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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Date
2020-07-21
Authors
Marcucci, Maura
Duceppe, Emmanuelle
Le Manach, Yannick
Kearon, Clive
Eikelboom, John W
Pohl, Kayla
Vincent, Jessica
Darvish-Kazem, Saeed
Srinathan, Sadeesh K
Neary, John D D
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Abstract
Abstract
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
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Citation
Pilot and Feasibility Studies. 2020 Jul 21;6(1):104