Debabrata Mukherjee, MD, MS, FACC Editor-in-Chief

As winter comes knocking on our doors, I hope you will find time to sit with a hot cup of tea or coffee and enjoy this issue of 

 which discusses many important articles and viewpoints that I am sure you will find enjoyable and useful reading.

, Drs. Navin Nanda and Siddharth Singh discuss the role of 

F-fluoride PET to identify ruptured and high-risk coronary atherosclerotic plaques. They suggest that clinical utility of 

F-NAF imaging in patients presenting with myocardial infarction may need more delineation, as most of these patients undergo coronary angiography and likely intervention. They state that the technique does hold promise to evaluate newer therapies for plaque stabilization by allowing in-vivo imaging of vulnerable plaques.

Drs. Kathleen M. Faulkenberg and Tracy E. Macaulay review the formulation of niacin with laropiprant, a prostaglandin D2 antagonist, aimed at reducing the incidence of flushing, thereby increasing patient adherence to lipid-lowering therapy with niacin. They note that although laropiprant reduced the flushing commonly associated with niacin therapy, it is arguable if the risk and other serious adverse events outweigh the benefit of lipid-lowering therapy with niacin. 

Dr. Harold Lazar discusses the extent of coronary and myocardial disease and benefits from revascularization in LV dysfunction. He reports that coronary bypass surgery remains an important intervention in those patients with multivessel disease and low ejection fraction. These patients may have the most to gain but are at the highest risk for perioperative morbidity and mortality. Further studies will be necessary to determine which subgroups of patients will benefit most from this therapy. In the meantime, decisions regarding the need for CABG surgery in these high-risk patients will need to be made on an individual basis with careful evaluation of existing comorbidities, which may limit both short-term and long-term survival.

Dr. Eric Bates reflects on choosing the best revascularization strategy in patients with left main coronary artery disease (CAD) and opines that the best revascularization strategy for a patient with left main CAD is based on the complexity and extent of CAD, the magnitude of left ventricular systolic dysfunction, physician expertise, patient preference, and consultation between the interventional cardiologist and the cardiac surgeon. Included in this discussion should be the increased risk of early stroke, other surgical complications, and the potential of later saphenous vein bypass graft disease with bypass graft surgery and the increased risk of MI and repeat revascularization after PCI.

Dr. Ragavendra R. Baliga touches on an important social issue: the  combined effect of physical activity and leisure time sitting on obesity risk. He points out that although lifestyle—including dietary and exercise patters&mdash;are shaped by cultural, environmental, technological, and economic factors, we need to modify factors with a range of initiatives from broad food and agricultural policies and targeted pricing and regulatory interventions, to specific harmful or beneficial exercise and dietary components.

Drs. Chintan Desai and Roger Blumenthal muse on noncardiovascular effects associated with statins and suggest that given the strong patient preferences that are often in play when discussing statin therapy, clinicians could further inform the risk discussion by estimating the risks of statin therapy on the basis of clinical characteristics, in a similar way to the estimation of bleeding risk with warfarin. In our clinical forum section, Drs. Gurm, Mohsin, and Quevedo engage in a lively debate on the role (if any) of beta-blockers in patients treated with primary PCI. Also, the compilation of major studies presented at European Society of Cardiology meetings by our insightful and talented managing editor, Ms Jackie Syrop, should keep you updated on the latest happenings in this field.

I hope that you will find these commentaries to be valuable and enjoyable. I encourage you to share your insights, thoughts, and personal experiences on the topics touched upon in this issue. On a broader level, I would love to hear feedback on how we can make this journal even better. My goal continues to be to make you look forward to every issue of 

Articles

In this issue of Cardiology Review, we cover a wide variety of topics while saying hello to the winter of 2014.

