ACC and HRS Downplay Data From Their Own Registry

[Updated]– A study in JAMA earlier this week received a lot of attention when it reported that 22.5% of ICD implantations in the US did not have a firm basis in evidence. The study was derived from a very large dataset taken from the NCDR ICD registry, which was established by the American College of…

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Bevacizumab in Breast Cancer Linked to Increase in Heart Failure Risk

A meta-analysis in the Journal of Clinical Oncology suggests that bevacizumab (Avastin) significantly raises the risk for heart failure when given to patients with breast cancer. Toni Choueiri and colleagues analyzed data from 3,784 patients and found a significant increase in the incidence of heart failure among those taking bevacizumab compared with those taking placebo…

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Study Finds Mixed Long-Term Results for AF Catheter Ablation

Long-term results after catheter ablation for AF are decidedly mixed, according to the longest study yet to follow patients after the procedure. In a report in the Journal of the American College of Cardiology, Rukshen Weerasooriya and colleagues followed 100 patients treated at a French hospital for 5 years. After a single procedure, the rates of arrhythmia-free survival…

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J&J Submits Application for Rivaroxaban for Stroke Prevention in AF

Johnson & Johnson announced today that it had submitted a new drug application to the FDA for rivaroxaban for the prevention of stroke and systemic embolism in AF patients. The submission is largely based on the recently reported ROCKET AF trial. J&J also said the company had submitted its response to the FDA’s request for…

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JAMA Study Finds 22.5% of ICDs Implanted Without Evidence Base

A paper in JAMA from a very large registry reports that a substantial proportion of ICD implantations are not supported by a firm evidence base. Sana Al-Khatib and colleagues examined data from the National Cardiovascular Data Registry (NCDR) including 117,707 patients who received ICDs between January 1, 2006 and June 30, 2009 and found that…

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PLATO CABG Substudy Raises Hope and Questions

The much-anticipated CABG substudy from the PLATO (Platelet Inhibition and Patient Outcomes) trialcomparing 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. The study protocol…

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Guest Post: Medicare: The MasterCard That Keeps On Giving

Editor’s Note: This following guest post by Dr. Shanti Bansai is reprinted with permission from CardioExchange. Medicare: The MasterCard That Keeps On Giving by Shanti Bansal, MD In the cardiac catheterization lab one Tuesday morning, I encountered a situation that made me reflect on a bit of 18th-century British history. At that time, the British government was overburdened…

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Abbott and AstraZeneca End Efforts to Develop Certriad (Rosuvastatin/Fenofibric Acid)

Abbott and AstraZeneca announced today that they were discontinuing their collaboration for the development of Certriad, the combination of rosuvastatin and fenofibric acid. The companies received a Complete Response Letter from the FDA earlier this year, and said “the resulting regulatory delay and the commercial attractiveness of the product in the U.S. market.”…

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Apixaban Beats Enoxaparin for Thromboprophylaxis After Hip Replacement

In the ADVANCE-3 trial 5,407 hip replacement patients were randomized to receive thromboprophylaxis with either the new oral factor Xa inhibitor apixaban or enoxaparin. The rate of DVT, nonfatal PE, or death from any cause was 1.4% in the apixaban group compared to 3.9% in the enoxaparin group (RR 0.36, CI 0.22-0.54, P<0.001), thereby demonstrating both…

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Guest Post: Survey or Advertisement?

Editor’s Note: This following guest post by Dr. Micah Eimer is reprinted with permission from CardioExchange. Dr. Eimer is a cardiologist in the northern suburbs of Chicago. Say Hello to Your New Drug Rep? by Micah Eimer, MD Most of the doctors I know have, at one time or another, responded to a web-based “survey”. While I have tried not…

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Guest Post: Another Highly Dubious Article in the American Journal of Cardiology

Editor’s Note: This following guest post by Dr. Roy Poses is reprinted with permission from Health Care Renewal. In the post, Poses finds severe faults with an American Journal of Cardiology review article on beta blockers. Digging further, he finds evidence that the article may only be the tip of a much larger iceberg. You can…

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Dronedarone, Rate Control, and Catheter Ablation Incorporated in Updated AF Guidelines

A focused update on the guidelines for the management of atrial fibrillation has been released by the ACC, AHA, and HRS. Most notably, the new guidelines incorporate recent data from clinical trials evaluating dronedarone, clopidogrel, strict rate control, and catheter ablation. Here are the major highlights of the document:…

