Study Uncovers Confusion About When To Use An Important Heart Test Reply

Appropriate use criteria (AUC) are designed to help make sure that medical procedures and interventions are performed in people most likely to benefit and, in turn, are not performed in people unlikely to gain benefit. Now a new study published in Annals of Internal Medicine suggests that the AUC for one very widely performed procedure, diagnostic cardiac catheterization, can provide a very rough indication of when it should and should not be performed, but that a great deal more work needs to be done before the criteria can be considered broadly reliable.

Click here to read the full post on Forbes.


Nonobstructive Coronary Artery Disease Linked to Elevated Risk Reply

A large number of people who undergo elective coronary angiography are found to have nonobstructive coronary artery disease, and these patients have significantly increased risk for myocardial infarction and death, according to a retrospective study published in JAMA.

Click here to read the full post on Forbes.



Stents Lose In Comparisons With Surgery And Medical Therapy Reply

Despite the enormous increase in the use of stents in recent decades, there is little or no good evidence comparing their use to the alternatives of CABG surgery or optimal medical therapy in patients also eligible for these strategies. Now two new meta-analyses published in JAMA Internal Medicine provide new evidence that the alternatives to PCI remain attractive and that some of the growth in PCI may have been unwarranted.

Click here to read the full post on Forbes.


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...


Younger Women With Acute Coronary Syndromes Less Likely To Have Classic Chest Pain Reply

Younger women with an acute coronary syndrome are slightly less likely than men to present with the classic symptom of chest pain, according to a new study published in JAMA Internal Medicine. In recent years there has been a growing understanding that women with ACS are less likely to have chest pain and, partly as a result, often fail to receive a correct diagnosis in the emergency department. However, there has only been limited data on whether this pattern is also true for younger women.

Nadia Khan and colleagues prospectively analyzed data from more than 1,000 ACS patients 55 years of age or younger– 30% of whom were women– participating in the GENESIS PRAXY study.  When compared with older cohorts in previous studies, patients in the study were more likely to have chest pain, but even in these younger patients women were less likely to have chest pain than men…

Click here to read the full story on Forbes.



Large Study Finds Genetic Links To Aortic Valve Calcification Reply

A genetic component is believed to play an important role in valvular heart disease, but the specific genes involved have not been identified. Now an interntional group of researchers has identified genetic variations that increase the risk for valvular calcification.

In a paper published in the New England Journal of Medicine, members of the Cohorts for Heart and Aging Research in Genome Epidemiology (CHARGE) consortium report on their search for genes associated with aortic valve calcification and mitral annular calcification in several of study cohorts. They found one SNP, in a gene previously shown to be associated with lipoprotein(a) levels and the risk of coronary artery disease, to be significantly associated with a doubling of the risk for aortic-valve calcification. This finding was replicated in additional cohorts.

Click here to read the full story on Forbes.

Autopsy Studies Find Large And Dramatic Drop In Early Atherosclerosis Over 60 Years 1

Service members who died over the past decade were far less likely to have atherosclerosis than service members who died in Korea or Vietnam, according to a new study published in JAMA. Although it is impossible to fully understand the causes and implications of the finding, the results provide powerful new evidence pointing toward a very long term, enormous reduction in the prevalence of coronary disease, especially in younger people, though an aging population and disturbing trends in obesity and diabetes mean that cardiovascular disease will continue to be a major public health problem for the foreseeable future.

Micrograph of an artery that supplies the hear...

Bryant Webber and colleagues analyzed autopsy reports and available health data from 3,832 service members who died of combat or unintentional injuries in Afghanistan and Iraq and compared their findings to similar studies performed during the Korean and Vietnam wars. 8.5% of the newest group had evidence of coronary atherosclerosis, compared with 77% in the Korean War group and 45% in the Vietnam War group. The authors acknowledge that there are many reasons why the groups should not be directly compared but conclude that the overall trend   in the reduced prevalence of atherosclerosis is undoubtedly true.

As might be expected, service members with atherosclerosis were older and more likely to have dyslipidemia, hypertension, or obesity than service members without atherosclerosis. Surprisingly, cigarette smoking was not significantly associated with atherosclerosis in this study.

