Ethicon has announced positive new data from the clinical development program for Evarrest fibrin sealant patch. More than 92% of patients treated during aortic reconstruction surgery with Evarrest achieved haemostasis on the first attempt within three minutes and maintained haemostasis throughout the duration of the surgery, compared with 33% for those treated with Baxter’s TachoSil patch and 46% for those treated with the standard of care—manual compression with or without an additional topical absorbable haemostat.
The results of the phase II study, as presented at The Houston Aortic Symposium (5–7 March, Houston, USA), demonstrate the potential of Evarrest as an adjunctive haemostatic agent in this setting.
“These findings demonstrate the potential clinical usefulness of the Evarrest fibrin sealant patch when surgically repairing an aortic aneurysm or aortic dissection,” said Sina L Moainie, cardiothoracic surgeon at St Vincent Heart Center of Indiana, USA, and one of the study’s investigators. “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.”
The current standard of care for controlling anastomotic suture line bleeding in aortic reconstruction surgery includes manual compression with or without a topical absorbable haemostat. This three-arm, randomised multicentre phase II clinical study compared the use of two human fibrinogen- and thrombin-containing fibrin sealant patch products—Ethicon’s EVARREST or Baxter’s TachoSil and the current standard of care method. Forty-two patients were randomised and treated during procedures involving elective repair of aortic aneurysm or aortic dissection. Patient age ranged from 29 to 83 years with 33 male patients and nine females.
In the study, 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 prior to heparin reversal. During the surgery, treatment in all study arms was applied with three minutes of continuous firm manual compression. Haemostasis was assessed four different times following application (at three, six and 10 minutes and up through immediately prior to initiation of final chest wall closure).
The core temperature of patients ranged from 21-38 degrees Celsius, meaning a thinner patient’s blood within a range of hypothermia, thereby making blood clotting more difficult. In the intent-to-treat primary endpoint analysis, 12 of 13 (92.3%) of Evarrest-treated patients achieved haemostasis within three minutes of product application. Haemostasis was maintained through the initiation of chest wall closure. Six of 18 (33.3%) of those treated on the TachoSil arm achieved the primary endpoint, while five of 11 (45.5%) achieved the primary endpoint in the standard of care arm. Despite the small sample in this study, Evarrest demonstrated a significant difference in efficacy versus the two comparator arms of the trial.
No safety signals were identified during the study. No patients treated with Evarrest experienced adverse events that were potentially related to re-bleeding at the target bleeding site or were reported as thrombotic events. Two patients treated with TachoSil had post-procedural haemorrhagic events potentially related to re-bleeding at the target site.
“The positive outcome of this research is an early sign of the unique enabling potential of Evarrest to aid surgeons in rapidly and reliably controlling problematic bleeding in cardiac surgery and even the most challenging patients and surgical situations,” said Dan Wildman, vice president, global franchise strategy and innovation for Ethicon. This study is a part of an ongoing investigational new drug application for Evarrest and is legally sponsored by Ethicon Biosurgery clinical development organisation.