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Journal Club 2 December 2015

Paper

Long-Term Effect of Goal-Directed Weight Management in an Atrial Fibrillation Cohort

Presenter

KC

Summary

BACKGROUND

Obesity and atrial fibrillation (AF) frequently coexist. Weight loss reduces the burden of AF, but whether this is sustained, has a dose effect, or is influenced by weight fluctuation is unknown. 

OBJECTIVES

This study sought to evaluate the long-term impact of weight loss and weight fluctuation on rhythm control in obese individuals with AF.

METHODS

Of 1,415 consecutive patients with AF, 825 had a body mass index $27 kg/m2 and were offered weight management. After screening for exclusion criteria, 355 were included in this analysis. Weight loss was categorized as group 1 ($10%), group 2 (3% to 9%), and group 3 (<3%). Weight trend and/or fluctuation was determined by yearly follow-up. We determined the impact on the AF severity scale and 7-day ambulatory monitoring.

RESULTS

There were no differences in baseline characteristics or follow-up among the groups. AF burden and symptom severity decreased more in group 1 compared with groups 2 and 3 (p < 0.001 for all). Arrhythmia-free survival with and without rhythm control strategies was greatest in group 1 compared with groups 2 and 3 (p < 0.001 for both). In multivariate analyses, weight loss and weight fluctuation were independent predictors of outcomes (p < 0.001 for both). Weight loss $10% resulted in a 6-fold (95% confidence interval: 3.4 to 10.3; p 5% partially offset this benefit, with a 2-fold (95% confidence interval: 1.0 to 4.3; p ¼ 0.02) increased risk of arrhythmia recurrence.

CONCLUSIONS

Long-term sustained weight loss is associated with significant reduction of AF burden and maintenance of sinus rhythm. (Long-Term Effect of Goal directed weight management on Atrial Fibrillation Cohort: A 5 Year follow-up study [LEGACY Study]

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Categories: Journal Club

Journal Club 25 November 2015

Paper

Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk

Presenter

VF

Summary

BACKGROUND

Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month.

METHODS

In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who under-went PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization.

RESULTS

We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated–stent group and in 154 patients (12.9%) in the bare-metal–stent group (risk difference, −3.6 percentage points; 95% confi-dence interval [CI], −6.1 to −1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P = 0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated–stent group and in 113 patients (9.8%) in the bare-metal–stent group (risk difference, −4.8 percentage points; 95% CI, −6.9 to −2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001).

CONCLUSIONS

Among patients at high risk for bleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet therapy.

Supplementary Material

Supplementary material is available here.

Journal Club 18 November 2015

Paper

A Randomized Trial of Intensive versus Standard Blood-Pressure Control

Presenter

AL

Summary

BACKGROUND

The most appropriate targets for systolic blood pressure to reduce cardiovascular morbidity and mortality among persons without diabetes remain uncertain.

METHODS

We randomly assigned 9361 persons with a systolic blood pressure of 130 mm Hg or higher and an increased cardiovascular risk, but without diabetes, to a systolic blood-pressure target of less than 120 mm Hg (intensive treatment) or a target of less than 140 mm Hg (standard treatment). The primary composite outcome was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes.

RESULTS

At 1 year, the mean systolic blood pressure was 121.4 mm Hg in the intensive-treatment group and 136.2 mm Hg in the standard-treatment group. The interven-tion was stopped early after a median follow-up of 3.26 years owing to a signifi-cantly lower rate of the primary composite outcome in the intensive-treatment group than in the standard-treatment group (1.65% per year vs. 2.19% per year; hazard ratio with intensive treatment, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P<0.001). All-cause mortality was also significantly lower in the intensive-treatment group (hazard ratio, 0.73; 95% CI, 0.60 to 0.90; P = 0.003). Rates of serious adverse events of hypotension, syncope, electrolyte abnormalities, and acute kidney injury or failure, but not of injurious falls, were higher in the intensive-treatment group than in the standard-treatment group.

