42 research outputs found
Comparison of international normalized ratio audit parameters in patients enrolled in GARFIELD-AF and treated with vitamin K antagonists
No full textVitamin K antagonist (VKA) therapy for stroke prevention in atrial fibrillation (AF) requires monitoring of the international normalized ratio (INR). We evaluated the agreement between two INR audit parameters, frequency in range (FIR) and proportion of time in the therapeutic range (TTR), using data from a global population of patients with newly diagnosed non-valvular AF, the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF). Among 17 168 patients with 1-year follow-up data available at the time of the analysis, 8445 received VKA therapy (+/- antiplatelet therapy) at enrolment, and of these patients, 5066 with >= 3 INR readings and for whom both FIR and TTR could be calculated were included in the analysis. In total, 70 905 INRs were analysed. At the patient level, TTR showed higher values than FIR (mean, 56.0% vs 49.8%; median, 59.7% vs 50.0%). Although patient-level FIR and TTR values were highly correlated (Pearson correlation coefficient [95% confidence interval; CI], 0.860 [0.852-0.867]), estimates from individuals showed widespread disagreement and variability (Lin's concordance coefficient [95% CI], 0.829 [0.821-0.837]). The difference between FIR and TTR explained 17.4% of the total variability of measurements. These results suggest that FIR and TTR are not equivalent and cannot be used interchangeably
Risk of developing Type 2 Diabetes Mellitus in a vulnerable community in northern Argentina
No full text
Introduction: Prevention of diabetes requires sustained lifestyle changes as well as identification of groups at higher risk. Objective: The aim of this research was to estimate the risk of diabetes in vulnerable subjects from a primary care center in northern Argentina, with no known glucose abnormalities, using the FINDRISC questionnaire, investigate the relationship between survey variables and the final score, and explore its association with metabolic risk factors and body composition. Methodology: This cross-sectional design included 498 patients without type 2 diabetes or known glycemic abnormalities. All subjects underwent a complete medical history and completed the FINDRISC questionnaire. Results: The predominant age group was 18-45 years old. Around 64% were physically active and 44% reported daily consumption of fruit and vegetables. Most of them had a BMI higher than 25 kg/m2. Regarding the risk of developing type 2 diabetes in the next 10 years, 24.3% were at low risk and the remaining fraction was distributed in slightly elevated, moderate, high and very high risk. All variables influenced the individuals\u27 variance (p < 0.05). The hierarchical clustering and principal component analysis (PCA) revealed that elevated FINDRISC score was strongly associated with: age > 65 years, fasting blood glucose, BMI ? 30 kg/m2 and antihypertensives use. CONCLUTION: We found a high percentage of obesity and overweight, as well as a high risk of cardiometabolic disease and of developing T2D. In addition, in the population studied, the variables that compose the FINDRISC did not influence the highest score in the same way.Introduction: Prevention of diabetes requires sustained lifestyle changes as well as identification of groups at higher risk. Objective: The aim of this research was to estimate the risk of diabetes in vulnerable subjects from a primary care center in northern Argentina, with no known glucose abnormalities, using the FINDRISC questionnaire, investigate the relationship between survey variables and the final score, and explore its association with metabolic risk factors and body composition. Methodology: This cross-sectional design included 498 patients without type 2 diabetes or known glycemic abnormalities. All subjects underwent a complete medical history and completed the FINDRISC questionnaire. Results: The predominant age group was 18-45 years old. Around 64% were physically active and 44% reported daily consumption of fruit and vegetables. Most of them had a BMI higher than 25 kg/m2. Regarding the risk of developing type 2 diabetes in the next 10 years, 24.3% were at low risk and the remaining fraction was distributed in slightly elevated, moderate, high and very high risk. All variables influenced the individuals\u27 variance (p < 0.05). The hierarchical clustering and principal component analysis (PCA) revealed that elevated FINDRISC score was strongly associated with: age > 65 years, fasting blood glucose, BMI ? 30 kg/m2 and antihypertensives use. CONCLUTION: We found a high percentage of obesity and overweight, as well as a high risk of cardiometabolic disease and of developing T2D. In addition, in the population studied, the variables that compose the FINDRISC did not influence the highest score in the same way
