ESC: apixaban beats aspirin for stroke prevention in AF

The AVERROES (Apixaban Versus Acetylsalicylic acid (ASA) to Prevent Strokes) trial randomized 5600 AF patients who were unable to take warfarin to receive either aspirin or apixaban, a Factor Xa inhibitor. (Another trial still underway, ARISTOTLE, is a direct comparison of warfarin and apixaban in AF.) AVERROES was stopped early after the Data Monitoring Committee…

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ESC: no benefits for low dose heparin over standard heparin in FUTURA OASIS 8

FUTURA (Fondaparinux Trial With Unfractionated Heparin During Revascularization in Acute Coronary Syndromes)/OASIS-8 is the first trial to compare low dose unfractionated heparin with conventional heparin dosing in PCI patients receiving fondaparinux. Sanjit Jolly and colleagues randomized 2026 non-STEMI  high-risk patients undergoing PCI within 72 hours to either low-dose unfractionated heparin or a standard dose of…

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ESC: positive results for rivaroxaban in EINSTEIN-DVT

The EINSTEIN-DVT study tested the effect of the new oral anticoagulant rivaroxaban in the setting of DVT. The open-label, non-inferiority study randomized more than 3,400 patients with acute, symptomatic DVT to either oral rivaroxaban or conventional therapy with enoxaparin followed by warfarin or acenocoumarol for three, six or 12 months, based on the attending physician’s…

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Circulation: African-Americans at higher risk for stent thrombosis

African-Americans are nearly three times more likely to develop stent thrombosis after receiving a drug-eluting stent, according to a new study appearing in Circulation. Ron Waksman and colleagues analyzed data from a large, single-center registry of 7,236 patients who received a DES and found that African-American race was the single strongest predictor for late stent thrombosis,…

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Dronedarone and ticagrelor speed into ESC guidelines

Getting into the guidelines can be a slow and laborious process. Some critics complain that it takes too long for new therapies to receive the guideline seal of approval. But with the new guidelines released at the ESC it’s unlikely that anyone will complain about such dawdling. With unprecedented speed, dronedarone  and ticagrelor have achieved…

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ESC: 4 year findings from the REACH registry

“Not all atherothrombosis is equal.” That’s the message from the latest findings of the international REACH (Reduction of Atherothrombosis for Continued Health) registry of more than 45000 patients with atherothrombosis. According to the REACH investigators, “easily demarcated subgroups of atherothrombotic patients had widely varying risks, ranging from 7% in nondiabetic patients with other risk factors…

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ESC responds to controversy over previous publication of a Hot Line trial

The ESC has responded to the controversy surrounding the previous publication of data presented in Sunday’s Hot Line session of the STAR Heart Study of stem cell therapy. (See our earlier story here.) The ESC statement said “this clearly breaks ESC rules for Hot Line Sessions which state that information must be first presented at ESC Congress…

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ESC: genetic substudies of large trials question value of clopidogrel genotyping

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….

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ESC: Superiority of dabigatran more evident in places where INR is not well controlled

At last year’s ESC the RE-LY trial heightened interest in the prospect of dabigatran as a potential replacement for warfarin. Now the RE-LY investigators have analyzed the trial in an attempt to see whether the local standard of care has an impact on the beneficial effects of switching to dabigatran. In a presentation at the…

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ESC: downshifting heart rate in HF found beneficial

Update: The ESC has posted the presentation and discussion slides for SHIFT. In the SHIFT trial Karl Swedberg and colleagues tested the effects of ivabradine, a selective sinus-node inhibitor, on 6558 patients with heart failure who had a heart rate > 70 bpm. After a median 22 months of followup, the rate of cardiovascular death…

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ESC hot line trial turns out to be ice cold

The thing about hot line sessions is that the trials are supposed to be hot, or at the very least lukewarm. Certainly they’re not supposed to be cold. But at the press conference for the first hot line session here in Stockholm today, reporters and other observers were caught off guard when they learned that…

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ESC: Alpha Omega Trial Tests n-3 Fatty Acids in CV Disease

Kromhout

To test the effect of n-3 fatty acids in cardiovascular disease, Kromhout and colleagues in the Alpha Omega Trial group randomized 4,837 patients with a history of MI to treatment with  4 different margarine preparations containing n-3 fatty acids: (EPA and DHA; ALA; EPA, DHA, and ALA; or placebo). After 40 months, the rate of…