Knocking on Winter's Door

 Eplerenone Reduced Death and Risk of Hospitalization in Patients With Systolic Heart Failure and Mild Symptoms

The EMPHASIS-HF trial showed that the aldosterone antagonist eplerenone produced large reductions in both the risk of death and the risk of hospitalization compared with placebo in patients with systolic heart failure (HF) and mild symptoms. The trial randomized 2737 patients with NYHA class II HF and an ejection fraction of no more than 35% to receive either eplerenone up to 50 mg/d or placebo in addition to recommended therapy. The results showed a 37% reduction in the primary end point of the composite of death from cardiovascular causes or hospitalizations for HF. The trial was halted early because of the drug’s significant benefits. The study was published in The New England Journal of Medicine; http://www.ncbi.nlm.nih.gov/pubmed/21073363

 The FDA Approved Rivaroxaban for Prevention of Stroke in Atrial Fibrillation

On November 4, 2011, the US Food and Drug Administration approved rivaroxaban (Xarelto) to reduce the risk of stroke in people with nonvalvular atrial fibrillation (AF). Rivaroxaban is the first oral direct factor Xa inhibitor approved in the United States. Rivaroxaban was previously approved to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism following knee or hip replacement surgery. It is marketed by Janssen Pharmaceuticals. www.fda.gov/newsevents/newsroom/pressannouncements/ucm 278646.htm

 PARTNER Cohort A Trial Shows TAVI Is Noninferior to Surgery

 The PARTNER Cohort A trial, which compared transcatheter- aortic valve implantation (TAVI) with surgical aortic valve replacement (AVR) for severe aortic stenosis, showed that the new catheter-based procedure is as good as surgery in surgery-eligible patients in terms of all-cause mortality. The results of the trial were presented at the American College of Cardiology 2011 Scientific Sessions. At 30 days, deaths were numerically lower in the TAVI group, but not statistically different. By the first year, deaths in both groups were nearly identical and met the definition of noninferiority. PARTNER Cohort A researchers concluded that TAVI is an acceptable alternative to AVR in selected high-risk operable patients. The study was published in The New England Journal of Medicine; http://www.nejm.org/doi/full/10.1056/NEJMoa11035100

 STICH Trial Substudy Suggests Myocardial Viability Testing Didn’t Impact Treatment Effectiveness

 A substudy of the Surgical Treatment for Ischemic Heart Failure (STICH) trial—a randomized comparison of medical therapy with or without bypass surgery for ischemic heart disease in patients with left ventricular (LV) systolic dysfunction&mdash; suggests that assessment of myocardial viability alone should not be the deciding factor in selecting the best therapy for patients with ischemic heart disease and LV dysfunction. Substantial viable myocardium evident in baseline imaging studies had no independent effect on all-cause mortality over 5 years, and viability did not influence the relative effectiveness of the 2 treatments, either for all-cause mortality or cardiovascular mortality and cardiovascular hospitalization. This study was published in The New England Journal of Medicine; http://www.ncbi.nlm.nih.gov/pubmed/21463153

Lipitor’s Patent Expired in 2011; Plavix’s Patent Expires in 2012

The patent on Pfizer’s blockbuster drug Lipitor (atorvastatin calcium) expired on November 30, 2011. The world’s biggest selling drug to date, Lipitor was still generating sales of almost $8 billion per year in the United States when it lost patent protection. How will the availability of generic Lipitor affect physicians’ prescribing behavior? Two generic HHS versions of atorvastatin are now available: one is made by Ranbaxy Laboratories, and the second is Watson’s authorized generic. Six months from the date of patent expiry, however, multiple generic versions of Lipitor will be allowed onto the market. As the data filters in with regard to Lipitor generics, a second big drug—sanofi-aventis/Bristol-Myers Squibb’s Plavix (clopidogrel bisulfate)&mdash;will lose patent protection on May 17, 2012. Bloomberg Businessweek, December 19, 2011

For the first time, the US Department of Health and Human Services has publicly overruled the FDA’s decision to approve a medication. On December 7, 2011, Secretary Kathleen Sebelius overruled the FDA’s decision to approve the application for over-the-counter (OTC) sale without age restrictions of Plan B One-Step, a single-dose emergency contraceptive tablet of the progestin levonorgestrel. The action has generated a great deal of controversy about whether the HHS decision was based on politics or science. The safety and efficacy of the emergency use of levonorgestrel has been well documented Top 10 Stories in Cardiology Top 10 Stories in Cardiology Debabrata Mukherjee, MD, MS,FACC, and Jackie Syrop, Managing Editor February 2012 | Cardiology Review 39 and was reviewed twice by the FDA—once in 2006 before Plan B was granted “behind the counter” status (permitting its sale without prescription to women 17 years or older, but requiring a prescription for those 16 years or younger) and in its most recent review for OTC use without age restrictions. doi:10.1056/NEJMp1114439