Estrategias de colaboración para la red de Revistas Cardiovasculares Iberoamericanas
No full textLa necesidad de colaboración entre las diferentes revis¬tas cardiológicas de Iberoamérica es evidente. Por ello, en 2009 se conformó la Red de Revistas Cardiovasculares Iberoamericanas (RCVIB) con el auspicio de la Sociedad Española de Cardiología y con el liderazgo del Dr. Fernan¬do Alfonso, entonces Editor-Jefe de la Revista Española de Cardiología. Para dar continuidad con dicho impulso, la III Reunión de Editores de Revistas Cardiovasculares Iberoamericanas tuvo lugar en el marco del LX Congreso Americano de Cardiología (American College of Cardiolo¬gy) en la ciudad de Nueva Orleans el 3 de abril de 2011. A continuación enumeramos y exponemos cada uno de los acuerdos tomados en esa reunión
Comparison of international normalized ratio audit parameters in patients enrolled in GARFIELD-AF and treated with vitamin K antagonists
No full textVitamin K antagonist (VKA) therapy for stroke prevention in atrial fibrillation (AF) requires monitoring of the international normalized ratio (INR). We evaluated the agreement between two INR audit parameters, frequency in range (FIR) and proportion of time in the therapeutic range (TTR), using data from a global population of patients with newly diagnosed non-valvular AF, the Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF). Among 17\ua0168 patients with 1-year follow-up data available at the time of the analysis, 8445 received VKA therapy (±antiplatelet therapy) at enrolment, and of these patients, 5066 with =3 INR readings and for whom both FIR and TTR could be calculated were included in the analysis. In total, 70\ua0905 INRs were analysed. At the patient level, TTR showed higher values than FIR (mean, 56·0% vs 49·8%; median, 59·7% vs 50·0%). Although patient-level FIR and TTR values were highly correlated (Pearson correlation coefficient [95% confidence interval; CI], 0·860 [0·852–0·867]), estimates from individuals showed widespread disagreement and variability (Lin's concordance coefficient [95% CI], 0·829 [0·821–0·837]). The difference between FIR and TTR explained 17·4% of the total variability of measurements. These results suggest that FIR and TTR are not equivalent and cannot be used interchangeably
Characteristics of patients with atrial fibrillation prescribed antiplatelet monotherapy compared with those on anticoagulants: Insights from the GARFIELD-AF registry
No full textAims Current atrial fibrillation (AF) guidelines discourage antiplatelet (AP) monotherapy as alternative to anticoagulants (ACs). Why AP only is still used is largely unknown. Methods and results Factors associated with AP monotherapy prescription were analysed in GARFIELD-AF, a registry of patients with newly diagnosed (6 weeks) AF and 1 investigator-determined stroke risk factor. We analysed 51 270 patients from 35 countries enrolled into five sequential cohorts between 2010 and 2016. Overall, 20.7% of patients received AP monotherapy, 52.1% AC monotherapy, and 14.1% AP AC. Most AP monotherapy (82.5%) and AC monotherapy (86.8%) patients were CHA2DS2-VASc 2. Compared with patients on AC monotherapy, AP monotherapy patients were frequently Chinese (vs. Caucasian, odds ratio 2.73) and more likely to have persistent AF (1.32), history of coronary artery disease (2.41) or other vascular disease (1.67), bleeding (2.11), or dementia (1.81). The odds for AP monotherapy increased with 5 years of age increments for patients 75 years (1.24) but decreased with age increments for patients 55-75 years (0.86). Antiplatelet monotherapy patients were less likely to have paroxysmal (0.67) or permanent AF (0.57), history of embolism (0.56), or alcohol use (0.90). With each cohort, AP monotherapy declined (P 0.0001), especially non-indicated use. AP AC and no antithrombotic therapy were unchanged. However, even in 2015 and 2016, about 50% of AP-Treated patients had no indication except AF (71% were CHA2DS2-VASc 2). Conclusion Prescribing AP monotherapy in newly diagnosed AF has declined, but even nowadays a substantial proportion of AP-Treated patients with AF have no indication for AP. All rights reserved
RBD-specific polyclonal F(ab )2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial
No full textAbstract: Background: passive immunotherapy is a therapeutic alternative for patients with COVID-19. Equine polyclonal antibodies (EpAbs) could represent a source of scalable neutralizing antibodies against SARS-CoV-2.
