12.8 Million More Adults Now Eligible For Statin Therapy Reply

Millions more people are now eligible for statin therapy under the new cholesterol guideline, according to a new estimate published in the New England Journal of Medicine.

There have been many attempts to quantify just how many more people are now eligible for statin therapy under the new guideline. Now in the new paper in NEJM, Michael Pencina and colleagues estimate that the new guideline results in a net increase of 12.8 million people who are now eligible for statins.

Click here to read the full post on Forbes.

 

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Heart Societies Issue New Guidelines For Valve Disease Reply

The American Heart Association and the American College of Cardiology today released new practice guidelines [PDF] for the management of patients with valvular heart disease (VHD). Among its most notable features, the new document provides a new system of classification for VHD and lowers the threshold for interventions, including, for the first time, transcatheter as well as surgical interventions.

Click here to read the full post on Forbes.

 

Minority Report: Five Guideline Authors Reject Change In Blood Pressure Goal Reply

It didn’t seem possible but the guideline situation just got even more confusing. Last December, after  years of delay and other twists and turns, the Eighth Joint National Committee (JNC 8) hypertension guideline was published in JAMA. The previous guideline recommended that all adults have a target systolic blood pressure below 140 mm Hg. In the new guideline, the target remained the same for adults under 60 years of age but for people over the age of 60 the new guideline set a more conservative, easier-to-achieve target of 150 mm Hg or lower.

Now, however,  five of the 17 JNC 8 authors have written a commentary, published in Annals of Internal Medicine, disagreeing with this change. They say they are in agreement with the other major recommendations of JNC 8 but that they reject the new target, arguing that the evidence does not support the change, and predict that the change may well lead to harmful consequences.

Click here to read the full post on Forbes.

Confusion

 

Cardiology in 2013: Like A Wrecking Ball 1

Perhaps I’m being overdramatic but I think  the best metaphor for the year in cardiology is Miley Cyrus on the wrecking ball.

The Guidelines Wrecking Ball: Like Hannah Montana guidelines are supposed to be boring and reliable.  But in 2013 the guidelines were more like Miley Cyrus. Like a wrecking ball, the NIH abandoned its long-entrenched and highly influential role in producing cholesterol and hypertension guidelines. Then the new ACC/AHA guidelines came along, abandoning tradition and targets and adopting a whole new approach. But the controversy didn’t go away. One easy prediction for 2014: we’ll see more debate about guidelines.

Click here to read the full post on Forbes.

Wrecking Ball

The New Guidelines

Miley Cyrus- Note: Cropped from larger image

The Old Guidelines

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.

Click here to read the full story on Forbes.

Original illustration by Max Husten

Original illustration by Max Husten

Dispatch From The Wild Frontier Of The Statin Wars Reply

The long simmering controversy over the relative benefits and harms of statins has heated to a high boil with the release of the new AHA/ACC US guidelines. But nowhere is the battle more intense right now than in Australia where, according to the National Heart Foundation, a TV show may be the cause of 2,000 heart attacks and strokes over the next five years.

The show was a 2-part documentary  (click here for part 1 and part 2) broadcast in October on the Australian ABC network about dietary fat and cholesterol.

The program, wrote Amy Corderoy, the health editor of the Sydney Morning Herald, “claimed the causal link between saturated fat, cholesterol and heart disease was ‘the biggest myth in medical history’… [and described statins] as toxic and potentially deadly.”

Catalyst delved into a raging debate: has dietary guidance telling us to avoid fats pushed us towards more harmful sugar and carbohydrates instead?

But the program also went a step further, arguing cholesterol was just an innocent bystander in the body’s attempts to deal with the sugar-damage. It was not a big leap to claim statins were dangerous, and the research supporting them fraudulent.

Click here to read the full post on Forbes.

 

Heart of the Matter screen shot

 

 

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

Click here to read the full post on Forbes.

Guideline Maze

Original illustration by Max Husten

 

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.

 

 

 

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.”

Click here to read the full story on Forbes.

 

NHLBI Director Dr. Gary Gibbons

NHLBI Director Dr. Gary Gibbons

New Guidelines Define State-of-the-Art STEMI Care Reply

New guidelines published online today in Circulation and the Journal of the American College of Cardiology provide an efficient overview of the best treatments for STEMI patients. (Click here to download the PDFs of the full version (64 pages) or the executive summary  (27 pages) of the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction.)

