Leading Israeli cardiologists blocking their country’s participation in planned NIH-funded ISCHEMIA trial

A group of prominent Israeli cardiologists is blocking their country’s participation in the ISCHEMIA trial, the planned NIH-funded follow-up to COURAGE. At a recent meeting of Israeli hospital cardiology department directors, according to an article in the Israeli newspaper Haaretz by Dan Even, the directors recommended that Israel not take part in the trial….

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ICTUS at 5 years still fails to find benefit for early invasive strategy in ACS

The 5-year clinical results of ICTUS (Invasive versus Conservative Treatment in Unstable coronary Syndromes) confirm and extend the one-year results of the trial, which found no evidence of an advantage for an early invasive strategy in the treatment of ACS. The 5-year paper is published online in the Journal of the American College of Cardiology. ICTUS…

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Second study on approval of CV devices largely confirms FDA deficiencies

On the heels of a JAMA study (which we reported earlier today), researchers from the FDA and Beth Israel Deaconess hospital released a similar paper appearing in the American Journal of Therapeutics. The report reaches many of the same conclusions as the JAMA paper, though, naturally, with a somewhat more sympathetic understanding of the FDA’s…

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JAMA review finds multiple flaws in FDA approval of CV devices

The FDA approval process for cardiovascular devices contains multiple flaws and weaknesses, according to a new article appearing in JAMA. Sanket Dhuva, Lisa Bero, and Rita Redberg performed a systematic review of 123 FDA summary of safety and effectiveness data (SSED) released by the FDA following premarket approval (PMA) of 78 CV devices. Although the PMA…

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ACC files lawsuit against HHS Secretary Sebelius over Medicare cuts

The ACC has filed a lawsuit against HHS Secretary Kathleen Sebelius over the 2010 Medicare Physician Fee Schedule. The deep cuts for cardiology services in the new fee schedule are the result of using invalid data “in a manner that threatens access to care for patients and precipitously increases medical care costs,” according to a…

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AHJ editorial calls for “something equivalent to fluoride in the drinking water” to fight SCD

“We believe that the epidemiologic prevention of sudden cardiac death will require something equivalent to fluoride in the drinking water that inhibited dental erosion, that is, a chemical additive to food or water that will stabilize the fibrous cap of the plaque, thereby reducing the probability of plaque erosion, plaque rupture, and sudden cardiac death,”…

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Study finds Sprint Fidelis lead fractures “increasing exponentially”

A large single-center study finds that the rate of Spring Fidelis lead fracture “is increasing exponentially with time and… occurring at a higher rate than the latest manufacturer’s performance update.” The study from the University of Rochester appears in the January 1 issue of the American Journal of Cardiology….

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NEJM: 1 in 6 persons have Lp(a) variant associated with increased CAD risk

Researchers from the Precocious Coronary Artery Disease (PROCARDIS) study have identified commonly occurring SNPs in the LPA gene for Lp(a) that may have an important future role in the diagnosis and treatment of coronary disease. According to the authors of the study in the New England Journal of Medicine, “one in six persons carries a…

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Medicines Company buys ApoA-1 Milano from Pfizer

The Medicines Company announced earlier today that it had acquired the worldwide rights to ApoA-1 Milano from Pfizer. ApoA-1 Milano became the subject of intense interest in 2003 when a study in JAMA by Nissen et al found that the naturally occurring variant of the important HDL apolipoprotein caused a significant regression of atherosclerosis as…

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Genes, stem cells, ticagrelor, and dabigatran among AHA’s top 10 for 2009

The AHA today released its list of the top 10 advances in research in 2009. Here are the titles of the papers:…

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FDA says cancer risk of Vytorin and Zetia is “unlikely”

The FDA “believes it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death.” The FDA statement is a follow-up to its August 2008 early communication about a safety review of the drugs following cancer concerns initially raised by the SEAS trial in August 2008. Despite the reassurance the FDA said it was…

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Lancet: Huge metaanalysis finds no causative role for CRP

CRP is a strong and consistent marker for CV disease and other non-vascular diseases, like cancer and lung disease, but does not appear to be a cause of disease, according to a new meta-analysis in the Lancet. The new study is the largest effort yet to to sort out the controversial role of CRP. The…

