000084339 001__ 84339
000084339 005__ 20200716101519.0
000084339 0247_ $$2doi$$a10.1186/s12872-019-1168-2
000084339 0248_ $$2sideral$$a112979
000084339 037__ $$aART-2019-112979
000084339 041__ $$aeng
000084339 100__ $$aMenendez-Jandula, Bárbara
000084339 245__ $$aLong-term effectiveness and safety of self-management of oral anticoagulants in real-world settings
000084339 260__ $$c2019
000084339 5060_ $$aAccess copy available to the general public$$fUnrestricted
000084339 5203_ $$aBackground The patient self-management (PSM) is an effective approach for controlling the international normalized ratio, INR, within the therapeutic range. Nevertheless, most of the literature derives from randomized clinical trials, and no from routine clinical practice. The main objective of the present study was to evaluate long-term effectiveness and safety of PSM of oral anticoagulants (OACs) in real-world settings. Methods This prospective cohort study involved 808 patients who were trained for PSM between July 2009 and March 2012, and followed-up for a maximum observational period of 5 years. The follow-up consisted of a visit to the physician every 6 months. All patients used the same type of portable coagulometer, able to store digitally up to 100 INR measurements. Effectiveness outcomes included the percentage of patients within the therapeutic range, the time within therapeutic range (TTR), and the evolution of the TTR over 365 days of follow-up. Long-term safety profile of PSM included the incidence of all-cause deaths and complications (thromboembolic or hemorrhagic) reported between July 2009 and June 2014, and the time to event. Results The median follow-up was 3.3 years. The percentage of patients within therapeutic INR target range was 67.5%. The median TTR was 71.5%. The TTR increased over the follow-up period, either overall and regarding target INR. All-cause mortality was 2.4 per 100 patient-years (59 cases). The thromboembolic event rate was 0.9 per 100 patient-years (24 cases). The rate of major hemorrhages was 0.45 per 100 patient-years. Patients who drop out the PSM to perform the conventional management had greater rates of complications: 2.4, 1.8, and 3.4 per 100 patient-years for thromboembolic complications, major hemorrhagic events, and mortality, respectively. Conclusions The PSM of OACs is effective for maintaining patients within the INR therapeutic range for a long period of time in routine clinical practice. Results of the present study suggest that its effectiveness is at least comparable to the conventional management. Moreover, it seems safe in real-world settings, by preventing all-cause mortality, and thromboembolic and major hemorrhagic complications.
000084339 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/
000084339 590__ $$a2.078$$b2019
000084339 591__ $$aCARDIAC & CARDIOVASCULAR SYSTEMS$$b82 / 138 = 0.594$$c2019$$dQ3$$eT2
000084339 592__ $$a0.794$$b2019
000084339 593__ $$aCardiology and Cardiovascular Medicine$$c2019$$dQ2
000084339 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000084339 700__ $$aGarcia-Erce, José Antonio
000084339 700__ $$aZazo, Claro
000084339 700__ $$0(orcid)0000-0002-3380-4449$$aLarrad-Mur, Luis
000084339 773__ $$g19, 1 (2019), 186 [8 pp.]$$pBMC cardiovasc. disord.$$tBMC CARDIOVASCULAR DISORDERS$$x1471-2261
000084339 8564_ $$s246041$$uhttp://zaguan.unizar.es/record/84339/files/texto_completo.pdf$$yVersión publicada
000084339 8564_ $$s44273$$uhttp://zaguan.unizar.es/record/84339/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000084339 909CO $$ooai:zaguan.unizar.es:84339$$particulos$$pdriver
000084339 951__ $$a2020-07-16-09:25:21
000084339 980__ $$aARTICLE