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Background Recombinant Factor VIIa (rFVIIa), a hemostatic agent approved for hemophilia, is increasingly used for off-label indications. Purpose To evaluate benefits and harms of rFVIIa use for five off-label, in-hospital indications: intracranial hemorrhage, cardiac surgery, trauma, liver transplantation, and prostatectomy. Data Sources Ten databases (including PubMed, EMBASE, and Cochrane Library) queried from the advent of each through December 2010. English language articles were analyzed. Study Selection Two 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 Extraction Two reviewers independently assessed study characteristics and rated study quality and indication-wide strength of evidence. Data Synthesis Inclusion criteria were met by 17 RCTs, 33 comparative observational studies, and 23 non-comparative observational studies. Identified comparators were limited to placebo (RCTs) or usual care (observational studies). For intracerebral hemorrhage, mortality was not improved with FVIIa use across a range of rFVIIa doses. Arterial thromboembolism was increased with rFVIIa for medium-dose (risk difference 0.03 [0.01, 0.06]) and high-dose use (0.06 [0.01, 0.11]). For adult cardiac surgery, there was no mortality difference, but an increased risk of thromboembolism (0.05 [0.01, 0.10]) with rFVIIa. For body trauma, there were no differences in mortality or thromboembolism, but a reduced risk of acute respiratory distress syndrome (−0.05 [−0.02, −0.08]). Mortality and thromboembolism were consistently higher in observational studies compared to RCTs. Limitations The amount and strength of evidence was low for the majority of outcomes and indications. Publication bias could not be excluded. Conclusion Limited available evidence for five off-label indications indicates no mortality reduction with rFVIIa use. For some indications, rFVIIa increases thromboembolism. Primary Funding Source Agency for Healthcare Research and Quality
Background Recombinant Factor VIIa (rFVIIa), a hemostatic agent approved for hemophilia, is increasingly used for off-label indications. Purpose To evaluate benefits and harms of rFVIIa use for five off-label, in-hospital indications: intracranial hemorrhage, cardiac surgery, trauma, liver transplantation, and prostatectomy. Data Sources Ten databases (including PubMed, EMBASE, and Cochrane Library) queried from the advent of each through December 2010. English language articles were analyzed. Study Selection Two 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 Extraction Two reviewers independently assessed study characteristics and rated study quality and indication-wide strength of evidence. Data Synthesis Inclusion criteria were met by 17 RCTs, 33 comparative observational studies, and 23 non-comparative observational studies. Identified comparators were limited to placebo (RCTs) or usual care (observational studies). For intracerebral hemorrhage, mortality was not improved with FVIIa use across a range of rFVIIa doses. Arterial thromboembolism was increased with rFVIIa for medium-dose (risk difference 0.03 [0.01, 0.06]) and high-dose use (0.06 [0.01, 0.11]). For adult cardiac surgery, there was no mortality difference, but an increased risk of thromboembolism (0.05 [0.01, 0.10]) with rFVIIa. For body trauma, there were no differences in mortality or thromboembolism, but a reduced risk of acute respiratory distress syndrome (−0.05 [−0.02, −0.08]). Mortality and thromboembolism were consistently higher in observational studies compared to RCTs. Limitations The amount and strength of evidence was low for the majority of outcomes and indications. Publication bias could not be excluded. Conclusion Limited available evidence for five off-label indications indicates no mortality reduction with rFVIIa use. For some indications, rFVIIa increases thromboembolism. Primary Funding Source Agency for Healthcare Research and Quality
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