Background: There is an increasing use of rFVIIa (eptagog alpha, Novoseven) in cardiac surgery patients with critical bleeding. As the use of rFVIIa becomes more widespread, it is important to know whether there are increased rates of adverse events, specifically thromboembolic events, particularly in this vulnerable group of patients. To date, there have been no definitive randomised controlled trials of rFVIIa use in cardiac surgery. Conduct of such trials is difficult in this area given diversity of use and of circumstances surrounding cardiac surgery. Additionally there is a recognised high level of comorbidity in cardiovascular disease which adds complexity to trial design and implementation. Registries provide an opportunity to review the patients, reported response and adverse events for rFVIIa. Preliminary indications of association suggest increased use of rFVIIa results in improved outcomes. In the absence of randomised controlled trials, the data available in the Haemostasis Registry and the Australasian Society of Cardiac Surgeons’ Database provides an opportunity to evaluate outcomes and adverse events in patients in relation to treatment with rFVIIa. Methods: Through matching of patients in the Haemostasis Registry and the ASCTS Cardiac Surgery Database differences in adverse events and outcome measures were assessed for patients treated with rFVIIa versus those not treated with rFVIIa. Results: Adverse event rates for Haemostasis Registry cases are higher than those seen in total ASCTS data. However, when adjusted for case complexity, rates of adverse events in Haemostasis Registry data are not significantly different from those seen in ASCTS data. Haemostasis Registry cases were matched with ASCTS controls for age, gender, procedure type and urgency. Cases and controls were compared for the following outcomes measures: units RBC, FFP, cryoprecipitate and platelets, returns to theatre, mortality, hospital and ICU length of stay and adverse event rates. Discussion: This project has the potential to change practice in cardiac surgery by further elucidating the role of rFVIIa in bleeding associated with various subsets of cardiac surgery. The use of one of the largest cardiac surgery databases to describe risk adjusted outcomes following cardiac surgery and comparing with outcomes from the Haemostasis Registry allows us to identify potential benefits and risks from this therapy. Although this study is not equivalent to a randomised controlled trial, it provides the most accurate picture of benefits and potential risks currently available.
|Number of pages||1|
|Journal||Heart Lung and Circulation|
|Publication status||Published - 2 Feb 2009|
|Event||The Australasian Society of Cardiac and Thoracic Surgeons Annual Scientific Meeting 2007 - Sheraton Noosa Resort and Spa, Noosa Heads, Australia|
Duration: 16 Oct 2007 → 20 Oct 2007
Conference number: 5th