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Optimal Dosing of Prophylactic Enoxaparin after Surgical Procedures: Results of the Double-Blind, Randomized, Controlled FIxed or Variable Enoxaparin (FIVE) Trial.
Pannucci, Christopher J; Fleming, Kory I; Bertolaccini, Corinne; Agarwal, Jayant; Rockwell, W Bradford; Mendenhall, Shaun D; Kwok, Alvin; Goodwin, Isak; Gociman, Barbu; Momeni, Arash.
  • Pannucci CJ; From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.
  • Fleming KI; From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.
  • Bertolaccini C; From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.
  • Agarwal J; From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.
  • Rockwell WB; From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.
  • Mendenhall SD; From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.
  • Kwok A; From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.
  • Goodwin I; From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.
  • Gociman B; From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.
  • Momeni A; From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.
Plast Reconstr Surg ; 147(4): 947-958, 2021 04 01.
Article in English | MEDLINE | ID: covidwho-1174990
ABSTRACT

BACKGROUND:

The accepted "one-size-fits-all" dose strategy for prophylactic enoxaparin may not optimize the medication's risks and benefits after surgical procedures. The authors hypothesized that weight-based administration might improve the pharmacokinetics of prophylactic enoxaparin when compared to fixed-dose administration.

METHODS:

The FIxed or Variable Enoxaparin (FIVE) trial was a randomized, double-blind trial that compared the pharmacokinetic and clinical outcomes of patients assigned randomly to postoperative venous thromboembolism prophylaxis using enoxaparin 40 mg twice daily or enoxaparin 0.5 mg/kg twice daily. Patients were randomized after surgery and received the first enoxaparin dose at 8 hours after surgery. Primary hypotheses were (1) weight-based administration is noninferior to a fixed dose for avoiding underanticoagulation (anti-factor Xa <0.2 IU/ml) and (2) weight-based administration is superior to fixed-dose administration for avoiding overanticoagulation (anti-factor Xa >0.4 IU/ml). Secondary endpoints were 90-day venous thromboembolism and bleeding.

RESULTS:

In total, 295 patients were randomized, with 151 assigned to fixed-dose and 144 to weight-based administration of enoxaparin. For avoidance of under anticoagulation, weight-based administration had a greater effectiveness (79.9 percent versus 76.6 percent); the 3.3 percent (95 percent CI, -7.5 to 12.5 percent) greater effectiveness achieved statistically significant noninferiority relative to the a priori specified -12 percent noninferiority margin (p = 0.004). For avoidance of overanticoagulation, weight-based enoxaparin administration was superior to fixed-dose administration (90.6 percent versus 82.2 percent); the 8.4 percent (95 percent CI, 0.1 to 16.6 percent) greater effectiveness showed significant safety superiority (p = 0.046). Ninety-day venous thromboembolism and major bleeding were not different between fixed-dose and weight-based cohorts (0.66 percent versus 0.69 percent, p = 0.98; 3.3 percent versus 4.2 percent, p = 0.72, respectively).

CONCLUSION:

Weight-based administration showed superior pharmacokinetics for avoidance of underanticoagulation and overanticoagulation in postoperative patients receiving prophylactic enoxaparin. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, I.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Postoperative Complications / Enoxaparin / Venous Thromboembolism / Anticoagulants Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: Plast Reconstr Surg Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Postoperative Complications / Enoxaparin / Venous Thromboembolism / Anticoagulants Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: Plast Reconstr Surg Year: 2021 Document Type: Article