Document Detail

LOWERing the INtensity of oral anticoaGulant Therapy in patients with bileaflet mechanical aortic valve replacement: results from the "LOWERING-IT" Trial.
MedLine Citation:
PMID:  20598989     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Moderate anticoagulation after mechanical heart valve replacement has been proposed to reduce the risk of bleeding related to lifelong anticoagulation. However, the efficacy of such reduced antithrombotic regimens is still unknown. The present prospective open-label, single-center, randomized controlled trial aimed to evaluate the safety and feasibility of reduced oral anticoagulation after isolated mechanical aortic valve replacement. METHODS: Low-risk patients undergoing bileaflet mechanical aortic valve replacement were randomized to a low International normalized ratio (INR) target (1.5-2.5; LOW-INR group) or to the standard currently recommended INR (2.0-3.0; CONVENTIONAL-INR group) through daily coumarine oral therapy. No aspirin was added. Median follow-up was 5.6 years. The primary outcome was assessment of noninferiority of the low over the standard anticoagulation regimen on thromboembolic events. Secondary end point was the superiority of the reduced INR target strategy on bleeding events. RESULTS: We analyzed 396 patients (197 in the LOW-INR group and 199 in the CONVENTIONAL-INR group). The mean of INR was 1.94 +/- 0.21 and 2.61 +/- 0.25 in the LOW-INR and CONVENTIONAL-INR groups, respectively (P < .001). One versus three thromboembolic events occurred in the LOW-INR and CONVENTIONAL-INR, respectively, meeting the noninferiority criterion (P = .62). Total hemorrhagic events occurred in 6 patients in the LOW-INR group and in 16 patients in the CONVENTIONAL-INR group (P = .04). CONCLUSIONS: LOWERING-IT trial established that the proposed LOW-INR target is safe and feasible in low-risk patients after bileaflet aortic mechanical valve replacement. It results in similar thrombotic events and in a significant reduction of bleeding occurrence when compared to the conventional anticoagulation regimen.
Michele Torella; Daniele Torella; Paolo Chiodini; Marco Franciulli; Giampaolo Romano; Luca De Santo; Marisa De Feo; Cristiano Amarelli; Ferdinando C Sasso; Teresa Salvatore; Georgina M Ellison; Ciro Indolfi; Maurizio Cotrufo; Gianantonio Nappi
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  American heart journal     Volume:  160     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2010 Jul 
Date Detail:
Created Date:  2010-07-05     Completed Date:  2010-08-17     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  171-8     Citation Subset:  AIM; IM    
Copyright Information:
Copyright (c) 2010 Mosby, Inc. All rights reserved.
Department of Cardio-Thoracic and Respiratory Sciences, Second University of Naples, Naples, Italy.
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MeSH Terms
Administration, Oral
Anticoagulants / administration & dosage*,  adverse effects
Aortic Valve Stenosis / surgery*
Dose-Response Relationship, Drug
Follow-Up Studies
Heart Valve Prosthesis*
Italy / epidemiology
Middle Aged
Postoperative Hemorrhage / chemically induced,  epidemiology,  prevention & control*
Prospective Studies
Prosthesis Design
Risk Factors
Thrombosis / drug therapy
Young Adult
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