In an accompanying editorial, the Framingham Study’s Daniel Levy writes that “the main finding of this study is valid: the prevalence of atherosclerosis in young men today is much lower than the prevalence in the Korean or Vietnam War eras. If these findings are generalizable to the US population as a whole, then the cardiovascular health of the US population may have improved appreciably over the past 6 decades.”

Levy writes that the concurrent decline in mortality from cardiovascular disease is likely the result of advances in both prevention and treatment, but only advances in primary prevention can explain the trend found in the autopsy studies. Nevertheless, he notes, cardiovascular disease is still the leading cause of death in the US: “The national battle against heart disease is not over; increasing rates of obesity and diabetes signal a need to engage earlier and with greater intensity in a campaign of preemption and prevention.”
Click here to read the JAMA 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.

Meta-Analysis Finds No Advantages for PCI Over Medical Therapy in Stable Patients Reply

Patients with stable coronary artery disease (CAD) today do no better with stents than with medical therapy, according to a new meta-analysis published in the Archives of Internal Medicine. Kathleen Stergiopoulos and David Brown identified 8 trials with 7,229 patients comparing stents to medical therapy in which stents were used in the majority of PCI cases. ”By limiting the analysis to studies in which stent implantation was the predominant form of PCI,” they explained, their meta-analysis “compares contemporary versions of PCI and medical therapy. The exclusion of studies using balloon angioplasty as the primary form of PCI shifted the years of enrollment forward by almost a decade during which time optimal medical therapy evolved to the current regimen that includes aspirin, β-blockers, ACE-inhibitors (or angiotensin receptor blockers) and statins.”

After a mean followup of 4.3 years, there were no significant differences between the stent and medical therapy groups:

  • Death: 8.9% for PCI versus 9.1% for medical therapy (OR 0.98, CI 0.84-1.16)
  • Nonfatal MI: 8.9% versus 8.1% (OR 1.12,CI 0.93-1.34)
  • Unplanned revascularization: 21.4% versus 30.7% (OR 0.78, CI 0.57-1.06)
  • Persistent angina: 29% versus 33% (OR 0.80; CI 0.60-1.05)

The authors write that their study “suggests that up to 76% of patients with stable CAD can avoid PCI altogether if treated with optimal medical therapy, resulting in a lifetime savings of approximately $9450 per patient in health care costs.”

In an accompanying editorial, William Boden writes that “the inescapable fact is that it is increasingly harder to justify use of PCI solely for angina relief in such patients — especially as an initial approach to management, and if medical therapy has not been first instituted (or if efforts to optimize pharmacologic treatment in those treated initially medically are not undertaken).”

Boden responds to the failure of clinical trials like BARI-2D and his own COURAGE trial to effect change in clinical practice:

While physicians outwardly worship at the altar of evidence-based medicine, in reality, we more often tend to practice selective evidence-based medicine by adopting and embracing those trials and studies with results that reinforce our existing clinical practice preferences or biases, while we ignore or disdain the results of studies with results that are unpopular, conflict with our existing clinical practice beliefs, or collide with the conventional wisdom.

Archives editor Rita Redberg places the study in the journal’s “Less Is More” category and writes that, despite the evidence, “fewer than half of Americans with stable CAD who undergo stent placement have received medical therapy first.”

Here is the press release from Archives:

Study Suggests No Benefit Associated With Stent Implantation Compared to Initial Medical Therapy for Stable Coronary Disease

CHICAGO—A meta-analysis of eight previously published clinical trials suggests that initial stent implantation for patients with stable coronary artery disease is not associated with improved outcomes compared with initial medical therapy for prevention of death, nonfatal heart attacks, unplanned revascularization or angina, according to a study published in the Feb. 27 Archives of Internal Medicine, one of the JAMA/Archives journals. The article is part of the journal’s Less is More series.

While percutaneous coronary intervention (PCI) reduces death and nonfatal myocardial infarction (MI, heart attack) in acute coronary syndrome settings, its role in treating stable coronary artery disease (CAD) “remains controversial,” the authors write in their study background.

