Prolonged Dual Antiplatelet Therapy May Not Be Necessary For Second-Generation Drug-Eluting Stents Reply

The precise duration of dual antiplatelet therapy (DAPT) following implantation of a drug-eluting stent (DES) has been the subject of considerable controversy. On the one hand, prolonged therapy may help prevent late stent thrombosis, which was particularly evident in first generation DESs. On the other hand, the risk of stent thrombosis may have diminished in newer generation drug-eluting stents, and prolonged DAPT  is associated with a greater risk for bleeding complications and additional expense and management issues.

In the Optimized Duration of Clopidogrel Therapy Following Treatment With the Zotarolimus-Eluting Stent in Real-World Clinical Practice (OPTIMIZE) trial 3,119 patients with stable CAD or a history of low-risk acute ACS who received a zotarolimus-eluting stent (Endeavor, Medtronic) were randomized to either short-term (3 months) or long-term (12 months)  DAPT. The results of OPTIMIZE were presented at TCT 2013 in San Francisco and published online in JAMA.

At one year there were no significant differences between the groups. The primary endpoint– the composite of death, MI, stroke, or major bleeding– occurred in 6% of patients in the short term group versus 5.8% of patients in the long-term group (risk difference 0.17, CI -1.52 – 1.86, p = 0.002 for noninferiority). Between 3 months and 1 year there was an identical 2.6% rate of events in both groups.

Click here to read the full post on Forbes.

 

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EUROMAX Meets Primary Endpoint But Editorialist Raises Questions Reply

When started during transport to the hospital during a heart attack, bivalirudin (Angiox, Medicines Company) improves clinical outcomes and reduces major bleeding, though at the cost of a small but significant risk in stent thrombosis. The results of the European Ambulance Acute Coronary Syndrome (ACS) Angiography) Trial (EUROMAX) were presented today by Phillippe Gabriel Steg at the TCT conference in San Francisco and published simultaneously in the New England Journal of Medicine.

Click here to read the full post on Forbes.

 

 

 

FDA Throws More Cold Water On Amarin’s Hopes For Vascepa 1

Any remaining hopes for an expanded indication for Amarin’s Vascepa were largely dashed today by the FDA. Although it hasn’t yet rejected the proposed indication, the FDA today essentially overturned the foundation of the application, leaving little doubt as to the ultimate fate of the proposed new indication. As veteran biotechnology reporter Adam Feuerstein tweeted:

“The chance of FDA approval for Anchor went from 0.00000001% to 0.00000000001%.”

Click here to read the full post on Forbes.

 

And The Fat Lady Sings

Pivotal Results For Medtronic’s CoreValve Reply

Key data on what will likely be the second transcatheter aortic valve to gain approval in the US were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) 2013 Conference in San Francisco. Jeffrey Popma, co-principal investigator of the Trial, presented the major results from the CoreValve U.S. Pivotal Trial in patients who were too ill or frail for traditional open heart surgery.

In an as-treated analysis of 471 patients (the intention-to-treat population was 487), the primary endpoint– the rate of death or major stroke at one year– was 25.5% (CI 21.6-29.4). This was 40.7% lower than the prespecified performance goal of 43% (p<0.0001) based on historical standards.

Click here to read the full post on Forbes.

 

 

Radiation Dose Linked To Cardiac Risk In Breast Cancer Patients Reply

 

 

In the past, cardiovascular risk has been linked to the radiation dose received by breast cancer patients. Now, a new study published in JAMA Internal Medicine attempts to calculate the cardiac risk of breast cancer patients today undergoing current radiotherapy protocols.

 

David J. Brenner and colleagues calculated the excess cardiac risk for 48 patients who received radiotherapy at New York University. They estimated the 20-year cardiac risk based on baseline risk and patient-specific mean cardiac radiation dose. Cardiac dose was significantly higher in patients with left-sided radiotherapy. These patients also received significantly higher doses if they were treated in the supine body position instead of the prone position. Position did not significantly have an impact on cardiac dose in patients who received right-side radiotherapy.

 

Click here to read the full post on Forbes

 

70. breast cancer radiation http://goo.gl/gsQ8Q

 

FDA Approves Abbot’s MitraClip For Patients At Prohibitive Surgical Risk Reply

The FDA today approved Abbott’s catheter-based MitraClip device for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery. The company said it would launch the device immediately in the United States. The device is the first percutaneous nonsurgical therapy approved for the treatment of mitral valve disease.

