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Articles by J. S Rumsfeld
Total Records ( 7 ) for J. S Rumsfeld
  T. T Tsai , P. M Ho , S Xu , J. D Powers , N. M Carroll , S. M Shetterly , T. M Maddox , J. S Rumsfeld , K Margolis , A. S Go and D. J. Magid
  Background—

Studies suggest that extended clopidogrel use after drug-eluting stent (DES) implantation may decrease the risk of myocardial infarction (MI) and death. Little is known about the competing risk of bleeding from clopidogrel in "real world" clinical practice.

Methods and Results—

We studied 7689 patients undergoing drug-eluting stent implantation enrolled in the HMO Research Network-Stent Registry between 2004 and 2007. Patients were analyzed in 6-month intervals for the occurrence of major bleeding, MI, and death. Clopidogrel use was determined by pharmacy dispensing data. Regression models assessed the association between clopidogrel use and outcomes. Overall, 3603 patients (49.1%) received clopidogrel for >6 months. During a mean follow-up of 418 days (SD, ±168 days), 217 (2.9%) patients died, 279 (3.7%) had a MI, and 271 (3.6%) had major bleeding. After adjustment, patients on clopidogrel therapy were associated with increased major bleeding in all time intervals (0 to 6 months: relative risk (RR)=2.70, 95% CI=1.41 to 5.19; 7 to 12 months: RR=1.71, 95% CI=1.05 to 2.79; 13 to 18 months: RR=2.34, 95% CI=1.26 to 4.34), compared with patients off clopidogrel. Clopidogrel use was also associated with decreased risk of MI for all time intervals (0 to 6 months: RR=0.52, 95% CI=0.36 to 0.77; 7 to 12 months: RR=0.46, 95% CI=0.30 to 0.70; 13 to 18 months: RR=0.53, 95% CI=0.29 to 0.99) and decreased death in the 7 to 12 month interval (RR=0.50, 95% CI=0.30 to 0.83).

Conclusions—

Clopidogrel use was associated with increased major bleeding and decreased MI persisting to 18 months. Bleeding risks on clopidogrel therapy deserve consideration in the ongoing debate regarding optimal clopidogrel duration after PCI.

  E. D Peterson , M. T Roe , J. S Rumsfeld , R. E Shaw , R. G Brindis , G. C Fonarow and C. P. Cannon
 

Background— There is a recognized need for a national unified registry to track presenting features, care, and outcomes for patients with acute myocardial infarction. To address this need, the American Heart Association’s Get With the Guidelines–Coronary Artery Disease program joined the Acute Coronary Treatment and Intervention Outcomes Network (ACTION) Registry to create the National Cardiovascular Data Registry ACTION–Get With the Guidelines (AR-G) in June of 2008. This article outlines the objectives, operational structure, patient population, data elements, data collection methodology, and reporting components of this landmark registry.

Methods and Results— The AR-G was launched in January of 2007. The registry is led by a team of volunteers from the American Heart Association and the American College of Cardiology, and its data coordinating center resides at the Duke Clinical Research Institute. As of December 2008, 344 US hospitals already contributed detailed clinical information on 103 890 myocardial infarction patients (inclusive of 39% ST-segment myocardial infarction and 61% non–ST-segment myocardial infarction patients). Overall data quality has been excellent, with <5% clinical fields missing. Site quality improvement efforts are supported via detailed quarterly feedback reports, routine web educational programs, and sharing of "best practice" clinical support tools.

Conclusions— The AR-G represents a unified, national, acute myocardial infarction registry and supports a robust quality improvement effort designed to encourage evidence-based acute myocardial infarction care and, ultimately, improve patient outcomes.

  P. N Peterson , J. S Rumsfeld , L Liang , N. M Albert , A. F Hernandez , E. D Peterson , G. C Fonarow , F. A Masoudi and on behalf of the American Heart Association Get With the Guidelines Heart Failure Program
 

Background— Effective risk stratification can inform clinical decision-making. Our objective was to derive and validate a risk score for in-hospital mortality in patients hospitalized with heart failure using American Heart Association Get With the Guidelines–Heart Failure (GWTG-HF) program data.

