The AHA and the ACC have released updated 2011 guidelines for PCI and CABG. The guidelines are available online on the JACC website (here and here) and on the Circulation website. The new guidelines include for the first time a strong recommendation that hospitals adopt a “heart team” approach in choosing a treatment strategy for patients with coronary…

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The RECLOSE 2–ACS (Responsiveness to Clopidogrel and Stent Thrombosis 2–ACS) trial from Italy provides new information about platelet reactivity but doesn’t answer any of the key questions about the possible role of platelet function testing in clinical practice. In a paper published in JAMA, Guido Parodi and colleagues report on 1,789 ACS patients who underwent PCI and…

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AstraZeneca will be charging a premium price for its new antiplatelet drug ticagrelor (Brilinta). Wall Street analyst Timothy Anderson reports that the daily treatment cost for the drug will be $7.24 on a wholesaler acquisition cost (WAC) basis, which is approximately 20% higher than the daily cost of $6.08 for clopidogrel (Plavix) and about 25%…

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Three experts discuss whether — and with which patients — they will use ticagrelor in clinical practice.

Although the PLATO trial demonstrated the overall superiority of ticagrelor (Brilinta, AstraZeneca) to clopidogrel in more than 18,000 acute coronary syndrome patients worldwide, approval of the drug in the U.S. has been delayed because of ticagrelor’s lack of effect in the prespecified subgroup of patients from North America. Now, two analyses of the trial, presented…

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The much-anticipated CABG substudy from the PLATO (Platelet Inhibition and Patient Outcomes) trial comparing ticagrelor to clopidogrel in ACS patients has been published online in JACC. About 10% of the 18,624 patients enrolled in  PLATO underwent CABG. The substudy reports on the 1,261 who received the study drug within 7 days prior to their surgery….

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Despite widespread expectations of an easy approval, the FDA has issued a complete response letter to AstraZeneca for Brilinta (ticagrelor). According to a press release from the company, the FDA has asked for additional analyses of data from the pivotal PLATO trial, but did not request any additional studies. AstraZeneca said it is evaluating the…

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Ticagrelor has received approval for marketing in Europe, according to AstraZeneca. The drug, which will go under the brand name of Brilique in Europe, will not be available in most European countries until the second half of 2011, the company said. A decision about the approval of ticagrelor in the U.S., where it will be…

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FDA watchers require patience. AstraZeneca announced that the FDA had extended its review of ticagrelor (Brilinta) until December 16. The previous deadline had been September 16. In July, the FDA Cardiovascular and Renal Advisory Committee voted 7-1 in favor of approving ticagrelor for the indication of STEMI and NSTEMI patients, but the committee and the…

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Genetic substudies across a broad range of large clinical trials that used clopidogrel raise questions about the clinical utility of clopidogrel genotyping. The substudies come from large and important trials like PLATO, TRITON-TIMI 38, CURE, and ACTIVE A. A genetic substudy of PLATO finds that ticagrelor is superior to clopidogrel irrespective of genetic subtype. Therefore,…

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