Study suggests fixed doses of statins may be better than treating to target

In recent years the “treat to target” method for giving statins for prevention has gained widespread acceptance among healthcare professionals. Now a new study in the Annals of Internal Medicine finds evidence that an approach using fixed doses of statins based on the risk levels of individual patients might be better. Rodney Hayward and colleagues…

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Maryland hospital tells hundreds of heart patients their stents may have been unnecessary

St Joseph Medical Center in Towson, MD has informed hundreds of patients who received stents that they may have undergone an unnecessary procedure, according to a story by Robert Little in the Baltimore Sun. The action is the latest development in a federal investigation of health-care fraud into the hospital’s cardiology practice, according to the story….

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New research links radiation exposure to CV disease

Excess stroke and heart disease deaths may account for one-third as many radiation-associated excess deaths as cancer among survivors of Hiroshima and Nagasaki. That is the surprising and perhaps ominous finding of a prospective cohort study in BMJ of 86,611 atomic bomb survivors who received estimated radiation doses ranging from 0 to >3 Gy….

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Judge rejects ACC lawsuit against HHS Secretary Sebelius over Medicare cuts

A US District Court judge in Florida has blocked the ACC’s legal effort to overturn Medicare reimbursement cuts to cardiologists. The ACC published a statement on its website and the story was covered by Andis Robeznieks in Modern Healthcare….

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Lancet editorial on PLATO: ticagrelor the “new standard of care” in ACS

Results of the PLATO substudy of ACS patients undergoing an invasive strategy have been published in the Lancet, accompanied by a comment from Gregg Stone hailing  the introduction of ticagrelor as a landmark event that will redefine the care of ACS patients. The results of the substudy were originally presented by Chris Cannon at TCT and…

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SYNTAX: have drug-eluting stents removed the “death penalty” associated with diabetes and multivessel PCI?

A study of the 1-year results of diabetics enrolled in SYNTAX shows, as expected, that diabetic patients treated with a Taxus stent have a higher rate of revascularization than their counterparts randomized to surgery, but has somewhat unexpectedly found no significant differences in the composite safety end point of death, stroke, or MI. “Although further…

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Cocaine plays role in 3% of sudden deaths in Spain

Cocaine plays a role in 3% of sudden deaths in Spain, according to a new study appearing in the European Heart Journal. Most of the cocaine-related deaths were due to cardiac or cerebrovascular causes. Forensic pathologists in Spain carefully studied all the surrounding circumstances of a consecutive series of sudden deaths and found that 21…

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Increasing adherence to statins would save twice the number of lives as expanding eligibility

Although the beneficial effects of statins have been widely recognized, there is no agreement over the exact composition of the population who should receive statins. Now a new study from the UK makes the important point that extending the statin-eligible patient population would be far less effective than improving adherence in patients who are already…

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FDA’s Cardiorenal panel unanimously rejects nebivolol for HF

The FDA’s Cardiovascular and Renal Drugs advisory committee has unanimously voted to reject a heart failure indication for Forest Laboratories’ Bystolic (nebivolol). The vote follows an extremely negative FDA staff review posted last week, as reported by CardioBrief at the time. Click here to read a Dow Jones news report on the panel meeting. Click…

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Archives: Not all guidelines are created equal

Guidelines are supposed to ease the digestion by busy doctors of all the new data being crammed down their throats, but a new study in Archives of Internal Medicine suggests that doctors may one day need guidelines for the guidelines….

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Reevaluating ESAs: too little, too late?

The NEJM Perspective by 4 top FDA officials raises several questions: what was the FDA’s role in creating the current situation? And is the “reevaluation” mentioned by the FDA officials a good example of “too little, too late”? Anyone reading the article would be hard-pressed to know that the FDA played a key role in…

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Completion of IMPROVE-IT now delayed until June 2013

To the surprise of absolutely no one, the latest forecast for the completion of the long-awaited IMPROVE-IT trial has been moved back a year to June 2013. Merck announced the change, which appeared on the IMPROVE-IT page on ClinicalTrials.Gov, in a press release (below) and a FAQ….

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COMPARE investigators in the Lancet: “paclitaxel-eluting stents should no longer be used in everyday clinical practice”

Everolimus-eluting stents are superior to paclitaxel-eluting stents, and the latter should no longer be used in everyday clinical practice. That’s the conclusion of the COMPARE investigators in a report published online in the Lancet. But at least one expert in the field, David Kandzari, thinks the conclusion, though justified by the data, goes beyond the simple…

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FDA staff recommends against heart failure indication for Bystolic (nebivolol)

FDA staff reviewers have strongly recommended that Bystolic (nebivolol) not receive a new indication for heart failure. The scathing review was published on the FDA’s website in advance of next Monday’s meeting of the Cardiovascular and Renal Advisory Drugs committee. The recommendation of the clinical reviewer was about as clear and concise as you will…

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Note to readers: CardioBrief editor to join forces with NEJM’s CardioExchange

Dear Reader, I am pleased to invite you to participate in CardioExchange, an exciting new cardiology community in the early stage of development by the New England Journal of Medicine and Journal Watch….

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NEJM: FDA to reevaluate ESAs in treatment of anemia

The FDA plans to convene an advisory panel in 2010 “to reevaluate the use of ESAs in the treatment of anemia due to chronic kidney disease,” according to a “Perspective” written by four FDA officials in the New England Journal of Medicine. In response to the failure of 3 large clinical trials to establish any…

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Braunwald: “In all fairness, what was OK three years ago is not OK now.”

A new policy from Partners Healthcare that limits compensation to doctors from industry is provoking lots of discussion (see below), at least in part because of a story in the New York Times by Duff Wilson. (Click here to read the press release Partners issued last April. Click here to read the full report.) One…

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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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