Daiichi Sankyo PREFER in AF registry suggests increased stroke risk among diabetic atrial fibrillation patients

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DiabetesDaiichi Sankyo has announced data from new sub-analyses of the Prevention of thromboembolic events—European Registry in Atrial Fibrillation (PREFER in AF) patient registry, which reveal at-risk patient groups, current treatment gaps in the management of atrial fibrillation and trends associated with specific patient characteristics. These data were presented at the European Society of Cardiology Congress 2016, August 27-31, in Rome, Italy.

The registry, sponsored by Daiichi Sankyo, informs on atrial fibrillation patient profiles in a real-world clinical context, intended to help identify specific at-risk patient groups, including those with co-morbidities that predispose them to thrombotic events. Data from the registry reveals that atrial fibrill
ation patients with diabetes—on insulin treatment—are at a significantly increased risk of stroke/systemic embolism at one year follow-up compared to atrial fibrillation patients without diabetes (5.2% versus 1.9% respectively; hazard ratio 2.89, 95% confidence interval 1.67-5.02; p=0.0002) and compared to those with diabetes not on insulin treatment (5.2% versus 1.8% respectively; HR 2.96, 1.49-5.87; p=0.0019). Interestingly, diabetic patients not receiving insulin therapy had similar incidence of thromboembolic events than patients without diabetes (HR 0.97, 0.58-1.61; p=0.9).

“These results are greatly beneficial to physicians in clinical practice,” comments Giuseppe Patti, Campus Bio-Medico University, Rome, Italy and lead author of the study. “The burden of atrial fibrillation is a considerable healthcare issue which carries a heightened risk of stroke for over six million sufferers in Europe. The availability of robust, real-world data to inform on patients at even greater risk of stroke or systemic embolism, will help identify where specific care is needed to minimise these outcomes.”

According to a company release, the registry has also enabled a comparison of specific patient characteristics such as gender alongside clinical aspects including therapy choice and clinical outcomes. The registry has revealed that women experience a greater burden of symptoms compared to men and that treatment with oral anticoagulation is similar in both genders. Compared to men, women were found to be at 65% lower age and country-adjusted risk of coronary revascularisation at one year (95% CI [0.22, 0.56]), 40% lower risk of acute coronary syndrome (0.38 to 0.93) and 20% lower risk of chronic heart insufficiency/reduced left ventricular ejection fraction (0.68, 0.96). There was no evidence that men and women differed in stroke, transient ischaemic attack, arterial thromboembolic events and major bleeding events over one year. Further research is needed to establish whether this can be used to enhance atrial fibrillation management, determining prevention and treatment needs.

“Atrial fibrillation represents a significant concern across Europe, and we are pleased that the PREFER in AF registry sheds light on the current management of atrial fibrillation in a clinical setting, through delivery of this additional sub-study data,” states Juan-Carlos Jaramillo, Senior Vice President, Head of Market Access & Medical Affairs, Daiichi Sankyo Europe GmbH. “By adding to the data available in this important disease area, Daiichi Sankyo is committed to supporting advancement in cardiovascular medicine and improvements in patient care.”

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