Association of oral anticoagulants with risk of brain haemorrhage expansion compared to no-anticoagulation
Roland VeltkampKirsten HaasViktoria RückerUwe MalzahnAllen HeegerDavid KinzlerPatrick MüllerPascal RappardTimolaos RizosJohannes SchieferChristian OpherkWaltraud PfeilschifterKatharina AlthausPeter D. SchellingerBernadette GaidaMaria M. GabrielGeorg RoylDarius G. NabaviKarl Georg HæuslerChristian H. NolteMarc E. WolfSven PoliM. SieberPascal J. MosimannPeter U. HeuschmannJan C. PurruckerSolveig HorstmannAlexandra KraußCaroline RenningerPeter RinglebArno ReichE. KöhlerErendira Gabriela BossJan Hendrik SchaeferMarc Andre PflugBettina von SarnowskiGerrit M. GroßeJohanna ErnstKarin WeißenbornRamona SchupperHans WorthmannSusanne RiebauOlaf CromeBoris DimitrijeskiJens OffermannIda RangusElisabeth SchmidKhouloud PoliJohannes TünnerhoffDominik MichalskiJohann PelzMartin JuenemannThomas MüllerKatja E. WartenbergAndreas BinderJohannes MeyneBenno IkenbergJohanna HärtlMichael OhmsSebasitan EdelbuschMarc FatarA. Husilllos AlonsoMartin NückelFrank ErbguthAlexandra GrauUdo SeligRainer DziewasJens MinnerupKristian BarlinnKathrin HaaseGötz ThomallaMilani Deb‐ChatterjiMathias MäurerMathias PfauPeter MichelsZ VukovićTimo UphausKlaus GröschelSonja GröschelMarianne HahnJohannes MühlerKlaus DötterMichaela Wagner-HeckFrank A. WollenweberSebastian JanderJohn‐Ih LeeWolf‐Rüdiger SchäbitzInken PiehlMichael FrattnerDimitre StaykovChristian UrbanekStefan SchröderSylke Düllberg-BodenPawel KermerMatthias KasteLars MarquardtH. KazariansChristoph KleinschnitzPeter KraftFrank HoffmannAndrea KraftJürgen FaissGernot ReimannMichael SchwarzThorsten SteinerAlbrecht GüntherUta Meyding LamadéMatthias Lorenz
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Abstract Background The impact of direct oral anticoagulants (DOAC) on haematoma size after intracerebral haemorrhage (ICH) compared to no-anticoagulation is controversial and prospective data are lacking. Methods The investigator-initiated, multicentre, prospective RASUNOA-prime study enrolled patients with non-traumatic ICH and atrial fibrillation while on a DOAC, vitamin K antagonist (VKA) or no anticoagulation (non-OAC). Neuroimaging was reviewed centrally blinded to group allocation. Primary endpoint was haematoma expansion (≥ 6.5 ml or ≥ 33%, any new intraventricular blood or an increase in modified Graeb score by ≥ 2 points) between baseline and follow-up scan within 72 h after symptom onset. Results Of 1,440 patients screened, 951 patients with ICH symptom onset less than 24 h before admission were enrolled. Baseline scans were performed at a median of 2 h (IQR 1–6) after symptom onset. Neurological deficit and median baseline haematoma volumes (11 ml; IQR 4–39) did not differ among 577 DOAC, 251 VKA and 123 non-OAC patients. Haematoma expansion was observed in DOAC patients in 142/356 (39.9, 95%-CI 34.8–45.0%), VKA in 47/155 (30.3, 95-CI 23.1%–37.6%), versus non-OAC in 22/74 (29.7, 19.3–40.1%). Unspecific reversal agents in DOAC-ICH (212/356, 59.6%) did not affect the haematoma expansion rate compared to no-antagonization. Conclusion Baseline haematoma volume and risk of haematoma expansion did not differ statistically significantly in patients with and without DOAC.Keywords:
Vitamin K antagonist
Clinical endpoint
The application of non-vitamin K antagonist oral anticoagulant (NOAC) reduces the risk of intracerebral hemorrhage (ICH) in comparison with vitamin K antagonist (VKA). However, the features and outcomes of NOAC-associated ICH are still unclear, especially for Asian populations.We retrospectively analyzed 49 consecutive patients who had spontaneous ICH while using NOAC or VKA. We compared the clinical characteristics, ICH volume, 7-day and 3-month mortality, and functional outcomes at discharge and 3 months post-stroke using the modified Rankin Scale (mRS) between NOAC- and VKA-associated ICH. The clinical features, ICH volume, ICH location, and/or treatment methods were statistically adjusted.Among the 49 ICH patients, 15 (30.6%) were using NOAC and 34 (69.4%) were taking VKA. There were no significant differences in the initial ICH volume between groups (mean volume 34.2 ± 43.8 vs. 59.4 ± 46.5 mL, p = 0.061). The percentage of early mortality (within 7 days post-ICH) was significantly lower in the NOAC group (13.3% vs. 44.1%; p = 0.047), but the 3-month mortality was similar (33.3% vs. 47.1%; p = 0.294). The functional outcome was equally poor in both groups at discharge (p = 0.670) and 3 months post-ICH (mean mRS score 4.7 ± 1.3 vs. 4.6 ± 1.7, p = 0.766).There were no significant differences in initial ICH volume, 90-day mortality, or functional outcomes between NOAC and VKA-associated ICH in Asians.
