Aprotinin during coronary artery bypass graft surgery has long-term
mortality risks
Patients given aprotinin, a serine protease inhibitor, to reduce blood loss during coronary artery bypass graft (CABG) surgery are at an increased risk of death after five years' follow-up, a study published this week in JAMA suggests (2007;
297:471).
The study involved 4,374 patients who received aprotinin, tranexamic
acid, aminocaproic acid (not available in the UK) or no antibleeding
agent during CABG surgery — the main outcome measure was all-cause
mortality over five years. Aprotinin treatment was associated with increased
mortality compared with the control group (five-year mortality, 20.8
per cent versus 12.7 per cent; covariate adjusted hazard ratio 1.48,
95 per cent confidence interval 1.19–1.85; P<0.001). Conversely,
neither tranexamic acid nor aminocaproic acid were associated with significantly
increased mortality over the five-year follow-up compared with control.
The authors say: “Importantly, aprotinin’s association with
death sustained comprehensive covariate challenges, remaining significant
when assessed among multiple subgroups with differing risk profiles and
among patients surviving the [surgical admission].” They suggest
that serious safety concerns extend beyond the perioperative period and
that safer alternatives such as tranexamic acid should be used.
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