Dataset Information

Outcomes of Patients With Atrial Fibrillation Newly Recommended for Oral Anticoagulation Under the 2014 American Heart Association/American College of Cardiology/Heart Rhythm Society Guideline.

ABSTRACT:

Background

In March 2014, the American Heart Association updated their guidelines for the management of oral anticoagulation (OAC) in atrial fibrillation, recommending OAC for all patients with CHA₂DS₂-VASc ≥2. Previously, only patients with CHADS₂ ≥2 were recommended for anticoagulation. This study compared effectiveness and safety outcomes of OAC among patients who would receive OAC using the 2014 guidelines but not the 2011 guidelines.

Methods and results

Using claims data from a 5% sample of 2013-2014 Medicare beneficiaries, we identified patients with initially diagnosed atrial fibrillation between 2013 and 2014 and selected those who would receive OAC under the 2014 guidelines but not the 2011 guidelines (those with CHA₂DS₂-VASc score ≥2 or CHADS₂ score <2). Patients were categorized according to their use of OAC after first atrial fibrillation diagnosis (2937 users and 2914 nonusers). Primary outcomes included the composite of ischemic stroke, systemic embolism and death, and any bleeding event. Cox proportional hazard models were constructed to compare the risk of primary outcomes between the 2 groups, while controlling for patient demographic and clinical characteristics. There was no difference in the combined risk of stroke, systemic embolism, and death between the treatment groups (hazard ratio, 1.00; 95% confidence interval, 0.84-1.20). The risk of bleeding was higher for patients receiving OAC than for patients not receiving OAC (hazard ratio, 1.70, 95% confidence interval, 1.46-1.97).

Conclusions

The benefit of OAC is not well defined in this patient population, and new studies that minimize residual confounding are needed to fully understand the risk/benefit of OAC in patients with atrial fibrillation and low to moderate stroke risk.

SUBMITTER: Gray MP

PROVIDER: S-EPMC5778974 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ImportanceThe 2013 American College of Cardiology/American Heart Association (ACC/AHA) Cholesterol Management Guideline recommends moderate-intensity to high-intensity statin therapy in eligible patients.ObjectiveTo examine adoption of the 2013 ACC/AHA guideline in US cardiology practices.Design, setting, and participantsAmong 161 cardiology practices, trends in the use of moderate-intensity to high-intensity statin and nonstatin lipid-lowering therapy (LLT) were analyzed before (September 1, 2012, to November 1, 2013) and after (February 1, 2014, to April 1, 2015) publication of the 2013 ACC/AHA guideline among 4 mutually exclusive risk groups within the ACC Practice Innovation and Clinical Excellence Registry. Interrupted time series analysis was used to evaluate for differences in trend in use of moderate-intensity to high-intensity statin and nonstatin LLT use in hierarchical logistic regression models. Participants were a population-based sample of 1 105 356 preguideline patients (2 431 192 patient encounters) and 1 116 472 postguideline patients (2 377 219 patient encounters). Approximately 97% of patients had atherosclerotic cardiovascular disease (ASCVD).ExposuresModerate-intensity to high-intensity statin and nonstatin LLT use before and after publication of the 2013 ACC/AHA guideline.Main outcomes and measuresTime trend in the use of moderate-intensity to high-intensity statin and nonstatin LLT.ResultsIn the study cohort, the mean (SD) age was 69.6 (12.1) years among 1 105 356 patients (40.2% female) before publication of the guideline and 70.0 (11.9) years among 1 116 472 patients (39.8% female) after publication of the guideline. Although there was a trend toward increasing use of moderate-intensity to high-intensity statins overall and in the ASCVD cohort, such a trend was already present before publication of the guideline. No significant difference in trend in the use of moderate-intensity to high-intensity statins was observed in other groups. The use of moderate-intensity to high-intensity statin therapy was 62.1% (before publication of the guideline) and 66.6% (after publication of the guideline) in the overall cohort, 62.7% (before publication) and 67.0% (after publication) in the ASCVD cohort, 50.6% (before publication) and 52.3% (after publication) in the cohort with elevated low-density lipoprotein cholesterol levels (ie, ≥190 mg/dL), 52.4% (before publication) and 55.2% (after publication) in the diabetes cohort, and 41.9% (before publication) and 46.9% (after publication) in the remaining group with 10-year ASCVD risk of 7.5% or higher. In hierarchical logistic regression models, there was a significant increase in the use of moderate-intensity to high-intensity statins in the overall cohort (4.8%) and in the ASCVD cohort (4.3%) (P < .01 for slope for both). There was no significant change for other risk cohorts. Nonstatin LLT use remained unchanged in the preguideline and postguideline periods in the hierarchical logistic regression models for all of the risk groups.Conclusions and relevanceAdoption of the 2013 ACC/AHA Cholesterol Management Guideline in cardiology practices was modest. Timely interventions are needed to improve guideline-concordant practice to reduce the burden of ASCVD.

