FDA says it will review the ACCORD data 1

The FDA announced today that it will conduct a review of the ACCORD data. As reported here yesterday, ACCORD found that fenofibrate, when added to statins, failed to improve outcome in patients with type 2 diabetes.

The FDA said it “has made no new conclusions or recommendations regarding the combination use of simvastatin or other statin drugs and fenofibrate.” The FDA noted that the labeling for Trilipix “currently states that no incremental benefit of Trilipix on cardiovascular morbidity and mortality over and above that demonstrated for statin use alone had been established.”
Click here to read the complete FDA statement to healthcare professionals…

Optimal duration of dual antiplatelet therapy still unresolved Reply

The optimal duration of dual antiplatelet therapy following DES implantation is unknown and the subject of intense interest among cardiologists. “Sadly,” writes Peter Berger in an editorial in the New England Journal of Medicine, a study from Korea that attempts to shed light on this issue will “fail to inform physicians’ practice with any degree of confidence… It is an interim analysis of two ongoing, underpowered studies,” he writes.
Click to continue reading, including a comment from Sanjay Kaul…

SORT OUT III chucks out zotarolimus-eluting stents 1

Discussion of drug-eluting stent trials in the interventional cardiology community today is a bit reminiscent of medieval scholars debating the number of angels that can dance on the head of a pin. The debates can be very spirited and each side can find more than enough evidence to support its position.

The latest contribution to the debate comes from Denmark, where the SORT OUT III study group randomized 2332 patients in Denmark to either the zotarolimus-eluting (ZES) or sirolimus-eluting stent (SES). Results of the trial are being presented in Atlanta at the ACC and are now published online in the Lancet.
Click to continue reading, including a detailed comment by David Kandzari…

Boston Scientific suspends ICD sales due to administrative errors Reply

Boston Scientific has suspended sales of its ICDs. The suspension occurred after the company discovered that some of its manufacturing practices had not been submitted for FDA approval. The nature of the error and the duration of the suspension have not been revealed. News of the suspension was originally reported by a Sanford Bernstein analyst. Boston Scientific is reportedly working with the FDA to resolve the problem.

Shares of Boston Scientific were down 15% on Monday morning. Boston Scientific issued the following press release on Monday morning:
Click here to read the Boston Scientific press release…

NAVIGATOR provides little guidance in diabetes Reply

Attempts to navigate the tempestuous waters of diabetes have once again been dashed against the rocks of clinical reality. The trial failed to find any evidence of clinical benefit for either valsartan of nateglinide in patients with impaired glucose tolerance.

Results of NAVIGATOR (Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research) were presented today in Atlanta at the ACC and published simultaneously in the New England Journal of Medicine.
Click to continue reading, including a detailed (and highly critical) comment from James Stein…

EVEREST II: Catheter-based mitral repair system reaches new peak 1

The MitraClip catheter-based mitral valve repair system appears to be safer than mitral valve repair surgery at 30 days and as effective at one year. Ted Feldman reported the results of EVEREST II (Endovascular Valve Edge-to-Edge Repair Study ) this morning at the ACC.

Feldman concluded his presentation by saying that “the MitraClip procedure is an important therapeutic option for selected patients with significant mitral regurgitation given the demonstrated safety, effectiveness and clinical benefit.”
Click to continue reading, including a detailed comment by David Kandzari…

ACCORD fails to find benefits for fenofibrate or lower blood pressure target 1

When added to statins, fenofibrate failed to improve outcome in patients with type 2 diabetes. In addition, lowering systolic blood pressure to 120 mm Hg or lower was no better than the traditional target of 140 mm Hg. These are the main results of the two arms of ACCORD (Action to Control Cardiovascular Risk in Diabetes Study), which were presented this morning at the ACC in Atlanta and published simultaneously in the New England Journal of Medicine.
Click to continue reading, including a comment from Sanjay Kaul…

Plavix label gets black box warning about poor metabolizers 1

The FDA announced today that it had added a boxed warning to the Plavix (clopidogrel) label, warning patients and doctors that the drug may be less effective in people who are unable to metabolize the drug and convert it to its active form.

The FDA said that healthcare professionals “should consider use of other anti-platelet medications or alternative dosing strategies for Plavix in these patients.” The FDA said that patients should not stop taking Plavix without talking to their physician.

Harlan Krumholz provided the following comment to CardioBrief:
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Landslide of Lancet papers suggest importance of blood pressure variability 2

By focusing on blood pressure variability in addition to mean systolic BP a UK researcher may have found an important clue to solving some of the most important lingering mysteries in understanding and treating hypertension. With the extraordinary simultaneous publication of three papers in the Lancet and one in Lancet Neurology, Peter Rothwell has cut to the front of the line and appears to have placed hypertension variability as a top priority for further research.
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NEJM study finds “low diagnostic yield” for coronary angiography Reply

Only a bit more than one-third of patients without known coronary artery disease (CAD)  are found to have obstructive CAD upon elective catheterization, according to data from the ACC National Cardiovascular Data Registry (NCDR).

Manesh Patel and colleagues report in the New England Journal of Medicine on nearly 400,000 patients who underwent elective catheterization. Here are the main results:
Click to continue reading, including comments from George Diamond…

Redberg critical of Obama’s coronary calcium scan Reply

Rita Redberg, in an early release editorial in Archives of Internal Medicine writes that she “was troubled to read” that during his recent physical examination President Obama had received an EBCT coronary calcium scan. Redberg writes: “this screening test likely exposed Mr Obama to significant radiation unnecessarily, increasing his risk of future cancer. A single electron beam CT scan is estimated to result in a lifetime excess cancer risk of 9 (range, 3-42) additional cancers per 100 000 persons for men. In light of this radiation risk,and the lack of proven benefit in low-risk persons, the US Preventive Services Task Force (USPSTF) recommends against this test in men such as Mr Obama. In addition, the leading professional cardiology societies do not recommend coronary calcium screening for such men.”
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Calcium scans: do they now come with a warranty? 2

James Min and colleagues followed 422 patients who had normal (CAC=0) calcium scans and asked the question: “What is the ‘warranty period’ for remaining normal”? The study, along with a provocative editorial by Harvey Hecht,  appears in the March 16 issue of JACC.