“We’re looking to a future where more patients survive with less heart damage and function well for years thereafter,” said Patrick O’Gara, the chair of the guidelines writing committee, in a press release. “We hope the guidelines will clarify best practices for healthcare providers across the continuum of care of STEMI patients.”

The new document strongly supports the establishment and maintenance of regional systems to treat STEMI, which should include assessment and continuous quality improvement programs.

Primary PCI remains the preferred method of reperfusion when it can be performed by experienced operators in a timely fashion. For people who can’t receive primary PCI within 120 minutes of arrival, fibrinolytic therapy should be given within 12 hours of the the onset of symptoms.

The first medical contact (FMC)-to-device time should be 90 minutes at PCI-capable hospitals. Patients who arrive at non PCI-capable hospitals should be transported to a PCI-capable hospital within 30 minutes and should be treated with a FMC-to-device system goal of 120 minutes of less.

Drug-eluting stents should not be used in patients who can’t or won’t comply with long-term dual antiplatelet therapy (DAPT). After receiving a stent patients should receive DAPT with aspirin and either clopidogrel, prasugrel, or ticagrelor.

Click here to read the AHA press release…

Comprehensive Guidelines for Stable Ischemic Heart Disease Released Reply

Stephan D. Fihn, MD

New comprehensive guidelines for the diagnosis and treatment of stable ischemic heart disease have been released by the American College of Cardiology (ACC)/American Heart Association (AHA) Task Force on Practice Guidelines, along with the American College of Physicians (ACP), American Association for Thoracic Surgery (AATS), Preventive Cardiovascular Nurses Association (PCNA), Society for Cardiovascular Angiography and Interventions (SCAI), and The Society of Thoracic Surgeons (STS). The guidelines are being published in the Journal of the American College of Cardiology and Annals of Internal Medicine and will be available on the ACC Cardiosource website and the SCAI website.

The chairman of the writing committee, Stephan Fihn, provided the following summaries of the key points of the document for professionals and for patients:

For professionals:

a. Management of SIHD, including diagnosis, risk assessment, treatment and follow-up should be based upon strong scientific evidence and the patient’s preferences.

b. All patients who present with angina should be categorized as stable vs. unstable angina. Those with moderate or high risk unstable angina should be treated emergently for acute coronary syndrome.

c. For patients with an interpretable ECG and who are able to exercise, a standard exercise test should be the first choice test for diagnosis of IHD, especially if the likelihood is intermediate (i.e., 10 to 90%). Those who have an uninterpretable ECG and are able to exercise, should undergo an exercise stress with nuclear MPI or echocardiography, particularly if the likelihood of IHD is intermediate to high. For patients unable to exercise, nuclear MPI or echocardiography with pharmacologic stress is recommended.

d. Patients diagnosed with SIHD should undergo assessment of risk for death or complications of IHD. For patients with an interpretable ECG and who are able to exercise, a standard exercise test is also the preferred choice for risk assessment. Those who have an uninterpretable ECG and are able to exercise, should undergo an exercise stress with nuclear MPI or echocardiography, while for patients unable to exercise, nuclear MPI or echocardiography with pharmacologic stress is recommended.

e. Patients with SIHD should generally receive a “package” of Guideline-Directed Medical Therapy (GDMT) that include lifestyle interventions and medications shown to improve outcomes which includes (as appropriate):

  • Diet, weight loss and regular physical activity;
  • If a smoker, smoking cessation;
  • Aspirin 75-162mg daily;
  • A statin medication in moderate dosage;
  • If hypertensive, antihypertensive medication to achieve a BP <140/90;
  • If diabetic, appropriate glycemic control.

f. Patients with angina should receive sublingual nitroglycerin and a beta-blocker. When these are not tolerated or are ineffective, a calcium-channel blocker or long-acting nitrate may be substituted or added.

g. Coronary arteriography should be considered for patients with SIHD whose clinical characteristics and results of noninvasive testing indicate a high likelihood of severe IHD and when the benefits are deemed to exceed risk.

h. The relatively small proportion of patients who have “high-risk” anatomy (e.g., >50% stenosis of the left main coronary artery), revascularization with CABG should be considered to potentially improve survival. Most of the data showing improved survival with surgery compared to medical therapy are several decades old and based on surgical techniques and medical therapies that have advanced considerably. There are no conclusive data demonstrating improved survival following PCI.