CONCLUSIONS

Among patients at high risk for cardiovascular events but without diabetes, target-ing a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in lower rates of fatal and nonfatal major cardiovascular events and death from any cause, although significantly higher rates of some adverse events were observed in the intensive-treatment group.

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Journal Club 11 November 2015

Paper

Apixaban for Extended Treatment of Venous Thromboembolism

Presenter

SP

Summary

Background

Apixaban, an oral factor Xa inhibitor that can be administered in a simple, fixed-dose
regimen, may be an option for the extended treatment of venous thromboembolism.

Methods

In this randomized, double-blind study, we compared two doses of apixaban (2.5 mg
and 5 mg, twice daily) with placebo in patients with venous thromboembolism who
had completed 6 to 12 months of anticoagulation therapy and for whom there was
clinical equipoise regarding the continuation or cessation of anticoagulation therapy.
The study drugs were administered for 12 months.

Results

A total of 2486 patients underwent randomization, of whom 2482 were included in
the intention-to-treat analyses. Symptomatic recurrent venous thromboembolism
or death from venous thromboembolism occurred in 73 of the 829 patients (8.8%)
who were receiving placebo, as compared with 14 of the 840 patients (1.7%) who
were receiving 2.5 mg of apixaban (a difference of 7.2 percentage points; 95% confidence
interval [CI], 5.0 to 9.3) and 14 of the 813 patients (1.7%) who were receiving
5 mg of apixaban (a difference of 7.0 percentage points; 95% CI, 4.9 to 9.1)
(P<0.001 for both comparisons). The rates of major bleeding were 0.5% in the placebo
group, 0.2% in the 2.5-mg apixaban group, and 0.1% in the 5-mg apixaban
group. The rates of clinically relevant nonmajor bleeding were 2.3% in the placebo
group, 3.0% in the 2.5-mg apixaban group, and 4.2% in the 5-mg apixaban group.
The rate of death from any cause was 1.7% in the placebo group, as compared with
0.8% in the 2.5-mg apixaban group and 0.5% in the 5-mg apixaban group.

Conclusions

Extended anticoagulation with apixaban at either a treatment dose (5 mg) or a
thromboprophylactic dose (2.5 mg) reduced the risk of recurrent venous thromboembolism
without increasing the rate of major bleeding.

Supplementary Material

ESC Venous Thromboembolism Guidelines

Journal Club 21 October 2015

Paper

High-sensitivity cardiac troponin I at presentation in patients with suspected acute coronary syndrome: a cohort study

Presenter

SB

Summary

Summary

Background Suspected acute coronary syndrome is the commonest reason for emergency admission to hospital and is a large burden on health-care resources. Strategies to identify low-risk patients suitable for immediate discharge would have major benefits.

Methods

We did a prospective cohort study of 6304 consecutively enrolled patients with suspected acute coronary syndrome presenting to four secondary and tertiary care hospitals in Scotland. We measured plasma troponin concentrations at presentation using a high-sensitivity cardiac troponin I assay. In derivation and validation cohorts, we evaluated the negative predictive value of a range of troponin concentrations for the primary outcome of index myocardial infarction, or subsequent myocardial infarction or cardiac death at 30 days. This trial is registered with ClinicalTrials.gov (number NCT01852123).

Findings

782 (16%) of 4870 patients in the derivation cohort had index myocardial infarction, with a further 32 (1%) re-presenting with myocardial infarction and 75 (2%) cardiac deaths at 30 days. In patients without myocardial infarction at presentation, troponin concentrations were less than 5 ng/L in 2311 (61%) of 3799 patients, with a negative predictive value of 99·6% (95% CI 99·3–99·8) for the primary outcome. The negative predictive value was consistent across groups stratifi ed by age, sex, risk factors, and previous cardiovascular disease. In two independent
validation cohorts, troponin concentrations were less than 5 ng/L in 594 (56%) of 1061 patients, with an overall negative predictive value of 99·4% (98·8–99·9). At 1 year, these patients had a lower risk of myocardial infarction and cardiac death than did those with a troponin concentration of 5 ng/L or more (0·6% vs 3·3%; adjusted hazard ratio
0·41, 95% CI 0·21–0·80; p<0·0001).

