A phase II dose-response study of hemoglobin raffimer (Hemolink) in elective coronary artery bypass surgery.

BACKGROUND: We performed this study to determine the dose-response of hemoglobin raffimer administered in conjunction with intraoperative autologous donation in patients undergoing coronary artery bypass grafting surgery. A secondary objective was to evaluate hemoglobin raffimer for reducing the incidence of allogeneic red blood cell transfusions. METHODS: This was a phase II, single-blind, multicenter, placebo-controlled, open-label study. Patients undergoing coronary artery bypass grafting with cardiopulmonary bypass and intraoperative autologous donation were randomized to receive a single dose of hemoglobin raffimer or control (10% pentastarch). Patients were sequentially enrolled in a dose block of 250, 500, 750, and 1000 mL. RESULTS: Sixty patients received hemoglobin raffimer (n = 30) or control (n = 30). Hemoglobin raffimer was well tolerated. Most (98%) adverse events were mild or moderate in severity. There was an expected dose-dependent increase in the incidence of blood pressure increases and jaundice in hemoglobin raffimer-treated patients. In a dose-pooled analysis of hemoglobin raffimer versus control, increased blood pressure (43% vs 17%), nausea (37% vs 33%), and atrial fibrillation (37% vs 17%) were the most frequently reported adverse events. All serious adverse events were considered unrelated or unlikely to be related to study drug. No hemoglobin raffimer-treated patient required an intraoperative allogeneic red blood cell transfusion, compared with 5 (17%) pentastarch-treated patients (P =.052). This advantage of hemoglobin raffimer was maintained at 24 hours after surgery (7% vs 37%; P =.010) and up to 5 days after surgery (10% vs 47%; P =.0034). CONCLUSIONS: Hemoglobin raffimer was not associated with any serious adverse events in patients undergoing primary coronary artery bypass grafting with cardiopulmonary bypass and intraoperative autologous donation in a dose-response study up to 1000 mL. Hemoglobin raffimer was effective in facilitating decreased exposure or avoidance of allogeneic red blood cell transfusions when used in conjunction with intraoperative autologous donation.

Postoperative atrial fibrillation: a comparison of off-pump coronary artery bypass surgery and conventional coronary artery bypass graft surgery.

OBJECTIVE: To compare the incidence and pattern of onset of postoperative atrial fibrillation (AF) in patients undergoing coronary artery bypass graft (CABG) surgery with and without cardiopulmonary bypass (CPB). DESIGN: Retrospective, cohort-controlled study. SETTING: University hospital and tertiary referral center. PARTICIPANTS: A group of 108 consecutive patients who underwent primary off-pump coronary artery bypass (OP-CAB) surgery and a control group of 100 patients who underwent CABG surgery with CPB. All patients underwent surgery between January and September 1999. INTERVENTIONS: Patients in the OP-CAB surgery group were operated on by either of 2 surgeons. The CABG surgery group was drawn from the general pool of patients operated on by 1 of 10 surgeons. All patients underwent median sternotomy and received standard anesthesia and intensive care unit management for this institution. MEASUREMENTS AND MAIN RESULTS: Data from 99 OP-CAB surgery patients (data incomplete in 9 patients) were compared with data from 100 CABG surgery patients. General demographics were similar except the CABG surgery group received a higher mean number of distal anastomoses (3.3 v 3.0; p = 0.028) The incidence of AF was similar in both groups (OP-CAB surgery, 25% v CABG surgery, 18%; p = 0.228). The peak incidence of AF was postoperative day 2 in both groups. The median hospital length of stay was increased in patients developing AF. CONCLUSION: Avoiding CPB does not seem to reduce the incidence of postoperative AF in CABG surgery. The similar time distribution of onset of AF in OP-CAB surgery patients and CABG surgery patients may point toward a common cause.