Project description:ImportanceLittle is known regarding the durability of clinical practice guideline recommendations over time.ObjectiveTo characterize variations in the durability of class I ("procedure/treatment should be performed/administered") American College of Cardiology/American Heart Association (ACC/AHA) guideline recommendations.Design, setting, and participantsTextual analysis by 4 independent reviewers of 11 guidelines published between 1998 and 2007 and revised between 2006 and 2013.Main outcomes and measuresWe abstracted all class I recommendations from the first of the 2 most recent versions of each guideline and identified corresponding recommendations in the subsequent version. We classified recommendations replaced by less determinate or contrary recommendations as having been downgraded or reversed; we classified recommendations for which no corresponding item could be identified as having been omitted. We tested for differences in the durability of recommendations according to guideline topic and underlying level of evidence using bivariable hypothesis tests and conditional logistic regression.ResultsOf 619 index recommendations, 495 (80.0%; 95% CI, 76.6%-83.1%) were retained in the subsequent guideline version, 57 (9.2%; 95% CI, 7.0%-11.8%) were downgraded or reversed, and 67 (10.8%; 95% CI, 8.4%-13.3%) were omitted. The percentage of recommendations retained varied across guidelines from 15.4% (95% CI, 1.9%-45.4%) to 94.1% (95% CI, 80.3%-99.3%; P < .001). Among recommendations with available information on level of evidence, 90.5% (95% CI, 83.2%-95.3%) of recommendations supported by multiple randomized studies were retained, vs 81.0% (95% CI, 74.8%-86.3%) of recommendations supported by 1 randomized trial or observational data and 73.7% (95% CI, 65.8%-80.5%) of recommendations supported by opinion (P = .001). After accounting for guideline-level factors, the probability of being downgraded, reversed, or omitted was greater for recommendations based on opinion (odds ratio, 3.14; 95% CI, 1.69-5.85; P < .001) or on 1 trial or observational data (odds ratio, 3.49; 95% CI, 1.45-8.41; P = .005) vs recommendations based on multiple trials.Conclusions and relevanceThe durability of class I cardiology guideline recommendations for procedures and treatments promulgated by the ACC/AHA varied across individual guidelines and levels of evidence. Downgrades, reversals, and omissions were most common among recommendations not supported by multiple randomized studies.

Project description:ImportanceClinical decisions are ideally based on evidence generated from multiple randomized controlled trials (RCTs) evaluating clinical outcomes, but historically, few clinical guideline recommendations have been based entirely on this type of evidence.ObjectiveTo determine the class and level of evidence (LOE) supporting current major cardiovascular society guideline recommendations, and changes in LOE over time.Data sourcesCurrent American College of Cardiology/American Heart Association (ACC/AHA) and European Society of Cardiology (ESC) clinical guideline documents (2008-2018), as identified on cardiovascular society websites, and immediate predecessors to these guideline documents (1999-2014), as referenced in current guideline documents.Study selectionComprehensive guideline documents including recommendations organized by class and LOE.Data extraction and synthesisThe number of recommendations and the distribution of LOE (A [supported by data from multiple RCTs or a single, large RCT], B [supported by data from observational studies or a single RCT], and C [supported by expert opinion only]) were determined for each guideline document.Main outcomes and measuresThe proportion of guideline recommendations supported by evidence from multiple RCTs (LOE A).ResultsAcross 26 current ACC/AHA guidelines (2930 recommendations; median, 121 recommendations per guideline [25th-75th percentiles, 76-155]), 248 recommendations (8.5%) were classified as LOE A, 1465 (50.0%) as LOE B, and 1217 (41.5%) as LOE C. The median proportion of LOE A recommendations was 7.9% (25th-75th percentiles, 0.9%-15.2%). Across 25 current ESC guideline documents (3399 recommendations; median, 130 recommendations per guideline [25th-75th percentiles, 111-154]), 484 recommendations (14.2%) were classified as LOE A, 1053 (31.0%) as LOE B, and 1862 (54.8%) as LOE C. When comparing current guidelines with prior versions, the proportion of recommendations that were LOE A did not increase in either ACC/AHA (median, 9.0% [current] vs 11.7% [prior]) or ESC guidelines (median, 15.1% [current] vs 17.6% [prior]).Conclusions and relevanceAmong recommendations in major cardiovascular society guidelines, only a small percentage were supported by evidence from multiple RCTs or a single, large RCT. This pattern does not appear to have meaningfully improved from 2008 to 2018.

