Dataset Information

Clinical effectiveness of coronary stents in elderly persons: results from 262,700 Medicare patients in the American College of Cardiology-National Cardiovascular Data Registry.

ABSTRACT: The aim of this study was to compare outcomes in older individuals receiving drug-eluting stents (DES) and bare-metal stents (BMS).Comparative effectiveness of DES relative to BMS remains unclear.Outcomes were evaluated in 262,700 patients from 650 National Cardiovascular Data Registry sites during 2004 to 2006 with procedural registry data linked to Medicare claims for follow-up. Outcomes including death, myocardial infarction (MI), revascularization, major bleeding, stroke, death or MI, death or MI or revascularization, and death or MI or stroke were compared with estimated cumulative incidence rates with inverse probability weighted estimators and Cox proportional hazards ratios.The DES were implanted in 217,675 patients and BMS were implanted in 45,025. At 30 months, DES patients had lower unadjusted rates of death (12.9% vs. 17.9%), MI (7.3 of 100 patients vs. 10.0 of 100 patients), and revascularization (23.0 of 100 patients vs. 24.5 of 100 patients) with no difference in stroke or bleeding. After adjustment, DES patients had lower rates of death (13.5% vs. 16.5%, hazard ratio [HR]: 0.75, 95% confidence interval [CI]: 0.72 to 0.79, p < 0.001) and MI (7.5 of 100 patients vs. 8.9 of 100 patients, HR: 0.77, 95% CI: 0.72 to 0.81, p < 0.001), with minimal difference in revascularization (23.5 of 100 patients vs. 23.4 of 100 patients; HR: 0.91, 95% CI: 0.87 to 0.96), stroke (3.1 of 100 patients vs. 2.7 of 100 patients, HR: 0.97, 95% CI: 0.88 to 1.07), or bleeding (3.4 of 100 patients vs. 3.6 of 100 patients, HR: 0.91, 95% CI: 0.84 to 1.00). The DES survival benefit was observed in all subgroups analyzed and persisted throughout 30 months of follow-up.In this largest ever real-world study, patients receiving DES had significantly better clinical outcomes than their BMS counterparts, without an associated increase in bleeding or stroke, throughout 30 months of follow-up and across all pre-specified subgroups.

SUBMITTER: Douglas PS

PROVIDER: S-EPMC2841783 | biostudies-literature | 2009 May

REPOSITORIES: biostudies-literature

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Clinical effectiveness of coronary stents in elderly persons: results from 262,700 Medicare patients in the American College of Cardiology-National Cardiovascular Data Registry.

Douglas Pamela S PS Brennan J Matthew JM Anstrom Kevin J KJ Sedrakyan Art A Eisenstein Eric L EL Haque Ghazala G Dai David D Kong David F DF Hammill Bradley B Curtis Lesley L Matchar David D Brindis Ralph R Peterson Eric D ED

Journal of the American College of Cardiology 20090501 18

<h4>Objectives</h4>The aim of this study was to compare outcomes in older individuals receiving drug-eluting stents (DES) and bare-metal stents (BMS).<h4>Background</h4>Comparative effectiveness of DES relative to BMS remains unclear.<h4>Methods</h4>Outcomes were evaluated in 262,700 patients from 650 National Cardiovascular Data Registry sites during 2004 to 2006 with procedural registry data linked to Medicare claims for follow-up. Outcomes including death, myocardial infarction (MI), revascul ...[more]

PMID: 19406337

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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: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:Background Clinical implications of change in the 2017 American College of Cardiology (ACC)/American Heart Association (AHA) guideline on the diagnosis and management of hypertension, compared with recommendations by 2014 expert panel and Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7), are not known. Methods and Results Using data from the NCDR (National Cardiovascular Data Registry) PINNACLE (Practice Innovation and Clinical Excellence) Registry (January 2013-Decemver 2016), we compared the proportion and clinical characteristics of patients seen in cardiology practices diagnosed with hypertension, recommended antihypertensive treatment, and achieving blood pressure (BP) goals per each guideline document. In addition, we evaluated the proportion of patients at the level of practices meeting BP targets defined by each guideline. Of 6 042 630 patients evaluated, 5 027 961 (83.2%) were diagnosed with hypertension per the 2017 ACC/AHA guideline, compared with 4 521 272 (74.8%) per the 2014 panel and 4 545 976 (75.2%) per JNC7. The largest increase in hypertension prevalence was seen in younger ages, women, and those with lower cardiovascular risk. Antihypertensive medication was recommended to 70.6% of patients per the ACC/AHA guideline compared with 61.8% and 65.9% per the 2014 panel and JNC7, respectively. Among those on antihypertensive agents, 41.2% achieved BP targets per the ACC/AHA guideline, compared with 79.4% per the 2014 panel and 64.3% per JNC7. Lower proportions of women, non-White (Black and "other") races, and those at higher cardiovascular risk achieved BP goals. Median practice-level proportion of patients meeting BP targets per the 2014 panel but not the ACC/AHA guideline was 37.8% (interquartile range, 34.8%-40.7%) and per JNC7 but not the ACC/AHA guideline was 22.9% (interquartile range, 19.8%-25.9%). Conclusions Following publication of the 2017 guideline, significantly more people, particularly younger people and those with lower cardiovascular risk, will be diagnosed with hypertension and need antihypertensive treatment compared with previous recommendations. Significant practice-level variation in BP control also exists. Efforts are needed to improve guideline-concordant hypertension management in an effort to improve outcomes.

