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For six decades, warfarin cemented its reputation as the world's most effective anticoagulant--and the most troublesome to dose appropriately. In recent years, a host of new agents have been vying to be the long-sought-after alternative to warfarin by posing fewer risks and doing away with the need for regular INR monitoring.
Two separate experiences with dabigatran from different US centers showing very different results, and new cost-effectiveness analyses with the new drugs were reported in a poster session at last week's ACC meeting.
In its final draft guidance, the UK National Institute for Clinical Excellence has recommendedrivaroxaban as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation.
UPDATED // The FDA has granted priority review to rivaroxaban for the additional indication of ACS, meaning a decision will be made within six months of the filing of this application rather than 10. The agency has also extended the review time for apixaban for prevention of stroke in atrial fibrillation by three months, because of additional clinical information submitted by the manufacturers.
Substudies of the ARISTOTLE and AVERROES trials find apixaban is safe and effective for patients with previous events vs warfarin and aspirin respectively.
Dr Valentin Fuster sits down with Drs William Boden, John Chapman, Keith Fox, Anne Gillis, Jessica Mega, and Clyde Yancy to tackle the brave new world of antithrombotics and to ask whether academics have left the real world, and their patients, behind.
The US consumer group says there are several areas of uncertainty in the ROCKET-AF trial that raise questions as to whether rivaroxaban is as safe and effective as warfarin and asserts that the new indication should not be approved until further studies have been conducted to address these issues.
Join Drs Samuel Goldhaber, Jean-Pierre Bassand, Stavros Konstantinides, and Alexander GG Turpie as they guide the clinical practitioner through the landscape of novel anticoagulants in AF.
UPDATED WITH COMMENTARY//In the FDA briefing documents for the committee, which were posted online Tuesday, the clinical review recommends that a complete response letter be issued and that the drug's sponsor conduct additional studies before the FDA approves the latest anticoagulant on the scene for stroke prevention in atrial fibrillation.
Share the excitement from the blockbuster ESC 2011 Congress with Drs Valentin Fuster, Mariell Jessup, Adnan Kastrati, Magnus Ohman, Terje Pedersen, Silvia Priori, and Bryan Williams.
With ROCKET-AF meeting its primary end point and now being published in the New England Journal of Medicine, the next step for the new oral anticoagulant will be the FDA advisory panel review in September.
One investigator says the idea of adding anticoagulants to antiplatelet therapy following acute coronary syndrome is likely "just not a good idea in your run-of-the-mill post-ACS patients."
CORRECTED // When the ESC was planning new guidelines on the treatment of atrial fibrillation, the task force expected to be able to include information on trials of many new anticoagulants that were about to come on the market. But only a few of these expected trials were complete when guidelines were published in September 2010, so the ESC is considering another update.
Researchers say new bleeding-risk data from the RE-LY trial suggest that the 110-mg dose may be best for patients older than 75 years and provide a rationale for the FDA to revisit this issue.
A new factor Xa inhibitor, apixaban, has cleared the penultimate hurdle on the road to EU approval for the prevention of venous thromboembolism in patients undergoing elective hip- or knee-replacement surgery.
It seems likely that there will be two new oral anticoagulants available in the not-too-distant future that can be used as an alternative to warfarin in the prevention of stroke in AF patients. But how do the two new agents compare with each other, and what about other possible indications and the host of other similar agents in development?
CORRECTED // The investigational factor Xa inhibitor edoxaban will not be developed for the prevention of VTE in the US and EU; rather, the company is concentrating its efforts on AF and treatment of VTE. For these indications, edoxaban will be racing another factor Xa inhibitor, apixaban, to market.
The absolute reduction in VTE risk was 0.76%, meaning that for every 125 patients treated with apixaban instead of enoxaparin, clinicians would prevent one episode of major VTE, report investigators.
In a week when new factor-Xa inhibitors have dominated the news, the announcement that yet another agent in this class has run into trouble will raise questions about ACS trials for its competitors.
UPDATED WITH COMMENTARY // ROCKET AF, as previously reported, met its primary end point of noninferiority, but one of two prespecified superiority analyses, the gold standard intention-to-treat, failed to show the drug was better than warfarin for the prevention of thromboembolic events in patients with nonvalvular AF. The second per-protocol on-treatment analysis, however, showed superiority.
The European Society of Cardiology announced new clinical guidelines for atrial fibrillation at its congress in Stockholm last week, the first time such recommendations have been prepared by European societies acting alone. Highlights include guidance on the use of dronedarone, better risk profiling for stroke in anticipation of new oral anticoagulants, the formal acceptance of ablation as a treatment option, and the recognition that lenient rate control is a satisfactory alternative to strict control.
Atrial-fibrillation patients in the trial treated with apixaban had a 54% lower risk of stroke or systemic embolic events, and, of note, the reduction came without an increase in bleeding events. The positive results now leave clinicians awaiting head-to-head comparisons of warfarin vs apixaban in the atrial-fibrillation setting.