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1.
Stroke ; : STROKEAHA120030356, 2021 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-33423512

RESUMO

BACKGROUND AND PURPOSE: The influence of body mass index (BMI) on clinical outcomes in patients with atrial fibrillation remains controversial, especially among Asians. We aimed to evaluate the association between BMI and clinical outcomes in Asian patients with atrial fibrillation receiving oral anticoagulants. METHODS: Using the Korean National Health Insurance database between January 2015 and December 2017, we identified oral anticoagulant new users among patients with nonvalvular atrial fibrillation who had BMI information. We analyzed ischemic stroke, intracranial hemorrhage, hospitalization for gastrointestinal bleeding, major bleeding, all-cause death, and the composite clinical outcome according to BMI categories. RESULTS: A total of 43 173 patients were included across BMI categories (kg/m2): underweight (<18.5) in 3%, normal (18.5 to <23) in 28%, overweight (23 to <25) in 24%, obese I (25 to <30) in 39%, and obese II (≥30) in 6%. Higher BMI (per 5 kg/m2 increase) was significantly associated with lower risks of ischemic stroke (hazard ratio [HR], 0.891 [95% CI, 0.801-0.992]), hospitalization for gastrointestinal bleeding (HR, 0.785 [95% CI, 0.658-0.937]), major bleeding (HR, 0.794 [95% CI, 0.686-0.919]), all-cause death (HR, 0.658 [95% CI, 0.605-0.716]), and the composite clinical outcome (HR, 0.751 [95% CI, 0.706-0.799]), except for intracranial hemorrhage (HR, 0.815 [95% CI, 0.627-1.061]). The underweight group was associated with an increased risk of composite clinical outcome (HR, 1.398 [95% CI, 1.170-1.671]), mainly driven by an increased risk of all-cause death. The effects of non-vitamin K antagonist oral anticoagulant versus warfarin on clinical outcomes were similar across BMI groups. CONCLUSIONS: Higher BMI was independently associated with a lower risk of ischemic stroke, major bleeding, and better survival. Underweight patients had a higher risk of all-cause death and composite clinical outcome. The optimal BMI for patients with atrial fibrillation should be defined and managed according to an integrated care pathway.

2.
Stroke ; : STROKEAHA120030761, 2021 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-33412904

RESUMO

BACKGROUND AND PURPOSE: Limited data support the benefits of non-vitamin K oral anticoagulants (NOACs) among atrial fibrillation patients with prior gastrointestinal bleeding (GIB). We aimed to evaluate the effectiveness and safety of NOACs compared with those of warfarin among atrial fibrillation patients with prior GIB. METHODS: Oral anticoagulant-naive individuals with atrial fibrillation and prior GIB between January 2010 and April 2018 were identified from the Korean claims database. NOAC users were compared with warfarin users by balancing covariates using the inverse probability of treatment weighting method. The primary outcomes were ischemic stroke, major bleeding, and the composite outcome (combined ischemic stroke and major bleeding). Fatal events from each outcome were evaluated as secondary outcomes. RESULTS: A total of 42 048 patients were included (24 781 in the NOAC group and 17 267 in the warfarin group). The mean time from prior GIB to the initiation of oral anticoagulant was 3.1±2.6 years. After inverse probability of treatment weighting, baseline characteristics were balanced between the two groups (mean age, 72 years; men, 56.8%; and mean CHA2DS2-VASc score, 3.7). Lower risks of ischemic stroke, major bleeding, and the composite outcome were associated with NOAC use than with warfarin use (weighted hazard ratio, 0.608 [95% CI, 0.543-0.680]; hazard ratio, 0.731 [95% CI, 0.642-0.832]; and hazard ratio, 0.661 [95% CI, 0.606-0.721], respectively). For all secondary outcomes, NOACs showed greater risk reductions compared with warfarin. CONCLUSIONS: NOACs were associated with lower risks of ischemic stroke and major bleeding than warfarin among atrial fibrillation patients with prior GIB.

