Abstract 314: The Safety of Preoperative Vardenafil in Patients Undergoing Coronary Bypass Surgery.
Objectives Advances in cardiac surgery have significantly improved the outcomes for patients with myocardial ischemia. However, ischemia/ reperfusion injury represents a mechanism that continues to limit the effectiveness of coronary bypass graft surgery (CABG). Phosphodiesterase 5 inhibitors have been shown to exhibit powerful cardioprotective effects in animal models of ischemia-reperfusion injury. We evaluated the safety of vardenafil in patients undergoing cardiac surgery.
Methods 10 male patients undergoing CABG with or without valve surgery were enrolled in the study. Subjects were given a onetime dose of 10 mg oral vardenafil on the morning of surgery. They were monitored for adverse events and left ventricular ejection fraction changes; pertinent clinical parameters were also recorded. Their postoperative parameters and outcomes were also compared with 47 patients who underwent CABG in the same period of time (control group).
Results The study drug was tolerated well. There were no episodes of hypotension or deaths in the group receiving vardenafil. The left ventricular ejection fraction did not change significantly after surgery (0.54±0.08 vs 0.53±0.09; P=0.76) in the vardenafil group. The vardenafil group and the control group were similar in terms of clinical characteristics. The type of operation and operative parameters were also similar between the two groups. Peak troponinT levels were not significantly lower in the vardenafil group compared to the control group (9.1 ± 8.3 vs 12.5 ± 9.3 ng/mL; P = 0.26, respectively). The median duration of intubation was not significantly different in the vardenafil group compared to the control group (21.4 ± 10.1 vs 27.4 ± 15.2 h; P = 0.14). The length of hospital stay was also not significantly different between the vardenafil group and the control group (11.1 ± 13.2 vs 10.0 ± 4.7 days; P=0.80, respectively).
Conclusions Vardenafil is well tolerated when given to patients immediately prior to CABG surgery and appears safe especially in the setting of the intensive care unit where blood pressure and other vital signs are closely monitored. A larger trial is needed to document the cardioprotective effects of the drug in these patients.
- © 2013 by American Heart Association, Inc.