Tranexamic acid and rosuvastatin in patients at risk of cardiovascular events after noncardiac surgery: a pilot of the POISE-3 randomized controlled trial

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dc.contributor.authorMarcucci, Maura
dc.contributor.authorDuceppe, Emmanuelle
dc.contributor.authorLe Manach, Yannick
dc.contributor.authorKearon, Clive
dc.contributor.authorEikelboom, John W
dc.contributor.authorPohl, Kayla
dc.contributor.authorVincent, Jessica
dc.contributor.authorDarvish-Kazem, Saeed
dc.contributor.authorSrinathan, Sadeesh K
dc.contributor.authorNeary, John D D
dc.contributor.authorParlow, Joel L
dc.contributor.authorKurz, Andrea
dc.contributor.authorGross, Peter L
dc.contributor.authorMrkobrada, Marko
dc.contributor.authorBalasubramanian, Kumar
dc.contributor.authorSessler, Daniel I
dc.contributor.authorDevereaux, P. J
dc.date.accessioned2020-08-01T06:42:03Z
dc.date.issued2020-07-21
dc.date.updated2020-08-01T06:42:03Z
dc.description.abstractAbstract Background Surgical bleeding is associated with postoperative cardiovascular complications. The efficacy and safety of tranexamic acid (TXA) in noncardiac surgery are still uncertain. Statins may prevent perioperative cardiovascular complications. We conducted a pilot to assess the feasibility of a perioperative trial of TXA and rosuvastatin. Methods Using a factorial design, we randomized patients at cardiovascular risk undergoing noncardiac surgery to intravenous TXA (1 g at the start and end of surgery) or placebo, and oral rosuvastatin (40 mg before and 20 mg daily for 30 days after surgery) or placebo. Feasibility outcomes included recruitment rates, follow-up, and compliance to interventions. Clinical outcomes were secondarily explored. Results After 3 months, we changed the design to a partial factorial due to the difficult recruitment of statin-naive patients. Over 6 months, 100 patients were randomized in the TXA trial (49 TXA, 51 placebo), 34 in the rosuvastatin trial (18 rosuvastatin, 16 placebo). Ninety-two percent (95% CI 80–98) of TXA and 86% (95% CI 74–94) of TXA-placebo patients received the 2 study doses. Thirty-three percent (95% CI 13–59) of rosuvastatin patients and 37% (95% CI 15–65) of rosuvastatin-placebo patients discontinued the study drug. A major cardiovascular complication occurred at 30 days in 1 TXA and 6 TXA-placebo patients, and 1 rosuvastatin and no rosuvastatin-placebo patients. Conclusions Our pilot study supports the feasibility of a perioperative TXA trial in noncardiac surgery. Feasibility of a perioperative rosuvastatin trial is uncertain because of a high prevalence of statin use in the target population and concerns about compliance. Trial registration ClinicalTrials.gov NCT02546648 .
dc.identifier.citationPilot and Feasibility Studies. 2020 Jul 21;6(1):104
dc.identifier.urihttps://doi.org/10.1186/s40814-020-00643-9
dc.identifier.urihttp://hdl.handle.net/1993/34835
dc.language.rfc3066en
dc.rightsopen accessen_US
dc.rights.holderThe Author(s)
dc.titleTranexamic acid and rosuvastatin in patients at risk of cardiovascular events after noncardiac surgery: a pilot of the POISE-3 randomized controlled trial
dc.typeJournal Article
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