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SHR Neuro Cancer Cardio Lipid Metab Microb
Marcucci, M; Duceppe, E; Le Manach, Y; Kearon, C; Eikelboom, JW; Pohl, K; Vincent, J; Darvish-Kazem, S; Srinathan, SK; Neary, JDD; Parlow, JL; Kurz, A; Gross, PL; Mrkobrada, M; Balasubramanian, K; Sessler, DI; Devereaux, PJ.
Tranexamic acid and rosuvastatin in patients at risk of cardiovascular events after noncardiac surgery: a pilot of the POISE-3 randomized controlled trial
PILOT FEASIBILITY ST. 2020; 6(1): 104
Doi: 10.1186/s40814-020-00643-9
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- Co-authors Med Uni Graz
- Kurz Andrea
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- Abstract:
- BackgroundSurgical 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.MethodsUsing a factorial design, we randomized patients at cardiovascular risk undergoing noncardiac surgery to intravenous TXA (1g at the start and end of surgery) or placebo, and oral rosuvastatin (40mg before and 20mg daily for 30days after surgery) or placebo. Feasibility outcomes included recruitment rates, follow-up, and compliance to interventions. Clinical outcomes were secondarily explored.ResultsAfter 3months, we changed the design to a partial factorial due to the difficult recruitment of statin-naive patients. Over 6months, 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 30days in 1 TXA and 6 TXA-placebo patients, and 1 rosuvastatin and no rosuvastatin-placebo patients.ConclusionsOur 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 registrationClinicalTrials.govNCT02546648.
- Find related publications in this database (Keywords)
- Tranexamic acid
- Rosuvastatin
- Noncardiac surgery
- Pilot
- Feasibility