3.
Mayo Clin Proc ; 96(1): 52-65, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33413835

RESUMO

OBJECTIVE: To investigate the influences of non-vitamin K antagonist oral anticoagulants (NOACs) on rates of initiations of oral anticoagulants (OACs) and outcomes among elderly patients with atrial fibrillation (AF). METHODS: From January 1, 2009, to December 31, 2015, 33,539 newly-diagnosed AF patients older than 85 years old who survived more than 180 days after AF diagnosis were studied. Temporal trends regarding OAC initiation rates after incident AF were analyzed. The 1-year risks of ischemic stroke, intracranial hemorrhage, and mortality of incident AF patients diagnosed each year were compared with that of the year 2009. RESULTS: Initiation rates of OACs after AF was newly diagnosed in the elderly significantly increased from 9.5% to 34.3%, mainly due to the introduction of NOACs (from 0% to 26.2%). Several clinical factors were associated with OACs underuse, including chronic obstructive pulmonary disease, abnormal renal function, anemia, and history of bleeding. Compared with year 2009 (incidence rate, 5.55%/year), the 1-year risk of ischemic stroke after AF diagnosis decreased in the era of NOACs (incidence rate, 4.20%/year; adjusted hazard ratio [aHR], 0.748 in year 2012; 4.39%/year, aHR, 0.789 in 2014; 2.75%/year; aHR, 0.513 in year 2015; all P<.01, except for year 2013, 4.80%/year [P=.07]). Also, the risks of mortality were lower in years 2012 to 2015, while the risk of ICH remained unchanged. CONCLUSION: Initiation rates of OACs after AF was newly diagnosed in the elderly significantly increased following the introduction of NOACs. A lower risk of ischemic stroke, mortality, and composite adverse events was observed, which was temporally associated with the increasing prescription rates of OACs.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Acidente Vascular Cerebral/prevenção & controle , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Taiwan/epidemiologia , Resultado do Tratamento
4.
Pharmacol Res ; : 105418, 2021 Jan 12.
Artigo em Inglês | MEDLINE | ID: mdl-33450384

RESUMO

Statins are effective for reducing cardiovascular disease in patients at risk or with cardiovascular disease. The benefit of statin therapy on adverse cardiovascular outcomes in patients with non-valvular atrial fibrillation (AF) is not clear. We performed a systematic review and meta-analysis of studies retrieved from MEDLINE via PubMed and Cochrane (CENTRAL) database of studies investigating the efficacy of statins in AF patients. The principal endpoint was all-cause mortality. Other endpoints were cardiovascular mortality, ischemic stroke, composite endpoints and any bleeding. We included 14 studies (2 post-hoc analysis of randomized clinical trials, 8 prospective and 4 retrospective) with 100,287 AF patients, of whom 23,228 were on statins. The pooled hazard ratio (HR) for all-cause mortality was 0.59 (95% Confidence Interval [CI] 0.54-0.65). This association was consistent by aging, sex and prevalent cardiovascular or cerebrovascular disease. and the beneficial effect was evident already after 12 months of therapy. The absolute risk reduction for all-cause mortality in patients treated with statins was 10% (95%CI 9-10). The pooled HR for statins against cardiovascular mortality was 0.75 (95% CI 0.58-0.96). No association was found with other secondary endpoints. Regarding bleeding events, the pooled HR for statin use was 0.60 (95%CI 0.48-0.76). Our meta-analysis shows that in AF patients, statin therapy was associated with a reduction in all-cause and cardiovascular mortality are reduced by 41% and 25%, respectively. Randomized clinical trials in AF patients are necessary, as well as clarity on AF-specific LDL cholesterol targets.

5.
Eur J Clin Invest ; 51(1): e13361, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33448356

RESUMO

BACKGROUND: Atrial fibrillation (AF) and hypertension are independently associated with impaired autonomic function determined using heart rate variability (HRV). As these conditions frequently co-exist, we sought to determine whether AF would worsen HRV in hypertensive patients. DESIGN: We studied HRV in AF (and hypertension) (n = 61) and hypertension control group (n = 33). The AF (and hypertension) group was subdivided into permanent AF (n = 30) and paroxysmal AF (n = 31) and re-studied. Time-domain, frequency-domain and nonlinear measures of HRV were determined. Permanent AF group (n = 30) was followed up after 8 weeks following optimisation of their heart rate and blood pressure (BP). RESULTS: Time-domain and nonlinear indices of HRV were higher in AF (and hypertension) group compared to hypertensive controls (P ≤ .01). Time-domain and nonlinear indices of HRV were higher in permanent AF group compared to paroxysmal AF (P ≤ .001). Permanent AF was an independent predictor of HRV on multivariable analysis (P = .006). Optimisation of heart rate and BP had no significant impact on HRV in permanent AF. CONCLUSIONS: AF, independent of hypertension, is characterised with marked HRV and is possibly related to vagal tone. HRV is higher in permanent AF compared to paroxysmal AF suggesting evident autonomic influence in the pathophysiology of permanent AF. Modulation of autonomic influence on cardiovascular system should be explored in future studies.

