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Aprotinin in high-risk isolated coronary artery bypass graft patients: a 3-year propensity matched study
Rishab Makam1,2, Ayush Balaji3, Marwan Al Munaer4
1Department of Cardiothoracic Surgery, Castle Hill Hospital, Hull University Teaching Hospitals Trust, Cottingham, UK. rishab.makam@nhs.net.
Insights
Aprotinin use in high-risk isolated Coronary Artery Bypass Graft (iCABG) surgery did not significantly increase in-hospital mortality or major adverse events. This suggests aprotinin may be safe for select iCABG patients when carefully chosen.
Area of Science:
- Cardiovascular Surgery
- Pharmacology
- Patient Safety
Background:
- Aprotinin, a serine protease inhibitor, has a controversial safety profile in cardiac surgery.
- Previous studies have led to ongoing debates regarding aprotinin's safety.
- This study focuses on the outcomes of aprotinin in high-risk isolated Coronary Artery Bypass Graft (iCABG) patients.
Purpose of the Study:
- To assess the safety and outcomes of aprotinin in high-risk iCABG patients.
- To evaluate the impact of aprotinin on in-hospital mortality and key secondary outcomes.
- To determine if aprotinin can be safely reintroduced in specific high-risk surgical populations.
Main Methods:
- Retrospective analysis of 1026 iCABG patients, with 51 receiving aprotinin.
- Propensity score matching using logistic regression to create a comparable control group of 96 patients.
- Primary outcome: in-hospital death. Secondary outcomes: renal dysfunction, stroke, myocardial infarction, re-exploration, and postoperative stay.
Main Results:
- The aprotinin cohort presented higher preoperative risk (EUROSCORE II 7.5 vs. 3.9).
- No statistically significant increase in in-hospital mortality was observed (p=0.44).
- Rates of renal replacement therapy and postoperative stroke were statistically insignificant between groups.
Conclusions:
- Aprotinin may be safely administered to carefully selected high-risk iCABG patients.
- The findings support potential benefits of aprotinin in managing bleeding during high-risk surgeries.
- Further research, including larger controlled studies, is essential to fully understand aprotinin's risk-benefit profile.
Background:
Aprotinin, a serine protease inhibitor, has been used variably in cardiac surgery amidst ongoing debates about its safety following several previous studies. This study assesses the outcomes of aprotinin in high-risk isolated Coronary Artery Bypass Graft (iCABG) patients.
Methods:
The study retrospectively analysed a cohort of 1026 iCABG patients, including 51 patients who underwent aprotinin treatment. Logistic regression powered score matching was employed to compare aprotinin patients with a control group, in a propensity-matched cohort of 96 patients. The primary outcome measured was in-hospital death, with secondary outcomes including renal dysfunction, stroke, myocardial infarction, re-exploration for bleeding or tamponade, and postoperative stay durations.
Results:
The aprotinin cohort had high-risk preoperative patients with significantly higher EUROSCORE II values, 7.5 (± 4.2), compared to 3.9 (± 2.5) in control group. However, aprotinin group showed no statistically significant increase (p-value: 0.44) in hospital mortality with OR 2.5 [95% CI 0.51, 12.3]. Major secondary outcome rates of renal replacement therapy and postoperative stroke compared to the control group were also statistically insignificant between the two groups.
Conclusion:
This study suggests that aprotinin may be safely used in a select group of high-risk iCABG patients. The reintroduction of aprotinin under specific conditions reflects its potential benefits in managing bleeding in high-risk surgeries, but also underscores the complexity of its risk-benefit profile in such critical care settings. Nonetheless, it highlights the importance of carefully selecting patients and conducting additional research, including larger and more controlled studies to fully comprehend the potential risks and benefits of aprotinin.
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