Literature Review

Multifaceted Intervention Improves Anticoagulant Use in Patients With Atrial Fibrillation

The intervention may help optimize the choice of anticoagulant and reduce the risk of stroke.


 

A customized educational intervention significantly increases the use of oral anticoagulants among patients with atrial fibrillation at risk for stroke, according to data published online ahead of print August 28 in Lancet. The intervention also appears to reduce the risk of stroke.

“If this intervention could be broadly applied, which we believe is possible, the public health implications would be substantial,” said Christopher B. Granger, MD, Professor of Medicine at Duke University School of Medicine in Durham, North Carolina. “More than 33 million people worldwide have atrial fibrillation, which is a leading cause of stoke. Improving adherence to anticoagulation therapy would be a lifesaver.”

Christopher B. Granger, MD

Data suggest that approximately two-thirds of strokes related to atrial fibrillation can be prevented with oral anticoagulants. Among patients for whom guidelines recommend these agents, about half are treated. In addition, one study found that more than 30% of appropriately treated patients had stopped oral anticoagulation by the end of the first year of treatment.

Intervention Included Education and Monitoring

Dr. Granger and colleagues conducted IMPACT-AF—a prospective, cluster-randomized, controlled trial—to evaluate the effect of a multifaceted educational intervention on the use of oral anticoagulation in patients with atrial fibrillation, compared with usual care. The study was conducted in Argentina, Brazil, China, India, and Romania. Eligible patients were 18 or older, had atrial fibrillation not resulting from reversible causes, and had an indication for oral anticoagulation. Patients with an absolute contraindication to oral anticoagulation, those with a mechanical prosthetic valve, and those who were not able to have one year of follow-up were excluded.

Clusters (ie, sites) in each country were paired and randomized 1:1 to receive an educational intervention or usual care. The intervention’s two components were education and regular monitoring. Education was provided through various media (eg, web-based materials, videos, and guideline recommendations) to patients, their families, and healthcare providers. It was customized for each country and described the benefits, risks, and costs of anticoagulant therapies. The monitoring component, which included feedback, was designed to promote anticoagulant initiation among appropriate candidates who were not being treated, prevent discontinuation among treated patients, and improve adherence. The investigators collected data at baseline, six months, and 12 months at all sites. The intervention sites had additional telephone calls or patient visits at one month, three months, and nine months.

The primary end point was the change in the proportion of patients treated with oral anticoagulants from baseline to one year. Key secondary end points included the proportion of patients who were on oral anticoagulation at baseline, six months, and 12 months; and the proportion of patients who were not on oral anticoagulation at baseline, but were on this therapy at six months and 12 months. Other secondary clinical outcomes included all-cause death, stroke, transient ischemic attack, and major bleeding.

Anticoagulant Use Increased

In all, researchers enrolled 2,281 participants at 48 clusters. Mean age was approximately 70, and about 47% of participants were women. Five patients (three in the intervention group) were lost to follow-up after baseline. The median follow-up duration was 12 months. Age, sex, educational level, and socioeconomic factors were well balanced between the two groups. The intervention group, however, had a higher proportion of patients with permanent atrial fibrillation, history of major bleeding, systemic embolism, and uncontrolled hypertension, and a lower proportion of patients with rheumatic valvular heart disease, heart failure or left ventricular dysfunction, vascular disease, and previous myocardial infarction, than the control group.

The proportion of patients on oral anticoagulation increased from 68% at baseline to 80% at one year in the intervention group and from 64% to 67% in the control group. The absolute difference between groups in the change of oral anticoagulation use was 9.1%. This result yielded an odds ratio of 3.28, representing the proportional increase in anticoagulation use from baseline to one year in the intervention group, compared with the control group. The effect size in favor of the intervention was consistent across prespecified subgroups. The primary outcome result was consistent in all five countries.

Furthermore, 95% of patients who were on oral anticoagulants at baseline in the intervention group and 94% of patients in the control group continued taking oral anticoagulants at one year. For patients who were not on oral anticoagulants at baseline, 48% in the intervention group and 18% in the control group were on oral anticoagulants at one year. This result yielded an odds ratio of 4.60, representing the proportional increase in anticoagulation use from baseline to one year in the intervention group, compared with the control group.

“Our study also found a reduction in strokes in the intervention group, compared with the control group,” said Renato D. Lopes, MD, PhD, Professor of Medicine at Duke University School of Medicine and principal investigator for Brazil. The hazard ratio of stroke was 0.48 for the intervention group, compared with the control group. “While this was a secondary outcome, it highlights the potential benefit of improved anticoagulation care,” he added.

The number needed to treat was 100 patients exposed to intervention to prevent one stroke event over one year. The rates of all-cause death and the composite of stroke, systemic embolism, or major bleeding did not differ between the intervention and control groups.

Intervention Might Help Patients Worldwide

The majority of participants were using vitamin K antagonists at baseline, and data suggest that non-vitamin K antagonists have advantages (eg, reduced intracerebral bleeds) over this class of oral anticoagulants. Approximately 8% of participants in the intervention group had switched from vitamin K antagonists to non-vitamin K antagonists at one year, while participants in the control group did not change their medication. “A similar educational approach could be used for all anticoagulant classes with even greater benefit to patients,” said Michael D. Ezekowitz, MD, a cardiologist at Lankenau Medical Center in Wynnewood, Pennsylvania, and Anthony P. Kent, MD, a resident at Bridgeport Hospital in Bridgeport, Connecticut, in an accompanying editorial.

The study was limited to five countries and relied on a technological intervention, which might hinder the generalization of the results to broader clinical practice, said Drs. Ezekowitz and Kent. Nevertheless, “we are confident that the impact of IMPACT-AF will benefit patients with atrial fibrillation worldwide,” they concluded.

Erik Greb

Suggested Reading

Ezekowitz MD, Kent AP. The impact of IMPACT-AF. Lancet. 2017 Aug 28 [Epub ahead of print].

Vinereanu D, Lopes RD, Bahit MC, et al. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017 Aug 28 [Epub ahead of print].

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