title: Periprocedural warfarin reversal with prothrombin complex concentrate.
abstract: BACKGROUND
  Approximately 10% of chronically anticoagulated patients require an invasive procedure annually. One in 10 procedures is emergent and requires prompt anticoagulation reversal. The study objective is to determine the safety and efficacy of a 3 factor prothrombin complex concentrate (PCC) for periprocedural anticoagulation reversal.
  
  
  METHODS
  Consecutive patients receiving 3 factor PCC for warfarin reversal for either urgent/emergent invasive procedures or major bleeding were analyzed. Primary endpoints included percent achieving INR <1.5, peri-operative major hemorrhage, thromboembolism and death during the 40day post-infusion period.
  
  
  RESULTS
  Between January 1, 2010-December 31, 2012, 52 patients were treated with PCC for pre-procedural warfarin reversal and 113 patients for major bleeding. Within the peri-procedure group, there were 24 intra-abdominal surgeries, 12 percutaneous interventions, 6 cardiothoracic surgeries, 5 orthopedic and 3 endoscopic procedures. INR values <1.5 were achieved in 51% at 2.5h post-infusion. Major bleeding (13%), thromboembolism (13%) and mortality rates (15%) were high. Within the major bleeding group, PCC therapy reversed INR values (<1.5) in 75% of patients within 4h. For this group, thromboembolism (21%) and mortality rates (16%) were likewise high. Post-PCC anticoagulation, reinitiated in 37%, had no impact on bleeding or thrombotic complications. Mortality rates were threefold higher for those patients not restarting warfarin therapy.
  
  
  CONCLUSIONS
  Although PCC therapy promptly and effectively reverses INR values for patients requiring urgent/emergent invasive procedure both thromboembolic and fatal complications are soberingly high and call for judicious use of these agents in these high risk populations.
authors.affiliation: Department of Internal Medicine, Mayo Clinic, Rochester, MN, United States.
authors.forename: Meera
authors.initials: M
authors.lastname: Sridharan
authors.affiliation: Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, United States; Division of Hematology Research, Mayo Clinic, Rochester, MN, United States.
authors.forename: Waldemar E
authors.initials: WE
authors.lastname: Wysokinski
authors.affiliation: Division of Hematology Research, Mayo Clinic, Rochester, MN, United States.
authors.forename: Rajiv
authors.initials: R
authors.lastname: Pruthi
authors.affiliation: Pharmacy Services, Mayo Clinic, Rochester, MN, United States.
authors.forename: Lance
authors.initials: L
authors.lastname: Oyen
authors.affiliation: Department of Neurology, Mayo Clinic, Rochester, MN, United States.
authors.forename: William D
authors.initials: WD
authors.lastname: Freeman
authors.affiliation: Department of Neurology, Mayo Clinic, Jacksonville, FL, United States.
authors.forename: Alejandro A
authors.initials: AA
authors.lastname: Rabinstein
authors.affiliation: Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, United States; Division of Hematology Research, Mayo Clinic, Rochester, MN, United States. Electronic address: mcbane.robert@mayo.edu.
authors.forename: Robert D
authors.initials: RD
authors.lastname: McBane
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D001777:Blood Coagulation / Q000187:drug effects*; D001779:Blood Coagulation Factors / Q000009:adverse effects / Q000627:therapeutic use*; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D003029:Coagulants / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D012189:Retrospective Studies; D013514:Surgical Procedures, Operative; D013923:Thromboembolism / Q000139:chemically induced; D014859:Warfarin / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D001779:Blood Coagulation Factors; D003029:Coagulants; C025667:prothrombin complex concentrates; D014859:Warfarin
keywords: Anticoagulants; Bleeding; Prothrombin complex concentrate (PCC); Thrombosis; Warfarin