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Niacin helps restore protective effects of HDL in diabetics

HDL in diabetics is less protective than HDL in nondiabetics, but niacin can help restore some of its protective effects, according to a new study appearing in Circulation. Investigators from Switzerland and Germany studied HDL from 10 healthy subjects and 33 patients with type 2 diabetes. Sajoscha Sorrentino and colleagues found that HDL from the healthy…

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Primary PCI without surgical backup deemed safe in NYS study

STEMI patients who receive primary PCI in hospitals without surgical backup have no significant differences in rates of death and the need for emergency surgery as similar patients treated at hospitals with surgical backup, according to a new study from the New York State PCI registry appearing in Circulation: Cardiovascular Interventions. However, patients at the…

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Cardiome says vernakalant bests amiodarone in acute conversion of AF

Cardiome announced today that the AVRO study had met its primary endpoint and demonstrated that IV vernakalant was superior to IV amiodarone in the acute conversion of AF. AVRO, according to the company, is a phase 3 European Comparator Study of 254 patients with symptomatic AF of 3 to 48 hours duration….

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AHA: CV disease will cost $500 billion in 2010

The combined direct and indirect costs of cardiovascular disease in the US in 2010 will be half a trillion dollars, according to the AHA, which has just released its Heart Disease and Stroke Statistics – 2010 Update. Here are some other key statistics: In 2006 the overall death rate from CVD was 262.5 per 100 000: white males:…

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Roche announces positive results for 2 more taspoglutide trials

Roche today announced positive results from two more trials with taspoglutide, a once-weekly GLP-1 inhibitor under development. Two weeks ago the company made a similar announcement about two other trials, as we reported here….

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TCFA: “the most relevant form of human disease in the history of mankind”

It’s usually not stated quite so clearly. In an editorial in Circulation: Interventions Mt Sinai’s Pedro Moreno writes: “…our field continues to struggle with the concept that percutaneous intervention may not prevent myocardial infarction or death in the stable patient. The main reason behind this controversial but rather accepted statement is that life-threatening coronary events…

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FDA advisory panel backs expanded indication for Crestor (rosuvastatin)

The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 12-4 today in favor of an expanded indication for rosuvastatin (Crestor). According to an FDA analysis, the expanded indication means an additional 6.5 million people would be eligible to take the drug….

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Review finds “no consistent or reproducible treatment effect” for serial calcium scans

There is no evidence to support annual coronary artery calcium (CAC) screening to measure atherosclerosis progression, according to a systematic review in Archives of Internal Medicine by Peter McCullough and Kavitha Chinnaiyan. Further, an accompanying editorial by Patrick O’Malley argues that “the answer to the problem of rescanning in the community… is to stop the…

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Are CT scans the wild west of today’s medicine?

Are CT scans the wild west of today’s medicine, with little sense of law or regulation and a heightened expectation of premature death? Two new studies appearing in the Archives of Internal Medicine suggest the analogy might not be entirely inappropriate. More than 70 million CT scans are performed each year, representing a tripling of…

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FDA sets stage for Tuesday’s Crestor (rosuvastatin) advisory panel

The FDA has released briefing information for next Tuesday’s advisory panel meeting to consider an expanded indication for rosuvastatin (Crestor). The proposed expanded indication is based on the results of JUPITER and reads as follows:…

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Lancet: bleeding risk in MI patients increases with dual and triple therapy

The risk of bleeding increases as MI patients receive more anthrombotic agents, according to a large new study from Denmark in the Lancet. Investigators studied data from 40,000 first-time MI patients and looked at hospital readmission for bleeding based on the number of antithrombotic agents being taken at discharge….

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Wired: David Eddy’s efforts to replace human trials with computer models

We’re a little behind in our reading so we didn’t notice until now a fascinating feature article by Jennifer Kahn in the December Wired that’s likely to be of significant interest to many CardioBrief readers. The article provides an in-depth look at the efforts of David Eddy to develop highly sophisticated computer models to diminish…

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Medtronic cardiac rhythm device unit under investigation in California

California officials are scrutinizing Medtronic’s cardiac rhythm devices business unit, the company disclosed today. Here is the text on page 51 of the company’s quarterly report:…

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