| Is aprotinin safe to use in a cohort at increased risk for thrombotic events: results from a randomized, prospective trial in off-pump coronary artery bypass. | |
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MedLine Citation:
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PMID: 18721566 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Multiple randomized trials have established a favorable safety profile for aprotinin use during cardiac surgery, but recent database analyses suggest an increased risk of adverse thrombotic events. Our group previously demonstrated that off-pump coronary artery bypass (OPCAB) is linked to a postoperative hypercoagulable state. In this study, we tested whether aprotinin influences thrombotic events after OPCAB. METHODS: Patients randomly received saline (n = 61) or aprotinin (2 x 10(6) kallikrein inhibiting units (KIU) loading dose, 0.5 x 10(6) KIU/hour [n = 59]) during OPCAB. Aprotinin levels (KIU/mL) were analyzed before, and 30 minutes (peak) and 4 hours after the loading dose. Estimated glomerular filtration rate (eGFR) was calculated daily based on Cockcroft equation with acute kidney injury (AKI) defined as eGFR less than 75% of baseline. Major adverse cardiac and cerebrovascular events (MACCE) were monitored during the first year, including acute graft failure by predischarge computed tomographic angiography. RESULTS: Compared with placebo, the aprotinin group developed a significantly lower eGFR on day 3 (p < 0.006), but this difference resolved by day 5. Peak aprotinin level correlated with the degree of eGFR decline noted on day 3 (r = 0.56, p < 0.03) and independently predicted postoperative AKI (odds ratio 8.8, p < 0.008). The receiver operating characteristic analysis demonstrated that peak aprotinin level strongly predicts AKI (area under the curve = 0.86, 95% confidence interval 0.69 to 1.00). The percentage of patients reaching the composite MACCE endpoint was significantly reduced in the aprotinin versus placebo group (12 vs 34%, p = 0.01). CONCLUSIONS: Compared with placebo, aprotinin use was associated with less MACCE but more AKI after OPCAB. The strong relationship between the peak aprotinin level and subsequent AKI suggests weight-based protocols for dosing aprotinin may reduce this risk. |
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Authors:
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Michael C Grant; Zachary Kon; Ashish Joshi; Eric Christenson; Seeta Kallam; Nicholas Burris; Junyan Gu; Robert S Poston |
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Publication Detail:
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Type: Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The Annals of thoracic surgery Volume: 86 ISSN: 1552-6259 ISO Abbreviation: Ann. Thorac. Surg. Publication Date: 2008 Sep |
Date Detail:
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Created Date: 2008-08-25 Completed Date: 2008-09-19 Revised Date: 2011-08-01 |
Medline Journal Info:
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Nlm Unique ID: 15030100R Medline TA: Ann Thorac Surg Country: Netherlands |
Other Details:
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Languages: eng Pagination: 815-22; discussion 815-22 Citation Subset: AIM; IM |
Affiliation:
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Division of Cardiac Surgery, Department of Surgery, University of Maryland Medical System, Baltimore, Maryland, USA. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Aprotinin
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administration & dosage,
adverse effects*,
blood Blood Coagulation Tests Coronary Artery Bypass, Off-Pump* Follow-Up Studies Glomerular Filtration Rate / drug effects Hemostatics / administration & dosage, adverse effects*, blood Humans Platelet Function Tests Postoperative Complications Prospective Studies Thrombosis / etiology* |
| Grant Support | |
ID/Acronym/Agency:
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R01 HL084080-01A1/HL/NHLBI NIH HHS; R01 HL084080-02/HL/NHLBI NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Hemostatics; 9087-70-1/Aprotinin |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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