CardioBrief

The FDA today announced an expanded indication for rosuvastatin (Crestor) for the primary prevention of cardiovascular disease. The decision follows a positive vote last December by an FDA advisory panel.

Notably, the new label does not endorse the use of rosuvastatin for everyone with elevated CRP levels and does not contain an indication for the reduction of total mortality or cardiovascular death. Sanjay Kaul, who served on the FDA advisory panel and has been skeptical of a broad interpretation of JUPITER, provided the following comment: “The FDA recommendation for the use of Crestor is faithful to the evidence because in the JUPITER study individuals with less than two risk factors failed to derive significant treatment benefit. Furthermore, the label appropriately does not include a mortality indication.”

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A calcium score of zero does not completely rule out significant coronary disease, according to the surprising results of a substudy of the CORE64 multicenter trial, in which patients referred for angiography were also asked to undergo a calcium scan. Ilan Gottlieb and colleagues report in the Journal of the American College of Cardiology on 291 patients enrolled in the study, of whom 72 had a calcium score of zero. 14 of these patients (19%) had at least one lesion with > 50% stenosis. In the study as a whole there were 64 totally occluded vessels, of which 13 (20%) had no calcium. 9 patients with no calcium underwent revascularization.
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Updated with remarks from William Maisel and a statement from Boston Scientific– A case of a weakened bond between the header and case of a subcutaneously implanted Cognis CRT-D is raising new concerns about the Boston Scientific Cognis and Teligen ICDs. Last December Boston Scientific issued a product advisory based on two cases of a weakened header bond in ICDs that had been implanted subpectorally. Subpectoral implants account for approximately 5% of procedures, according to the company. Now, with the report of a weakened header bond in a Cognis ICD that had been implanted subcutaneously, concerns are being raised about a much larger number of devices that have already been implanted.
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On the one hand, a lot of people who should be taking aspirin aren’t doing so. On the other hand, a lot of people who are taking aspirin shouldn’t be doing so. Those are the dual conclusions of a new report and accompanying editorial from the REACH Registry appearing in the American Journal of Cardiology.

Chris Cannon and fellow REACH registry investigators analyzed data from more than 25,000 US patients with vascular disease or multiple risk factors and found that only 70% were taking aspirin. Approximately half of these were taking other antithrombotic agents, but the other half– 15% of the study population– were not receiving any antithrombotic therapy.
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Following implantation of a drug-eluting stent (DES), patients who were taking a proton pump inhibitor (PPI) had more major adverse events (MACE) than patients not taking a PPI, according to a new report by Gaglia et al published online in the American Journal of Cardiology.
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Mauricio Arruda performed a live AF ablation at University Hospitals in Cleveland on the Today Show yesterday morning.

The 6-minute segment was relentlessly upbeat. The TV producers pulled every trick in the book to overcome the inherent difficulty of portraying a hard-to-explain disease like AF and an even harder-to-explain procedure like catheter ablation. Instead of making any effort to truly educate their viewers, the producers took the easy route. Arruda, staring at a bank of large display monitors, might as well have been playing a video game, for all anyone watching might have known. And the reporter, NBC Medical correspondent Dr Nancy Snyderman, substituted schmaltz for substance and presented the “heartwarming” story of the patient, a great-grandmother, accompanied by stirring music and sentimental images.
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In the absence of “definitive evidence,” universal dietary sodium reductions are a “rash route,”  writes Michael Alderman in a JAMA commentary. Although measures to cut salt have been gaining widespread support– see the recent study and editorial in the NEJM, as well as a detailed discussion of US efforts to cut salt in heartwire– Alderman says these measures have not been validated, and he calls for “large-scale, population-based randomized clinical trials.”
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Boston Scientific said today that it had paid Johnson & Johnson $1.725 billion to settle 3 longstanding patent disputes. The Wall Street Journal Health Blog observed that J&J’s total sales of drug-eluting stents last year were only $919 million.
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Editor’s Note: The following is a guest post by Joseph Ross, an assistant professor at the Mt Sinai School of Medicine. This post originally appeared on CardioExchange, an online cardiology community in the early stages of development by the New England Journal of Medicine. The editor-in-chief of CardioExchange is Harlan Krumholz, who frequently collaborates with Ross. CardioBrief’s Larry Husten is the news editor of CardioExchange.

Chantix and Cardiovascular Risk: Another Weak Safety Study

by Joseph S. Ross, MD, MHS

In 2008, Dr. John Spangler of the Wake Forest University School of Medicine wrote a letter to the editor of Current Medical Research and Opinion expressing concern about a Pfizer-funded, randomized, placebo-controlled trial of the smoking-cessation drug varenicline (Chantix). By 1 year, the varenicline group had experienced a higher rate of serious adverse events than the placebo group; many were cardiovascular (CV) events. The difference was not statistically significant, but Spangler considered it clinically significant and deserving of further study.
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In its first months on the market, sales of prasugrel (Effient, Lilly and Daiichi Sankyo) appear to have been modest, according to figures released by Eli Lilly today as part of their fourth-quarter and year-end report.
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Click here for a listing of the ACC late-breaking clinical trials…

Observing the QT interval when a patient stands up quickly can provide a simple and quick method to identify patients who may have Long QT syndrome (LQTS), according to Sami Viskin and colleagues in an expedited study in JACC.