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Objective To investigate the expression of HIF-1αin intracerebral hemorrhage and find out its significance and its correlation with the time of intracerebral hemorrhage.Methods The expression of HIF-1α were assessed by Immunohistochemistry staining.Results In 65 cease of intracerebral hemorrhage positive expression rates of HIF-1α was 61.5%(40/65) and 0 in normal braintissues.The positive rate was significantly higher in intracerebral hemorrhage than in normal brain tissues(P0.05).HIF-1α positive expression rates were 20%(3/15) in 6h,62.5%(20/32) between 6h to 24h and 94.4%(17/18) after 24h of intracerebral hemorrhage.HIF-1α expression was closely related with time of operation after intracerebral hemorrhage(P0.05).Conclusion HIF-1α was over expressed in intracerebral hemorrhage,and there is a significant correlation with the time after intracerebral hemorrhage.It can help hypoxic neurons survive in the condition of hypoxia.
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Aims To examine the long-term persistence and safety of the non-vitamin-K-antagonist oral anticoagulants (NOACs) dabigatran (D), rivaroxaban (R) and apixaban (A) in patients with non-valvular atrial fibrillation (AF) treated in the framework of a well structured, nurse-based AF unit for initiation and follow-up of NOAC.Methods Retrospective clinical data were collected for 766 consequent patients from a single cardiology outpatient clinic incorporating the AF unit.Results The follow-up time, median (q1-q3), was 367 days (183–493) for D patients (n = 233), 432 days (255–546) for R patients (n = 282) and 348 days (267–419) for A patients (n = 251). No significant differences were found between the three groups with regard to age, sex, renal function, or CHA2DS2-VASc score. For all bleeding events the incidence rates per 100 patient-years of follow-up (95% confidence interval [CI], p-value) were reported more often for treatment with R (17.2, 12.7–22.8) than for D (7.0, 4.0–11.3, p = 0.001) and A (8.7, 5.2–13.6, p = 0.013). The differences remained significant after adjustment for clinically relevant variables. Discontinuation rates (n = 167) were lower for A (11.5, 7.5–16.8) than for D (30, 23.4–37.9, p < 0.001) and R (23.9, 18.6–30.1, p = 0.001), and were mainly attributed to drug-specific side effects and bleedings. The majority of discontinued patients (n = 142, 85%) proceeded with other types of oral anticoagulants.Limitation The main limitation of the study is the small patient population with a short follow-up time.Conclusion In a retrospective study at a single AF clinic, NOACs showed significantly different bleeding rates and varied discontinuation rates when compared to each other, related mainly to agent-specific side effects and bleedings. The majority of patients that discontinued proceeded with other types of oral anticoagulant.
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valvular heart disease
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Abstract Introduction Treatment burden (TB) is defined as the overall workload that maintenance or improvement of their functioning and well-being poses on patients with chronic medical conditions. A high patient-reported TB has been associated with lower adherence to treatment and increased risk of major adverse events including death. We explored the differences in patient-reported TB value and prevalence of unacceptably high TB score (≥59 points) between patients receiving vitamin K antagonist oral anticoagulants (VKA) and non-vitamin K antagonist oral anticoagulants (NOAC). Furthermore, we explored contributory factors associated with TB and the relationship between TB and quality of life (QoL) in these patients. Methods A single-centre study included consecutive adult in- and outpatients on long-term oral anticoagulation, seen at a university clinical centre a from April to June 2019, who were willing to complete the Treatment Burden Questionnaire encompassing 13 items assessing the TB associated with taking medicine, self-monitoring, laboratory assessments, medical consultations, organisational and administrative requirements, adherence to dietary and physical activity recommendations, as well as the social repercussions of the treatment. Results Of 320 enroled patients, 206 (64.4%) were taking a VKA. Atrial fibrillation was the most common indication for long-term oral anticoagulation (n=299, 93.4%). The mean TB score was significantly higher in patients on VKA versus those taking a NOAC (48.8 ±26.5 vs. 41.8 ±19.7, P= 0.014), mostly owing to significantly higher TB values for questions related to self-monitoring, including the International Normalized Ratio (INR) control (3.85±3.32 vs. 1.62±1.38, P<0.001) and diet restrictions (3.98±3.43 vs. 2.48±2.49, P<0.001) in patients taking VKA (Figure 1). In addition, these patients significantly more often reported an unacceptably high TB of ≥59 points compared with those taking NOAC (30.1% vs 18.4%, P= 0.024). Multivariable regression analysis of predictors of TB in patients taking a VKA or NOAC are presented in Table 1. Conclusion In our study, patients receiving a VKA reported significantly higher TB compared to those using NOAC, especially regarding the questions about self-monitoring (including INR control) and diet restrictions. An unacceptably high TB was also more prevalent among patients receiving a VKA. Our findings suggest that prescribing NOACs in preference to VKAs could help in decreasing the self-reported TB in patients who need oral anticoagulant therapy.
