title: The duration of anticoagulation bridging therapy in clinical practice may significantly exceed that observed in clinical trials.
abstract: BACKGROUND
  Clinical trials involving frequent, standardized monitoring of the international normalized ratio (INR) demonstrated that a short course of low-molecular-weight-heparin (LMWH) can successfully bridge patients to oral anticoagulation. However, rigidly performed INR testing is often not feasible in the outpatient setting in actual clinical practice. The purpose of this study was to determine if the anticoagulation results of clinical trials of LMWH bridging therapy are also achieved in a single-center clinical practice setting.
  
  
  METHODS
  We conducted a retrospective analysis of 100 patients initiating warfarin while receiving LMWH under the care of a university-based anticoagulation management service.
  
  
  RESULTS
  Mean patient age was 56.1 +/- 16.3 years. The commonest indications for anticoagulation were venous thrombosis (57%) and atrial fibrillation (25%). Mean initial warfarin dose was 5.1 +/- 1.8 mg/day; 30% of patients received antiplatelet therapy. The mean total duration of LMWH therapy was 12.0 +/- 8.2 days, of which 9.8 +/- 8.0 days (median 7.5 days; interquartile range 4.3-13.0 days) occurred in the outpatient setting. Forty-one percent of patients received outpatient LMWH for < 7 days, 40% for 7-14 days, and 19% for > 14 days. A mean of 3.9 +/- 2.0 INRs were performed during LMWH therapy. Complications included 11 minor and 1 major bleeding episodes and 1 thrombotic event.
  
  
  CONCLUSIONS
  The duration of LMWH bridging therapy in practice may be significantly greater than previously reported in clinical trials, and the incidence of patients requiring prolonged (>14 days) LMWH therapy is relatively high. Outpatient LMWH as employed in clinical practice safely bridges patients to oral anticoagulation. Strategies to shorten the duration of LMWH therapy are needed and are likely to improve clinical outcomes and reduce health care expenses. In prospective clinical trials low-molecular-weight-heparin (LMWH) has proven effective in transitioning patients with venous thromboembolic disease to therapeutic warfarin anticoagulation. However, it is unknown if the anticoagulation results obtained in these trials, which involved rigidly performed anticoagulation monitoring, are achieved in standard clinical practice involving patients with a variety of indications for anticoagulation. We conducted a retrospective analysis of 100 patients initiating warfarin while receiving LMWH under the management of a university-based anticoagulation management service. The mean total duration of LMWH therapy was 12.0 +/- 8.2 days, of which 9.8 +/- 8.0 days (median 7.5 days; interquartile range 4.3-13.0 days) occurred in the outpatient setting. Forty-one percent of patients received outpatient LMWH for <7 days, 40% for 7-14 days, and 19% for >14 days. We conclude that the duration of LMWH bridging therapy in practice may be significantly greater than previously reported in clinical trials, and the incidence of patients requiring prolonged (>14 days) LMWH therapy is relatively high.
authors.affiliation: Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Jacob P
authors.initials: JP
authors.lastname: Deerhake
authors.forename: Julie C
authors.initials: JC
authors.lastname: Merz
authors.forename: Jeanna V
authors.initials: JV
authors.lastname: Cooper
authors.forename: Kim A
authors.initials: KA
authors.lastname: Eagle
authors.forename: William P
authors.initials: WP
authors.lastname: Fay
mesh_terms: D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D000925:Anticoagulants / Q000008:administration & dosage*; D001281:Atrial Fibrillation; D002986:Clinical Trials as Topic; D004334:Drug Administration Schedule; D004347:Drug Interactions; D016903:Drug Monitoring; D019317:Evidence-Based Medicine; D005260:Female; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage*; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D012189:Retrospective Studies; D013927:Thrombosis / Q000188:drug therapy; D014859:Warfarin / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; D014859:Warfarin