Raising HDL, by itself, has no effect on coronary heart disease rates, according to a large new analysis in the British Medical Journal. An international team analyzed 108 clinical trials including nearly 300,000 patients and found no correlation between changes in HDL and outcome. By contrast, changes in LDL were strongly associated with outcome. The authors write: “Raising high density lipoprotein cholesterol without considering effects on high density lipoprotein function seem to have little promise for the prevention of cardiovascular events.”

A new study in JACC: Cardiovascular Interventions may revive interest in the idea of PFO closure for the treatment of migraines. This area has been highly controversial in recent years. Now a new study from Italy suggests that closure of large PFOs may in fact be beneficial in these patients.

Peter Wilmshurst, who has been at the center of the controversy surrounding the MIST trial, writes in an accompanying editorial: “We don’t really know what’s going on. A stroke could be caused if a blood clot passes across a PFO and travels to the brain, but with migraine we don’t yet know what the trigger substance is that crosses the shunt. Not everyone with migraine has a PFO, and not everyone with a PFO has migraine; there are other causes that we don’t yet understand.”

Here is the ACC Press Release:

Closure of Patent Foramen Ovale May Benefit Migraine Sufferers

Reducing the frequency and severity of disabling migraines is crucial for quality of life. A new study, published in the February 2009 issue of JACC: Cardiovascular Interventions, finds significant improvement of migraine following catheter-based closure of patent foramen ovale (PFO)—a slight opening in the wall between the right and left atria.

These findings confirm those of previous observational studies, which consistently show that when a PFO is closed—whether it’s following a stroke or decompression illness—migraine also tends to improve in the majority of cases (approximately 75 percent). However, the present study was the first to enroll patients with severe migraine, a large PFO and no history of stroke or transient ischemic attacks, but with silent brain lesions on magnetic resonance imaging.

“The study suggests closure of a large PFO may improve migraine in patients with subclinical brain lesions, as well as those with prior stroke,” says Carlo Vigna, M.D., of Casa Sollievo della Sofferenza IRCCS Hospital, San Giovanni Rotondo, Italy. “In the past, the beneficial effect on migraine was occasionally seen after PFO closure was performed for other reasons, for example, unexplained stroke. Conversely, the recently published MIST trial did not show significant improvement of symptoms in ‘pure migraneurs’ in the absence of symptomatic or subclinical cerebral ischemia. As compared with these two extremes, we enrolled patients with an intermediate subset of characteristics.”

Patients were divided into either the closure (n=53) or control (n=29) group based on their consent to undergo percutaneous PFO closure, and prospectively examined for 6 months. Compared with the medically treated control group, closure of a PFO resulted in greater numbers of patients who had cessation of migraine attacks, cessation of disabling attacks and over 50 percent reduction in migraine attacks.

While this may be good news for certain migraine sufferers, researchers say a larger randomized trial focusing on this patient population is needed. In addition, the relationship between PFO and migraine must be further examined and understood.

“We don’t really know what’s going on. A stroke could be caused if a blood clot passes across a PFO and travels to the brain, but with migraine we don’t yet know what the trigger substance is that crosses the shunt,” says Dr. Peter Wilmshurst, Royal Shrewsbury Hospital, United Kingdom. “Not everyone with migraine has a PFO, and not everyone with a PFO has migraine; there are other causes that we don’t yet understand.”
Background: It is widely accepted that migraine is associated with higher rates of stroke. Research also suggests that people with migraine also have a higher prevalence of right-to-left shunts on contrast echocardiograms, which are, by and large, due to PFO—something each of us has while in the womb to divert blood away from the lungs. However, for one in four people, a hole remains after birth.

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Two gene variants that encode for natriuretic peptides are associated with significant differences in blood pressure, according to a new study published in Nature Genetics.
Click here to read the press release from Nature Genetics…

A year after the launch of the second generation drug-eluting stents the clear winners and losers are emerging, according to a Dow Jones story by Jon Kamp.
Medtronic’s Endeavor stent seems stuck with only a 10% market share, while Abbot’s Xience stent (also marketed by Boston Scientific) holds about half the market.