6.
Eur J Intern Med ; 2021 Jan 02.
Artigo em Inglês | MEDLINE | ID: mdl-33402281

RESUMO

BACKGROUND: New-onset atrial fibrillation (AF) in non-cardiac postoperative setting is common and is associated with a high risk of in-hospital mortality and morbidity. The long-term risks of stroke, mortality and AF recurrence rate in patients with postoperative AF (POAF) are unclear. METHODS: We performed a systematic literature review in electronic databases from inception to March 5th, 2020 of studies reporting the incidence of stroke, mortality and AF recurrence in patients with POAF. We confined our analysis to studies with a cohort of at least 150 patients with POAF and with a median follow-up of 12 months as a minimum. Odds Ratios (OR) were pooled using a random-effects model. RESULTS: Qualitative analysis included 8 studies (7 observational cohort studies and 1 randomized controlled trial) enrolling 3,718,587 patients. Six studies underwent metanalysis comprising 17,684 postoperative patients with POAF and 2,169,248 postoperative patients without POAF. The development of POAF conferred a four-fold increased risk of stroke in the long-term [OR 4.05; 95% confidence interval (CI) 2.91-5.62]. Mortality in the two studies reporting long-term data was higher in patients with POAF compared to those without POAF (OR 3.59; CI 95% 2.84-4.53). Data about recurrence were too heterogeneous to undergo metanalysis. CONCLUSIONS: POAF is associated with a greater risk of stroke and mortality over the long-term period. Studies focusing on AF recurrence are needed to address the perception of POAF as a benign transient entity. The increased mortality risk following POAF should encourage systematic detection and prevention of this arrhythmia.

7.
Ann Med ; 53(1): 17-25, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32700579

RESUMO

OBJECTIVE: We investigated the impact of multimorbidity and polypharmacy on the management of atrial fibrillation (AF) patients in clinical practice and assessed factors associated with polypharmacy and oral anticoagulation (OAC) use in AF patients with multimorbidity and polypharmacy. METHODS: A 14-week prospective study of consecutive non-valvular AF patients was performed in seven Balkan countries. RESULTS: Of 2712 consecutive patients, 2263 patients (83.4%) had multimorbidity (AF + ≥2 concomitant diseases) and 1505 patients (55.5%) had polypharmacy. 1416 (52.2%) patients had both multimorbidity and polypharmacy. Overall, 1164 (82.2%) patients received OAC, 200 (14.1%) patients received antiplatelet drugs alone and 52 (3.7%) patients had no antithrombotic therapy (AT). Non-emergency centre and paroxysmal AF were significantly associated with OAC non-use in patients with multimorbidity, whilst age ≥80 years and non-emergency centre were identified to be independent predictors of OAC non-use in patients with polypharmacy. CONCLUSIONS: Multimorbidity and polypharmacy were common among AF patients in our study. AT was suboptimal and approximately 18% of multimorbid patients with polypharmacy were not anticoagulated. Pattern of AF and non-emergency centre were associated with OAC non-use in AF patients with multimorbidity, whilst non-emergency centre and age ≥80 years were associated with OAC non-use in AF patients with polypharmacy. Key Message Multimorbidity and polypharmacy are common among patients with AF. Antithrombotic therapy was suboptimal in AF patients with multimorbidity and polypharmacy. Approximately, 18% of multimorbid patients with polypharmacy were not anticoagulated.

