Cardiology Group Withdraws ‘Choosing Wisely’ Recommendation Reply

In the end it wasn’t wisdom for the ages. The American College of Cardiology said today that it was withdrawing one of its five recommendations in the “Choosing Wisely” campaign.  In 2012 the ACC recommended that heart attack patients should have only their culprit artery unblocked. It said that patients and caregivers should question whether complete revascularization of all nonculprit lesions in heart attack patients should be performed.

The original recommendation was based on non-randomized studies suggesting that treating all significantly blocked vessels in heart attack patients could be harmful. “However,” the ACC now states, “over the last two years, new science has emerged showing potential improvements for some patients in their overall outcomes as a result of complete revascularization.”

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Click here to read the full post on Forbes.

 

What To Expect At The American College of Cardiology Meeting Reply

The ACC begins this Saturday in Washington, DC. Here’s a preview of some of the most highly-anticipated late-breaking clinical trials.

On Saturday morning at the opening session the world will finally learn more about the failure of Symplicity HTN-3, the Medtronic trial of renal denervation….

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 Click here to read the entire post on Forbes.

 

More Guideline Controversy: Blood Pressure Expert Decries ‘Political Correctness’ Reply

Now add “political correctness” to the long list of criticisms directed against the recent publication of new and updated cardiovascular guidelines. One leading hypertension expert writes that the authors of the recent AHA/ACC/CDC Science Advisory on blood pressure control were chosen not for their expertise but for political expediency.

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Click here to read the full post on Forbes.

Confusion (Photo credit: quinn.anya)

Missing High Blood Pressure Guideline Turns Up In JAMA Reply

After  years of delay and many twists and turns, the hypertension guideline originally commissioned by the NIH has now finally been published in JAMA. The evidence-based document contains a major revision of hypertension treatment targets and includes new and somewhat simplified recommendations for drug treatment.

The previous US hypertension guideline was published more than a decade ago. After many delays the new guideline was ready for publication earlier this year, but then the NIH decided to get out of the guidelines business. The American Heart Association and the American College of Cardiology assumed responsibility for the development and publication of cardiovascular guidelines and last month published four new cardiovascular guidelines, with the notable exception of the hypertension guideline. As an accompanying JAMA editorial explains:  “Rather than go through an additional review process with the AHA and the ACC the authors decided to publish their guideline in JAMA on their own.”

The big headline of the new guideline is an important change in treatment targets.

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Click here to read the full story on Forbes.

Original illustration by Max Husten

Controversy Erupts Over Accuracy Of Cardiovascular Risk Calculator For Guidelines Reply

In the face of a highly critical story in the New York Times by Gina Kolata about the new cardiovascular guidelines, authors of the guidelines and leaders of the American Heart Association and the American College of Cardiology defended the value and integrity of the guidelines.

The Times story claims that the cardiovascular risk calculator used to assess individual risk in the new guidelines is deeply flawed. “In a major embarrassment to the health groups, the calculator appears to greatly overestimate risk, so much so that it could mistakenly suggest that millions more people are candidates for statin drugs.” The story quotes former ACC president Steve Nissen: “It’s stunning. We need a pause to further evaluate this approach before it is implemented on a widespread basis.”

But the guideline authors and AHA/ACC officials strenuously defended the guideline at a news conference Monday morning at the American Heart Association meeting in Dallas. They said  the new risk calculator is far superior to previous efforts, incorporating far more data that now includes stroke assessment and for the first time provides specific predictions for African Americans.

The assembled officials rejected any call to delay implantation of the guidelines, but one author, Donald Lloyd-Jones said that “over time we will modify the risk scores so that they get better and better.”

“We think we’ve done our due diligence,” said AHA president Mariell Jessup. “We have faith and trust in the people who developed the guidelines.”

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Click here to read the full story on Forbes.

 

The Fate Of New Cholesterol Drugs Depends On IMPROVE-IT Reply

Prospects for the highly anticipated new class of cholesterol-lowering drugs, the PCSK9 inhibitors, took a wild roller coaster ride this week. The publication of new lipid guidelines by the American Heart Association and the American College of Cardiology led many observers to think that the promising new drugs under development by Regeneron (in partnership with Sanofi), Amgen, and Pfizer might suffer significant delays.

The guidelines delivered a strong statement questioning the increasingly controversial theory that LDL lowering by itself is beneficial. “We found that non-statin therapies really didn’t provide an acceptable risk reduction benefit compared to their potential for adverse effects in the routine prevention of heart attack and stroke,” said the co-chair of the guideline. This led many observers to think that the FDA would likely require the developers of PCSK9 inhibitors to complete cardiovascular outcome trials before getting US approval. This decision would delay approval for several years.