Methods: we conducted a double-blind, randomized, placebo-controlled trial to assess efficacy and safety of
EpAbs (INM005) in hospitalized adult patients with moderate and severe COVID-19 pneumonia in 19 hospitals of Argentina. Primary endpoint was improvement in at least two categories in WHO ordinal clinical scale
at day 28 or hospital discharge (ClinicalTrials.gov number NCT04494984).
Findings: between August 1st and October 26th, 2020, a total of 245 patients were enrolled. Enrolled patients
were assigned to receive two blinded doses of INM005 (n = 118) or placebo (n = 123). Median age was 54
years old, 65 1% were male and 61% had moderate disease at baseline. Median time from symptoms onset to
study treatment was 6 days (interquartile range 5 to 8). No statistically significant difference was noted
between study groups on primary endpoint (risk difference [95% IC]: 5 28% [-3 95; 14 50]; p = 0 15). Rate
of improvement in at least two categories was statistically significantly higher for INM005 at days 14 and 21
of follow-up. Time to improvement in two ordinal categories or hospital discharge was 14 2 (§ 0 7) days in
the INM005 group and 16 3 (§ 0 7) days in the placebo group, hazard ratio 1 31 (95% CI 1 0 to 1 74). Subgroup analyses showed a beneficial effect of INM005 over severe patients and in those with negative baseline
antibodies. Overall mortality was 6 9% the INM005 group and 11 4% in the placebo group (risk difference
[95% IC]: 0 57 [0 24 to 1 37]). Adverse events of special interest were mild or moderate; no anaphylaxis was
reported.
Interpretation: Albeit not having reached the primary endpoint, we found clinical improvement of hospitalized patients with SARS-CoV-2 pneumonia, particularly those with severe disease
Association of body mass index with outcomes in patients with newly diagnosed atrial fibrillation: GARFIELD-AF
No full textOBJECTIVE: While greater body mass index (BMI) is associated with increased risk of developing atrial fibrillation (AF), the impact of BMI on outcomes in newly diagnosed AF is unclear. We examine the influence of BMI on outcomes and whether this is modified by sex and evaluate the effect of non-vitamin K oral anticoagulants (NOACs) in patients with high BMI. METHODS: GARFIELD-AF is a prospective registry of 52 057 newly diagnosed AF patients. The study population comprised 40 482 participants: 703 underweight (BMI <18.5 kg/m(2)), 13 095 normal (BMI=18.5–24.9 kg/m(2)), 15 043 overweight (BMI=25.0–29.9 kg/m(2)), 7560 obese (BMI=30.0–34.9 kg/m(2)) and 4081 extremely obese (BMI ≥35.0 kg/m(2)). Restricted cubic splines quantified the association of BMI with outcomes. Comparative effectiveness of NOACs and vitamin K antagonists (VKAs) by BMI was performed using propensity score overlap-weighted Cox models. RESULTS: The median age of participants was 71.0 years (Q1; Q3 62.0; 78.0), and 55.6% were male. Those with high BMI were younger, more often had vascular disease, hypertension and diabetes. Within 2-year follow-up, a U-shaped relationship between BMI and all-cause mortality was observed, with BMI of ~30 kg/m(2) associated with the lowest risk. The association with new/worsening heart failure was similar. Only low BMI was associated with major bleeding and no association emerged for non-haemorrhagic stroke. BMI was similarly associated with outcomes in men and women. BMI did not impact the lower rate of all-cause mortality of NOACs compared with VKAs. CONCLUSIONS: In the GARFIELD-AF registry, underweight and extremely obese AF patients have increased risk of mortality and new/worsening heart failure compared with normal or obese patients
Analysis of Outcomes in Ischemic vs Nonischemic Cardiomyopathy in Patients With Atrial Fibrillation: A Report From the GARFIELD-AF Registry.
