The FDA rejected a new indication for Merck’s Vytorin and Zetia (ezetimibe plus simvastatin and ezetimibe alone) in chronic kidney disease patients. As a consolation prize, however, the agency approved a new label for Vytorin that will incorporate the results of SHARP (Study of Heart and Renal Protection), which found that the drug combination reduced the incidence…

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Although venous thromboembolism (VTE) is a serious problem for acutely ill patients in the hospital, a new study published in the New England Journal of Medicine failed to find any improvement in mortality associated with thromboprophylaxis. Ajay Kakkar and the LIFENOX investigators randomized 8307 acutely ill patients to receive enoxaparin or placebo for 10 days. All patients wore…

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A large new study from Denmark provides the best evidence yet that third-generation oral contraceptives (OCs) containing drospirenone, desogestrel, or gestodene (sometimes used to treat dysmenorrhea) are associated with twice the risk for venous thromboembolism (VTE) as second-generation OCs containing levonorgestrel. In a paper published in BMJ,  Øjvind Lidegaard and colleagues analyzed data from national registries containing…

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The ACC and the AHA have released updated guidelines for managing peripheral artery disease (PAD). The document is available online in the Journal of the American College of Cardiology and in Circulation. The new guidelines place a greater emphasis on tobacco cessation, requesting healthcare providers to consistently ask patients about their smoking status and to offer support to help them…

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Experience really does count when it comes to carotid artery stenting, and that may be a big problem, since most current operators do not have substantial experience with the procedure.

In an observational study involving Medicare patients undergoing carotid stenting between 2005 and 2007, Dr. Brahmajee Nallamothu and colleagues showed that low annual operator volume and early experience are associated with increased 30-day mortality. CardioExchange Interventional Cardiology moderators Rick Lange and David Hillis have posed the following questions to Dr. Nallamothu: RL and DH: Did…

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In recent years stenting for intracranial arterial stenosis has become widespread. Now, however, a trial testing the procedure has been terminated early, raising serious questions about both the safety and efficacy of the technique. In the SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) trial, which has now been published…

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In January 2011, we blogged about ABSORB, a  bioresorbable stent, when it received CE approval for use in Europe. Drug-eluting stents (DES) are composed of a metal scaffold that is coated with a polymer containing an antiproliferative agent , which is released gradually over the weeks to months after the stent is inserted.  The durable polymer residue…

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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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The difference in stroke mortality among countries in Europe and Central Asia is large and, somewhat surprisingly, is growing larger, according to a new analysis of data from the World Health Organization. In a paper published online in the European Heart Journal, Josep Redon and colleagues examine recent 15-year trends from 39 countries. They report…

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