Despite a marginal advantage at 4 months, after two years PCI does not improve the quality of life when compared to medical therapy after late opening after MI, according to a new report from the Occluded Artery Trial Investigators published in the New England Journal of Medicine. In addition, PCI, as expected, is more expensive than the medical approach.
In a separate report, published in Circulation earlier this week, OAT investigators reported the electrophysiologic effects of late PCI in their trial. They found that late PCI had no effect on heart rate variability, signal-averaged ECG, or T-wave variability. Click here to view the OAT slideset on ClinicalTrialResults.Com.
Click here to read commentary on OAT from William Boden and David Kandzari…
Pharmacogenetics: a better path to warfarin dosing? 1
Using a pharmacogenetic algorithm to estimate the initial warfarin dose is better than using the usual clinical or fixed-dose approaches, according to a new study from the Imternational Warfarin Pharmacogenetics Consortium published in the New England Journal of Medicine. The benefits of the pharmacogenetic algorithm were especially noticeable in those…
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New analysis casts doubt on HDL as target for therapy Reply
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.”
New data on sudden death in young athletes published 1
Barry Maron and colleagues have now provided the most clear and comprehensive perspective yet available on the rate and cause of sudden death in young athletes in the US. Examining data from 1980-2006, the investigators found, in a report published online in Circulation, that cardiovascular disease accounted for 56% of all cases, with more than a third of these caused by hypertrophic cardiomyopathy. Over the last six years an average of 66 deaths have occurred each year. The authors conclude that “the absolute number of cardiovascular sudden deaths in young US athletes was somewhat higher than previous estimates but relatively low nevertheless.”
Click here to read the AHA press release…
PFO and migraine: the next chapter Reply
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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Elderly in cardiogenic shock benefit from early PCI Reply
Elderly patients in cardiogenic shock may benefit from early use of PCI, according to a new study in JACC: Cardiovascular Interventions. “Although mortality occurs in roughly half of patients in these high risk situations, without this aggressive treatment, the prospect of survival is very poor,” said David Clark, in an ACC press release. “A patient’s age in and of itself should not be used to deny someone more aggressive, invasive care with angioplasty for cardiogenic shock,” commented Judith Hochman, who is the author of an accompanying editorial. “Having said that, Click to continue reading
Researchers identify first common genes variants that regulate blood pressure Reply
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…
SALT II: letter writers react to Alderman’s NY Times op-ed piece 1
Letter writers to the New York Times, responding to Michael Alderman’s op-ed critique of proposed low salt regulations, are ready to go biblical on Alderman and turn him into a pillar of salt. [See our previous coverage of this here.]
Dr. Steven Havas notes that high sodium consumption causes at least 150,000 prematures deaths each year in the United States. Nephrologist Sheldon Hirsch responds to Alderman’s point that most people would not benefit from sodium restrictions: “But public policy is meant to advance the general welfare. It does not necessarily provide all individuals with equal (or even any) benefit, nor must it necessarily impinge on individual medical decisions.” But at least one writer expressed strong approval for Alderman’s position: “I’m not sure I like the idea of the government’s telling me what to eat. No, let me rephrase that: I do not want the government in my kitchen.”
You can read the letters here.
Stent wars: Abbott wins and Medtronic loses Reply
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.
Heartwire story provides most detailed account yet of prasugrel hearing 1
A story in Heartwire by Michael O’Riordan has provided the most detailed account yet of the issues surrounding the FDA’s prasugrel hearing. The story quotes FDA officials, panel members, and outside observers such as William Boden, who said the absence of Sanjay Kaul “raises some obvious red flags.”
John Jenkins, the FDA director of the Office of New Drugs, explains that Kaul’s eligibility had not been thoroughly examined by the FDA, though not due to any fault of Kaul’s, who fully disclosed all “necessary information” to the FDA. However, Jenkins statements in the story make it clear why Kaul was really disqualified: “we want the committee members to come to the table with an open mind, so they can give us advice based on the data, the presentations, and the discussions that are held at the committee meeting itself.” Kaul’s publications critical of prasugrel trials “constituted an intellectual bias,” according to Jenkins.
Steve Nissen notes that eliminating a critic like Kaul “undermines the credibility of the panel.”
The Heartwire story also includes detailed discussions of the controversy over the issue of a cancer warning for the drug, and of the definition of MI used in the trials.
FDA advisory committee to consider dronedarone in March Reply
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.
Judge who ruled in favor of Medtronic failed to disclose family link to company 1
The judge who ruled in Medtronic’s favor by dismissing a big lawsuit against the company didn’t disclose that his son is a partner in a law firm that has Medtronic as a client, according to a story by Thomas Burton in Friday’s Wall Street Journal. Applying the principle of preemption, which…
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Registry sheds light on Takotsubo cardiomyopathy Reply
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.”
After FAME: New study offers clues to utility of FFR Reply
The recent publication of FAME in the NEJM drew attention to FFR (fractional flow reserve) to guide PCI during angiography. Now, a new study published online in the American Journal of Cardiology may shed some light on its practical clinical utility. In a study of 142 patients with intermediate LMCA stenosis, the researchers concluded that “FFR measurement is helpful in guiding the decision whether to revascularize patients with intermediate LMCA stenosis. However,
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FDA provides “explanation” for Sanjay Kaul’s absence 3
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.
I have asked the FDA to clarify these issues. Stay tuned for the next chapter of this saga…
Contrast echo found useful in technically difficult cases Reply
The precise role of contrast echocardiography in clinical practice has been difficult to determine. Now a new study in JACC from Methodist Hospital in Houston, TX, has found that CE can dramatically reduce the percentage of uninterpretable studies and technically difficult studies in a series of 632 patients.
ATHENA published in NEJM: dronedarone benefits AF patients 1
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.
Prasugrel: now the real work starts 1
The spotlights have been turned elsewhere, but it’s only now that thereal work on prasugrel will take place. As a brief item in Inside Indiana Business notes, Lilly officials will now begin “a period of intense discussions” with the FDA over labeling of the drug.
In an accompanying video interview, Lilly VP Tony Ware said that approval of prasugrel could help prevent…
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SPIRIT III trial published Reply
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.
List of ACC 2009 Late-Breakers published Reply
The ACC has posted the schedule of Late-Breakers for the 2009 Scientific Sessions and i2 Summit. There are 6 ACC and 3 i2 Late-Breaker sessions, and on Monday morning you’ll have to choose between two simultaneous sessions.
You can search or browse using the online planner by starting at this link.
Or you can download a Word document with the complete list of ACC and i2 Late-Breakers right here.
Or you can view the list of Late-Breakers in your web browser by clicking here…
David Sabiston Jr, pioneering surgeon, dead at 84 Reply
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…
PCI for MI: Experienced hospitals and physicians are best Reply
Practice makes perfect. A new study in JACC shows that high volume hospitals and high volume physicians do far better for their patients than their low-volume counterparts. The data is taken from the New YorkState PCI registry. “When rare but severe complications arise, a team experienced in its recognition and treatment may be the difference between life and death,” comments James Jollis, in an accompanying editorial.
Click to read the JACC press release…
Expensive urine: multivitamins have no effect on major endpoints 1
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…
Study finds lower risk of death for primary prevention use of statins Reply
Patients who take statins for primary prevention have a lower risk of death, according to a large new observational study published in Archives of Internal Medicine. “The observed benefits from statins were greater than expected from randomized clinical trials, emphasizing the importance of promoting statin therapy and increasing its continuation over time for both primary and secondary prevention, write the study authors.
Click here to read the Archives press release…
Mass General under scrutiny for high mortality rate in cath lab 1
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.