Then, on Thursday, the companies developing PCSK9 inhibitors received some apparent good news. Bloomberg News reported that an FDA official said that the drugs “will only have to meet the U.S. Food and Drug Administration’s existing standards for clearance, including whether they cut cholesterol and reduce blood pressure or inflammation.”

But then the FDA added one other very important caveat. Here’s how they phrased it to me:

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After Long Wait, Updated US Cardiovascular Guidelines Now Emphasize Risk Instead Of Targets 1

Updated cardiovascular health guidelines were released today by  the American Heart Association (AHA) and the American College of Cardiology (ACC). The guidelines are designed to provide primary care physicians with evidence-based expert guidance on cholesterol, obesity, risk assessment, and healthy lifestyle.

The new guidelines reinforce many of the same messages from previous guidelines, but also represent a sharp change in philosophy. That change is most evident in the new lipid guidelines, in which the focus has shifted away from setting numerical targets for cholesterol levels in favor of treatment decisions based on individual risk status.

“This guideline represents a departure from previous guidelines because it doesn’t focus on specific target levels of low-density lipoprotein cholesterol, commonly known as LDL, or ‘bad cholesterol,’ although the definition of optimal LDL cholesterol has not changed,” said Neil J. Stone, chair of the lipid expert panel that wrote the new guideline. “Instead, it focuses on defining groups for whom LDL lowering is proven to be most beneficial.”

The long-awaited and often controversial guidelines are the successors to the extremely influential NHLBI guidelines, including the Adult Treatment Panel (ATP) series of guidelines that brought cholesterol to the consciousness of millions of people. Earlier this year the NHLBI announced that it would no longer issue guidelines but would, instead, provide support for guidelines produced by other organizations. Following the NHLBI announcement, the AHA and the ACC said that they would take over publication of the guidelines.

Statins Indicated for Four Broad Groups

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Original illustration by Max Husten

 

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.

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Both Overuse And Underuse Explain Disparities In Heart Procedures Reply

A new study finds that groups who have often been found to receive less medical care– non-whites, women, and people without private insurance or who are from urban and rural areas– are less likely to undergo coronary revascularization. But the same study finds that this disparity may be in no small part due to the fact that these same groups are less likely to receive inappropriate procedures. The study, published online in the  Journal of the American College of Cardiology, suggests, therefore, that the apparent underuse of healthcare in some groups may be partly counterbalanced by overuse in other groups.

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In an interview with CardioExchange, Chan said that although “we have come a long way in ensuring that care is delivered equitably and thoughtfully in the US… there is no doubt that underuse in certain populations remains a persistent and huge problem. For policymakers… it highlights the importance of thinking about differences in treatment in a more complex way– as due to underuse and also potential overuse. Therefore, the goal may be to narrow the gap in vulnerable populations in instances where treatment has clearly established benefit rather than assuming that the measured difference is entirely due to a disparity in care.” Chan also said the paper was consistent with the hypothesis that patients for whom physicians are paid more are more likely to undergo inappropriate procedures.

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Click here to read the full story on Forbes.

 

 

 

 

 

Fuster To Succeed DeMaria As Editor Of JACC Reply

The American College of Cardiology has announced that Valentin Fuster will be the next editor-in-chief of the Journal of the American College of Cardiology. Fuster will succeed the current editor, Anthony DeMaria, beginning in 2014.

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Observational Study Lends Support to CRT Guidelines Reply

A large observational study published in JAMA suggests that patients with left bundle-branch block (LBBB) and longer QRS duration derive the most benefit from a cardiac resynchronization therapy defibrillator (CRT-D). The findings appear to support current, but often criticized, guidelines from the American College of Cardiology, American Heart Association, and the Heart Rhythm Society, in which a class I recommendation is restricted to patients with LBBB and QRS duration of 150 ms or greater.

Click here to read the full post on Forbes.

 

 

 

The Guidelines Are Dead. Long Live The Guidelines. Reply

Following last month’s surprising announcement that the National Heart, Lung, and Blood Institute would no longer issue guidelines, leaders of the American Heart Association and the American College of Cardiology have now announced that are “officially assuming the joint governance, management and public distribution” of the enormously influential cardiovascular prevention guidelines, including the much-delayed and much-anticipated hypertension and cholesterol guidelines (formerly known as JNC 8 and ATP IV). The ACC and AHA will also assume responsibility for guidelines on cardiovascular risk assessment, cardiovascular lifestyle interventions and obesity.

In an editorial published in Circulation and the Journal of the American College of Cardiology, leaders of the NHLBI, AHA, and ACC provide a little more information on how the new model will work. One important announcement, that “all chairs and members of the current writing panels have been invited to continue to work together with the ACC and AHA to finalize the guidelines,” might indicate that the hypertension and cholesterol guidelines could see the light of day in the not-too-far-distant future. In June the NHLBI’s Michael Lauer expressed confidence that these guidelines would appear in less than a year, but the AHA said that no timeline had yet been established.