8.
Eur Heart J Cardiovasc Pharmacother ; 7(1): 68-73, 2021 Jan 16.
Artigo em Inglês | MEDLINE | ID: mdl-32379867

RESUMO

In accordance with the 2018 joint consensus document issued by the European Heart Rhythm Association (EHRA), European Society of Cardiology (ESC) Working Group on Thrombosis, European Association of Percutaneous Cardiovascular Interventions (EAPCI), and European Association of Acute Cardiac Care (ACCA), and endorsed by the Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS), Latin America Heart Rhythm Society (LAHRS), and Cardiac Arrhythmia Society of Southern Africa (CASSA), as well as with other recent ESC Guidelines, the management of antithrombotic therapy of patients with atrial fibrillation undergoing percutaneous coronary intervention requires that multiple and interconnected issues, including, duration of initial triple antithrombotic therapy, selection of P2Y12 inhibitor, choice of oral anticoagulant to be combined with antiplatelet therapy, intensity of oral anticoagulation throughout combination therapy, and choice of oral anticoagulant for indefinite therapy, are addressed. To assist the responsible physician in clinical decision making, a series of practical questions are proposed and discussed in the chronological sequence they should likely be answered.

9.
Am J Med ; 134(1): 67-75.e5, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32634387

RESUMO

BACKGROUND: We aimed to investigate whether history of venous thromboembolism should be considered a prognostic factor for future thromboembolic events in patients with atrial fibrillation. METHODS: This was a nationwide cohort study of patients with incident atrial fibrillation from 2000-2017, defined and characterized using Danish health registries. Cox regression analyses were used to calculate hazard ratios and 95% confidence intervals for the outcomes ischemic stroke or systemic embolism, and ischemic stroke, systemic embolism, or venous thromboembolism, according to history of venous thromboembolism. Analyses were adjusted for components of the CHA2DS2-VASc score and time-varying use of oral anticoagulation. RESULTS: The study included 246,313 patients with incident atrial fibrillation, of which 6,516 (2.6%) had previous venous thromboembolism. Patients with previous venous thromboembolism carried an overall similar adjusted risk of ischemic stroke or systemic embolism compared with patients without previous venous thromboembolism (reference; hazard ratio 0.99; 95% confidence interval, 0.90-1.09). When analyzing a composite thromboembolic outcome of ischemic stroke, systemic embolism, or venous thromboembolism, patients with previous venous thromboembolism were at high-risk (hazard ratio 1.76; 95% confidence interval, 1.64-1.90). Similar conclusions were drawn when stratifying by venous thromboembolism subtype, and when restricting to patients with low CHA2DS2-VASc scores or the non-anticoagulated subset of the study population. CONCLUSION: Patients with atrial fibrillation and previous venous thromboembolism carried similar risk of ischemic stroke or systemic embolism compared with patients with atrial fibrillation without previous venous thromboembolism. Nonetheless, patients with previous venous thromboembolism remain a high-risk population due to an excess risk of future venous thromboembolism. Patients and physicians should keep this excess thromboembolic risk in mind when weighing the expected risks and benefits of oral anticoagulation in patients with atrial fibrillation.

11.
Expert Rev Neurother ; 21(1): 65-79, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33047640

RESUMO

INTRODUCTION: Amongst the 25.7 million survivors and 6.5 million deaths from stroke between 1990 and 2013, ischemic strokes accounted for approximately 70% and 50% of the cases, respectively. With patients still suffering from complications and stroke recurrence, more questions have been raised as to how we can better improve patient management. AREAS COVERED: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and Newcastle-Ottawa Scale (NOS) were adopted to ensure a comprehensive inclusion of quality literature from various sources. PubMed and Embase were searched for evidence on thrombolysis, mechanical thrombectomy, artificial intelligence (AI), antiplatelet therapy, anticoagulation and hypertension management. EXPERT OPINION: The directions of future research in these areas are dependent on the current level of validation. Endovascular therapy and applications of AI are relatively new compared to the other areas discussed in this review. As such, future studies need to focus on validating their efficacy. As for thrombolysis, antiplatelet and anticoagulation therapy, their efficacy has been well-established and future research efforts should be directed toward adjusting its use according to patient-specific factors, starting with factors with the most clinical relevance and prevalence.

