Dataset Information

Guideline-directed medical therapies for comorbidities among patients with atrial fibrillation: results from GARFIELD-AF.

ABSTRACT:

Aims

This study aimed to identify relationships in recently diagnosed atrial fibrillation (AF) patients with respect to anticoagulation status, use of guideline-directed medical therapy (GDMT) for comorbid cardiovascular conditions (co-GDMT), and clinical outcomes. The Global Anticoagulant Registry in the FIELD (GARFIELD)-AF is a prospective, international registry of patients with recently diagnosed non-valvular AF at risk of stroke (NCT01090362).

Methods and results

Guideline-directed medical therapy was defined according to the European Society of Cardiology guidelines. This study explored co-GDMT use in patients enrolled in GARFIELD-AF (March 2013-August 2016) with CHA₂DS₂-VASc ≥ 2 (excluding sex) and ≥1 of five comorbidities-coronary artery disease, diabetes mellitus, heart failure, hypertension, and peripheral vascular disease (n = 23 165). Association between co-GDMT and outcome events was evaluated with Cox proportional hazards models, with stratification by all possible combinations of the five comorbidities. Most patients (73.8%) received oral anticoagulants (OACs) as recommended; 15.0% received no recommended co-GDMT, 40.4% received some, and 44.5% received all co-GDMT. At 2 years, comprehensive co-GDMT was associated with a lower risk of all-cause mortality [hazard ratio (HR) 0.89 (0.81-0.99)] and non-cardiovascular mortality [HR 0.85 (0.73-0.99)] compared with inadequate/no GDMT, but cardiovascular mortality was not significantly reduced. Treatment with OACs was beneficial for all-cause mortality and non-cardiovascular mortality, irrespective of co-GDMT use; only in patients receiving all co-GDMT was OAC associated with a lower risk of non-haemorrhagic stroke/systemic embolism.

Conclusion

In this large prospective, international registry on AF, comprehensive co-GDMT was associated with a lower risk of mortality in patients with AF and CHA₂DS₂-VASc ≥ 2 (excluding sex); OAC therapy was associated with reduced all-cause mortality and non-cardiovascular mortality, irrespective of co-GDMT use.

Clinical trial registration

Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362.

SUBMITTER: Camm AJ

PROVIDER: S-EPMC10246824 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

Guideline-directed medical therapies for comorbidities among patients with atrial fibrillation: results from GARFIELD-AF.

Camm Alan John AJ Steffel Jan J Virdone Saverio S Bassand Jean-Pierre JP Fox Keith A A KAA Goldhaber Samuel Z SZ Goto Shinya S Haas Sylvia S Turpie Alexander G G AGG Verheugt Freek W A FWA Misselwitz Frank F Herreros Ramón Corbalán RC Kayani Gloria G Pieper Karen S KS Kakkar Ajay K AK

European heart journal open 20230519 3

<h4>Aims</h4>This study aimed to identify relationships in recently diagnosed atrial fibrillation (AF) patients with respect to anticoagulation status, use of guideline-directed medical therapy (GDMT) for comorbid cardiovascular conditions (co-GDMT), and clinical outcomes. The Global Anticoagulant Registry in the FIELD (GARFIELD)-AF is a prospective, international registry of patients with recently diagnosed non-valvular AF at risk of stroke (NCT01090362).<h4>Methods and results</h4>Guideline-di ...[more]

PMID: 37293139

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Project description:BackgroundOral anticoagulation (OAC) in atrial fibrillation (AF) reduces the risk of stroke/systemic embolism (SE). The impact of OAC discontinuation is less well documented.ObjectiveInvestigate outcomes of patients prospectively enrolled in the Global Anticoagulant Registry in the Field-Atrial Fibrillation study who discontinued OAC.MethodsOral anticoagulation discontinuation was defined as cessation of treatment for ≥7 consecutive days. Adjusted outcome risks were assessed in 23 882 patients with 511 days of median follow-up after discontinuation.ResultsPatients who discontinued (n = 3114, 13.0%) had a higher risk (hazard ratio [95% CI]) of all-cause death (1.62 [1.25-2.09]), stroke/systemic embolism (SE) (2.21 [1.42-3.44]) and myocardial infarction (MI) (1.85 [1.09-3.13]) than patients who did not, whether OAC was restarted or not. This higher risk of outcomes after discontinuation was similar for patients treated with vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) (p for interactions range = 0.145-0.778). Bleeding history (1.43 [1.14-1.80]), paroxysmal vs. persistent AF (1.15 [1.02-1.29]), emergency room care setting vs. office (1.37 [1.18-1.59]), major, clinically relevant nonmajor, and minor bleeding (10.02 [7.19-13.98], 2.70 [2.24-3.25] and 1.90 [1.61-2.23]), stroke/SE (4.09 [2.55-6.56]), MI (2.74 [1.69-4.43]), and left atrial appendage procedures (4.99 [1.82-13.70]) were predictors of discontinuation. Age (0.84 [0.81-0.88], per 10-year increase), history of stroke/transient ischemic attack (0.81 [0.71-0.93]), diabetes (0.88 [0.80-0.97]), weeks from AF onset to treatment (0.96 [0.93-0.99] per week), and permanent vs. persistent AF (0.73 [0.63-0.86]) were predictors of lower discontinuation rates.ConclusionsIn GARFIELD-AF, the rate of discontinuation was 13.0%. Discontinuation for ≥7 consecutive days was associated with significantly higher all-cause mortality, stroke/SE, and MI risk. Caution should be exerted when considering any OAC discontinuation beyond 7 days.