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Click here to read the full story on Forbes.

Cardiology Goes Better With Coke 3

At the bottom of this post I’ve reprinted an email cardiologists are receiving from the American College of Cardiology. See the bottom of the message for the disclosure that Coca Cola is paying for this educational program. I don’t have much to say about this though I wonder what the faculty of this program will say about the role of sugared soda and obesity. I also wonder what position the ACC will take on public health efforts to curb sugar consumption.

There’s no reason to be surprised about this. Last year the president of the ACC was one of 22 participants chosen by the Coca-Cola Company to carry the Olympic Flame. And the ACC is far from the only mainstream medical organization to take money from Big Sugar. Coke pays a lot of money to the National Heart Lung and Blood Institute to put a red dress logo on the Diet Coke label and the American Heart Association has struck deals with, among others, Cheetos and Subway.

See Yoni Freedhoff’s Weighty Matters blog for much more about Coca Cola’s efforts to influence medical organizations.

Here’s the ACC email:

The American College of Cardiology is teaming up with the Preventive Cardiovascular Nurses Association (PCNA) to offer Never Too Early, Never Too Late: Cardiovascular Health for Women Throughout the Lifespan, an educational webinar, on Wednesday, August 14th from 1:00 p.m. – 2:00 p.m. EDT. This complimentary webinaroffers a comprehensive view of women’s cardiovascular health as they age. Our expert faculty, Jo-Ann Eastwood, PhD, RN, CCNS, ANCP-BC and Martha Gulati, MD, MS, FACC, will provide perspectives on clinical encounters during the childbearing years, perimenopausal period and in later life, while presenting opportunities to focus on, when indicated, cardiovascular disease (CVD) risk reduction, and the session will be moderated by JoAnne Foody, MD, FACC. During this webinar, the educators will encourage clinicians to seek and seize opportunities to discuss optimal cardiovascular management with their women patients in clinical practice settings, and as equally important, to champion them with their colleagues in the primary care and women’s health fields.Webinar highlights include: A look at how gestational diabetes, pregnancy-associated hypertension and preeclampsia predict future CVD risk Exploration into the prevalence of hypertension in women vs. men throughout the lifespan Why gender differences matter with regard to tobacco use and cessation The impact of women’s physical activity level on cardiovascular risk Examples of successful cardiovascular health improvement programs targeted to women in a variety of age cohorts One hour of CME, CNE and RD credit Click here for additional registration, accreditation and faculty information for this complimentary educational course, Never Too Early, Never Too Late: Cardiovascular Health for Women Throughout the Lifespan. We hope you will join us on August 14th from 1:00 p.m. – 2:00 p.m. EDT! This course is being presented by the American College of Cardiology and the Preventive Cardiovascular Nurses Association (PCNA) through an educational grant from

Hypertension And Cholesterol Guidelines Delayed Again As NHLBI Gets Out Of The Guidelines Business Reply

The National Heart, Lung, and Blood Institute (NHLBI) will no longer issue guidelines, including the much-delayed and much-anticipated hypertension (JNC 8) and cholesterol (ATP IV) guidelines. Instead, the NHLBI will perform systematic evidence reviews that other organizations, including the American Heart Association and the American College of Cardiology, will use as a resource for their own guidelines.

The exact fate and form of the delayed hypertension and cholesterol guidelines has not yet been decided, though the NHLBI’s Michael Lauer said he was confident that these guidelines would appear in less than a year. But a lot of work remains before the documents can be published. ACC President John Harold said that  “the ACC has not formally agreed to or begun the process of updating” the NHLBI documents, “but we are open to this role and look forward to working out details with NHLBI and the American Heart Association.”

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Click here to read the full story on Forbes.

 

NHLBI Director Dr. Gary Gibbons

Spinning RECORD: Battle Over Rosiglitazone Heats Up Two Weeks Before Crucial FDA Meeting 1

Battle lines are being drawn two weeks before a highly unusual two-day FDA advisory committee meeting to discuss the contentious diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). This will be the second time an FDA panel has wrestled with the fate of the drug and expectations have been that the discussion will once again be heated.