12.
Am J Cardiol ; 140: 25-32, 2021 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-33144164

RESUMO

Type 2 diabetes mellitus (DM) has a detrimental impact on cardiovascular outcomes, with implications for prognosis following ST elevation myocardial infarction (STEMI).The aim was to evaluate the impact of DM and myocardial perfusion on the long-term risk of heart failure (HF) and/or all-cause mortality following primary percutaneous coronary intervention (pPCI) for STEMI. A total of 406 STEMI patients (104 with DM) treated with pPCI were enrolled in this observational study. Myocardial perfusion was reassessed with the Quantitative Myocardial Blush Evaluator. Follow-up data on HF (ICD10 [International Statistical Classification of Diseases] codes I50.0 - I50.9) and all-cause mortality were obtained from the National Health Fund. During a 6-year follow-up, 36 (35%) patients with DM died compared with 45 (15%) patients without DM (p <0.001). Also, 24 (23%) patients with DM developed HF compared with 51 (17%) patients without DM (p = 0.20). Patients with DM and HF had the highest mortality rate (75%), and those with DM and a QuBE score below the median value (9.0 arb. units) had significantly higher risk of HF (hazard ratio [HR] =1.96, 95% CI 1.18 to 3.27, p = 0.0099) and the composite of HF and/or all-cause mortality (HR = 1.89, 95% CI 1.33 to 2.69, p = 0.0004). In conclusion DM (type 2) and diminished myocardial perfusion increase the risk of HF and/or all-cause mortality during a 6-year follow-up after pPCI for STEMI.

13.
Eur Heart J Cardiovasc Pharmacother ; 7(1): 59-67, 2021 Jan 16.
Artigo em Inglês | MEDLINE | ID: mdl-32096865

RESUMO

The global prevalence of obesity has reached epidemic proportions, paralleled by a rise in cases of atrial fibrillation (AF). Data from epidemiological cohorts support the role of obesity as an independent risk factor for AF. Increasing evidence indicates that obesity may contribute to the AF substrate through a number of pathways including by altering epicardial adipose tissue biology, inflammatory pathways, structural cardiac remodelling, and inducing atrial fibrosis. Due to changes in pharmacokinetics and pharmacodynamics, specific therapeutic considerations are required to guide management of patients with AF including anticoagulation and rhythm control. Also, weight loss in patients with AF has been associated with reduced progression from paroxysmal to persistent AF and indeed regression from persistent to proximal AF. However, the role of dietary intervention in AF control remains to be fully elucidated and hard prospective outcome data to support weight loss are required in AF to determine its role as part of a comprehensive risk factor management strategy for AF in obese patients.

14.
Can J Cardiol ; 37(1): 113-121, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32492401

RESUMO

BACKGROUND: Evidence of clinical outcomes for oral anticoagulants and antiplatelet treatment (APT) in patients with atrial fibrillation (AF) and critical limb ischemia (CLI) is very limited. METHODS: In this nationwide retrospective cohort study collected from Taiwan National Health Insurance Research Database, 1223 patients with AF and CLI taking direct-acting oral coagulants (DOACs), warfarin, or APT were identified from June 1, 2012, to December 31, 2017. We used propensity score stabilized weighting (PSSW) to balance covariates across study groups. RESULTS: After PSSW, DOAC (n = 446) was associated with lower risks of ischemic stroke/systemic embolism (IS/SE), all major adverse limb events, and all major bleeding events compared with warfarin (n = 237). DOAC was associated with lower risks of IS/SE, acute myocardial infarction (AMI), and all major adverse limb events and a comparable risk of major bleeding events compared with APT (n = 540). DOAC has a lower risk of composite net-clinical-benefit outcome (IS/SE, AMI, all major adverse limb events, plus all major bleeding events) compared with warfarin (hazard ratio [HR]: 0.48; 95% confidence interval [CI]: 0.35-0.65; P < 0.0001) or APT (HR: 0.44; 95% CI: 0.34-0.56; P < 0.0001). The composite net-clinical-benefit outcome was comparable for warfarin vs APT. The reduced risk of net-clinical-benefit outcome for DOAC vs warfarin or APT persisted in high subgroups including age > 75 years, presence of diabetes mellitus, or chronic kidney disease. CONCLUSIONS: DOAC was associated with a significantly lower risk of composite net-clinical-benefit outcome than either warfarin or APT in patients with AF and concomitant CLI. Further prospective study is necessary to validate the findings in the future.

15.
Stroke ; 52(1): 91-99, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33280548

RESUMO

BACKGROUND AND PURPOSE: The causes of recurrent ischemic stroke despite anticoagulation for atrial fibrillation are uncertain but might include small vessel occlusion. We investigated whether magnetic resonance imaging markers of cerebral small vessel disease (SVD) are associated with ischemic stroke risk during follow-up in patients anticoagulated for atrial fibrillation after recent ischemic stroke or transient ischemic attack. METHODS: We analyzed data from a prospective multicenter inception cohort study of ischemic stroke or transient ischemic attack anticoagulated for atrial fibrillation (CROMIS-2 [Clinical Relevance of Microbleeds in Stroke Study]). We rated markers of SVD on baseline brain magnetic resonance imaging: basal ganglia perivascular spaces (number ≥11); cerebral microbleeds (number ≥1); lacunes (number ≥1); and white matter hyperintensities (periventricular Fazekas grade 3 or deep white matter Fazekas grade ≥2). We investigated the associations of SVD presence (defined as presence of ≥1 SVD marker) and severity (composite SVD score) with the risk of ischemic stroke during follow-up using a Cox proportional hazards model adjusted for congestive heart failure, hypertension, age >75, diabetes, stroke, vascular disease, age 65-74, female score. RESULTS: We included 1419 patients (mean age: 75.8 years [SD, 10.4]; 42.1% female). The ischemic stroke rate during follow-up in patients with any SVD was 2.20 per 100-patient years (95% CI, 1.60-3.02), compared with 0.98 per 100 patient-years (95% CI, 0.59-1.62) in those without SVD (P=0.008). After adjusting for congestive heart failure, hypertension, age >75, diabetes, stroke, vascular disease, age 65-74, female score, SVD presence remained significantly associated with ischemic stroke during follow-up (hazard ratio, 1.89 [95% CI, 1.01-3.53]; P=0.046); the risk of recurrent ischemic stroke increased with SVD score (hazard ratio per point increase, 1.33 [95% CI, 1.04-1.70]; P=0.023). CONCLUSIONS: In patients anticoagulated for atrial fibrillation after ischemic stroke or transient ischemic attack, magnetic resonance imaging markers of SVD are associated with an increased risk of ischemic stroke during follow-up; improved stroke prevention treatments are required in this population. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02513316.

16.
Thromb Res ; 197: 69-76, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33189061

RESUMO

INTRODUCTION: Atrial fibrillation (AF) is associated with increased risk of stroke and thromboembolism. Patients with AF have a higher incidence of renal impairment, which may influence the risks of systemic thromboembolism or bleeding. We determined how different oral anticoagulants affect plasma clot properties and whether progressive renal dysfunction affects plasma clot properties in patients on warfarin. MATERIALS AND METHODS: We studied 257 patients with AF receiving oral anticoagulants. Furthermore, we recruited 192 separate patients with AF on warfarin and divided them in 4 groups based on estimated glomerular filtration rate (eGFR). Platelet poor plasma was prepared and clot formation and fibrinolysis was monitored kinetically up to 1 h. RESULTS: Rate of clot formation was significantly slower with dabigatran and rivaroxaban. Time between 50% clotting and 50% lysis was prolonged in patients receiving warfarin compared to NOACs. Time to 50% lysis from maximum absorbance was significantly shorter in patients receiving rivaroxaban. Time between 50% clotting and 50% lysis became significantly prolonged with worsening eGFR. Time to 50% lysis from maximum absorbance was prolonged as renal function worsened. CONCLUSIONS: Compared to warfarin, NOACs differently modulate coagulation and fibrinolysis under ex vivo conditions. Worsening renal function in AF patients on warfarin prolongs fibrinolysis, potentially increasing the risk of thrombosis.

