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Archive for October, 2014

Ebola American Hospital Associations PowerPoint Presentation

Find the American Hospital Association Powerpoint presentation here.

Categories: Uncategorized

Metaregression of FFR trials: clinical end-points.T

The paper here explores clinical end-point relationship with continuous FFR from FFR trials using metaregression.

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Journal Club 22 October 2014

Paper

Increased Mortality Associated With Digoxin in Contemporary Patients With Atrial Fibrillation Findings From the TREAT-AF Study

Presenter

AB

Summary

BACKGROUND

Despite endorsement of digoxin in clinical practice guidelines, there exist limited data on its safety in
atrial fibrillation/flutter (AF).

OBJECTIVES

The goal of this study was to evaluate the association of digoxin with mortality in AF.
METHODS Using complete data of the TREAT-AF (The Retrospective Evaluation and Assessment of Therapies in AF)
study from the U.S. Department of Veterans Affairs (VA) healthcare system, we identified patients with newly diagnosed,
nonvalvular AF seen within 90 days in an outpatient setting between VA fiscal years 2004 and 2008. We used multivariate
and propensity-matched Cox proportional hazards to evaluate the association of digoxin use with death. Residual
confounding was assessed by sensitivity analysis.

RESULTS

Of 122,465 patients with 353,168 person-years of follow-up (age 72.1 10.3 years, 98.4% male), 28,679
(23.4%) patients received digoxin. Cumulative mortality rates were higher for digoxin-treated patients than for untreated
patients (95 vs. 67 per 1,000 person-years; p < 0.001). Digoxin use was independently associated with mortality after
multivariate adjustment (hazard ratio [HR]: 1.26, 95% confidence interval [CI]: 1.23 to 1.29, p < 0.001) and propensity
matching (HR: 1.21, 95% CI: 1.17 to 1.25, p < 0.001), even after adjustment for drug adherence. The risk of death was not
modified by age, sex, heart failure, kidney function, or concomitant use of beta-blockers, amiodarone, or warfarin.

CONCLUSIONS

Digoxin was associated with increased risk of death in patients with newly diagnosed AF, independent
of drug adherence, kidney function, cardiovascular comorbidities, and concomitant therapies. These findings challenge
current cardiovascular society recommendations on use of digoxin in AF.

Supplementary Material

AFFIRM study
AFFIRM subset
AFFIRM subset editorial

Journal Club 8 October 2014

Paper

Fractional Flow Reserve–Guided PCI for Stable Coronary Artery Disease

Presenter

CC

Summary

Background

We hypothesized that in patients with stable coronary artery disease and stenosis,
percutaneous coronary intervention (PCI) performed on the basis of the fractional
flow reserve (FFR) would be superior to medical therapy.

Methods

In 1220 patients with stable coronary artery disease, we assessed the FFR in all
stenoses that were visible on angiography. Patients who had at least one stenosis
with an FFR of 0.80 or less were randomly assigned to undergo FFR-guided PCI plus
medical therapy or to receive medical therapy alone. Patients in whom all stenoses
had an FFR of more than 0.80 received medical therapy alone and were included in
a registry. The primary end point was a composite of death from any cause, nonfatal
myocardial infarction, or urgent revascularization within 2 years.

Results

The rate of the primary end point was significantly lower in the PCI group than in
the medical-therapy group (8.1% vs. 19.5%; hazard ratio, 0.39; 95% confidence interval
[CI], 0.26 to 0.57; P<0.001). This reduction was driven by a lower rate of urgent
revascularization in the PCI group (4.0% vs. 16.3%; hazard ratio, 0.23; 95% CI,
0.14 to 0.38; P<0.001), with no significant between-group differences in the rates of
death and myocardial infarction. Urgent revascularizations that were triggered by
myocardial infarction or ischemic changes on electrocardiography were less frequent
in the PCI group (3.4% vs. 7.0%, P = 0.01). In a landmark analysis, the rate of death or
myocardial infarction from 8 days to 2 years was lower in the PCI group than in the
medical-therapy group (4.6% vs. 8.0%, P = 0.04). Among registry patients, the rate of
the primary end point was 9.0% at 2 years.

Conclusions

In patients with stable coronary artery disease, FFR-guided PCI, as compared with
medical therapy alone, improved the outcome. Patients without ischemia had a favorable
outcome with medical therapy alone.

Journal Club 1 October 2014

Paper

Angiotensin–Neprilysin Inhibition versus Enalapril in Heart Failure

Presenter

LC

Summary

Background

We compared the angiotensin receptor–neprilysin inhibitor LCZ696 with enalapril in patients who had heart failure with a reduced ejection fraction. In previous stud-ies, enalapril improved survival in such patients

Methods

In this double-blind trial, we randomly assigned 8442 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive either LCZ696 (at a dose of 200 mg twice daily) or enalapril (at a dose of 10 mg twice daily), in addition to recommended therapy. The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure, but the trial was designed to detect a difference in the rates of death from cardiovascular causes.

Results

The trial was stopped early, according to prespecified rules, after a median follow-up of 27 months, because the boundary for an overwhelming benefit with LCZ696 had been crossed. At the time of study closure, the primary outcome had occurred in 914 patients (21.8%) in the LCZ696 group and 1117 patients (26.5%) in the enalapril group (hazard ratio in the LCZ696 group, 0.80; 95% confidence interval [CI], 0.73 to 0.87; P<0.001). A total of 711 patients (17.0%) receiving LCZ696 and 835 patients (19.8%) receiving enalapril died (hazard ratio for death from any cause, 0.84; 95% CI, 0.76 to 0.93; P<0.001); of these patients, 558 (13.3%) and 693 (16.5%), respectively, died from cardiovascular causes (hazard ratio, 0.80; 95% CI, 0.71 to 0.89; P<0.001). As compared with enalapril, LCZ696 also reduced the risk of hospi-talization for heart failure by 21% (P<0.001) and decreased the symptoms and physical limitations of heart failure (P = 0.001). The LCZ696 group had higher pro-portions of patients with hypotension and nonserious angioedema but lower pro-portions with renal impairment, hyperkalemia, and cough than the enalapril group.

Conclusions

LCZ696 was superior to enalapril in reducing the risks of death and of hospitaliza-tion for heart failure.

Summary

The editorial is available here.