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

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON Canada. GRID: grid.25073.33. ISNI: 0000 0004 1936 8227 Department of Medicine, McMaster University, Hamilton, ON Canada. GRID: grid.25073.33. ISNI: 0000 0004 1936 8227 Population Health Research Institute, Hamilton, ON Canada. GRID: grid.415102.3. ISNI: 0000 0004 0545 1978 Department of Medicine, University of Montreal, Montreal, QC Canada. GRID: grid.14848.31. ISNI: 0000 0001 2292 3357 Department of Anesthesia, McMaster University, Hamilton, ON Canada. GRID: grid.25073.33. ISNI: 0000 0004 1936 8227 William Osler Health System, Brampton, ON Canada. GRID: grid.498791.a. ISNI: 0000 0004 0480 4399 Department of Surgery, University of Manitoba, Winnipeg, MB Canada. GRID: grid.21613.37. ISNI: 0000 0004 1936 9609 Department of Anesthesiology and Perioperative Medicine, Kingston General Hospital and Queen's University, Kingston, ON Canada. GRID: grid.415354.2. ISNI: 0000 0004 0633 727X Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH USA. GRID: grid.239578.2. ISNI: 0000 0001 0675 4725 Department of Medicine, University of Western Ontario, London, ON Canada. GRID: grid.39381.30. ISNI: 0000 0004 1936 8884

Pilot Feasibility Stud. 2020;6:104
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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.govNCT02546648.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine