Optimal Enoxaparin Dosing In Plastic Surgery Inpatients: Results Of A Two Year, Double Blind, Randomized Control Trial
Christopher Pannucci, MD MS, Kory Fleming, MPH, Corinne Bertolaccini, PharmD, Shaun Mendenhall, MD, Isak Goodwin, MD, Brad Rockwell, MD, Jay Agarwal, MD, Barbu Gociman, MD PHD, Alvin Kwok, MD, Arash Momeni, MD.
University of Utah, Salt Lake City, UT, USA.
Current “one size fits all” strategies for enoxaparin prophylaxis in plastic surgery inpatients may not optimize the risks and benefits of perioperative anticoagulation. Methods: This prospective, randomized, double blind clinical trial compared enoxaparin 40mg BID versus enoxaparin 0.5mg/kg BID. Primary hypotheses were 1) weight-based is non-inferior to fixed dose for avoiding under-anticoagulation (aFXa<0.2 IU/mL) and 2) weight-based is superior to fixed dose for avoiding over-anticoagulation (aFXa>0.4 IU/mL). Secondary endpoints were 90-day VTE and bleeding. Results: 295 patients were randomized over two years (Fig1). Weight-based enoxaparin was not inferior to fixed dose for avoiding under-anticoagulation (79.9% vs. 76.6%); the 95% CI (-7.0% to 13.6%) did not cross the noninferiority margin of -12% (Fig2). Weight-based enoxaparin was superior to fixed dose for avoidance of over-anticoagulation (90.6% vs. 82.2%); the 95% CI (0.1%-16.6%) showed significant safety superiority (p=0.046) (Fig3). VTE or major bleeding were not different between fixed and weight-based cohorts (0.66% vs. 0.69% p-=0.98; 3.3% vs. 4.2% p=0.72). Conclusions: Compared to fixed dose, the pharmacokinetics of weight-based enoxaparin were superior for avoidance of under and over-anticoagulation.
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