Project description:ObjectivesThe AHA/ACC-2017 hypertension guideline recommends an age-independent target blood pressure (BP) of less than 130/80 mmHg. In an elderly cohort without established cardiovascular disease (CVD) at baseline, we determined the impact of this guideline on the prevalence of hypertension and associated CVD risk.MethodsNineteen thousand, one hundred and fourteen participants aged at least 65 years from the ASPirin in Reducing Events in the Elderly (ASPREE) study were grouped by baseline BP: 'pre-2017 hypertensive' (BP ≥140/90 mmHg and/or on antihypertensive drugs); 'reclassified hypertensive' (normotensive by pre-2017 guidelines; hypertensive by AHA/ACC-2017 guideline), and 'normotensive' (BP <130 and <80 mmHg). For each group, we evaluated CVD risk factors, predicted 10-year CVD risk using the Atherosclerotic Cardiovascular Disease (ASCVD) risk equation, and reported observed CVD event rates during a median 4.7-year follow-up.ResultsOverall, 74.4% (14 213/19 114) were 'pre-2017 hypertensive'; an additional 12.3% (2354/19 114) were 'reclassified hypertensive' by the AHA/ACC-2017 guideline. Of those 'reclassified hypertensive', the majority (94.5%) met criteria for antihypertensive treatment although 29% had no other traditional CVD risk factors other than age. Further, a relatively lower mean 10-year predicted CVD risk (18% versus 26%, P < 0.001) and lower CVD rates (8.9 versus 12.1/1000 person-years, P = 0.01) were observed in 'reclassified hypertensive' compared with 'pre-2017 hypertensive'. Compared with 'normotensive', a hazard ratio (95% confidence interval) for CVD events of 1.60 (1.26-2.02) for 'pre-2017 hypertensive' and 1.26 (0.93-1.71) for 'reclassified hypertensive' was observed.ConclusionApplying current CVD risk calculators in the elderly 'reclassified hypertensive', as a result of shifting the BP threshold lower, increases eligibility for antihypertensive treatment but documented CVD rates remain lower than hypertensive patients defined by pre2017 BP thresholds.

Project description:BackgroundOver 10 years, achieving and maintaining 2017 ACC/AHA guideline goals could prevent 3.0 million (UR, 1.1-5.1 million), 0.5 million (UR, 0.2-0.7 million), and 1.4 million (UR, 0.6-2.0 million) cardiovascular disease (CVD) events compared with maintaining current blood pressure (BP) levels, achieving 2003 Seventh Joint National Committee Report goals, and achieving 2014 Eighth Joint National Committee goals, respectively. We estimated the number of cardiovascular disease events prevented and treatment-related serious adverse events incurred over 10 years among US adults with hypertension by achieving 2017 ACC/AHA guideline-recommended BP goals compared with (1) current BP levels, (2) achieving 2003 Seventh Joint National Committee Report BP goals, and (3) achieving 2014 Eighth Joint National Committee panel member report BP goals.MethodsUS adults aged ≥45 years with an indication for BP treatment were grouped according to recommendations for antihypertensive drug therapy in the 2017 ACC/AHA guideline, 2003 Seventh Joint National Committee Report, and 2014 Eighth Joint National Committee. Population sizes were estimated from the 2011 to 2014 National Health and Nutrition Examination Surveys. Rates for fatal and nonfatal CVD events (stroke, coronary heart disease, or heart failure) were estimated from the REGARDS (REasons for Geographic And Racial Differences in Stroke) study, weighted to the US population. CVD risk reductions with treatment to BP goals and risk for serious adverse events were obtained from meta-analyses of BP-lowering trials. CVD events prevented and treatment-related nonfatal serious adverse events over 10 years were calculated. Uncertainty surrounding main data inputs was expressed in uncertainty ranges (UR).ResultsOver ten years, achieving and maintaining 2017 ACC/AHA guideline goals compared with current BP levels, achieving 2003 Seventh Joint National Committee Report goals, or achieving 2014 Eighth Joint National Committee goals could prevent 3.0 million (UR, 1.1-5.1 million), 0.5 million (UR, 0.2-0.7 million), or 1.4 million (UR, 0.6-2.0 million) CVD events, respectively. Compared with current BP levels, achieving and maintaining 2017 goals could prevent 71.9 (UR, 26.6-122.3) CVD events per 1000 treated. Achieving 2017 guideline BP goals compared with current BP levels could also lead to nearly 3.3 million more serious adverse events over 10 years (UR, 2.2-4.4 million).ConclusionsAchieving and maintaining 2017 ACC/AHA BP goals could prevent a greater number of CVD events than achieving 2003 Seventh Joint National Committee Report or 2014 Eighth Joint National Committee BP goals but could also lead to more serious adverse events.