Year 2011 in Review: Top 10 Stories in Cardiology

Cardiology Review® Online, February 2012, Volume 28, Issue 1

1:

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

2:

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

3:

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

4:

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— 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

5: 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)—will lose patent protection on May 17, 2012. Bloomberg Businessweek, December 19, 2011

6:

HHS Overrules FDA on Drug’s Approval

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

7:

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

8:

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).

9:

CMS Launching Prepayment Audit Program

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

10:

Nutrition Affects Stroke Risk

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—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