Click here to read the full post on Forbes.

 

Mitraclip

 

The Good, The Bad, And The Ugly: Stents In The News Reply

Three big stent stories were in the news today. You’d never know that all 3 were about the same topic.

 

The Ugly

 

The ugly side of stents is emphasized in David Armstrong’s Bloomberg News story on Mehmood Patel, the Louisiana interventional cardiologist serving a 10-year prison sentence for Medicare fraud. These days Patel “leads health-conscious inmates on a morning walk, then cracks open one of the medical journals on his prison-approved reading list. Counseling fellow convicts to keep their blood pressure down is about the extent of the doctoring done by the man who once boasted he was the busiest cardiologist in the nation.”

 

The Bad

 

Unlike Patel, Mark Midei, the poster-boy of overstenting, never faced criminal charges, but he did lose his medical license and faced an avalanche of lawsuits. Many have been settled our of court, but an important decision was reached yesterday in one very large remaining case. Jessica Anderson reports in the Baltimore Sun that a jury ruled that Midei “improperly placed three stents in the heart of a prominent businessman who didn’t need them.” The businessman is suing Midei and the former owners of his hospital, St. Joseph Medical Center, for $150 million. The businessman claims that he “lost millions of dollars after scaling back his career” after “Midei falsely led him to believe that he had serious coronary artery disease requiring stents.”

 

The Good

 

But it’s not all bad news for stents. In the New Yorker‘s Elements blog, cardiology fellow Lisa Rosenbaum adopts a much more nuanced view of stents. She writes that “stories about cardiologists behaving badly validate the conviction, common among both policymakers and the public, that misaligned financial incentives drive doctors to do things that they shouldn’t.”

 

But, she argues, the conservative view, based largely on the well known COURAGE trial, that medical therapy is just as good as a stent, “is a colossal oversimplification.”

 

Successful conservative management, however, depends on seeing patients regularly, so that you can titrate their medications and make sure that their cardiovascular risk factors are controlled. But Sun Kim didn’t come back.

 

Click here to read the full story on Forbes.

 

The Good, the Bad and the Ugly is a well-known...

 

Surgery Preferable To Stents In Elderly People With Carotid Disease Reply

Age should play an important role in choosing a revascularization procedure for people with blocked carotid arteries, according to a new paper published in JAMA Surgery.  Carotid endarterectomy surgery (CEA) is preferable to carotid artery stenting (CAS) in elderly people; for younger patients the two revascularization procedures are broadly similar.

George Antoniou and colleagues analyzed data from 44 studies containing more than half a million CEA and 75,000 CAS procedures. In the CAS group, when compared to younger patients elderly patients were at increased risk for stroke (odds ratio 1.56,CI 1.40-1.75). In the CEA group the stroke results were “equivalent” in the older and younger groups (OR 0.94, CI 0.88-0.99). In the CEA group there was a small but statistically significant increase in the mortality rate in the older group compared with the younger group (0.5% versus 0.4%, OR 1.62, CI 1.47-1.77). No significant difference in mortality between the older and younger groups emerged in the CAS group. In both the CAS and the CEA groups, increased age was associated with a greater risk of adverse cardiac events.

Click here to read the full story on Forbes.

 

Flu Vaccine May Help Prevent Cardiovascular Events Reply

A new meta-analysis published in JAMA offers the best evidence yet that the flu vaccine may help prevent cardiovascular events.

Jacob  Udell and colleagues analyzed data from 5 published clinical trials in which 6,469 patients were randomized. People who received the flu vaccine had a significantly lower risk of cardiovascular events. The protective effect was largely restricted to people who had had a recent acute coronary syndrome (ACS). Cardiovascular events occurred in 2.9% of people in the vaccination group versus 4.7% of controls (RR 0.64, CI 0.48-0.86, p = .003).

Click here to read the full post on Forbes.

 

FDA Approves First New Atherectomy Device In 20 Years Reply

The FDA today granted PMA approval to the Diamondback 360 Coronary Orbital Atherectomy System (OAS) for the treatment of severely calcified coronary arteries. Cardiovascular Systems, the manufacturer of the device, said that the OAS  was the first new coronary atherectomy system to receive FDA approval in 2 decades. The company said  it would begin a controlled launch of the device immediately, focusing initially on “a limited number of the top medical institutions in the United States.”