Kathleen Stergiopoulos, M.D., Ph.D, and David L. Brown, M.D., of Stony Brook University Medical Center, New York, conducted a meta-analysis of previous randomized clinical trials that compared initial coronary stent implantation and medical therapy with initial medical therapy alone. Eight trials that enrolled 7,229 patients between 1997 and 2005 were included. Of those patients, 3,617 were randomized to receive stent placement and medication therapy and 3,612 were randomized to receive medication therapy alone.

“The significant finding of this analysis is that compared with a strategy of initial medical therapy alone, coronary stent implantation in combination with medical therapy for stable CAD is not associated with a significant reduction in mortality, nonfatal MI, unplanned revascularization or angina after a mean (average) follow-up of 4.3 years,” the researchers comment.

They explain their results are in contrast to two recent meta-analyses that found reductions in mortality and angina (discomfort, tightness or heaviness in the chest) in patients assigned to initial PCI. They suggest that an aspect of the current study may explain the difference.

“By limiting the analysis to studies in which stent implantation was the predominant form of PCI, this meta-analysis, for the first time that we know of, compares contemporary versions of PCI and medical therapy. The exclusion of studies using balloon angioplasty as the primary form of PCI shifted the years of enrollment forward by almost a decade during which time optimal medical therapy evolved to the current regimen that includes aspirin, β-blockers, ACE-inhibitors (or angiotensin receptor blockers) and statins,” they note.

Of the total 649 deaths among the 7,229 patients in the trials, 322 occurred among 3,617 patients in the stent groups (8.9 percent) and 327 occurred among 3,612 patients in the medical therapy groups (9.1 percent). Nonfatal MI was reported in 323 of 3,617 patients in the stent groups (8.9 percent) compared with 291 of 3,612 patients in the medical therapy groups (8.1 percent.) Unplanned revascularization was performed in 774 of 3,617 stent patients (21.4 percent) and 1,049 of 3,420 medical therapy patients (30.7 percent).

Data on angina were available for 4,122 patients. Among the initial stent implantation patients, 597 of 2,070 experienced persistent angina (29 percent) compared with 669 of 2,052 medical therapy patients (33 percent).

“In the context of controlling rising health care costs in the United States, this study suggests that up to 76 percent of patients with stable CAD can avoid PCI altogether if treated with optimal medical therapy, resulting in a lifetime savings of approximately $9,450 per patient in health care costs,” the authors conclude.

Commentary: Mounting Evidence for Lack of Percutaneous Coronary Intervention in Stable Heart Disease

In an invited commentary, William E. Boden, M.D., of the Samuel S. Stratton VA Medical Center, Albany, N.Y., writes: “What is the practicing clinician to take away from the present study in the context of other published meta-analyses? First, the totality of evidence does not support any demonstrable clinical benefit for PCI in patients with stable CAD in terms of reducing death, nonfatal MI, hospitalization for ACS (acute coronary syndrome), need for unplanned revascularization and a durable, sustained effect on angina relief.”

He continues: “Finally, given the spiraling health care costs that we have witnessed in the United States over the past decade, and the financial burden this places on our existing health care system, businesses and health care consumers, we certainly have abundant scientific evidence to support a more selective, measured and balanced approach to the initial management of SIHD (stable ischemic heart disease) and one that promotes and embraces optimal medical therapy for the majority of patients as a proven alternative to revascularization.”
(Arch Intern Med. 2012;172[4]:312-319172[4]:319-321)

FDA Approves Medtronic’s Resolute Drug-Eluting Stent for Treatment of CAD, Including Diabetics Reply

The FDA has approved the Medtronic Resolute zotarolimus-eluting stent for the treatment of coronary artery disease. The Resolute DES is approved for use in a wide variety of patients, including diabetics. The new stent uses the same drug-and-polymer combination as the popular Resolute Integrity DES. The Resolute clinical trial program enrolled more than 5,000 patients worldwide, a third of whom had diabetes.

