| Part one:A comparison before and after aprotinin was suspended in cardiac surgery: Different results in real world from a single cardiac center of China.Objective: Use of aprotinin has been suspended in cardiac surgery since recent studies reported its risks associated with mortality and other adverse events. This study was to investigate the safety and efficacy of aprotinin through a comparison before and after aprotinin was suspended in cardiac surgery.Methods: We designed a case control study in two groups of patients who underwent cardiac surgery just before and after aprotinin was suspended in China. Aprotinin group (n=1699) was defined as operations from June 19,2007 to Dec 18,2007, when aprotinin was used in all the patients. Control group (n=2225) was defined as operations from Dec 19, 2007 to June 18, 2008, when aprotinin was not used. We compared early postoperative outcomes between the two groups.Results: The aprotinin group had less postoperative blood loss, transfusion requirement and reoperation for bleeding. Application of aprotinin did not increase the risk of in-hospital mortality (0.5% vs. 1.0% p=0.08) and other major adverse outcome events, including renal, cardiac, neurological and pulmonary complications.The aprotinin group had a shorter mechanical ventilation time (p=0.04), a lower rate of delayed mechanical ventilation time (p=0.04) and a higher PaO2/FiO2 in arterial blood gas analysis (p<0.001). Multivariable Logistic regression analysis confirmed findings from univariate analysis. After propensity adjustment for the baseline characteristics, we got similar results.Conclusions: Use of aprotinin in cardiac surgery could reduce blood loss and transfusion requirement significantly, and showed a protective effect on the lungs, but did not increase the risk of mortality or major complications. Part two:Does Aprotinin Really Increase the Mortality and Complications after Coronary Surgery?—Different Short-term and Long-term Outcomes from Chinese Population.Objective: Recent studies about aprotinin demonstrated that its use would increase the mortality and complications after coronary artery bypass grafting (CABG). This study was to investigate effect of aprotinin during isolated primary CABG on postoperative short-term and long-term outcomes in patients of Chinese population.Methods: We studied 5103 consecutive Chinese patients who underwent isolated primary CABG at a single cardiac center from January 1, 1999 to December 31, 2005. Of all the patients, 4122 received aprotinin during operation (aprotinin grouop) and 981 received no aprotinin or other antifibrinolytic therapy (control group). Short-term complications and mortality after operation were analyzed with multivariable logistic regression analysis. Long-term mortality and major adverse cardiac and cerebrovascular events (MACCEs) were analyzed with Cox regression analysis. Propensity adjustment method was used to minimize the selection bias between the two groups, and propensity matching method was used to yield two well-matched groups for further comparison.Results: Blood loss after operation was significantly reduced in aprotinin group as compared with that in the control group (462.4±251.7 vs 739.5±342.4 p<0.001). Application of aprotinin was not associated with the perioperative mortality (1.2% vs 1.0% p=0.57) and other main complications. Multivariable Logistic regression analysis confirmed the initial results. In the Cox regression analysis, use of aprotinin was not associated with the the long-term mortality (p=0.21 , relative risk, 1.26; 95% CI, 0.88 to 1.82) and MACCEs (p=0.82, relative risk, 0.98; 95% CI, 0.84 to 1.15). After propensity adjustment for the baseline characteristics, we got similar results. In addition, comparison between the two well-matched groups showed no significant difference either in baseline characteristics or in postoperative outcome events.Conclusions: Application of aprotinin during isolated primary CABG could reduce the blood loss significantly, but was not associated with the short-term or long-term mortality and complications. Aprotinin during primary CABG in Chinese (Asian) population might be safe and effective. Part 3:Effects of tranexamic acid on postoperative outcomes in patients undergoing off-pump coronary artery bypass grafting.Objective: Tranexamic acid is being used more and more in cardiac surgery after aprotinin was suspended for its safety concerns. This study was to investigate the safety and efficacy of tranexamic acid in patients undergoing off-pump coronary artery bypass grafting.Methods: 151 selective patients undergoing off-pump coronary artery bypass grafting were randomly assigned to two groups: tranexamic acid group and control group. FuII-dose tranexamic acid was administered in tranexamic acid group but no tranexamic acid was used in control group. We compared early postoperative outcomes between the two groups, including blood loss, transfusion requirement, reoperation for bleeding, mortality and other major complications. All analyses were performed using SPSS statistical software (version 11.0). Statistical significance was set at P<0.05.Results: There were 75 patients in the tranexamic acid group and 76 patients in the control group. The comparison of baseline characteristics showed no significant difference between two groups except weight, rate of hypertention and smoking. The tranexamic acid group had less postoperative blood loss: 6 hours (284.0+ 129. 1ml vs 411.1±191.3ml p<0.001), 24hours (701.1±269. 5ml vs 915. 9±310. 1ml p<0.001), 48 hours (876.1±326.4ml vs 1120.0±454. 6ml p<0.001), and total blood loss (923.1±361. 3ml vs 1215. 8±651.1 p=0.001) . Transfusion requirement in the tranexamic acid group was less than the control group, but did not reach statistically significant difference. There were no reoperation for bleeding and death after operation. Application of tranexamic acid did not increase the risk of other major adverse outcome events, including renal, cardiac, neurological and pulmonary complications. Furthermore, there were no significant difference in the length of ICU stay, length of in-hospital stay, total mechanical ventilation time, and PaO2/FiO2 in the blood gas analysis of 24 hours after operation.Conclusions: Use of tranexamic acid in patients undergoing off-pump coronary artery bypass grafting could reduce blood loss significantly, but did not increase the risk of mortality or major complications.
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