Nafamostat Mesilate, as a Treatment for Heparin Resistance, Is Not Associated With Perioperative Ischemic Stroke in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Abstract

Nafamostat mesilate, a short-acting protease inhibitor, treats heparin resistance during cardiopulmonary bypass. This study tested whether nafamostat mesilate is associated with perioperative ischemic stroke. A retrospective observational study. A total of 870 adult cardiac surgery patients. The authors retrospectively identified the patients who received nafamostat mesilate and who suffered symptomatic ischemic stroke within 30 postoperative days. The authors evaluated perioperative patient characteristics in association with perioperative ischemic stroke and death. The patients were identified as heparin resistant if they had an activated coagulation time of <480 seconds after the administration of heparin at 400 to 500 U/kg. Heparin-resistant patients received a 10- to 20-mg bolus plus 25 to 50 mg/h of nafamostat mesilate and heparin at 100 U/kg intravenously every 1.5 to 2.0 hours to maintain an activated coagulation time over 480 seconds. Of the 870 patients, 11 (1.3%) suffered a perioperative ischemic stroke. Of the 190 (21.8%) patients who received nafamostat mesilate, 1 (0.5%) suffered ischemic stroke compared with 10 (1.5%) in 680 patients without nafamostat mesilate (Fisher exact test; p = 0.47; regression analysis; odds ratio, 0.35; 95% confidence interval, 0.45-2.8; p = 0.32); 3 (1.6%) patients with nafamostat mesilate died postoperatively within 30 days compared with 11 (1.6%) without nafamostat mesilate (Fisher exact test; p > 0.99, regression analysis; odds ratio, 0.98; 95% confidence interval, 0.27-3.5; p = 0.97). No evidence was found that nafamostat mesilate was associated with perioperative ischemic stroke in heparin-resistant patients undergoing cardiac surgery with cardiopulmonary bypass.