In separate news, Medtronic yesterday announced the launch of its Export Advance aspiration catheter for coronary thrombus removal. The device was recently approved by the FDA. The company said the device features a pre-loaded stylet that “increases the deliverability and kink resistance of the new device while traversing the vasculature to reach the aspiration site.”

Click here to read the full post on Forbes.

A Paper In The American Journal Of Cardiology About A Study That Was ‘Not Real’ Reply

New allegations about scientific misconduct have been raised about a cardiology group in a hospital in Italy. Some of the allegations come from a surprising source: Maria Grazia Modena, the former and highly prominent chief of cardiology at the hospital where the research was said to have been performed.

The new allegations are the latest episode in an ongoing saga that began last year involving many of the same researchers, including Maria Grazia Modena herself. As I first reported last November, nine Italian cardiologists were arrested as part of a broad investigation into serious medical misconduct at Modena Hospital (Policlinico di Modena). The charges included conspiracy, fraud, embezzlement, bribery, forgery and performing unauthorized clinical trials. The most prominent person arrested was Maria Grazia Modena, who is also a former president of the Italian Society of Cardiology. (The fact that she shares her last name with the city and the hospital where she works appears to be a coincidence.)

The suspicion that there might be problems with the paper  first emerged when Maria Grazia Modena, who was originally listed as a co-author, publicly distanced herself from the paper and said that she was not an author of the paper and had had nothing to do with the study. To date the only public acknowledgement that there might be problems with the paper is an erratum published in AJC stating that Modena “was not associated with this manuscript” and that “the authors apologize for this error.”

I personally asked the physicians and fellows who were working in the department (except the authors of the manuscript) if anyone have ever heard about the study. Nobody had ever seen informed consents or appointments for study-related peripheral echo in 8 years.

 In the methods section of their manuscript, the authors stated that echo examinations  were made with [a GE Healthcare transducer]… That echocardiography machine was bought around 2005-2006 (the authors  report they started the study  in 2002).

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No Support For Broad Screening Of Chronic Kidney Disease 1

Although taught in  medical school and widely used in clinical practice, broad screening of otherwise healthy people for chronic kidney disease (CKD) is unwarranted, according to new recommendations from the American College of Physicians published in the Annals of Internal Medicine. People with early kidney disease, who are classified as having stages 1 to 3 CKD, usually do not have symptoms and are generally diagnosed with labarotory tests or imaging. People who progress to advanced kidney disease are at greatly increased risk for dialysis, end-stage renal disease, and death.

The authors of “Screening, Monitoring, and Treatment of Stage 1-3 Chronic Kidney Disease” discuss the paucity of evidence in the field and highlight the absence of randomized, controlled trials evaluating the risks and benefits of screening for CKD or evaluating the sensitivity and specificity of screening tests.

Click here to read the full post on Forbes.

 

 

Could Terrorists Have Hacked Dick Cheney’s ICD? 3

It happened in Homeland. Could it happen in real life?

In a 60 Minutes segment scheduled for broadcast tomorrow, Dick Cheney says that his doctors turned off the wireless function of his implanted cardiac defibrillator (ICD) “in case a terrorist tried to send his heart a fatal shock,” according to the Associated Press.

Years later, Cheney watched an episode of the Showtime series “Homeland” in which such a scenario was part of the plot.

“I found it credible,” Cheney tells “60 Minutes” in a segment to be aired Sunday. “I know from the experience we had, and the necessity for adjusting my own device, that it was an accurate portrayal of what was possible.”

I asked three experienced electrophysiologists– the cardiologists who devote a good part of their professional life implanting ICDs– whether this was a realistic concern…

Click here to read the full story on Forbes.

 

FDA Approves New Pulmonary Hypertension Drug From Actelion Reply

The FDA today approved macitentan (Opsumit, Actelion), a new oral endothelin-receptor antagonist that is an enhanced version of the company’s bosentan (Tracleer). The drug is indicated to delay disease progression in patients who have pulmonary arterial hypertension (WHO Group I).

Click here to read the full post on Forbes.