But at least one source of fierce criticism won’t be participating in the panel. Steve Nissen, who originally raised concerns about the drug and who has remained the most consistent critic of the drug, will not participate in the deliberations or present to the committee. Early on Thursday Nissen contributed a blog post on Forbes accusing the FDA of stacking the committee in favor of rosiglitazone. The FDA leadership, he says, is trying to use the meeting to “whitewash” its reputation:

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GlaxoSmithKline said that “many inaccuracies exist in Dr. Nissen’s commentary and need to be addressed.” The company specifically denied the multitude of reports over the years that it had suppressed negative data about rosiglitazone over the years. The GSK response offers one potentially very important piece of news. The main focus of the June 5-6 hearing will be the re-adjudication of the RECORD trial performed by the Duke Clinical Research Institute. No public disclosure of the results of the re-adjudication have been made, and in the normal course of events the details of the re-adjudication, along with the rest of the committee’s briefing documents, would appear two days before the start of the hearing on the FDA website. But FDA staff, advisory panel members, and the drug sponsor (GSK) have almost certainly already seen the re-adjudication. In its statement, GSK flatly states that the re-adjudication confirms the safety of rosiglitazone:

The RECORD study is the largest clinical trial designed to evaluate the cardiovascular safety of Avandia. The study conclusions have now been confirmed through a re-examination by one of the leading independent institutions in the country (Duke Clinical Research Institute). In the accepted hierarchy of evidence generation, the results of a randomized, controlled clinical trial usually take precedence over other forms of evidence such as meta-analysis and observational studies. Despite some limitations of trial design, including the open label nature of the study, RECORD remains the only randomized trial of cardiovascular outcomes for Avandia at this time. The confirmation of the RECORD results by the independent re-examination support a positive risk/benefit profile for Avandia for the treatment of type 2 diabetes in appropriate patients.

It remains to be seen whether this is more RECORD spinning or an accurate summary of the Duke re-adjudication.

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Click here to read the full story on Forbes.

 

 

Actelion Executive To Head American College of Cardiology Reply

Shalom “Shal” Jacobovitz will be the new chief executive officer of the American College of Cardiology, the ACC announced today. Jacobovitz is currently the president of the US division of Actelion Pharmaceuticals, best known for its pulmonary hypertension drugs.

Click here to read the complete story on Forbes.

 

The PREVAIL Fail Revisited: Spinning The Truth 1

The biggest story at the American College of Cardiology meeting last week was the missing story. As reported here and just about everywhere else, the PREVAIL trial, probably the most-anticipated late-breaker of the meeting, was pulled from the program at the last minute by the ACC leadership after Boston Scientific broke the embargo by issuing a press release several hours before the scheduled presentation.

To understand this event we first need to know what happened in the week before the ACC. And there’s a major gap in the story that has not come out before that I think holds the key to a full understanding of the story.

More than a week before the scheduled presentation I received an email invitation from a PR firm representing Boston Scientific:

“If you have any interest in speaking about the trial under embargo with Dr. Ken Stein, chief medical officer, Cardiac Rhythm Management, Boston Scientific, I have a few slivers of availability early next week. As you know, the embargo lifts at the time of presentation and I’ll need written confirmation of your embargo agreement.”

Now I’ve been down this road before, as some of you may recall. Several years ago I was offered embargoed access to data from an important upcoming trial by Medtronic (suggesting that this is a systemic problem) under the condition that I agree to a briefing from a trial investigator. I told the company that I would respect the embargo but that I wanted to review the data on my own and that I would get back to them if I had any questions. Their response: no briefing, no data.

Here’s the problem in both cases: forcibly linking access to the trial data with a company-arranged briefing is an egregious perversion of the embargo system.

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Click here to read the full post on Forbes.

 

Following An Embargo Break PREVAIL Trial Won’t Be Presented At ACC 2

UPDATED–The already complicated story behind the PREVAIL trial, which was designed to confirm the safety and efficacy of the Watchman left atrial appendage closure device, just got even more complicated. This morning, after the trial’s sponsor, Boston Scientific, prematurely distributed to investors a press release summarizing the results of the trial, the ACC announced that the scheduled presentation of the results at the main opening session of the meeting would not take place.

 

By way of background, last week the trial’s sponsor, Boston Scientific, first announced that the  principal investigator of the trial, David Holmes, would only “present the acute procedural safety results” from the trial. Then the company reversed itself two days later and announced that Holmes would present all three co-primary endpoints.

Holmes intended presentation this morning at the ACC in San Francisco makes clear why there was so much confusion. (The slides from his presentation have been made available to the media.) Although the trial results appear largely positive, the trial missed one of its three primary endpoints, and experts will likely spend a lot of time and energy trying to interpret the results.

Click here to read the full story on Forbes.

 

 

 

Trials Of Niacin And Atrial Fibrillation Device Will Headline American College Of Cardiology Program Reply

Two big trials will highlight this year’s American College of Cardiology meeting in March in San Francisco. First is the PREVAIL trial testing Boston Scientific‘s long-anticipated Watchman left atrial appendage closure device for stroke prevention in patients with atrial fibrillation. Second is  the detailed presentation of the controversial failed HPS2-THRIVE trial of extended-release niacin and laropiprant.

Read my complete story on Forbes, along with a list of the late-breakers.