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Background Non-vitamin K antagonist oral anticoagulants (NOACs) are broadly preferable to vitamin K antagonists (VKAs) for stroke prevention in non-valvular atrial fibrillation (AF) given their overall net clinical benefit. We report an audit of the profile of OAC usage and adverse events in patients attending a specialist AF clinic. Methods Patients attending our specialist AF clinic who were commenced on NOACs for SPAF between January 2013 and August 2014 were included and electronic medical records were retrospectively reviewed between August 2014 and November 2014, to collect demographic, clinical and outcome data. Outcomes included cerebrovascular and bleeding events, death, switching between NOACs or to VKA, dose changes, cessation of NOACs and the reasons for these. To provide perspective, descriptive comparisons were made with a historical cohort of warfarin users attending the specialist AF clinic prior to the introduction of NOACs. Results We report data on 813 patients as follows: (i) 233 consecutive patients (mean (standard deviation) age 74 (10) years, 45.1% female) initiated on NOACs, with median (interquartile range) CHA2DS2-VASc score 3 (2–5) and HAS-BLED score 1 (1–2); and (ii) a historical cohort of 580 patients on warfarin (mean (SD) age 75 (10) years, 42.1% female) with broadly similar demographics. Overall, 54.5% (127/233) were started on rivaroxaban, 22.7% (53/233) on dabigatran and 22.7% on apixaban. Two patients experienced a transient ischaemic attack; 31 patients (13%) contributed to 37 documented bleeding events of which five bleeds (in four patients, 1.7%) were classified as major. There were seven deaths; cause of death was not available for three and the others were not related to NOACs. Eighteen (7.7%) patients switched NOACs, 2 (0.9%) patients switched to warfarin and 8 (3.4%) had their NOACs stopped. There were no ischaemic strokes in the NOAC cohort, compared with nine in the warfarin cohort, with a similar rate of major bleeding (1.7% for NOACs and 1.6% for warfarin). There were more gastrointestinal haemorrhages in the NOAC cohort (3.4% vs. 0.7% with warfarin). Conclusion In this specialist AF clinic, patients prescribed NOACs had a favourable adverse event profile with good efficacy for stroke prevention, with a low rate of cessation or switch to warfarin.
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Background Atrial fibrillation is an important risk factor for stroke but there are limited data on atrial fibrillation-related stroke from the Middle East. Methods We interrogated the Qatar Stroke Database to establish the occurrence, clinical features, and outcomes of atrial fibrillation-related stroke at Hamad General Hospital, the sole provider of acute stroke care in Qatar. Results A total of 4079 patients (81.4% male, mean age 55.4 ± 13.3 years) were enrolled in the stroke database between January 2014 and 21 October 2017. Atrial fibrillation was present in 260 (6.4%) patients, of whom 106 (2.6%) had newly diagnosed atrial fibrillation. The National Institute of Health Stroke Scale (NIHSS) was significantly higher (7.9 + 7.0 (median 6; IQR 11) vs. 5.9 + 6.4 (median 4; IQR 6), P < 0.001) in atrial fibrillation patients. The modified Rankin Score (mRS) (P < 0.001) and mortality at 90-day follow-up (P = 0.002) were significantly higher in atrial fibrillation compared to non-atrial fibrillation stroke patients. Conclusion We demonstrate a low rate of atrial fibrillation and stroke in Qatar, perhaps reflecting the relatively young age of these patients. Atrial fibrillation-related strokes had higher admission NIHSS, greater disability, and higher mortality at 90 days when compared to non-atrial fibrillation strokes.
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