ESC: apixaban beats aspirin for stroke prevention in AF Reply

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 found clear evidence of clinically important benefit and an acceptable safety profile.

Stuart Connolly reported a reduction in the primary endpoint of the study, a composite of stroke or systemic embolism, from 3.6% per year in the aspirin group to 1.7% per year in the apixaban group (HR 0.46, CI 0.33-0.64, p<0.001). The rate of major bleeding was 1.4% per year on apixaban and 1.2% per year on aspirin (HR 1.14, CI0.74–1.75, p=0.56). Hemorrhage stroke occurred at a rate of 0.2% per year in both treatment groups.
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ESC: no benefits for low dose heparin over standard heparin in FUTURA OASIS 8 Reply

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 heparin adjusted by ACT in addition to fondaparinux. The results were presented at the ESC in Stockholm and published simultaneously in JAMA.
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ESC: positive results for rivaroxaban in EINSTEIN-DVT Reply

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 assessment at baseline.

Dr Harry Büller reported that recurrent symptomatic venous thromboembolism took place in 2.1% of patients in the rivaroxaban group compared to 3.0% of the subjects on conventional therapy (p<0.0001 for non-inferiority). The rate of major and clinically relevant non-major bleeding was 8.1% in each group. Büller reported there were no signals of liver toxicity and that the drug was well-tolerated during the trial.
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Circulation: African-Americans at higher risk for stent thrombosis Reply

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, even after taking other known risk factors into consideration, and even though African-Americans were more likely to comply with their prescriptions for antiplatelet therapy. The late stent thrombosis rate for African-Americans, compared to non-African-Americans, was:
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Dronedarone and ticagrelor speed into ESC guidelines 1

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  class 1 recommendations in the new ESC guidelines released in Stockholm this week. Dronedarone (Multaq, Sanofi) gained a class 1 recommendation for the first line treatment of AF patients who do not have heart failure in the ESC guidelines for the management of atrial fibrillation, while ticagrelor (Brilinta, Astra-Zeneca) which has not yet received regulatory approval anywhere in the world, received a class 1 indication for the treatment of NSTE-ACS and STEMI in the new ESC guideliens for myocardial revascularization. But not everyone is convinced that such haste is warranted.
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ESC: 4 year findings from the REACH registry Reply

“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 for atherothrombosis to 25% in patients with polyvascular disease and prior ischemic events.”
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ESC responds to controversy over previous publication of a Hot Line trial Reply

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 in order to qualify for presentation in a Hot Line session.”
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ESC: Superiority of dabigatran more evident in places where INR is not well controlled Reply

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 ESC in Stockholm and a simultaneous publication in the Lancet, Lars Wallentin and the RE-LY investigators estimated the time in the therapeutic range at each center (cTTR) in the trial. They found that, irrespective of cTTR, when compared to warfarin  high dose dabigatran was effective at reducing stroke, low dose dabigatran was effective at reducing bleeding, and both doses reduced intracranial bleeding. The investigators wrote that the “advantages of dabigatran were greater at sites with poor INR control than at those with good INR control,” and concluded that “overall, these results show that local standards of care affect the benefits of use of new treatment alternatives.”
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ESC: downshifting heart rate in HF found beneficial 2

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 or hospital admission for worsening heart failure was 24% in the ivabradine group and 29% in the placebo group (HR 0.82, 95% CI 0.75–0.90, p<0.0001). The results were presented at the ESC in Stockholm and published simultaneously in the Lancet.
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ESC hot line trial turns out to be ice cold Reply

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 all of the data in one of the day’s hot line trials, The STAR Heart Study, had been previously published in the July isue of the European Journal of Heart Failure.