Following their initial scans, study subjects then received annual calcium scans. Over the course of five years, 25% of the subjects went on to “convert” to a calcium score greater than zero. “Incidence of conversion to CAC > 0 was nonlinear and was highest in the fifth year,” the authors noted. They were unable to identify clinical factors that would trigger earlier calcium re-tests.
Click to continue reading, including a comment from George Diamond…

ADVANCE-2 apixaban study published in Lancet 1

The ADVANCE-2 study, which was initially presented last summer at the ISTH meeting in Boston, has now been published in the Lancet. The trial randomized 3057 patients undergoing knee replacement surgery for thormboprophylaxis with either apixaban (2.5 mg daily) or subcutaneous enoxaparin (40 mg once daily).

The primary composite endpoint, consisting of asymptomatic and symptomatic deep vein thrombosis, non-fatal pulmonary embolism, and all-cause death during treatment, was reached in 15% of apixaban patients compared to 24% of enoxaparin patients (p<0.0001).  Bleeding was also reduced in the apixaban group.
Click to continue reading…

Guest Post: Sanjay Kaul answers questions about rosiglitazone Reply

Editor’s Note: This post originally appeared on CardioExchange, an online cardiology community in the early stages of development by the New England Journal of Medicine.  In the following piece, CardioExchange editor-in chief Harlan Krumholz and associate editors Anju Nohria and Susan Cheng pose questions about rosiglitazone to Sanjay Kaul, lead author of the recent AHA/ACC science advisory about the cardiovascular risks of thiazolidinedione drugs. CardioBrief readers who are medical professionals are invited to join CardioExchange by registering at the site. (CardioBrief’s Larry Husten is the news editor of CardioExchange.)

Ask the Expert: Rosiglitazone: When Evidence Is Inconclusive Even After FDA Approval

You and your coauthors call the evidence on the cardiovascular risks of rosiglitazone “inconclusive.” When you prescribe a thiazolidinedione, which agent do you choose and why?

For diabetic patients with known ischemic heart disease — particularly older, high-risk patients who take nitrates, ACE inhibitors, or insulin — I prefer pioglitazone over rosiglitazone. Indeed, the FDA has warnedabout the risk for myocardial ischemia from rosiglitazone (but not pioglitazone) in some of these high-risk patients. That said, for a diabetic patient without high-risk characteristics and with well-controlled blood sugar on rosiglitazone, I see no compelling reason to switch to pioglitazone. However, I don’t object if such a patient wants to switch to pioglitazone or any other antidiabetic drug.
Click to continue reading…

ICD implantation may cause cognitive problems, small study suggests 1

ICD implantation may cause cognitive problems, according to a small study published in Circulation: Arrhythmia and Electrophysiology as a rapid access report. Researchers in the UK administered neuropsychological tests to 52 patients before ICD implantation and then at 6 weeks, 6 months, and 12 months following the procedure.

The researchers found that 31-39% of their subjects exhibited neuropsychological problems compared to baseline at some time in the study. Although most problems resolved within a year, the results were not consistent over time. 10% of patients first exhibited problems at 12 months.
Click to continue reading, including a comment from William Maisel…

Screening young athletes: to ECG or not to ECG? Reply

To ECG or not ECG? That is the question ever since Italian investigators claimed that adding an ECG test to the mandatory routine preparticipation screening of young athletes was feasible and effective in reducing the incidence of sudden cardiac death in young athletes. Now two new studies and an accompanying editorial have appeared in Annals of Internal Medicine. But since the papers contain quite different if not exactly contradictory messages, it is unlikely they will provide any resolution to the controversy.

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CREST finds carotid stenting broadly equivalent to endarterectomy Reply

Carotid endarterectomy and carotid stenting produced broadly similar results in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), the largest comparison yet of the two procedures. The results were presented in San Antonio this morning at the American Stroke Association’s International Stroke Conference 2010.

CREST, which was funded by NINDS and Abbott, randomized 2,502 symptomatic and asymptomatic patients with carotid stenosis at 117 centers in the US and Canada. The primary endpoint was the 30 day rate of stroke, death, and MI combined with the rate of ipsilateral stroke over the next 4 years. There was no significant difference between the two procedures (7.2% for stenting versus 6.8% for surgery) at a median followup of 2.5 years.
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Carotid endarterectomy beats stenting in first results from ICSS 1

An interim safety analysis of the ongoing International Carotid Stenting Study (ICSS) offers strong temporary evidence that carotid endarterectomy is preferable to carotid stenting. In a paper appearing in the Lancet, the ICSS investigators report on the incidence of stroke, death, or procedural MI in the 1,713 patients enrolled in the trial. In the carotid stenting group the rate was 8.5% (72 events) versus 5.2% (44 events) in the endarterectomy group (HR 1.69, 1.16-2.45, p=0.006).
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Avandia: a plaque on both your houses! 5

Comment on the News: Avandia continues to dominate cardiovascular-related news this week. Last night the AHA and the ACC issued a highly detailed, thoughtful, though perhaps slightly over-diplomatic science advisory on TZDs and CV risk. Taking a completely opposite tack, GSK, in no mood to take prisoners, and apparently about to nominate itself for a Nobel Prize, issued a 30 page White Paper in response to the Senate report published on Saturday.
Click to continue reading…