Interpretation

Low plasma troponin concentrations identify two-thirds of patients at very low risk of cardiac events who could be discharged from hospital. Implementation of this approach could substantially reduce hospital admissions and have major benefi ts for both patients and health-care providers.

Supplementary Material

The editorial is available here.

Journal Club

Paper

Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease

Presenter

PS

Summary

BACKGROUND

In patients with coronary artery disease who receive metallic drug-eluting coronary
stents, adverse events such as late target-lesion failure may be related in part
to the persistent presence of the metallic stent frame in the coronary-vessel wall.
Bioresorbable vascular scaffolds have been developed to attempt to improve longterm
outcomes.

METHODS

In this large, multicenter, randomized trial, 2008 patients with stable or unstable
angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting
bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting
cobalt–chromium (Xience) stent (686 patients). The primary end point, which was
tested for both noninferiority (margin, 4.5 percentage points for the risk difference)
and superiority, was target-lesion failure (cardiac death, target-vessel myocardial
infarction, or ischemia-driven target-lesion revascularization) at 1 year.

RESULTS

Target-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and
in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95%
confidence interval, −0.5 to 3.9; P = 0.007 for noninferiority and P = 0.16 for superiority).
There was no significant difference between the Absorb group and the
Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P = 0.29), targetvessel
myocardial infarction (6.0% and 4.6%, respectively; P = 0.18), or ischemiadriven
target-lesion revascularization (3.0% and 2.5%, respectively; P = 0.50). Device
thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in
0.7% of patients in the Xience group (P = 0.13).

CONCLUSIONS

In this large-scale, randomized trial, treatment of noncomplex obstructive coronary
artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared
with an everolimus-eluting cobalt–chromium stent, was within the prespecified
margin for noninferiority with respect to target-lesion failure at 1 year.

Supplementary Material

ABSORB Japan trial
ABSORB China slides

Journal Club 30 September 2015

Paper

Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure

Presenter

JA

Summary

BACKGROUND

Central sleep apnea is associated with poor prognosis and death in patients with
heart failure. Adaptive servo-ventilation is a therapy that uses a noninvasive ventilator
to treat central sleep apnea by delivering servo-controlled inspiratory pressure
support on top of expiratory positive airway pressure. We investigated the effects
of adaptive servo-ventilation in patients who had heart failure with reduced ejection
fraction and predominantly central sleep apnea.

METHODS

We randomly assigned 1325 patients with a left ventricular ejection fraction of 45%
or less, an apnea–hypopnea index (AHI) of 15 or more events (occurrences of apnea
or hypopnea) per hour, and a predominance of central events to receive
guideline-based medical treatment with adaptive servo-ventilation or guidelinebased
medical treatment alone (control). The primary end point in the time-toevent
analysis was the first event of death from any cause, lifesaving cardiovascular
intervention (cardiac transplantation, implantation of a ventricular assist
device, resuscitation after sudden cardiac arrest, or appropriate lifesaving shock),
or unplanned hospitalization for worsening heart failure.

RESULTS

In the adaptive servo-ventilation group, the mean AHI at 12 months was 6.6 events
per hour. The incidence of the primary end point did not differ significantly between
the adaptive servo-ventilation group and the control group (54.1% and
50.8%, respectively; hazard ratio, 1.13; 95% confidence interval [CI], 0.97 to 1.31;
P = 0.10). All-cause mortality and cardiovascular mortality were significantly
higher in the adaptive servo-ventilation group than in the control group (hazard
ratio for death from any cause, 1.28; 95% CI, 1.06 to 1.55; P = 0.01; and hazard
ratio for cardiovascular death, 1.34; 95% CI, 1.09 to 1.65; P = 0.006).

CONCLUSIONS

Adaptive servo-ventilation had no significant effect on the primary end point in
patients who had heart failure with reduced ejection fraction and predominantly
central sleep apnea, but all-cause and cardiovascular mortality were both increased
with this therapy.

Supplementary Material

A copy of the CANPAP is available here.