i. For the vast majority of patients with SIHD, a trial of GDMT is warranted before consideration of revascularization to improve symptoms. Deferral of revascularization is not associated with worse outcomes.

j. Prior to performing revascularization to improve symptoms, coronary anatomy should be carefully correlated with functional studies to ensure the highest likelihood that lesions responsible for symptoms are targeted.

k. All patients with SIHD should receive careful follow-up to monitor for progression of disease, complications and adherence to therapy. Exercise and imaging studies need not be performed annually and should generally be repeated only when there is a change in clinical status or when clinical features suggest a significant change in risk of death or complications from IHD.

For patients:

a. Nearly 9 million persons in the U.S. have angina, the most common symptom of IHD and the prevalence is as high as 15-33% among persons over age 60.

b. If you develop chest discomfort or shortness of breath with activity, seek immediate medical attention.

c. The choice of tests to diagnose IHD is complicated and is based upon your symptoms, personal and health characteristics and preferences. If you able to exercise, a standard exercise test is often the first-choice test.

d. If you are found to have IHD, it is important for your physician to assess your risk of a heart attack or other undesirable outcomes. This may require additional exercise or imaging tests.

e. Most patients with IHD should adopt lifestyle changes that include a healthy, low-fat diet; regular exercise and when warranted, weight loss. Other important steps (when applicable): include smoking cessation; good control of high blood pressure; a statin medication to lower LDL (bad) cholesterol; good control of diabetes; daily aspirin; and medications to eliminate chest pain (angina) such as nitroglycerin and beta-blockers. This “package” of activities and medications is called Guideline-Directed Medical Therapy.

f. When angina does not respond to medications, patients may decide with their medical team, to undergo a procedure to improve circulation to the heart. This can be accomplished either with surgery (coronary artery bypass grafting) or with a catheter (PCI – percutaneous coronary intervention). The choice should be based upon the clinical characteristics of the patient and the results of testing including cardiac catherization. Both surgery and PCI are relatively safe and effective in eliminating chest pain BUT surgery improves survival only in a relatively small group of patients with very severe blockages of the left main coronary artery or several arteries, while PCI has not been conclusively shown to improve survival in any group of patients.

g. Patients with SIHD should receive regular medical follow-up from a primary care provider or cardiologist. The purpose is to answer any questions that arise, monitor therapy for effectiveness and possible adverse events, and check for any new complications related to IHD. Annual stress tests are usually not necessary and your provider should determine what tests are necessary and how often they should be performed based upon your personal clinical characteristics.

Screening For AAA Comes Under Renewed Scrutiny And Criticism Reply

A 2007 Medicare initiative to increase AAA (abdominal aortic aneurysm) screening in appropriate patients failed to prevent AAA rupture or reduce all-cause mortality, according to a new study published in Archives of Internal Medicine. The larger implications of the study are unclear, but two accompanying papers, an invited commentary and a perspective, emphasize the darker side of AAA screening.

Jacqueline Baras Shreibati and colleagues examined the effect of the 2007 Screening Abdominal Aortic Aneurysms Very Efficiently (SAAAVE) Act which provided Medicare coverage for a one-time ultrasound screening for new Medicare patients who were men and who had a history of smoking or women with a family history of AAA. The SAAAVE Act was based on 2005 US Preventive Services Task Force recommendations.

Using Medicare data from 2004 to 2008, the investigators found a modest increase in AAA screening among eligible 65-year-old Medicare men during the study period, from 7.6% in 2004 to 9.6% in 2008. The SAAAVE Act resulted in no significant differences in the rates of AAA repair, AAA rupture, or all-cause mortality, they concluded.

In an invited commentary, Russell Harris, Stacey Sheridan, and Linda Kinsinger write that the evidence about AAA screening has changed since the 2005 USPSTF recommendations. In the past 10-15 years, they write, mortality from ruptured AAA has been cut nearly in half. AAA screening, they maintain, has had little to do with this change; rather, the change is more likely due to long term trends in the reduction of smoking prevalence and the incidence of MI.
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Updated Rhythm Device Guidelines Clarify And Expand CRT Criteria Reply

A newly released update of 2008 guidelines for device-based therapy of cardiac arrhythmias contains some much-needed clarification about indications for cardiac resynchronization therapy (CRT). The document was developed jointly by the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society.

