Ethicon* has announced new data from a global cardiovascular (CV) Phase III clinical trial of the EVARREST® Fibrin Sealant Patch. Seventy five percent of patients treated during aortic reconstruction surgery with EVARREST® achieved hemostasis on the first attempt within three minutes and maintained hemostasis throughout the duration of the surgery, as compared to 45 percent for those treated with Baxter's TachoSil®. Results from this investigational study will be presented at The Houston Aortic Symposium.
The EVARREST® CV Phase III study concludes a series of pivotal trials designed to demonstrate the fibrin sealant patch's safety and efficacy in a variety of tissue types. This latest evidence is part of a pending regulatory submission to the U.S. Food and Drug Administration ("FDA") to expand the indication for EVARREST® in the United States.
EVARREST® is currently approved for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding during open retroperitoneal, intra-abdominal, pelvic, and non-cardiac thoracic surgery when control of bleeding by standard surgical methods of hemostasis (e.g., suture, ligature, cautery) is ineffective or impractical. If approved by the FDA, EVARREST® could be used as an adjunct for general hemostasis.
"Controlling bleeding in a highly complex surgical procedure, like aortic reconstruction, can be challenging," said Sina Moainie, M.D., cardiothoracic surgeon at St. Vincent Heart Center of Indiana in Indianapolis and one of the study's investigators. "Once again, EVARREST® demonstrated positive results -- even under the most challenging circumstances such as when applied to a prosthetic graft while on cardiopulmonary bypass and hypothermia."
The objective of this randomized multicenter Phase III clinical study was to evaluate the hemostatic efficacy and safety of EVARREST® as an adjunct to conventional hemostasis for anastomotic suture line bleeding during aortic reconstruction surgery. A total of 156 patients from North America, Europe and Asia were randomized to either EVARREST® or TachoSil. In this study, the treated target bleeding sites were aortic graft anastomotic suture line bleeding identified upon cardiac reperfusion and while on cardiopulmonary bypass. Hemostasis at the target bleeding site was assessed at three minutes, six minutes, ten minutes and up to the time of chest closure. Patient age ranged from 24 to 83 years with 117 male patients and 39 females.
In the intent-to-treat primary endpoint analysis, 57 of 76 (75%) of patients treated with EVARREST® achieved hemostasis within three minutes of product application. Hemostasis was maintained through the initiation of chest wall closure. Thirty six of 80 (45%) of those treated on the TachoSil arm achieved the primary endpoint. In the secondary endpoint analysis, 77.6% and 84.2% of patients treated with EVARREST® achieved hemostasis at six minutes and ten minutes, respectively, and maintained hemostasis through initiation of chest wall closure. In the TachoSil® arm, 56.3% and 70% of patients achieved hemostasis at six minutes and ten minutes, respectively, and maintained hemostasis through initiation of chest wall closure.
No major safety concerns were identified during the study.
"This study adds to the increasing body of evidence on EVARREST® and its use to control problematic bleeding situations in even the most challenging patients and surgical situations," said Dr. Richard Kocharian, Franchise Medical Director, Ethicon. "Ethicon will continue to bring meaningful innovation, like EVARREST®, to more surgeons and their patients to help address significant healthcare needs."