Supreme Court Will Review Constitutionality of the Affordable Care Act’s Medicaid Expansion Mandate

 The US Supreme Court’s upcoming review of the constitutionality of the Affordable Care Act’s (ACA) individual mandate to obtain health insurance will also examine the constitutionality of the ACA’s Medicaid expansion provision—the Act’s requirement that starting in 2014, state Medicaid plans cover all persons under 65 years of age with individual or family incomes up to 133% of the federal poverty level. Medicaid has not previously set a baseline income level for mandatory eligibility for adults. When fully phased in, the ACA will provide 90% federal matching funds for newly eligible beneficiaries. To remain eligible for any federal Medicaid matching funds, states are obliged to accept these new requirements. At the same time, traditional Medicaid will no longer be a possible option for states because the current federal support will stop in 2014. Florida’s lawsuit challenging the ACA’s mandatory Medicaid expansion requirements centers on the US Constitution’s Taxing and Spending Clause. Stay tuned. doi:10.1056/NEJMp1113416

 MI FREEE Trial: Access to Free Heart Meds Reduces MIs, Heart Failure

Results of the Post-Myocardial Infarction Free Rx Event and Ecomonic Evaluation (MI FREEE) study, funded by Aetna, revealed that patients who had suffered heart attacks, and whose entire costs for heart medications were covered by Aetna, had lower rates of rehospitalization for MI and heart failure (HF) than patients who had co-pays for these prescriptions. While there was no reduction in the rate of revascularization procedures, Aetna’s costs decreased despite the expense of completely covering heart medications, because the company spent less to treat subsequent health problems. Patients who received free medications also were more likely to take them as directed. Patients saved more than 25% on their overall out-of-pocket health care costs and payed fewer co-pays because their health had improved. Aetna said it will begin offering a benefit plan that will allow MI survivors to get some medications at no cost, or reduced cost, beginning in 2013 (see page 10).

The Centers for Medicare and Medicaid Services (CMS) Recovery Audit Contractors (RACs) have successfully used random audits to recoup billions in reimbursement payments resulting from fraud, abuse, and error, and to avoid what CMS terms the “pay and chase” scenario. In November 2011, CMS announced a new pilot program taking effect on January 1, 2012, with the goal of reducing improper payments by $50 billion and halving payment errors: RACs in certain high-volume or high-population states will begin pre-payment audits of many cardiovascular (and orthopedic) procedure claims prior to paying providers. The new process affects all procedures in certain cardiovascular diagnosis-related groups (DRGs) in 11 states (Florida, California, Michigan, Texas, New York, Louisiana, Illinois, Pennsylvania, Ohio, North Carolina, Montana) that have high CMS fraud rates or high claims volumes for short inpatient hospital stays. Submission of a claim under any of these DRGs will trigger a mandatory review prior to payment by Medicare. The program expires on December 31, 2014. Cardiology organizations have expressed concerns about the program disrupting care and placing burdens on providers and patients. www.theheart.org/article/1325457.do https://www.cms.gov/CERT/05_RAC_Prepay_Demo.asp

An Australian study found that overeating and salt are the 2 biggest threats to health and contributors to increased risk of stroke, and the overall quality of a person’s diet and the balance between caloric intake and expenditure are more important factors in stroke risk than the actual foods and nutrients consumed. Dr Graeme J. Hankey reviewed studies on the link between nutrition or diet and the risk of stroke published between 1970 and 2011. Between 1970 and 2008 the incidence of stroke in high-income countries fell by 42%—most likely because of reduced smoking and more attention to hypertension and high cholesterol&mdash;but in poorer nations, the incidence of stroke increased by more than 100%. The rise in stroke incidence coincided with food and lifestyle changes associated with urbanization and industrialization. Further research is needed to improve the quality of the evidence about nutrients, foods, and dietary patterns with stroke risk, and the role of exercise and how it affects nutrition or stroke risk. The study was published in Lancet Neurology; www.thelancet.com/ journals/laneur/article/PIIS1474-4422(11)70265-4/abstract