Highlights of the documents include:

  • The Class 1 recommendation for CRT for patients with systolic heart failure (HF) is now limited to patients with a QRS duration of at least 150 ms but has been expanded to include both patients with NYHA class II symptoms and LBBB patients.
  • A Class IIa recommendation for patients with a QRS duration of 120-149 who otherwise meet the criteria for a Class 1 recommendation.
  • A new Class IIB recommendation for patients with NYHA class I symptoms with LVEF < 30, ischemic HF, sinus rhythm, and LBBB with a QRS duration >150 ms.
  • Recommendations from 2008 remain in effect for hypertrophic cardiomyopathy, arrhythmogenic RV  dysplasia/cardiomyopathy, genetic arrhythmias, congenital disease, primary electrical disease, and terminal care.

The document also provides updated information about remote followup and monitoring of patients with cardiovascular implantable electronic devices.

“There is growing evidence that patients with the widest, most abnormal looking ECG potentially benefit most compared to patients whose ECG are less abnormal,” said Cynthia M. Tracy, the chair of the writing group, in a press release. She noted that patients with LBBB particularly benefit from CRT.

The authors noted that a separate document under development will define appropriate use criterial and “will help to further interpret the best science and apply it to various clinical scenarios.”

Republished with permission from CardioExchange, a NEJM group publication.

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Guest Post: Children Should Have Their Cholesterol Checked Reply

Editor’s Note: CardioBrief is pleased to publish this guest post written by Samuel Gidding, the head of the cardiology division at the Nemours Cardiac Center at A. I. DuPont Hospital for Children and a professor of pediatrics at Jefferson Medical College. CardioBrief invited Gidding, a member of the NHLBI panel that recommended universal lipid screening at ages 9-11 years, to respond to James Stein’s critique of those guidelines.

Children Should Have Their Cholesterol Checked

Samuel S. Gidding, MD

Dr. Stein, in his post, presents several arguments against cholesterol screening  in childhood.  I would like to present the view of those who drafted the document and suggest that some of Dr. Stein’s arguments are incorrect.

First, since conflicts of interest were part of his argument, I must be transparent about mine.  I have never participated in a drug industry sponsored trial of a cholesterol lowering medication.  I had no conflicts with industry until late 2009, after the main work on the guideline was complete.  Both of these are related to evidence gaps identified in the literature review for the guideline.  The first is as a member of the Data and Safety Monitoring Board for a trial of losartan to lower blood pressure in severely hypertensive children less than 6 years of age. The reimbursement for this work is deposited into a research fund to support medical students and residents performing research without another source of support.  The second is to conduct a clinical trial of fish oil for elevated triglycerides in adolescents.  There is no clinical trial data regarding medication use for elevated triglycerides in children and no recommendations were made regarding use of medications for this purpose in the NHLBI sponsored statement.  This money is provided as a grant, the trial is completely of my design and my research program manages the trial without input from the company.  There is no oversight by the company of the trial other than I have to recruit a specified number of patients and complete a manuscript to receive payment.   My reimbursement from the grant is for managing the coordinating center of the trial (there are 3 sites), analyzing the data, and for performance of various medical duties in conducting the trial.

The NHLBI guideline was strictly conducted according to the recommendations of the Institute of Medicine and other bodies that have been interested in guideline integrity. Several thousand research papers meeting preselected criteria as evidence were considered in the evaluation of recommendations for 14 different risk factors.  A paper describing the panel’s process has recently been published. (Gidding SS et al, Pediatrics, 2012)  The Lipid section of the guideline was drafted by the three members of the panel with the most knowledge about lipids.  However the recommendation of this group was debated and voted upon by the entire committee, which had a diverse composition consistent with the Institute of Medicine recommendations.  NHLBI officials cognizant of conflict of interest issues were also present and contributed to the discussion.  With one exception, none of the other 11 committee members had participated in an industry sponsored cholesterol drug trial.