Update: The ESC has responded to the STAR controversy.
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ESC: Alpha Omega Trial Tests n-3 Fatty Acids in CV Disease Reply

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 major cardiovascular events was not significantly different in any of the groups. There was a trend towards a reduction in events in the subgroup of women who received ALA as compared with women who received placebo and EPA/DHA. The results were presented at the ESC in Stockholm and published simultaneously in the New England Journal of Medicine.
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FDA approves combination of aliskiren and amlodipine for treatment of hypertension Reply

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 or amlodipine alone.
Click here to read the press release from Novartis…

The debate over CME and industry influence continues 1

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 has provoked a fascinating and (highly welcome) civil debate about the role of CME and industry influence. Now Cooney has responded to my most recent comment. His response is reprinted below. The rest of the exchange is available here. I will respond to Cooney’s points late next week after the ESC meeting concludes.

September 5 Update: My response to Bill Cooney has been added at the bottom of this post.
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AHA Late-Breakers: ASCEND-HF, ROCKET-AF, GRAVITAS, BASKET PROVE, DEFINE and more Reply

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– standard versus high-dose clopidogrel according to platelet function testing after PCI
  • BASKET PROVE– late stent thrombosis in DES compared to BMS
  • ASCOT– CRP as an independent predictor of cardiovascular outcomes
  • DEFINE– a first look at anacetrapib, a new CETP inhibitor

Click here for the complete list of late-breakers…

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

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 within this heterogeneous population,” according to Latha Palaniappan, chair of the AHA committee that wrote the advisory, in an AHA press release. The statement is published in Circulation.
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Saving time and setting the clock back in STEMI Reply

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 primary PCI, they found a strong relationship between system delay and long-term mortality:
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Debating medical promotion and education 1

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 a debate which I hope may continue. In any case, I’ve copied and posted here the two rounds of debate. Readers are invited to join the discussion.
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CardioBriefs: Red meat, antagonistic people, and chocolate 1

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 Swedish women found that over 9 years of follow-up, women who regularly consumed moderate amounts of chocolate had a lower risk for developing heart failure than those who ate no chocolate at all. However, no protective effect was observed in women who consumed chocolate one or more times per day. In their paper in Circulation: Heart Failure, Elizabeth Mostofsky and colleagues note that the high-quality chocolate consumed in Sweden contained higher cocoa concentrations, which has been linked to beneficial cardiovascular effects, than chocolate consumed in the United States.
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CRESCENDO: The Fat Lady Sings for Rimonabant Reply

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. At the time of termination 18,695 patients had been enrolled for a mean of 13.8 months. In a report in the Lancet Eric Topol and colleagues report no significant difference between the rimonnabant and placebo groups in the combined rate of cardiovascular death, MI, or stroke. There were 4 suicides in the rimonabant group and 1 in the placebo group. Gastrointestinal, neuropsychiatric, and serious psychiatric side-effects occurred more frequently in the rimonabant group. In their conclusion the investigators note that the trial has significant implications for clinical research and regulators: “The new precedent here is the capacity for such regulatory agencies to stop an ongoing clinical research project.”
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AJC editorial seriously proposes that statins be offered freely at fast food restaurants 3

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 editorial in the American Journal of Cardiology is sure to provoke a heavy barrage of criticism (which has already started in the British press– see articles here and here), the authors actually anticipate, and offer quite brilliant responses to, some of the many expected criticisms. My best guess is that we will all have to wait a long time before ordering a “MacStatin,” but at the very least Darrell Francis and his colleagues have provided fresh food for thought worth chewing over slowly.
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SHAPE shifting: transforming guidelines into a business venture 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 evidence suggests that the non-profit organization has aligned itself with a commercial venture, and presumably stands to benefit from the success of these projects.

A key player is Jeffrey Fine, MS, PhD, the President and CEO of J&J Medical, LLC. The announcement from SHAPE about the new Task Force lists Fine as the “SHAPE Task Force II Executive Coordinator.” On his company website Fine is described in glowing terms:

Dr. Fine is a nationally recognized expert in the fields of coronary artery disease identification, and heart attack prevention including coronary calcium scoring.

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