Low-dose anticoagulation after isolated mechanical aortic valve replacement with Liva Nova Bicarbon prosthesis: A post hoc analysis of LOWERING-IT Trial View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2018-12

AUTHORS

Michele Torella, Iolanda Aquila, Paolo Chiodini, Cristiano Amarelli, Gianpaolo Romano, Ester Elena Della Ratta, Marisa De Feo, Alessandro Della Corte, Ciro Indolfi, Daniele Torella, Luca Salvatore De Santo

ABSTRACT

Thromboembolic complications after cardiac valve replacement are due to a complex interplay between patients' characteristics, device features and anticoagulation intensity. Subtle design and material differences in available prostheses may thrombosis. We conducted a post-hoc sub-analysis of the LOWERING-IT database to test the safety and feasibility of a low-level oral anticoagulant regime in low-risk patients with aortic LivaNova prosthetic valve replacement. The study population included 148 patients randomized to a low INR target (1.5-2.5; LOW-INR group), and 144 patients to the standard INR (2.0-3.0; CONVENTIONAL-INR group). The non-inferiority of thromboembolic events between LOW-INR and CONVENTIONAL-INR groups was tested. Cumulative follow-up reached 1,545 patient/years. The mean INR was 1.91 ± 0.23 in the LOW-INR group, and 2.59 ± 0.26 in the CONVENTIONAL-INR group (P < 0.001). There were 3 thromboembolic events, all in the CONVENTIONAL-INR group. Comparison of thromboembolic events was not significant. The 1-sided 97.5% exact CI for the difference in primary event proportion was 0.54%, satisfying criteria non-inferiority. Bleeding events were significantly different: 6.61 per 1,000 patient-year in LOW-INR group vs 18.65 per 1,000 patient-year in CONVENTIONAL-INR group (p < 0.045, RR 0.37). In conclusions these data suggest that low-dose anticoagulation is safe in selected patients after aortic LivaNova Bicarbon prosthesis implantation. More... »

PAGES

8405

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/s41598-018-26528-9

DOI

http://dx.doi.org/10.1038/s41598-018-26528-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1104216280

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/29849105


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