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FDA approves combination of aliskiren and amlodipine for treatment of hypertension

Novartis announced that it had received FDA approval to market Tekamlo, a combination of aliskiren and amlodopine. The drug has been approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals, and as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren…

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The debate over CME and industry influence continues

Editor’s note: Back in June (Listening to industry: what’s the ROI of medical education?) I commented on some statements made by Bill Cooney, the President & CEO of Medpoint Communications, which is, in its own words, “a global leader in diversified communications services for leading pharmaceutical and biotechnology companies.” Cooney recently commented on my post, and this…

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FDA sets September 20 date for dabigatran (Pradaxa) advisory panel

The FDA has announced that dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in atrial fibrillation will be the subject of a Cardiovascular and Renal Drugs ADvisory Committee on September 20. (h/t to Larry Biegelsen)…

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I guess the ESC is really happening…

ESC start

The ESC just tweeted this picture:…

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AHA Late-Breakers: ASCEND-HF, ROCKET-AF, GRAVITAS, BASKET PROVE, DEFINE and more

The AHA has published the list of late-breaking clinical trials to be presented at scientific sessions in November. Some highly anticipated trials include: ASCEND-HF– the 7000 patient trial with nesiritide designed to resolve the long-standing controvery over the drug) ROCKET-AF– the pivotal trial for the factor Xa inhibitor rivaroxaban for stroke prevention in AF GRAVITAS–…

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CardioBrief: AHA Science Advisory Calls for More Research on CVD in Asian-Americans

In a “Call to Action” contained in a new scientific statement, the American Heart Association says that more research is needed on cardiovascular disease in Asian-Americans. “Available research shows that subgroups of Asian-Americans are at increased risk of complications and death from cardiovascular disease; however, Asian-Americans are often studied as a group, which masks the differences…

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GSK letter to TIDE investigators provokes Avandia critics

A letter describing the July FDA advisory panel on Avandia that was sent by GlaxoSmithKline to TIDE investigators has sparked criticism from some FDA officials and panel members, according to an article by Gardiner Harris in the New York Times….

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Saving time and setting the clock back in STEMI

Efforts to speed delivery of PCI to STEMI patients have focused on shortening the door-to-balloon time. Now a group of Danish researchers propose that efforts to improve care must include assessment of treatment from the time of the patient’s first contact with the emergency medical system. Analyzing historical data from 6209 MI patients who received…

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Debating medical promotion and education

Back in June (Listening to industry: what’s the ROI of medical education?) I commented on some statements made by Bill Cooney, the President & CEO of Medpoint Communications, which is, in its own words, “a global leader in diversified communications services for leading pharmaceutical and biotechnology companies.” Cooney recently commented on my post, and this has provoked…

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CardioBriefs: Red meat, antagonistic people, and chocolate

The following items are republished with permission from CardioExchange, a new website for cardiovascular healthcare professionals from the New England Journal of Medicine. CardioBrief readers who are healthcare professionals are invited to join the site. A Treat for Chocolate Lovers from Sweden In a report that will surely provide comfort to millions, a study of 31,823…

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CRESCENDO: The Fat Lady Sings for Rimonabant

The CRESCENDO (Comprehensive Rimonabant Evaluation Study of Cardiovascular Endpoints and Outcomes) trial testing the effects of the endocannabinoid receptor blocker rimonabant for the prevention of cardiovascular events was terminated early at the request of regulatory agencies in several countries following growing concern at the time that people taking rimonabant were more likely to commit suicide….

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AJC editorial seriously proposes that statins be offered freely at fast food restaurants

Macstatin

At the height of the optimism over statins people used to joke that statins should be put in the water. No one is arguing for that anymore, but now a British cardiologist is proposing– apparently seriously– that statins should be made freely available just like ketchup and other condiments at fast food restaurants. Although the…

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SHAPE shifting: transforming guidelines into a business venture

SHAPE Center 1

Earlier this week we reported that SHAPE was preparing to update its controversial guidelines. It now appears that the guidelines are only the public facade of a larger program designed to encourage the growth of, and take a larger share of, the business of cardiovascular screening. Although conflict-of-interest concerns have previously swirled around SHAPE, new…

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