Methods and Results— A cohort of 39 783 patients admitted January 1, 2005, to June 26, 2007, to 198 hospitals participating in GWTG-HF was divided into derivation (70%, n=27 850) and validation (30%, n=11 933) samples. Multivariable logistic regression identified predictors of in-hospital mortality in the derivation sample from candidate demographic, medical history, and laboratory variables collected at admission. In-hospital mortality rate was 2.86% (n=1139). Age, systolic blood pressure, blood urea nitrogen, heart rate, sodium, chronic obstructive pulmonary disease, and nonblack race were predictive of in-hospital mortality. The model had good discrimination in the derivation and validation datasets (c-index, 0.75 in each). Effect estimates from the entire sample were used to generate a mortality risk score. The predicted probability of in-hospital mortality varied more than 24-fold across deciles (range, 0.4% to 9.7%) and corresponded with observed mortality rates. The model had the same operating characteristics among those with preserved and impaired left ventricular systolic function. The morality risk score can be calculated on the Web-based calculator available with the GWTG-HF data entry tool.

Conclusions— The GWTG-HF risk score uses commonly available clinical variables to predict in-hospital mortality and provides clinicians with a validated tool for risk stratification that is applicable to a broad spectrum of patients with heart failure, including those with preserved left ventricular systolic function.

  P. M Ho , T. T Tsai , T. M Maddox , J. D Powers , N. M Carroll , C Jackevicius , A. S Go , K. L Margolis , T. A DeFor , J. S Rumsfeld and D. J. Magid
 

Background— Adjuvant clopidogrel therapy is essential after drug-eluting stent (DES) implantation. The frequency with which patients delay filling a clopidogrel prescription after DES implantation and the association of this delay with adverse outcomes is unknown.

Methods and Results— This was a retrospective cohort study of patients discharged after DES implantation from 3 large integrated health care systems. Filling a clopidogrel prescription was based on pharmacy dispensing data. The primary end point was all-cause mortality or myocardial infarction (MI). Of 7402 patients discharged after DES implantation, 16% (n=1210) did not fill a clopidogrel prescription on day of discharge and the median time delay was 3 days (interquartile range, 1 to 23 days). Compared with patients filling clopidogrel on day of discharge, patients with any delay in filling clopidogrel had higher death/MI rates during follow-up (14.2% versus 7.9%; P<0.001). In multivariable analysis, patients with any delay had increased risk of death/MI (hazard ratio, 1.53; 95% confidence interval, 1.25 to 1.87). Patients with any delay remained at increased risk of adverse outcomes when the delay cutoff was changed to >1, >3, or >5 days after discharge. Factors associated with delay included older age, prior MI, diabetes, renal failure, prior revascularization, cardiogenic shock, in-hospital bleeding, and clopidogrel use within 24 hours of admission.

Conclusions— One in 6 patients delay filling their index clopidogrel prescription after hospital discharge after DES implantation. This delay was associated with increased risk of adverse outcomes and highlights the importance of the transition period from hospital discharge to outpatient setting as a potential opportunity to improve care delivery and patient outcomes.

  P. M Ho , T. T Tsai , T. Y Wang , S. M Shetterly , C. L Clarke , A. S Go , A Sedrakyan , J. S Rumsfeld , E. D Peterson and D. J. Magid
 

Background— A prior study from the Veterans Health Administration found a clustering of cardiovascular events after clopidogrel cessation. We sought to confirm and expand these findings.

Methods and Results— This was a retrospective cohort study of 2017 patients with acute coronary syndrome discharged on clopidogrel from an integrated health care delivery system. Rates of all-cause mortality or acute myocardial infarction (MI) within 1 year after stopping clopidogrel were assessed among patients who did not have an event before stopping clopidogrel. Death/MI occurred in 4.3% (n=71) of patients. The rates of death/MI were 3.07, 1.62, 0.70, and 0.95 per 10 000 patient-days for the time intervals of 0 to 90, 91 to 180, 181 to 270, and 271 to 360 days after stopping clopidogrel. In multivariable analysis, the 0- to 90-day interval after stopping clopidogrel was associated with higher risk of death/MI (incidence rate ratio, 2.74; 95% confidence interval, 1.69 to 4.44) compared with 91- to 360-day interval. There was a similar trend of increased events after stopping clopidogrel for various subgroups (women versus men, medical therapy versus percutaneous coronary intervention, stent type, and ≥6 months or <6 months of clopidogrel treatment). Among patients taking clopidogrel but stopping ACE inhibitor medications, the event rates were similar in the 0- to 90-day versus the 91- to 360-day interval (2.67 versus 2.91 per 10 000 patient-days; P=0.91).