Year 2011 in Review: Top 10 Stories in Cardiology 

 hope everyone had a wonderful holiday season and I want to wish everyone a very happy New Year. We start the first 2012 issue of the journal with several key clinical studies. Dr Noel G. Boyle discusses the effect of rate control on quality of life (QOL) in patients with permanent atrial fibrillation (AF) based on an analysis of the RACE II trial data, in which patients with permanent AF were randomized to lenient or strict rate control. Dr Boyle concludes that there was no difference in overall QOL measurements between the strict and lenient rate control groups; further, he notes, symptoms, age, sex, and underlying heart disease—but not the amount of rate control&mdash;influenced QOL. He points out that the choice of rate control versus rhythm control should be individualized, as well as the choice of lenient versus strict rate control.

As for antithrombotic choices in AF, Drs Jennifer G. Bekker, Sara D. Brouse, and Tracy E. Macaulay discuss the role of apixaban versus warfarin in the context of the Apixaban versus Warfarin in Patients with Atrial Fibrillation (ARISTOTLE) trial. They state that apixaban is the first agent to demonstrate the combined benefit of increased efficacy and safety versus warfarin and a significant decrease in mortality. When approved by the FDA, it will likely represent a preferred option for a patient population that has been committed to warfarin for many decades past.

Dr Eric R. Bates discusses causes of delay and associated mortality in patients transferred with STEMI. This is a critical component of care for patients with heart attacks and has a direct influence on survival. Dr Bates states that the ideal transfer strategy for patients with STEMI is direct transport to an angioplasty center, bypassing hospitals without angioplasty capability, with prehospital diagnosis and notification of the cardiac catheterization laboratory. However, only 50% of patients use emergency medical services and some of them are required to transport to the nearest hospital. Therefore, ideally all hospitals without angioplasty capability need to develop and participate in a regional STEMI transfer system to increase timely access to primary angioplasty.

Dr Marco Roffi comments on predictors and impact of bleeding complications in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). Recent studies have highlighted the detrimental consequences of bleeding on survival, and Dr Roffi recommends being more selective in the administration of glycoprotein IIb/IIIa receptor inhibitors in patients treated with potent P2Y12 inhibitors such as prasugrel, and also increasing the use of a transradial approach that may reduce bleeding. We need to not only pay attention to ischemic events but also be cognizant of the risks associated with bleeding when using potent antithrombotics and antiplatelet agents.

Dr Gregory S. Pokrywka discusses an important societal issue—malpractice risk according to physician specialty. Overall, significant heterogeneity exists among specialtyspecific projections of career malpractice risk and cardiologists and internists are in the middle of the pack in terms of the proportion of physicians facing claims annually, both coming in slightly higher than the average for all physicians. Dr Pokrywka reminds us of the essential principles of being a good physician, which are to listen to our patients and respect them&mdash;2 of the best ways we can all prevent malpractice claims.

Several articles in this issue address optimizing secondary preventive therapies for cardiovascular diseases. Dr Peter H. Jones discusses statin usage and all-cause and diseasespecific mortality, confirming that long-term statin use provides one of the single most powerful ways to decrease cardiovascular deaths, with no trade-off on death from other causes. Along the same lines, Dr Leslie Cho discusses suboptimal management of cardiovascular risk factors, particularly in women, and recommends a disease-oriented team approach using other medical personnel such as nurses and pharmacists along with physicians to improve both adherence to guidelines and patient compliance with therapies. Dr Karla K. Quevedo discusses use of secondary prevention drugs for cardiovascular disease in the community and cogently points out that strategies need to be implemented according to the needs of the individual community; only with this targeted strategy will we be able to improve the population’s health and reduce the burden placed on health care resources related to CVD.

I hope that you will find these study synopses to be insightful and of value in your practice. I would like you to share your insights, thoughts, and experiences on topics touched upon in this issue. On a broader level, I would love to hear from you to provide feedback on how we can make this journal the best cardiology journal that reviews contemporary literature. My goal continues to be to make you look forward to every issue of 

Debabrata Mukherjee, MD, MS, FACC Editor-in-Chief

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