PMID- 16706967 OWN - NLM STAT- MEDLINE DCOM- 20071130 LR - 20230829 IS - 1538-7933 (Print) IS - 1538-7836 (Linking) VI - 4 IP - 6 DP - 2006 Jun TI - Clinical outcomes with unfractionated heparin or low-molecular-weight heparin as bridging therapy in patients on long-term oral anticoagulants: the REGIMEN registry. PG - 1246-52 AB - BACKGROUND: Patients who receive long-term oral anticoagulant (OAC) therapy often require interruption of OAC for an elective surgical or an invasive procedure. Heparin bridging therapy has been used in these situations, although the optimal method has not been established. No large prospective studies have compared unfractionated heparin (UFH) with low-molecular-weight heparin (LMWH) for the perioperative management of patients at risk of thromboembolism requiring temporary interruption of long-term OAC therapy. PATIENTS/METHODS: This multicenter, observational, prospective registry conducted in North America enrolled 901 eligible patients on long-term OAC who required heparin bridging therapy for an elective surgical or invasive procedure. Practice patterns and clinical outcomes were compared between patients who received either UFH alone (n = 180) or LMWH alone (n = 721). RESULTS: Overall, the majority of patients (74.5%) requiring heparin bridging therapy had arterial indications for OAC. LMWH, in mostly twice-daily treatment doses, represented approximately 80% of the study population. LMWH-bridged patients had significantly fewer arterial indications for OAC, a lower mean Charlson comorbidity score, and were less likely to undergo major or cardiothoracic surgery, receive intraprocedural anticoagulants or thrombolytics, or receive general anesthesia than UFH-bridged patients (all P < 0.05). The LMWH group had significantly more bridging therapy completed in an outpatient setting or with a < 24-h hospital stay vs. the UFH group (63.6% vs. 6.1%, P < 0.001). In the LMWH and UFH groups, similar rates of overall adverse events (16.2% vs. 17.1%, respectively, P = 0.81), major composite adverse events (arterial/venous thromboembolism, major bleed, and death; 4.2% vs. 7.9%, respectively, P = 0.07) and major bleeds (3.3% vs. 5.5%, respectively, P = 0.25) were observed. The thromboembolic event rates were 2.4% for UFH and 0.9% for LMWH. Logistic regression analysis revealed that for postoperative heparin use a Charlson comorbidity score > 1 was an independent predictor of a major bleed and that vascular, general, and major surgery were associated with non-significant trends towards an increased risk of major bleed. CONCLUSIONS: Treatment-dose LMWH, mostly in the outpatient setting, is used substantially more often than UFH as bridging therapy in patients with predominately arterial indications for OAC. Overall adverse events, including thromboembolism and bleeding, are similar for patients treated with LMWH or UFH. Postoperative heparin bridging should be used with caution in patients with multiple comorbidities and those undergoing vascular, general, and major surgery. These findings need to be confirmed using large randomized trials for specific patient groups undergoing specific procedures. FAU - Spyropoulos, A C AU - Spyropoulos AC AD - Lovelace Medical Center, Albuquerque, NM 87108, USA. alex.spyropoulos@lovelacesandia.com FAU - Turpie, A G G AU - Turpie AG FAU - Dunn, A S AU - Dunn AS FAU - Spandorfer, J AU - Spandorfer J FAU - Douketis, J AU - Douketis J FAU - Jacobson, A AU - Jacobson A FAU - Frost, F J AU - Frost FJ CN - REGIMEN Investigators LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - England TA - J Thromb Haemost JT - Journal of thrombosis and haemostasis : JTH JID - 101170508 RN - 0 (Anticoagulants) RN - 0 (Heparin, Low-Molecular-Weight) RN - 5Q7ZVV76EI (Warfarin) RN - 9005-49-6 (Heparin) SB - IM MH - Administration, Oral MH - Aged MH - Anticoagulants/adverse effects/*therapeutic use MH - Drug Administration Schedule MH - Elective Surgical Procedures MH - Female MH - Heparin/adverse effects/*therapeutic use MH - Heparin, Low-Molecular-Weight/administration & dosage/*adverse effects MH - Humans MH - Male MH - Multivariate Analysis MH - Observation MH - Perioperative Care MH - Postoperative Hemorrhage/*chemically induced MH - Practice Patterns, Physicians' MH - Prospective Studies MH - Registries MH - Risk Factors MH - Thromboembolism/*chemically induced/prevention & control MH - Treatment Outcome MH - Warfarin/adverse effects/therapeutic use EDAT- 2006/05/19 09:00 MHDA- 2007/12/06 09:00 CRDT- 2006/05/19 09:00 PHST- 2006/05/19 09:00 [pubmed] PHST- 2007/12/06 09:00 [medline] PHST- 2006/05/19 09:00 [entrez] AID - S1538-7836(22)14087-0 [pii] AID - 10.1111/j.1538-7836.2006.01908.x [doi] PST - ppublish SO - J Thromb Haemost. 2006 Jun;4(6):1246-52. doi: 10.1111/j.1538-7836.2006.01908.x.