17.
JAMA ; 324(24): 2497-2508, 2020 12 22.
Artigo em Inglês | MEDLINE | ID: mdl-33351042

RESUMO

Importance: There is little evidence to support selection of heart rate control therapy in patients with permanent atrial fibrillation, in particular those with coexisting heart failure. Objective: To compare low-dose digoxin with bisoprolol (a ß-blocker). Design, Setting, and Participants: Randomized, open-label, blinded end-point clinical trial including 160 patients aged 60 years or older with permanent atrial fibrillation (defined as no plan to restore sinus rhythm) and dyspnea classified as New York Heart Association class II or higher. Patients were recruited from 3 hospitals and primary care practices in England from 2016 through 2018; last follow-up occurred in October 2019. Interventions: Digoxin (n = 80; dose range, 62.5-250 µg/d; mean dose, 161 µg/d) or bisoprolol (n = 80; dose range, 1.25-15 mg/d; mean dose, 3.2 mg/d). Main Outcomes and Measures: The primary end point was patient-reported quality of life using the 36-Item Short Form Health Survey physical component summary score (SF-36 PCS) at 6 months (higher scores are better; range, 0-100), with a minimal clinically important difference of 0.5 SD. There were 17 secondary end points (including resting heart rate, modified European Heart Rhythm Association [EHRA] symptom classification, and N-terminal pro-brain natriuretic peptide [NT-proBNP] level) at 6 months, 20 end points at 12 months, and adverse event (AE) reporting. Results: Among 160 patients (mean age, 76 [SD, 8] years; 74 [46%] women; mean baseline heart rate, 100/min [SD, 18/min]), 145 (91%) completed the trial and 150 (94%) were included in the analysis for the primary outcome. There was no significant difference in the primary outcome of normalized SF-36 PCS at 6 months (mean, 31.9 [SD, 11.7] for digoxin vs 29.7 [11.4] for bisoprolol; adjusted mean difference, 1.4 [95% CI, -1.1 to 3.8]; P = .28). Of the 17 secondary outcomes at 6 months, there were no significant between-group differences for 16 outcomes, including resting heart rate (a mean of 76.9/min [SD, 12.1/min] with digoxin vs a mean of 74.8/min [SD, 11.6/min] with bisoprolol; difference, 1.5/min [95% CI, -2.0 to 5.1/min]; P = .40). The modified EHRA class was significantly different between groups at 6 months; 53% of patients in the digoxin group reported a 2-class improvement vs 9% of patients in the bisoprolol group (adjusted odds ratio, 10.3 [95% CI, 4.0 to 26.6]; P < .001). At 12 months, 8 of 20 outcomes were significantly different (all favoring digoxin), with a median NT-proBNP level of 960 pg/mL (interquartile range, 626 to 1531 pg/mL) in the digoxin group vs 1250 pg/mL (interquartile range, 847 to 1890 pg/mL) in the bisoprolol group (ratio of geometric means, 0.77 [95% CI, 0.64 to 0.92]; P = .005). Adverse events were less common with digoxin; 20 patients (25%) in the digoxin group had at least 1 AE vs 51 patients (64%) in the bisoprolol group (P < .001). There were 29 treatment-related AEs and 16 serious AEs in the digoxin group vs 142 and 37, respectively, in the bisoprolol group. Conclusions and Relevance: Among patients with permanent atrial fibrillation and symptoms of heart failure treated with low-dose digoxin or bisoprolol, there was no statistically significant difference in quality of life at 6 months. These findings support potentially basing decisions about treatment on other end points. Trial Registration: ClinicalTrials.gov Identifier: NCT02391337 and clinicaltrialsregister.eu Identifier: 2015-005043-13.

18.
Artigo em Inglês | MEDLINE | ID: mdl-33258897

RESUMO

AIMS: Patients with atrial fibrillation undergoing coronary intervention are at higher bleeding risk due to the concomitant need for oral anticoagulation and antiplatelet therapy. The RE-DUAL PCI trial demonstrated better safety with dual antithrombotic therapy (DAT: dabigatran 110 or 150 mg bid, clopidogrel or ticagrelor) compared to triple antithrombotic therapy (TAT: warfarin, clopidogrel or ticagrelor, and aspirin). We explored the impact of baseline bleeding risk based on the PRECISE-DAPT score for decision-making regarding DAT vs. TAT. METHODS AND RESULTS: A score ≥25 points qualified high bleeding-risk (HBR). Comparisons were made for the primary safety endpoint ISTH major or clinically relevant non-major bleeding, and the composite efficacy endpoint of death, thromboembolic events, or unplanned revascularization, analyzed by time-to-event analysis. PRECISE-DAPT was available in 2,336/2,725 patients, and 37.9% were HBR. Compared to TAT, DAT with dabigatran 110 mg reduced bleeding risk both in non-HBR (HR 0.42, 95%CI, 0.31-0.57) and HBR (HR 0.70, 95%CI, 0.52-0.94), with a greater magnitude of benefit among non-HBR (Pint=0.02). DAT with dabigatran 150 mg vs. TAT reduced bleeding in non-HBR (HR 0.60, 95%CI, 0.45-0.80), with a trend toward less benefit in HBR patients (HR 0.92, 95%CI, 0.63-1.34, Pint=0.08). Risk of ischaemic events was similar on DAT with dabigatran (both 110 and 150 mg) vs. TAT in non-HBR and HBR patients (Pint=0.45 and Pint=0.56, respectively). CONCLUSIONS: PRECISE-DAPT score appeared useful to identify AF patients undergoing PCI at further increased risk of bleeding complications, and may help clinicians identifying the antithrombotic regimen intensity with the best benefit-risk ratio in an individual patient.

