The Xa inhibitor apixaban proved superior to warfarin in preventing stroke or systemic embolism in patients with atrial fibrillation (AF) while also reducing the risk of major bleeding and death by any cause, according to results of the ARISTOTLE trial. The findings were presented Aug. 28 at the European Society of Cardiology Congress in Paris and simultaneously published in the New England Journal of Medicine.

Researchers have found that patients who receive cardiac electrophysiological devices (CIEDs) are at greater risk of contracting an infection sometime during the lifespan of the device today compared with previous years, according to a 16-year retrospective study published Aug. 30 in the Journal of American College of Cardiology.

IntriCon has received FDA 510(k) clearance for the first-generation wireless cardiac diagnostic monitoring device, which offers wireless transmission of patient data so physicians can continuously monitor cardiac events remotely.

As the race to find newer, safer anticoagulants that are better alternatives to warfarin continues, a study in the Aug. 10 issue of the New England Journal of Medicine showed that rivaroxaban may provide some competition and could be effective in preventing stroke in atrial fibrillation (AF) patients.

To add to the recent saga surrounding dronedarone (Multaq), results of an analysis of the ATHENA trial offered a dose of good news after researchers in Denmark found that the drug reduced the risk for cardiovascular hospitalization and total hospitalizations. The post-hoc data analysis was published in the August issue of Europace.

Cardiac resynchronization therapy with a defibrillator (CRT-D) shows benefit for the prevention of recurring heart failure (HF) events in patients who experienced an initial HF episode, according to a substudy of the MADIT-CRT clinical trial. The substudy also found that the recurrence of HF events greatly increased all-cause mortality risk in this patient population. In an accompanying editorial, the paper is praised for extending clinical knowledge about the long-term effects of CRT. Both the substudy and editorial appear in the Aug. 9 issue of the Journal of the American College of Cardiology.

While dabigatran etexilate (Pradaxa, Boehringer Ingelheim) is a promising alternative for atrial fibrillation (AF) patients who cannot tolerate warfarin, much controversy remains over the FDA's approval of the higher 150 mg dose rather than the lower 110 mg dosage. The drugs indication may very well extend to the elderly, a patient population that may be vulnerable to bleeding risk and overdose, researchers from France wrote in a clinical observation published in the July 25 issue of the Archives of Internal Medicine.

The FDA proposed requiring the filing of a premarket approval application or a notice of product development protocol for the Class III preamendments device implantable pacemaker pulse generator, according to a proposal published July 27 in the Federal Register.