Project description:BackgroundDifferences in the clinical outcomes and level of risk among Asian versus non-Asian patients with atrial fibrillation (AF) have been sparsely investigated.ObjectiveTo provide a contemporary prospective comparison of outcomes for newly diagnosed patients with AF, between Asian and non-Asian regions.MethodsSix Asian countries (China, Japan, India, Singapore, South Korea and Thailand) and 29 countries outside Asia participated in the Global Anticoagulant Registry in the FIELD-AF (GARFIELD-AF) study. Newly diagnosed patients with AF, enrolled between 2010 and 2016, were followed up for≥2 years. The outcome studies were all-cause, cardiovascular and non-cardiovascular mortality, non-haemorrhagic stroke/systemic embolism (SE), major bleeding. The association of geographical region with clinical outcomes (event rates per 100 person-years) were estimated using multivariable Cox models.Results13 841/52 057 (26.6%) GARFIELD-AF participants were enrolled in Asia. Average age and prevalence of cardiovascular comorbidities were lower than in non-Asian countries and patients at high risk of stroke (ie, CHA2DS2-VASc≥2 excl. sex) were less frequently anticoagulated (60.1% vs 73.2%). Non-vitamin K oral anticoagulant (NOAC) was similar in both regions (∼28%), though Asian patients were more frequently underdosed. Both Asian and non-Asian patients who received NOAC at enrolment experienced lower all-cause mortality and non-haemorrhagic stroke/SE compared with patients on other treatments or none.All-cause mortality, non-cardiovascular mortality and major bleeding were less frequent in patients from Asia versus non-Asia (HR (95% CI): 0.62 (0.39 to 0.99), 0.52 (0.28 to 0.97), 0.58 (0.36 to 0.96), respectively). Associations of moderate-to-severe chronic kidney disease and vascular disease with increased risk of all-cause mortality were stronger in Asian versus non-Asian patients (interaction p values: 0.0250 and 0.0076, respectively). There was notable heterogeneity in oral anticoagulant (OAC) usage within the Asian countries.ConclusionsPatients in Asian countries had a lower risk of all-cause mortality and major bleeding compared to the rest of the world. NOAC had evident benefits for reducing mortality and stroke across populations. Further studies on sociocultural impacts on OAC outcomes are needed.Trial registration numberClinicalTrials.gov NCT01090362.

Project description:AimsTo determine whether the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) integrated risk tool predicts mortality, non-haemorrhagic stroke/systemic embolism, and major bleeding for up to 2 years after new-onset AF and to assess how this risk tool performs compared with CHA2DS2-VASc and HAS-BLED.Methods and resultsPotential predictors of events included demographic and clinical characteristics, choice of treatment, and lifestyle factors. A Cox proportional hazards model was identified for each outcome by least absolute shrinkage and selection operator methods. Indices were evaluated in comparison with CHA2DS2-VASc and HAS-BLED risk predictors. Models were validated internally and externally in ORBIT-AF and Danish nationwide registries. Among the 52 080 patients enrolled in GARFIELD-AF, 52 032 had follow-up data. The GARFIELD-AF risk tool outperformed CHA2DS2-VASc for all-cause mortality in all cohorts. The GARFIELD-AF risk score was superior to CHA2DS2-VASc for non-haemorrhagic stroke, and it outperformed HAS-BLED for major bleeding in internal validation and in the Danish AF cohort. In very low- to low-risk patients [CHA2DS2-VASc 0 or 1 (men) and 1 or 2 (women)], the GARFIELD-AF risk score offered strong discriminatory value for all the endpoints when compared to CHA2DS2-VASc and HAS-BLED. The GARFIELD-AF tool also included the effect of oral anticoagulation (OAC) therapy, thus allowing clinicians to compare the expected outcome of different anticoagulant treatment decisions [i.e. no OAC, non-vitamin K antagonist (VKA) oral anticoagulants, or VKAs].ConclusionsThe GARFIELD-AF risk tool outperformed CHA2DS2-VASc at predicting death and non-haemorrhagic stroke, and it outperformed HAS-BLED for major bleeding in overall as well as in very low- to low-risk group patients with AF.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier for GARFIELD-AF: NCT01090362, ORBIT-AF I: NCT01165710; ORBIT-AF II: NCT01701817.

Dataset Information

Guideline-directed medical therapies for comorbidities among patients with atrial fibrillation: results from GARFIELD-AF.

Aims

Methods and results

Conclusion

Clinical trial registration

Publications

Guideline-directed medical therapies for comorbidities among patients with atrial fibrillation: results from GARFIELD-AF.

Similar Datasets

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