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

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 reason, of course, is that Partners is a major teaching affiliate of Harvard Medical School and includes top-rated Brigham and Women’s Hospital and Massachusetts General Hospital. Another reason is that the chairman of the policy-writing group was Eugene Braunwald.
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Leading Israeli cardiologists blocking their country’s participation in planned NIH-funded ISCHEMIA trial Reply

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 Reply

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 randomized 1,200 patients with ACS to an early invasive or selective invasive strategy. Here are the major results at 5 years:
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Second study on approval of CV devices largely confirms FDA deficiencies Reply

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 constraints.

A team led by William Maisel evaluated all 88 CV PMAs undertaken by the FDA between January 1, 2000 and December 31, 2007, including 132 clinical studies involving more than 37,000 study subjects. They found that safety and efficacy end points were “often not defined with precision” and concluded that their “study findings demonstrate that submitted studies frequently lack important details, including information about study subjects and study end point definitions.”
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JAMA review finds multiple flaws in FDA approval of CV devices 1

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 is reserved for class III devices, which is the highest risk category, the UCSF researchers found that PMA approval “is often based on studies that lack adequate strength and may be prone to bias.”

Among the findings:
Click to continue reading, including comments from William Maisel, Sanjay Kaul, and David Kandzari…

ACC files lawsuit against HHS Secretary Sebelius over Medicare cuts 1

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 press release from the ACC.

Click here to read a USA Today story by Steve Sternberg.
Click here to read the ACC press release…

AHJ editorial calls for “something equivalent to fluoride in the drinking water” to fight SCD 1

“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,” write Arthur Moss MD and Ilan Goldenberg, in a provocative editorial in the January American Heart Journal.
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Study finds Sprint Fidelis lead fractures “increasing exponentially” Reply

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 Reply

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 variant LPA allele and thus has a risk of coronary disease that is increased by a factor of 1.5.”
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Medicines Company buys ApoA-1 Milano from Pfizer Reply

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 measured by IVUS. The company that was developing ApoA-1 Milano, Esperion Therapeutics, was subsequently acquired by Pfizer. Over the years many knowledgeable observers were baffled by the lack of further development of the compound, particularly as Pfizer appeared to place most of its HDL-related efforts on torcetrapib, Pfizer’s CETP inhibitor.  Following the failure of torcetrapib, Pfizer sharply curtailed its cardiovascular research.

Steve Nissen sent the following comment to CardioBrief:
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FDA says cancer risk of Vytorin and Zetia is “unlikely” 1

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 unable to definitively rule out an association “at this time.”
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Lancet: Huge metaanalysis finds no causative role for CRP Reply

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 study, by John Danesh and colleagues in the Emerging Risk Factors Collaboration (ERFC), combined information from 54 studies including 160,000 people in 18 countries. “The relevance of CRP to such a range of disorders is unclear,” the authors write. “Associations with ischaemic vascular disease depend considerably on conventional risk factors and other markers of inflammation.”
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Niacin helps restore protective effects of HDL in diabetics 1

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 subjects, but not from the diabetics, stimulated endothelial nitric oxide production, reduced endothelial oxidant stress, and improved endothelium-dependent vasodilation and early endothelial progenitor cell–mediated endothelial repair, suggesting, “markedly impaired endothelial-protective properties of HDL.”
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Primary PCI without surgical backup deemed safe in NYS study Reply

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 PCI-only hospitals had higher rates of repeat target  vessel PCI, and patients who did not receive PCI had higher mortality rates.
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AHA: CV disease will cost $500 billion in 2010 Reply

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: 306.6 per 100 000
  • black males: 422.8 per 100 000
  • white females: 215.5 per 100 000
  • black females: 298.2 per 100 000

CVD deaths declines from 1996 to 2006 by 29.2%, but in 2006 still accounted for more than one-third (34.3%) of all deaths in the United States (831,272 out of 2,426,264).
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TCFA: “the most relevant form of human disease in the history of mankind” Reply

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 arise most frequently from lesions that escape proper diagnosis and treatment. As a result, our efforts in clinical practice are almost totally consumed by the treatment of lesions that have limited impact on the natural history of atherothrombosis and CAD. Thus, it is imperative to reflect on this paradox, and do something about it.”

Moreno’s editorial is prompted by an interesting but not terribly surprising study by Steven Marso’s group at the Mid America Heart Institute that used IVUS to show that the longer someone has diabetes the more likely they are to have coronary plaque classified as TCFA (thin-cap fibroatheroma). TCFA, of course, is the type of plaque closely tied to plaque rupture and acute events. As Moreno writes:
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Review finds “no consistent or reproducible treatment effect” for serial calcium scans 2

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 current practice of initial screening first.”
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Are CT scans the wild west of today’s medicine? Reply

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 usage since 1993, yet there is little standardization in utilization patterns or radiation doses, and the consequence may be a much higher rate than expected of cancer and death in the coming decades.

“15,000 persons may die as a direct result of CT scans physicians had ordered in 2007 alone,” writes Rita Redberg, in an accompanying editorial.

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Wired: David Eddy’s efforts to replace human trials with computer models 1

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 the need for human clinical trials. Eddy is a polymath who had originally planned to be a  cardiovascular surgeon and was training at Stanford before deciding to restart his career. For the last 30 years he’s held a wide variety of jobs, including a long-term postion as Chief Scientist of the Blue Cross Blue Shield Association/Kaiser Permanente Technology Evaluation and Coverage (TEC) Program.

As often happens in Wired articles, the first half of the article is guilty of untempered enthusiasm for new technology, and naive readers might think that clinical trials with actual human subjects are about to go on the endangered species list, but the second half of the article adds some much-needed balance and perspective, and the final product offers a provocative insight into Eddy’s quixotic efforts to replace or augment in vivo studies with in silico studies.

Kahn starts her article with the story of Eddy’s efforts in 2004 to use Archimedes, his computer model, to replicate the Collaborative Atorvastatin Diabetes Study (CARDS) months before the results of the study became known. Here is Kahn’s description of what happened:
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