No full textImportance: Congestive heart failure (CHF) is commonly associated with nonvalvular atrial fibrillation (AF), and their combination may affect treatment strategies and outcomes. Objective: To assess the treatment strategies and 1-year clinical outcomes of antithrombotic and CHF therapies for patients with newly diagnosed AF with concomitant CHF stratified by etiology (ischemic cardiomyopathy [ICM] vs nonischemic cardiomyopathy [NICM]). Design, Setting, and Participants: The GARFIELD-AF registry is a prospective, noninterventional registry. A total of 52 014 patients with AF were enrolled between March 2010 and August 2016. A total of 11 738 patients 18 years and older with newly diagnosed AF (≤6 weeks' duration) and at least 1 investigator-determined stroke risk factor were included. Data were analyzed from December 2017 to September 2018. Exposures: One-year follow-up rates of death, stroke/systemic embolism, and major bleeding were assessed. Main Outcomes and Measures: Event rates per 100 person-years were estimated from the Poisson model and Cox hazard ratios (HRs) and 95% confidence intervals. Results: The median age of the population was 71.0 years, 22 987 of 52 013 were women (44.2%) and 31 958 of 52 014 were white (61.4%). Of 11 738 patients with CHF, 4717 (40.2%) had ICM and 7021 (59.8%) had NICM. Prescription of oral anticoagulant and antiplatelet drugs was not balanced between groups. Oral anticoagulants with or without antiplatelet drugs were used in 2753 patients with ICM (60.1%) and 5082 patients with NICM (73.7%). Antiplatelets were prescribed alone in 1576 patients with ICM (34.4%) and 1071 patients with NICM (15.5%). Compared with patients with NICM, use of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (72.6% [3439] vs 60.3% [4236]) and of β blockers (63.3% [2988] vs 53.2% [3737]) was higher in patients with ICM. Rates of all-cause and cardiovascular death per 100 patient-years were significantly higher in the ICM group (all-cause death: ICM, 10.2; 95% CI, 9.2-11.1; NICM, 7.0; 95% CI, 6.4-7.6; cardiovascular death: ICM, 5.1; 95% CI, 4.5-5.9; NICM, 2.9; 95% CI, 2.5-3.4). Stroke/systemic embolism rates tended to be higher in ICM groups compared with NICM groups (ICM, 2.0; 95% CI, 1.6-2.5; NICM, 1.5; 95% CI, 1.3-1.9). Major bleeding rates were significantly higher in the ICM group (1.1; 95% CI, 0.8-1.4) compared with the NICM group (0.7; 95% CI, 0.5-0.9). Conclusions and Relevance: Patients with ICM received oral anticoagulants with or without antiplatelet drugs less frequently and antiplatelets alone more frequently than patients with NICM, but they received angiotensin-converting enzyme inhibitors/angiotensin receptor blockers more often than patients with NICM. All-cause and cardiovascular death rates were higher in patients with ICM than patients with NICM. Trial Registration: ClinicalTrials.gov Identifier: NCT01090362
Management and 1-Year Outcomes of Patients With Newly Diagnosed Atrial Fibrillation and Chronic Kidney Disease: Results From the Prospective GARFIELD - AF Registry.