 

Actelion

New Insights Into Surgery Versus Stents For Diabetics With Multivessel Disease Reply

Last year the large NHLBI FREEDOM trial demonstrated that bypass surgery was superior to PCI when treating diabetic patients who have multivessel coronary disease. CABG resulted in significant reductions in death and MI, but this was offset slightly by a higher rate of stroke in the CABG group. Now a new report from FREEDOM published in JAMA suggests that the reduction in important clinical endpoints may not translate into large differences in health status and quality of life.

Click here to read the full post on Forbes.

 

 

 

FDA Advisory Panel: No Expanded Indication For Vascepa Without Outcomes Trial Reply

An FDA advisory panel today failed to recommend an expanded indication for Vascepa, the purified EPA fish oil product from Amarin. Vascepa is currently indicated only for the relatively small number of people with severe hypertriglyceridemia (>500 mg/dl). The proposed new indication would have greatly expanded the patient population eligible to receive Vascepa to the 20% of the US population who have elevated triglycerides (>200 mg/dl) and existing CV disease or who are at high risk for CV disease.

Click here to read the full story on Forbes.

 

 

 

 

First Leadless Pacemaker Gains Approval In Europe Reply

St. Jude Medical announced on Monday that the world’s first leadless pacemaker had gained CE Mark approval in Europe. The company also announced that it was buying Nanostim, the company that developed the innovative device. The FDA recently granted conditional approval for an Investigational Device Exemption (IDE) application and a pivotal clinical trial, St. Jude also reported.

Click here to read the full story on Forbes.

 

Former ACC CEO Takes Reins Of Cardiovascular Research Foundation Reply

The Cardiovascular Research Foundation (CRF) announced today that it had appointed Jack Lewin as its next President and Chief Executive Officer.

Lewin is the former CEO of the American College of Cardiology. In April 2012 the ACC announced his abrupt departure from the college. No explanation was ever given for the sudden change.

Click here to read the full story on Forbes.

 

 

Why The FDA Probably Won’t Approve An Expanded Indication For Amarin’s Vascepa Reply

On Wednesday an FDA advisory  panel will consider an expanded indication for Amarin Pharmaceuticals’ Vascepa, an EPA fish oil product currently indicated only for people with severe hypertriglyceridemia (>500 mg/dl). The new indication would greatly expand the patient population eligible to receive Vascepa, from the relatively few people with severe hypertriglyceridemia to the many millions with elevated triglycerides (>200 mg/dl) and existing CV disease or at high risk for CV disease. The NDA for this indication is based on the ANCHOR trial, which showed that Vascepa lowered triglycerides in the target patient population.

The FDA review (available here) raises 2 troubling issues. The first is fairly simple and relates to the performance of the placebo in ANCHOR.  In its briefing documents the FDA raises the disturbing and unusual possibility that the mineral oil placebo used in the trial may not have been biologically inert. LDL levels in the placebo group went up 9% in the placebo group and this will make it difficult to assess the true effect of Vascepa. It’s unlikely that this issue by itself will entirely derail the NDA, but it may well serve to undermine confidence in the trial and put the panel in a critical frame of mind.

More significant, to my mind, is the lack of any evidence for any important improvement in clinical outcomes that can be tied to Vascepa….

Click here to read the full post on Forbes.

CardioMEMS Heart Failure Device Gets Mixed Reception From FDA Advisory Panel Reply

The FDA’s Circulatory System Devices Panel sent a mixed message to the FDA today about CardioMEMS Champion HF Pressure Measurement System.  The small implantable device provides provides daily pulmonary artery pressure measurements to guide physicians in their treatment of patients with congestive heart failure.

In December 2011 the same panel voted 9-1 that the device was safe, 7-3 that the device had not been shown to be effective, and 6-4 that the benefits did not outweigh the risks. Now, two years, later, the vote wasn’t much different: the panel agreed unanimously (11-0) that the device was safe; 7-4 that it had not been shown  to be effective, and 6-4-1 that the benefits outweighed the risks.

Click here to read the full story on Forbes.

 

CardioMEMS wireless sensor with quarter

 

Prevalence Of Cardiovascular Disease Likely To Increase Despite Gains In Treatment Reply

It is the best of times and the worst of times in the battle against cardiovascular disease. On the one hand, mortality rates from cardiovascular disease in the US have dropped by more than half in the last 30 years, likely due in large part to improvements in treatment for elevated blood pressure and cholesterol levels and big declines in smoking. On the other hand, it is uncertain whether these gains will continue, and many experts think that cardiovascular disease may well be on the rise once again, largely due to the aging of the population and to increases in obesity and diabetes.