The researchers studied 68 patients with LQTS and 82 controls. Each subject had a baseline ECG while lying down and was then asked to stand up quickly. Both groups had a similar heart rate acceleration in response to standing, but significant differences were found in the response of the QT interval.
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It turns out that blood glucose may be a lot like porridge, and that physicians, like Goldilocks, need to get it just right. In a new study appearing online first in the Lancet, researchers from Cardiff, UK and Eli Lilly examined data from 48,000 patients in the UK General Practice Research Database. All cause mortality was lowest in those who achieved an HbA1c level of 7.5%. Mortality increased as HbA1c levels increased or decreased from this level, which the investigators described as a U-shaped association. The analysis was adjusted for age, sex, smoking status, cholesterol, cardiovascular risk, and general morbidity.

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It may not be as sexy as Avatar in 3D at the local Imax, but recent advances in technology may one day allow cardiologists to see 3D images of the coronary arteries in the catheterization lab, according to a new feasibility study published in Circulation: Cardiovascular Interventions.

The new system uses existing X-ray systems in the cath lab and may decrease patient exposure to radiation and contrast dye, say the study’s authors, led by John Carroll at the University of Colorado, and including researchers from Philips. The study compared standard 2-D images to automatically generated, computer-reconstructed 3-D images in 23 patients. The images were obtained using rotational angiography and ECG gated iterative reconstruction.
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Catheter ablation of AF was superior to antiarrhythmic drugs in the ThermoCool AF Trial, according to a new report in JAMA.

Led by David Wilber, the trial investigators randomized 167 patients at 19 hospitals to the multicenter, randomized trial. The primary endpoint was the time to protocol-defined treatment failure within the 9 month evaluation period. At 9 months, 66% of the catheter ablation group were failure free, compared with only 16% of patients receiving drug therapy. At 30 days, major treatment-related adverse events had occurred in 8.8% of the drug therapy group versus 4.9% of the ablation group. In addition, quality of life was significantly better improved in the ablation group.
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The FDA announced today that it had approved liraglutide (Victoza, Novo Nordisk) for the treatment of type 2 diabetes. It is not recommended as initial therapy, and the label includes a black box warning about thyroid tumor risk.
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The FDA today approved the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System. It is the first percutaneous valve to receive FDA approval. The Melody valve is intended to help patients with poorly functioning pulmonary valve conduits delay the need for open-heart surgery.

The device was approved for use under the FDA’s Humanitarian Device Exemption (HDE) program. Use of the valve will therefore only be used at hospitals that have an Institutional Review Board. In October 2006, the valve received the CE mark in Europe, becoming the the first transcatheter valve to receive regulatory approval anywhere in the world.
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A generic form of enoxaparin (Lovenox) may be available in the US sooner than expected, according to Sanford Bernstein analyst Timothy Anderson. In partnership with the biotech company Momenta, Sandoz, the generic arm of Novartis, has been setting prices and soliciting pre-orders for generic enoxaparin, writes Anderson in a research report. “This covert action suggests Novartis believes approval of its generic might finally be nearing.”
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Updated–Following a recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) that sibutramine be withdrawn from European markets, Abbott announced today that it had suspended marketing of the drug in Europe.  The events in Europe  closely follow an announcement earlier in the day from the US FDA that sibutramine will now be contraindicated in people with cardiovascular disease. Abbott said sibutramine would remain available outside the EU.

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The FDA now says that sibutramine is contraindicated in people with a history of cardiovascular disease. The change comes as a result of a safety review of sibutramine announced by the FDA in November. (On the same day the EMEA issued a similar warning about sibutramine.)
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Generic versions of clopidogrel with the alternate besilate salt form have started to capture substantial portions of the Plavix/Iscover (clopidogrel bisulfate) market, according to a research report from Sanford Bernstein analyst Timothy Anderson. Many European countries– but not the US–  consider alternative salt forms of drugs to be acceptable generic equivalents.
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Reducing dietary salt in the US could save thousands of lives each year and prevent even more MIs and strokes, according to a new study in the New England Journal of Medicine. But at least one critic, hypertension expert Michael Alderman, maintains the data are not sufficient to justify a large-scale change in public policy.
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After failing to disclose substantial payments from Merck to Christie Ballantyne, Baylor College of Medicine (BCM) has been put on a very tight leash by the NIH,  according to an article in Nature News by Brendan Borrell. Baylor headed to the NIH’s doghouse last fall, when a Senate investigation uncovered significant expenditures from Merck to Ballantyne and many other researchers. Senator Grassley then sent a query to NIH about Ballantyne and other recipients of the Merck money who were also NIH grantees.

In a letter dated January 14, NIH director Francis Collins informed Grassley that the investigation “raised serious concerns regarding BCM’s compliance” with federal COI regulations. “As a result, the NIH has imposed special award conditions on all BCM grant awards until BCM can assure the NIH that the detected deficiencies noted in their response have been appropriately addressed and BCM can demonstrate compliance…”
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Thoratec’s HeartMate II continuous flow left ventricular assist system (LVAS) has received FDA approval for use as destination therapy for patients who are not eligible for a heart transplant. The device had been previous approved as a bridge-to-transplant.

“The approval of HeartMate II provides an option for heart failure patients who cannot receive a transplant,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in an FDA press release. “Its smaller size and mobility should allow more patients, including women and men of smaller stature, access to treatment.”
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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 estimated the treatment effect of a tailored treatment based on 5 year CAD risk, in which patients with a 5% to 15% risk received simvastatin 40 mg and patients with a CAD risk over 15% received atorvastatin. Compared to treat-to-target approaches from the National Cholesterol Education Program (NCEP) III guidelines, the tailored strategy treated saved 500,000 more quality-adjusted life-years and treated fewer people with high-dose statins.
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