Project description:OBJECTIVES:To identify the top priority areas for research to optimize pharmacotherapy in older adults with cardiovascular disease (CVD). DESIGN:Consensus meeting. SETTING:Multidisciplinary workshop supported by the National Institute on Aging, the American College of Cardiology, and the American Geriatrics Society, February 6-7, 2017. PARTICIPANTS:Leaders in the Cardiology and Geriatrics communities, (officers in professional societies, journal editors, clinical trialists, Division chiefs), representatives from the NIA; National Heart, Lung, and Blood Institute; Food and Drug Administration; Centers for Medicare and Medicaid Services, Alliance for Academic Internal Medicine, Patient-Centered Outcomes Research Institute, Agency for Healthcare Research and Quality, pharmaceutical industry, and trainees and early career faculty with interests in geriatric cardiology. MEASUREMENTS:Summary of workshop proceedings and recommendations. RESULTS:To better align older adults' healthcare preferences with their care, research is needed to improve skills in patient engagement and communication. Similarly, to coordinate and meet the needs of older adults with multiple comorbidities encountering multiple healthcare providers and systems, systems and disciplines must be integrated. The lack of data from efficacy trials of CVD medications relevant to the majority of older adults creates uncertainty in determining the risks and benefits of many CVD therapies; thus, developing evidence-based guidelines for older adults with CVD is a top research priority. Polypharmacy and medication nonadherence lead to poor outcomes in older people, making research on appropriate prescribing and deprescribing to reduce polypharmacy and methods to improve adherence to beneficial therapies a priority. CONCLUSION:The needs and circumstances of older adults with CVD differ from those that the current medical system has been designed to meet. Optimizing pharmacotherapy in older adults will require new data from traditional and pragmatic research to determine optimal CVD therapy, reduce polypharmacy, increase adherence, and meet person-centered goals. Better integration of the multiple systems and disciplines involved in the care of older adults will be essential to implement and disseminate best practices. J Am Geriatr Soc 67:371-380, 2019.

Project description:The American College of Cardiology (ACC) and European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) have recently published recommendations for the use of proprotein convertase subtilisin/kexin-9 (PCSK9) inhibitors in situations of very high risk. We aim to assess in the real world the suitability of PCSK9 inhibitors for acute coronary syndromes.We analyzed a prospective Swiss cohort of 2023 patients hospitalized for acute coronary syndromes between 2009 and 2014 with available data for low-density lipoprotein cholesterol and lipid-lowering therapy at 1 year. Clinical familial hypercholesterolemia was defined using the Dutch Lipid Clinic Network algorithm as unlikely, possible, probable, or definite. We simulated a fixed relative reduction of 24% in low-density lipoprotein cholesterol levels at 1 year in all patients not treated with ezetimibe, irrespective of the low-density lipoprotein cholesterol levels and statin regimen. At 1 year, 94.3% of patients were treated with statin, 5.8% with ezetimibe, and 35.8% of patients had on-target low-density lipoprotein cholesterol levels (<1.8 mmol/L); 25.6% met criteria for possible or probable/definite familial hypercholesterolemia. After a simulation of the lipid-lowering effect of ezetimibe, the proportion of patients who would be eligible for PCSK9 inhibitors at 1 year was 13.4% using American College of Cardiology criteria and 2.7% using European Society of Cardiology/European Atherosclerosis Society criteria. Patients with possible or probable/definite familial hypercholesterolemia were more eligible for PCSK9 inhibitors compared with their non-familial hypercholesterolemia counterparts: 27.6% versus 8.8% according to American College of Cardiology criteria and 6.6% versus 1.8% according to European Society of Cardiology/European Atherosclerosis Society criteria (P<0.001).Recommendations made by the American College of Cardiology guidelines would lead to 5-fold higher eligibility rates for PCSK9 inhibitors compared to the European Society of Cardiology/European Atherosclerosis Society consensus statement in acute coronary syndrome patients.

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.

Dataset Information

Clinical effectiveness of coronary stents in elderly persons: results from 262,700 Medicare patients in the American College of Cardiology-National Cardiovascular Data Registry.

Publications

Clinical effectiveness of coronary stents in elderly persons: results from 262,700 Medicare patients in the American College of Cardiology-National Cardiovascular Data Registry.

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