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ProPublica: Med Schools Flunk at Keeping Faculty Off Pharma Speaking Circuit

Editor’s Note: The following article is reprinted with permission from ProPublica, the “independent, non-profit newsroom that produces investigative journalism in the public interest.” This is a new installment in the ongoing investigation titled “Dollars for Doctors.” For more information and resources about the investigation, including a tool to look up drug company money paid to physicians,…

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CardioSource and Medpage Today Will Collaborate to Provide News Coverage of Major CV Meetings

Starting next month Medpage Today and ACC’s CardioSource will collaborate to offer detailed, in-depth coverage of more than 15 cardiovascular and cardiovascular-related medical meetings worldwide. The joint project, which will be called “On the Scene,” will be prominently displayed on each website and will be widely distributed via email newsletters to ACC members and cardiologists and…

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FDA Approves Cryoballoon Ablation Treatment for Paroxysmal AF

Medtronic announced today that it had received FDA approval for its Arctic Front® Cardiac CryoAblation Catheter system for the treatment of refractory paroxysmal AF….

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FDA Delays Approval of Brilinta (Ticagrelor)

Updated, Friday December 17, 1 PM– 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 the PLATO data, but did not request any additional studies. AstraZeneca said it…

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Heart Disease and Stroke in 2011: Mortality Continues to Decline, but Overall Burden Remains High

From 1997 to 2007, the death rate from heart disease declined 27.8% and the death rate from stroke declined 44.8%. But inpatient cardiovascular operations and procedures increased during the same period by 27%, and heart disease and stroke cost $286 billion in 2007, more than any other diagnostic group. These are some of the most…

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Dangling Doctors In Front of Journalists

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False-Positive CT Angiogram Leads to Heart Transplant

A 52-year old woman with atypical chest pain ended up with a heart transplant after a CT angiogram to “reassure” her sparked a devastating sequence of events. Following a false-positive CT angiogram, the patient underwent coronary angiography and suffered a dissection of the left main coronary artery, followed by emergency CABG, subsequent graft failure, and…

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Midei’s Business As Usual Defense:”This Is the Way It’s Done”

Mark Midei’s lawyer responded to the sensational reports earlier this week about his client’s relationship to Abbot. In defending his client he gave a preview of Midei’s defense. According to a story by Tricia Bishop in the Baltimore Sun, “it was business as usual for the medical profession.” “All of these events were legal; they were…

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NMT Gets Plugged (Not in a Good Way) by Ben Goldacre

Highly recommended weekend reading: in his Bad Science column in the UK’s Guardian, Ben Goldacre, the physician and best-selling author and columnist, brutally dissects NMT Medical, the troubled medical company that makes closure devices that have had a poor record in the clinical trial arena. CardioBrief readers will likely recall the company’s vicious assault on Peter…

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Spinning Out of Control: Another Look at the PROTECT II Press Release

Editor’s Note: This is a substantially updated version of a previously published story. It includes new commentary from David Hillis, Rick Lange, and myself. Additional update, December 11, 2010: The PROTECT II press release appears to be a very clear violation of the Ingelfinger Rule. Although companies are obligated to release the top line results…

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CDC Demotes Stroke to Fourth Leading Cause of Death

Chronic lower respiratory disease (CLRD) has replaced stroke as the third leading cause of death in the United States, according to preliminary 2008 statistics published by the CDC’s National Center for Health Statistics. In 2008, there were 133,750 deaths from stroke compared to 141,075 deaths from CLRD. Although the stroke rate has been declining for many…

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Meta-Analysis Finds Aromatase Inhibitors Increase Risk for Heart Disease

A new meta-analysis has found that postmenopausal women taking aromatase inhibitors (AIs) instead of tamoxifen to treat breast cancer appear to be at increased risk for cardiovascular complications. The results were presented at the San Antonio Breast Cancer Symposium….

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Abbott Subsidiary Pays $41 Million Penalty for Niaspan/Advicor Kickbacks

The US Department of Justice announced today that Kos Pharmaceuticals, a subsidiary of Abbott Laboratories, will pay $41 million dollars to resolve liability for paying kickbacks and engaging in other illegal activities in marketing Advicor and Niaspan. The Justice Department said that the company offered and paid “illegal kickbacks in the form of money, free…

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