No full textBackground Using data from the GARFIELD - AF (Global Anticoagulant Registry in the FIELD -Atrial Fibrillation), we evaluated the impact of chronic kidney disease ( CKD ) stage on clinical outcomes in patients with newly diagnosed atrial fibrillation ( AF ). Methods and Results GARFIELD - AF is a prospective registry of patients from 35 countries, including patients from Asia (China, India, Japan, Singapore, South Korea, and Thailand). Consecutive patients enrolled (2013-2016) were classified with no, mild, or moderate-to-severe CKD , based on the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative guidelines. Data on CKD status and outcomes were available for 33 024 of 34 854 patients (including 9491 patients from Asia); 10.9% (n=3613) had moderate-to-severe CKD , 16.9% (n=5595) mild CKD , and 72.1% (n=23 816) no CKD . The use of oral anticoagulants was influenced by stroke risk (ie, post hoc assessment of CHA 2 DS 2- VAS c score), but not by CKD stage. The quality of anticoagulant control with vitamin K antagonists did not differ with CKD stage. After adjusting for baseline characteristics and antithrombotic use, both mild and moderate-to-severe CKD were independent risk factors for all-cause mortality. Moderate-to-severe CKD was independently associated with a higher risk of stroke/systemic embolism, major bleeding, new-onset acute coronary syndrome, and new or worsening heart failure. The impact of moderate-to-severe CKD on mortality was significantly greater in patients from Asia than the rest of the world ( P=0.001). Conclusions In GARFIELD - AF , moderate-to-severe CKD was independently associated with stroke/systemic embolism, major bleeding, and mortality. The effect of moderate-to-severe CKD on mortality was even greater in patients from Asia than the rest of the world. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 01090362
Analysis of Outcomes in Ischemic vs Nonischemic Cardiomyopathy in Patients with Atrial Fibrillation:A Report from the GARFIELD-AF Registry
No full textImportance: Congestive heart failure (CHF) is commonly associated with nonvalvular atrial fibrillation (AF), and their combination may affect treatment strategies and outcomes. Objective: To assess the treatment strategies and 1-year clinical outcomes of antithrombotic and CHF therapies for patients with newly diagnosed AF with concomitant CHF stratified by etiology (ischemic cardiomyopathy [ICM] vs nonischemic cardiomyopathy [NICM]). Design, Setting, and Participants: The GARFIELD-AF registry is a prospective, noninterventional registry. A total of 52014 patients with AF were enrolled between March 2010 and August 2016. A total of 11738 patients 18 years and older with newly diagnosed AF (≤6 weeks' duration) and at least 1 investigator-determined stroke risk factor were included. Data were analyzed from December 2017 to September 2018. Exposures: One-year follow-up rates of death, stroke/systemic embolism, and major bleeding were assessed. Main Outcomes and Measures: Event rates per 100 person-years were estimated from the Poisson model and Cox hazard ratios (HRs) and 95% confidence intervals. Results: The median age of the population was 71.0 years, 22987 of 52013 were women (44.2%) and 31958 of 52014 were white (61.4%). Of 11738 patients with CHF, 4717 (40.2%) had ICM and 7021 (59.8%) had NICM. Prescription of oral anticoagulant and antiplatelet drugs was not balanced between groups. Oral anticoagulants with or without antiplatelet drugs were used in 2753 patients with ICM (60.1%) and 5082 patients with NICM (73.7%). Antiplatelets were prescribed alone in 1576 patients with ICM (34.4%) and 1071 patients with NICM (15.5%). Compared with patients with NICM, use of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (72.6% [3439] vs 60.3% [4236]) and of β blockers (63.3% [2988] vs 53.2% [3737]) was higher in patients with ICM. Rates of all-cause and cardiovascular death per 100 patient-years were significantly higher in the ICM group (all-cause death: ICM, 10.2; 95% CI, 9.2-11.1; NICM, 7.0; 95% CI, 6.4-7.6; cardiovascular death: ICM, 5.1; 95% CI, 4.5-5.9; NICM, 2.9; 95% CI, 2.5-3.4). Stroke/systemic embolism rates tended to be higher in ICM groups compared with NICM groups (ICM, 2.0; 95% CI, 1.6-2.5; NICM, 1.5; 95% CI, 1.3-1.9). Major bleeding rates were significantly higher in the ICM group (1.1; 95% CI, 0.8-1.4) compared with the NICM group (0.7; 95% CI, 0.5-0.9). Conclusions and Relevance: Patients with ICM received oral anticoagulants with or without antiplatelet drugs less frequently and antiplatelets alone more frequently than patients with NICM, but they received angiotensin-converting enzyme inhibitors/angiotensin receptor blockers more often than patients with NICM. All-cause and cardiovascular death rates were higher in patients with ICM than patients with NICM. Trial Registration: ClinicalTrials.gov Identifier: NCT01090362.</p