Conclusions— We observed a clustering of adverse events in the 0 to 90 days after stopping clopidogrel. This clustering of events was not present among patients stopping ACE inhibitors. These findings are consistent with a possible rebound platelet hyper-reactivity after stopping clopidogrel and additional platelet studies are needed to confirm this effect.

  P. N Peterson , J. S Rumsfeld , L Liang , A. F Hernandez , E. D Peterson , G. C Fonarow , F. A Masoudi and on behalf of the American Heart Association Get With The Guidelines Heart Failure Program
 

Background— Although the absolute benefits of an intervention are proportional to patients’ underlying risk, studies in heart failure have noted a paradoxical inverse relationship between treatment and risk. The extent to which this reflects higher rates of contraindications in patients with higher risk or larger gaps in care quality has not been explored.

Methods and Results— We studied 18 307 patients with left ventricular systolic dysfunction surviving hospitalization between January 2005 and June 2007 from 194 hospitals participating in Get With The Guidelines (GWTG)–Heart Failure. Patients were categorized according to their estimated risk for in-hospital mortality using a validated risk score. The proportions of patients with documented contraindications to angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and β-blockers as well as the use of these medications among patients without contraindications at hospital discharge was determined across levels of risk. For each therapy, the proportion of patients with contraindications was significantly higher with increasing patient risk (P<0.001 for each). Even after excluding those with contraindications, the use of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers and β-blockers was significantly lower with increasing risk (P<0.001 for each).

Conclusions— The use of evidence-based therapies is lower in patients with heart failure at higher risk of mortality both because of higher rates of contraindications to therapy and lower rates of use among eligible patients. Optimizing heart failure outcomes will require both the expansion of the evidence base for treating the highest-risk patients as well as the development of effective strategies to assure that eligible high-risk patients receive all appropriate therapies.

  T. M Maddox , C Ross , H. M Tavel , E. E Lyons , M Tillquist , P. M Ho , J. S Rumsfeld , K. L Margolis , P. J O'Connor , J. V Selby and D. J. Magid
  Background—

Blood pressure (BP) control among coronary artery disease patients remains suboptimal in clinical practice, potentially due to gaps in treatment intensification and medication adherence. However, longitudinal studies evaluating these relationships and outcomes are limited.

Methods and Results—

We assessed BP trajectories among health maintenance organization patients with hypertension and incident coronary artery disease. BP trajectories were modeled over the year after coronary artery disease diagnosis, stratified by target BP goal. Treatment intensification (increase in BP therapies in the setting of an elevated BP), medication adherence (percentage of days covered with BP therapies), and outcomes (all-cause mortality, myocardial infarction, and revascularization) were evaluated in multivariable models: 9569 patients had a <140/90 mm Hg BP target and 12 861 had a <130/80 mm Hg BP target. Within each group, 4 trajectories were identified: good, borderline, improved, and poor control. After adjustment, increasing BP treatment intensity was significantly associated with better BP trajectories in both groups. Medication adherence had inconsistent effects. There were no significant differences in combined outcomes by BP trajectory, but among the diabetes and renal disease cohort, borderline control patients were less likely to have myocardial infarction (odds ratio, 0.61; 95% confidence interval, 0.40–0.93), and good control patients were less likely to have myocardial infarction (odds ratio, 0.53; 95% confidence interval, 0.34–0.84) or a revascularization procedure (odds ratio, 0.66; 95% confidence interval, 0.47–0.93) compared with poor control patients.

Conclusions—

In this health maintenance organization population, treatment intensification but not medication adherence significantly affects BP trajectories in the year after coronary artery disease diagnosis. Better BP trajectories are associated with lower rates of myocardial infarction and revascularization.

 
 
 
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