Incidence of thromboembolic complications in patients with atrial fibrillation or mechanical heart valves with a subtherapeutic international normalized ratio: a prospective multicenter cohort study

Alessandra Malato, Sergio Siragusa, Elena Grifoni, Daniele Pastori, Elena Rancan, Daniela Poli, Matteo Nicola Dario Di Minno, Leonardo Di Gennaro, Elena Grifoni, Giovanni Di Minno, Alessandro Squizzato, Pasquale Pignatelli, Walter Ageno, Francesco Dentali, Domenico Policarpo

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Abstract

Subtherapeutic international normalized ratio (INR) is frequently encountered in clinical practice, and patients with high-risk atrial fibrillation (AF) and with mechanical heart valve (MHV) with inadequate anticoagulation may be exposed to an increased risk of thromboembolic events (TE). However, there are no prospective data evaluating this risk. Consecutive patients with a history of stable anticoagulation, but with a subtherapeutic INR, were prospectively included. Data on use and dose of low-molecular weight heparin (LMWH) bridging therapy were collected. The incidence of objectively confirmed TE and of major bleeding events within 90 days after the index INR was assessed. Five hundred and one patients with INR value 0.5-1 INR units below the lower limit of the patient-specific target INR were included in the study (280 with MHV and 221 with AF and CHADS2 score ≥3). LMWH was prescribed for 64 patients (12.8%). During follow-up, seven patients had a TE (1.40%; 95% confidence interval 0.68, 2.86%; 5.58 events for 100 patients year). All the events occurred within 14 days after the index INR. When we consider only patients who did not receive bridging therapy, the incidence of TE was 1.14% (5 of 437 patients; 95% confidence interval 0.49, 2.64%; 4.58 events for 100 patients year). There were no major bleeding events. The risk of TE in this population was not negligible. Given the frequent observation of subtherapeutic INR levels when monitoring vitamin K antagonists, this finding warrants additional investigation to improve the management of these patients. © 2012 Wiley Periodicals, Inc.
Lingua originaleEnglish
pagine (da-a)384-387
Numero di pagine4
RivistaAmerican Journal of Hematology
Volume87
Stato di pubblicazionePublished - 2012

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All Science Journal Classification (ASJC) codes

  • Hematology

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Malato, A., Siragusa, S., Grifoni, E., Pastori, D., Rancan, E., Poli, D., Minno, M. N. D. D., Gennaro, L. D., Grifoni, E., Minno, G. D., Squizzato, A., Pignatelli, P., Ageno, W., Dentali, F., & Policarpo, D. (2012). Incidence of thromboembolic complications in patients with atrial fibrillation or mechanical heart valves with a subtherapeutic international normalized ratio: a prospective multicenter cohort study. American Journal of Hematology, 87, 384-387.