairing an aortic aneurysm or aortic dissection. We will continue to study Evarrest in this setting to see if the positive results persevere, but we are encouraged by the data to date.” Dr. Moainie is a cardiothoracic surgeon at St. Vincent Heart Center of Indiana in Indianapolis, Indiana.