Following fast on the heels of the publication of the ATHENA trial in the NEJM, the FDA has announced that it will hold a hearing of the Cardiovascular and Renal Drugs Advisory Committee on March 18 to consider “the proposed indication in patients with a history of, or current atrial fibrillation or atrial flutter, for the reduction of the risk of cardiovascular hospitalization or death.”
The ATHENA slide set is available on ClinicalTrialResults.Com.

Stress-induced cardiomyopathy, otherwise known as Takotsubo cardiomyopathy, is now regarded as a genuine clinical entity. Data from a Rhode Island registry, published online in the American Journal of Cardiology, sheds light on its “characteristics, treatment strategies, and natural history”.  In a cohort of 70 patients, 95% were postmenopausal women. The authors observed a spike of cases in the summer months and concluded that “overall long-term prognosis and recovery of left ventricular function were excellent.”

In response to a query from CardioBrief.Org about Sanjay Kaul’s absence from the prasugrel advisory committee meeting (click to see our initial story that first reported his absence and our subsequent editorial about some serious questions raised by the advisory committee meeting), an FDA spokesperson has provided an explanation for Kaul’s absence:

“One thing I’d like to clarify regarding Dr. Sanjay Kaul is that the FDA wants to make it very clear that no determination was ever made that Dr. Kaul had any conflict of interest, there simply was not time to make a determination before he had to travel in for the meeting.  The FDA did not receive sufficient information until much later than we would prefer, very late in the process, and the agency was unable to go through the review process in sufficient time in order to make a decision on the member’s participation in the meeting. Thus, in this case, in order to enhance the credibility and transparency of the advisory committee proceeding and in an abundance of caution, the agency felt it was necessary for the member not to participate in this meeting.”

     –Sandy Walsh, FDA Office of Public Affairs

I am particularly confused by the statement that the “FDA did not receive sufficient information until much later than we would prefer…” It is my understanding that committee members undergo a very detailed and rigorous review process over a period of several months. If this process did not take place with Dr. Kaul, how was it that he was appointed to the committee?

I also don’t understand the remark that Kaul did not participate in the meeting “in order to enhance the credibility and transparency of the advisory committee proceeding and in an abundance of caution…” It seems to me that an equally credible argument could be made that the credibility and transparency of the meeting was harmed by his absence.

The ATHENA trial, originally presented last May at the Heart Rhythm Society meeting, has been published in the New England Journal of Medicine. The trial found that “dronedarone reduced the incidence of hospitalization due to cardiovascular events or death in patients with atrial fibrillation.”
The ATHENA slide set is available on ClinicalTRialResults.Com.

The two-year followup of the SPIRIT III trial comparing an everolimus- and a paclitaxel-eluting stent has been published in Circulation.
The slide set is available from ClinicalTrialResults.Com.

David Sabiston Jr, who performed an early version of coronary bypass surgery in 1962 while at Johns Hopkins, died last month. Sabiston’s early work helped pave the way for the ascension of CABG as a mainstay of modern medicine. Sabiston went on to become the head of Duke’s department of surgery. Sabiston’s textbook is a standard in the field. Click here for links to Sabiston obituaries and an online exhibit about his life…

Women who take multivitamins have the same risk for cancer, cardiovascular disease, and death as women who don’t take vitamins, according to a new study in the Archives of Internal Medicine. “These results suggest that multivitamin use does not confer meaningful benefit or harm in relation to cancer or cardiovascular disease risk in postmenopausal women,” say the study’s authors.
Click here to read the Archives press release…

The Boston Globe is reporting that Massachusetts General Hopsital and St Vincent Hospital in Worcester are being monitored by state officials for high death rates in 2007 in cardiac catheterization patients. At MGH, 43 or 1,543 patients died. In response, the hospitals claim the high rates are due to agressive treatment of exceptionally sick patients.

Nature Genetics has published 5 new genome wide association studies that may help unravel the genetic tangle behind heart attacks.

More…