19.
JACC Clin Electrophysiol ; 6(13): 1672-1682, 2020 Dec 14.
Artigo em Inglês | MEDLINE | ID: mdl-33334446

RESUMO

OBJECTIVES: This study sought to describe the risk of thromboembolism in nonanticoagulated atrial fibrillation patients with Evaluated Heartvalves, Rheumatic or Artificial (EHRA) Type 2 valvular heart disease (VHD) <65 or 65 to 74 years of age and with 0 or 1 non-sex comorbidity of the CHA2DS2-VASc score. BACKGROUND: A minor, but important, proportion of patients with atrial fibrillation and VHD beyond moderate-to-severe mitral stenosis and/or a mechanical prosthetic valve, so-called EHRA Type 2 VHD, have 0 or 1 coexisting non-sex comorbidities of the CHA2DS2-VASc score, and are therefore not strongly recommended oral anticoagulant therapy according to guidelines. Whether these patients are truly low risk of thromboembolism has not been investigated. METHODS: This was a cohort study of 55,613 patients identified in nationwide Danish registries from 2000 to 2018, of which 1,907 patients had EHRA Type 2 VHD. Risk of thromboembolism after 1 and 5 years of follow-up were calculated. RESULTS: At 1 year after atrial fibrillation diagnosis, patients with EHRA Type 2 VHD had a risk of thromboembolism between 1.2% and 1.5%, according to age group (<65 or 65 to 74 years of age), and number of non-sex comorbidities of the CHA2DS2-VASc score (0 or 1). Interestingly, in patients with EHRA Type 2 VHD <65 years of age with 0 or 1 comorbidity, the risk was 1.5% (95% confidence interval: 0.7% to 2.8%) and 1.5% (95% confidence interval: 0.6% to 3.4%) at 1 year after the atrial fibrillation diagnosis. CONCLUSIONS: These observations suggest that in atrial fibrillation patients with EHRA Type 2 VHD, who are not currently recommended oral anticoagulant therapy according to guidelines, the risk of thromboembolism may exceed the level above which oral anticoagulation is considered beneficial.

20.
Hellenic J Cardiol ; 2020 Dec 15.
Artigo em Inglês | MEDLINE | ID: mdl-33338644

RESUMO

AIM: The SAMe-TT2R2 score helps identify patients with atrial fibrillation (AF) likely to have poor anticoagulation control during anticoagulation with vitamin K antagonists (VKA), and those with scores >2 might be better managed with a target-specific oral anticoagulant (NOAC). We hypothesized that in clinical practice, VKAs may be prescribed less frequently to patients with AF and SAMe-TT2R2 scores >2 than to patients with lower scores. METHODS AND RESULTS: We analyzed the Phase III dataset of the Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF), a large, global, prospective global registry of patients with newly diagnosed AF and ≥1 stroke risk factor. We compared baseline clinical characteristics and antithrombotic prescriptions to determine the probability of VKA prescription among anticoagulated patients with baseline SAMe-TT2R2 score >2 and ≤2. Among 17,465 anticoagulated patients with AF, 4,828 (27.6%) were prescribed VKA and 12,637 (72.4%) a NOAC: 11,884 (68.0%) patients had SAMe-TT2R2 scores 0-2 and 5,581 (32.0%) had scores >2. The proportion of patients prescribed VKA was 28.0% among patients with SAMe-TT2R2 scores >2 and 27.5% in those with scores ≤2. CONCLUSIONS: The lack of clear association between the SAMe-TT2R2 score and anticoagulant selection may be attributed to the relative efficacy and safety profiles between NOACs and VKAs, as well as to the absence of trial evidence that a SAMe-TT2R2-guided strategy for the selection of the type of anticoagulation in NVAF patients has an impact on clinical outcomes of efficacy and safety. The latter hypothesis is currently being tested in a randomized controlled trial.

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