As dabigatran becomes more widely used in AF patients, electrophysiologists are trying to figure out how to handle anticoagulation in patients taking the drug and for whom AF ablation is planned. In a new study published in the Journal of the American College of Cardiology, Dhanunjaya Lakkireddy and colleagues report on a multicenter, observational study of 290 patients…

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A new meta-analysis finds that dabigatran is associated with a higher risk of myocardial infarction and acute coronary syndromes. An editorial raises questions about the enthusiasm to embrace new drugs.

The FDA announced today that it is initiating a safety review of dabigatran (Pradaxa, Boehringer Ingelheim). The review was prompted by reports of serious bleeding events in people taking the drug. Bleeding complications, the FDA acknowledges, are a “a well-recognized complication of all anticoagulant therapies.” The agency says it is “working to determine whether the reports of…

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Reports from Ireland and New Zealand may herald new concerns about Riata defibrillator leads (St. Jude Medical) and dabigatran (Pradaxa). A poster presented at the European Society of Cardiology meeting last month by researchers at the Royal Victoria Hospital in Belfast found that 15% of 212 patients who received Riata leads had an insulation breach on screening. The researchers reported…

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FDA reviewers have recommended against the approval of rivaroxaban (Xarelto, Johnson & Johnson), which will be the subject of a Cardiovascular and Renal Drugs Advisory Committee meeting on Thursday. The recommendation comes as a surprise, as many physicians and analysts had expected an easy approval for the drug. The bottom line from the FDA reviewers…

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There’s an old maxim in medicine that one shouldn’t be the first to prescribe a new drug, nor the last. A fascinating debate between Michael Ezekowitz from the U.S. and Felicita Andreotti from Italy highlighted the differences between warfarin and the newer oral anticoagulants (NOACs) apixaban, rivaroxaban, and dabigatran. Even Dr. Ezekowitz, the warfarin protagonist…

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In ancient Greece the philosopher Aristotle thought the golden mean was the desirable middle between two extremes, one of excess and the other of deficiency. In cardiology, apixaban may be the golden mean of anticoagulation, achieving the ideal balance of reduced strokes and deaths without causing any additional bleeding complications. The Apixaban for Reduction in Stroke and…

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An electrophysiologist and blogger places the recent approval of rivaroxaban in the context of the seismic changes that have taken place and that are still expected in the anticoagulant marketplace.

An 85-year-old woman with a history of hypertension and Crohn’s disease presented with severe pain in the left hand and was admitted to the hospital. Examination revealed a diminished left-radial pulse; arterial Doppler imaging showed a thrombus in the radial artery. The patient underwent surgical thrombectomy. The workup, including a hypercoagulability profile, was negative. Transthoracic…

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Following the approval last October of dabigatran, some observers criticized the FDA’s decision not to approve the lower 110 mg dose of the drug in addition to the higher 150 mg dose. Now, in a perspective in the New England Journal of Medicine, 3 FDA officials — B. Nhi Beasley, Ellis Unger, and Robert Temple — explain…

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