All the arguments discussed in critiques of the guideline emerged in this debate, in fact, the committee felt so strongly about the evidence limitations that a specific chapter of the guideline was written to include them, particularly the cost issue.  Nonetheless, the committee, with one exception, voted for universal screening because the weight of the evidence review favored this decision despite evidence gaps.  The fact that atherosclerosis begins in the second decade of life, that this atherosclerosis (including future atherosclerosis) is strongly related to non HDL cholesterol levels, that a small but significant number of children can be identified with high cardiovascular risk, that treatments highly likely to be successful are available, and that genetic  diseases causing both high and low LDL cholesterol were highly suggestive of the risk of high LDL cholesterol and the benefit of  lifetime low LDL cholesterol levels provided this weight.   It is inaccurate of Dr. Stein to say that the evidence evaluation for the cholesterol treatment recommendation does not reflect the types of studies included to support the recommendation.  The grade given is B (not A), evidence from clinical trials with potential flaws, high quality and consistent observational studies, and Mendelian Randomization (genetic research).  Hopefully, an outcome of the guideline will be high quality clinical trials of lipid lowering treatment that have been initiated by sponsors other than industry.
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Industry PR Efforts Influence Debate On Cholesterol Screening Guidelines For Children 4

Note: This post is accompanied by a separate guest post by James Stein.

What role should industry play in discussions about guidelines, especially when the debate about those guidelines includes allegations that industry may have influenced the final product of the guidelines? Should a public relations agency that represents a company with a product that would be affected by a guideline offer journalists a chance to interview an expert who has views that might benefit the company?

Let me first set the stage. An important debate assumed public form last November following the publication in Pediatrics of new NHLBI guidelines recommending universal cholesterol testing for children. The debate heated up earlier this year with two JAMA articles containing biting criticism of the guidelines, one of which was co-authored  by a dissenting member of the guidelines committee. Now the controversy has flared yet again, with the recent appearance of two articles in Pediatrics, one attacking the guidelines and the other a defense of the guidelines by several members of the committee.

Before getting into the role of industry in this debate, I first want to emphasize that the  scientific and public health issues involved in this debate are of the highest possible importance. Cardiovascular disease remains the number one killer in the world, and although efforts to reduce cardiovascular disease have achieved remarkable success in recent decades, the rising tide of obesity and diabetes threatens to roll back much of this progress and is reshaping (literally and figuratively) childhood and adolescence. So prevention of cardiovascular disease, which starts in childhood, is a very major concern which deserves serious discussion.

An excellent example of the type of discussion we need is provided in an accompanying article by James Stein. His eloquent piece provides a thoughtful perspective and overview of the debate. I don’t have much to offer beyond what Stein writes, but in this piece I’d like to present a recent and highly relevant anecdote that might help illuminate the part of his discussion about the role of industry influence in this debate.

A few days after the publication of the Pediatrics papers, I received an email message from a public relations agency. Here it is (names and other identifying details redacted):
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Guest Post: An Electrophysiologist Looks At The New HRS/ACCF Pacemaker Guidelines Reply

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

Overview of the New HRS/ACCF Pacemaker Guidelines

by Edward J Schloss MD 

Since the development of the first dual chamber pacemakers in the 1980s, doctors have had the choice of using single or dual chamber devices in patients with traditional pacing indications. Although a number of pacemaker guideline consensus statements have been published over the years, none have provided specific guidance on specific device type or pacing mode selection.

This week the Heart Rhythm Society and American College of Cardiology Foundation published online the HRS/ACCF Expert Consensus Statement on Pacemaker Device and Mode Selection.  The authors intend this to be a supplement to the 2008 published pacemaker guidelines and classify indications in similar fashion, ranging from Class I (general agreement regarding benefit) to Class III (not useful, or harmful).  Biventricular pacing is not addressed in these documents, having been covered elsewhere .

The document is concise and clearly stated, and I would refer all those close to the field to the link above.  Below, I will add my own brief summary and comments.
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Has COURAGE been vindicated? Reply

The ACC, the AHA, and a whole alphabet soup worth of other cardiovascular organizations (SCAI, STS, AATS, ASNC, ASE, HFSA SCCT) have published (or in some cases just endorsed) a report, called the ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary Revascularization. The report  will probably provide comfort to those who were big supporters of COURAGE. I’m guessing this will only initiate a new round of debate. It seems unlikely that there will be a widespread breakout of peace over this issue in 2009.

You can read a Dow Jones news story about the report.