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(Circulation. 2009;119:2920-2927.)
© 2009 American Heart Association, Inc.

Vascular Medicine

Standardized Low–Molecular-Weight Heparin Bridging Regimen in Outpatients on Oral Anticoagulants Undergoing Invasive Procedure or Surgery

An Inception Cohort Management Study

V. Pengo, MD; U. Cucchini, MD; G. Denas, MD; N. Erba, MD; G. Guazzaloca, MD; L. La Rosa, MD; V. De Micheli, MD; S. Testa, MD; R. Frontoni, MD; D. Prisco, MD; G. Nante, MD; S. Iliceto, MD, for the Italian Federation of Centers for the Diagnosis of Thrombosis and Management of Antithrombotic Therapies (FCSA)

From the Clinical Cardiology, Thrombosis Center, Department of Cardiothoracic and Vascular Sciences, University of Padova School of Medicine, Padova (P.V., C.U., D.G., I.S.); Merate General Hospital, Lecco (E.N.); University Hospital, Bologna (G.G.); General Hospital, Vimercate (L.L.); General Hospital, Lecco (D.V.); General Hospital, Cremona (T.S.); General Hospital, Macerata (F.R.); University of Firenze, Firenze (P.D.); and Geriatric Clinic, Padova (N.G.), Italy.

Correspondence to Vittorio Pengo, MD, Clinical Cardiology, Thrombosis Center, Via Giustiniani 2, 35128 Padova, Italy. E-mail vittorio.pengo{at}unipd.it

Received October 7, 2008; accepted April 10, 2009.

Background— Bridging therapy with low–molecular-weight heparin is usually recommended in patients who must stop oral anticoagulants before surgical or invasive procedures. To date, there is no universally accepted bridging regimen tailored to the patient’s thromboembolic risk. This prospective inception cohort management study was designed to assess the efficacy and safety of an individualized bridging protocol applied to outpatients.

Methods and Results— Oral anticoagulants were stopped 5 days before the procedure. Low–molecular-weight heparin was started 3 to 4 days before surgery and continued for 6 days after surgery at 70 anti–factor Xa U/kg twice daily in high-thromboembolic-risk patients and prophylactic once-daily doses in moderate- to low-risk patients. Oral anticoagulation was resumed the day after the procedure with a boost dose of 50% for 2 days and maintenance doses afterward. The patients were followed up for 30 days. Of the 1262 patients included in the study (only 15% had mechanical valves), 295 (23.4%) were high-thromboembolic-risk patients and 967 (76.6%) were moderate- to low-risk patients. In the intention-to-treat analysis, there were 5 thromboembolic events (0.4%; 95% confidence interval, 0.1 to 0.9), all in high-thromboembolic-risk patients. There were 15 major (1.2%; 95% confidence interval, 0.7 to 2.0) and 53 minor (4.2%; 95% confidence interval, 3.2 to 5.5) bleeding episodes. Major bleeding was associated with twice-daily low–molecular-weight heparin administration (high-risk patients) but not with the bleeding risk of the procedure.

Conclusions— This management bridging protocol, tailored to patients’ thromboembolic risk, appears to be feasible, effective, and safe for many patients, but safety in patients with mechanical prosthetic valves has not been conclusively established.

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