• Veronica Yank, C Vaughan Tuohy, Aaron C Logan, Dena M Bravata, Kristan Staudenmayer, Robin Eisenhut, Vandana Sundaram, Donal McMahon, Ingram Olkin, Kathryn M McDonald, Douglas K Owens, and Randall S Stafford.
• Stanford University, Stanford, CA, USA. vyank@stanford.edu
• Ann. Intern. Med. 2011 Apr 19; 154 (8): 529540529-40.

BackgroundRecombinant factor VIIa (rFVIIa), a hemostatic agent approved for hemophilia, is increasingly used for off-label indications.PurposeTo evaluate the benefits and harms of rFVIIa use for 5 off-label, in-hospital indications: intracranial hemorrhage, cardiac surgery, trauma, liver transplantation, and prostatectomy.Data SourcesTen databases (including PubMed, EMBASE, and the Cochrane Library) queried from inception through December 2010. Articles published in English were analyzed.Study SelectionTwo reviewers independently screened titles and abstracts to identify clinical use of rFVIIa for the selected indications and identified all randomized, controlled trials (RCTs) and observational studies for full-text review.Data ExtractionTwo reviewers independently assessed study characteristics and rated study quality and indication-wide strength of evidence.Data Synthesis16 RCTs, 26 comparative observational studies, and 22 noncomparative observational studies met inclusion criteria. Identified comparators were limited to placebo (RCTs) or usual care (observational studies). For intracranial hemorrhage, mortality was not improved with rFVIIa use across a range of doses. Arterial thromboembolism was increased with medium-dose rFVIIa use (risk difference [RD], 0.03 [95% CI, 0.01 to 0.06]) and high-dose rFVIIa use (RD, 0.06 [CI, 0.01 to 0.11]). For adult cardiac surgery, there was no mortality difference, but there was an increased risk for thromboembolism (RD, 0.05 [CI, 0.01 to 0.10]) with rFVIIa. For body trauma, there were no differences in mortality or thromboembolism, but there was a reduced risk for the acute respiratory distress syndrome (RD, -0.05 [CI, -0.02 to -0.08]). Mortality was higher in observational studies than in RCTs.LimitationsThe amount and strength of evidence were low for most outcomes and indications. Publication bias could not be excluded.ConclusionLimited available evidence for 5 off-label indications suggests no mortality reduction with rFVIIa use. For some indications, it increases thromboembolism.

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