“The Resolute Integrity DES offers several notable benefits, starting with outstanding deliverability, which means it’s exceptionally easy to navigate the stent on the delivery system through the coronary vasculature to the narrowed arterial segment that requires treatment,” said Martin B. Leon, a principal investigator of the RESOLUTE US clinical study, in a Medtronic press release. “Its approval by the FDA is based on the impressive performance of the Resolute DES in a wide variety of patients. With the device’s compelling combination of deliverability, efficacy and safety, not to mention that it is the first DES approved for patients with diabetes, the Resolute Integrity DES promises to gain rapid acceptance in cath labs nationwide.”
Click here to read the Medtronic press release…

The Y Chromosome May Explain Why Men Have Earlier Coronary Disease 1

The earlier onset of coronary artery disease in men has long provoked speculation and research. Now a new study in the Lancet suggests that common variations in the Y chromosome (which is transmitted directly from father to son and does not undergo recombination) may play an important role in the increased risk seen in men.

Using genetic information on the Y chromosome, an international team of researchers identified 9 different ancient lineages– haplogroups– in 3,233 British men. Two of the haplogroups accounted for nearly  90% of the subjects and men in one of these haplogroups, haplogroup I, had a 50% increase in the risk of coronary artery disease compared to  men with other haplotypes. This increase in risk was independent of other known risk factors. The investigators noted that haplogroup I appeared to exert a powerful effect on genes relating to inflammation and immunity. They further noted that haplotype I is generally more prevalent in northern than in southern Europe, and that this distribution is paralleled by an increased risk of coronary artery disease in northern Europe.

In an accompanying comment, Virginia Miller writes that the results of the study are “exciting because they identify a genetic haplotype linking response to infection (adaptive immunity) rather than innate immunity with perhaps an exaggerated inflammatory response and cardiovascular disease in men.”

Click here to read the press release from the Lancet…

CT Angiography Found Less Helpful in Patients With High Calcium Scores Reply

Computed tomography angiography (CTA) has been proposed as a less invasive method to exclude obstructive coronary artery disease (CAD), but no consensus has been achieved about its clinical role in different patient subsets. Now a new report published in JACC from the CORE-64 (Coronary Artery Evaluation Using 64-Row Multidetector Computed Tomography Angiography) study shows that CTA may not be worthwhile in people with a calcium score of 600 or above or who already have a high pre-test probability of having CAD.
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New Enrollment in FAME II Halted After Interim Analysis Shows Benefits of FFR 3

Following a positive interim analysis showing that fractional flow-reserve-guided PCI was superior to optimal medical treatment, an independent Data and Safety Monitoring Board (DSMB) has recommended that patient enrollment in the ongoing FAME II trial  be stopped. The news was announced by the trial sponsor, St. Jude Medical.

FAME II (Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease) investigators had planned to randomize 1,832 patients with stable coronary artery disease to either PCI guided by FFR plus optimal medical treatment (OMT) or OMT alone. At the time of the announcement 1,219 patients had been randomized.

According to the company, the DSMB recommendation was based on an increase in the risk of major adverse cardiac events (MACE) in patients randomized to OMT alone. “In particular, patients receiving OMT alone experienced a highly statistically significant increased risk of hospital readmission and urgent revascularization, and the DSMB determined that this difference was highly unlikely to change with inclusion of more patients,” the company stated. There were no significant differences in the rates of death or MI.

It should be noted that all patients in FAME II underwent FFR prior to randomization, according to the original announcement of the trial. Patients who had hemodynamically significant lesions as assessed by FFR were then randomized to PCI or OMT. The trial was designed to address the limitations of COURAGE, in which CAD patients as documented by angiography were randomized to PCI or OMT. However, the followup to COURAGE, the ISCHEMIA trial, will randomize ischemic patients to PCI or OMT without prior angiography. FAME II does not appear to address the question of which patients should undergo angiography in the first place.

Click here to read additional commentary about FAME II.

Click here to read the St. Jude press release…

Study Finds MR Superior to SPECT, But Clinical Role Is “Uncertain” Reply

Authors of a new study published online in the Lancet state that multiparametric cardiovascular magnetic resonance (CMR) is superior to single-photon emission computed tomography (SPECT) in patients with suspected coronary heart disease (CHD). But at least one expert states that the future role of the technique in clinical practice remains “uncertain.”

John Greenwood and colleagues compared the diagnostic accuracy of CMR and SPECT in 752 patients with suspected CHD. All the patients also underwent invasive x-ray angiography. The investigators calculated the sensitivity, specificity, positive predictive value (PPV), and the negative predictive value (NPV) of the two tests.
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