In an article in Health Affairs, Ankur Pandya and colleagues (including cardiologist Thomas Gaziano of the Brigham and Women’s Hospital) forecast cardiovascular disease trends through the year 2030 using data from the National Health and Nutrition Examination Survey. They project that although the age-adjusted risk for cardiovascular disease is likely to continue to decline through 2030, because of an aging population and the increase in obesity the overall incidence of cardiovascular disease will increase.

Click here to read the full story on Forbes.

 

 

 

New Drug For Pulmonary Hypertension Approved By FDA Reply

The FDA today approved a new drug for pulmonary hypertension. Bayer HealthCare’s riociguat (brand name Adempas) was approved for 2 indications:

  1. The treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (WHO* Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class
  2. The treatment of adults with pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening.

Click here to read the full story on Forbes.

People Who Live Near Airports At Increased Risk For Cardiovascular Disease Reply

Most previous research on the health effects of noise has focused on road noise. Now two new observational studies published in BMJ extend the research to noise from airports and provide fresh evidence that people who live near airports are at increased risk for cardiovascular disease.

In the first paper, Anna Hansell and colleagues in the UK analyzed data from 3.6 million people living near Heathrow airport in London. People who lived in the noisiest areas had an elevated risk for stroke, coronary heart disease, and cardiovascular disease. …

Click here to read the full story on Forbes.

 

NEAR LOGAN AIRPORT-AIRPLANE COMING IN FOR A LA...
 (Photo credit: Wikipedia) 

Study Supports Loosening Guidelines for Surgery After Stent Implantation Reply

According to current guidelines, noncardiac surgery should be delayed for six weeks after bare-metal stent (BMS) implantation and for one year after drug-eluting stent (DES) implantation, though there is little good evidence to support these recommendations. Stent thrombosis caused by discontinuation of antiplatelet therapy in order to lower the risk of bleeding during surgery is the biggest concern. Now, a new study published in JAMA suggests that the guidelines may be over strict and that delays recommended after DES implantation are longer than warranted.

Mary T. Hawn and colleagues analyzed data from nearly 125,000 VA patients who received a stent between 2000 and 2010. Within this group more than 28,000 (22.5%) had a noncardiac operation within 2 years…

Click here to read the full post on Forbes.

 

A Vision Unfulfilled: Reflections On The Death Of TheHeart.Org (1999-2013) Reply

(Updated, October 25–) On Friday, September 20 the cardiology website TheHeart.Org died. It lost its separate and unique identity and became a part of Medscape (which is owned by WebMD). I played a part in the founding and development of TheHeart.Org (THO) and I mourn its loss. What follows is some of that story and why I think the loss of THO is sad.

(For those of you who don’t know, THO is, or was, an extremely popular website for cardiologists. It has been widely regarded as the most reliable and authoritative source for news about cardiology. In 2005 it was bought by WebMD for nearly $20 million. In 2008 it had about $30 million in annual revenue.)

I was the editor of the TheHeart.Org from its launch in 1999 until December 2008. I believe the success of THO was largely due to the way it improved the state of medical journalism, which was in a pitiful state at that time. The creation of THO was without doubt the professional highlight of my career. But that feeling was always tempered by my recognition that there was still much more that remained to be done. I am still proud of what we achieved, and want to acknowledge that the new THO/Medscape retains value, but it no longer represents the future of medical journalism, or aspires to create something new and different.

Click here to read the full story on Forbes.

 

 

Update (October 25)– Since the announcement of the change I have watched with concern as significant amounts of Medscape-generated content have appeared on TheHeart.Org. Although the news generated by the Heartwire team continues to be valuable, the avalanche of additional so-called editorial content has had an unfortunate effect on the editorial balance, and it is harder to tell whether an individual item comes from the Heartwire editorial team or somewhere else.

This update was prompted by this tweet that came out a little while ago on TheHeart.Org twitter feed:

 

It’s hard to figure out how to respond to this sort of despicable clickbait. It demonstrates the complete rejection of any commitment to editorial excellence in favor of the cynical pursuit of page views. In this brave new world mindless content is king, as long as it contains nothing to which the sponsors might object.