AHA Puts on a Big Show in the City of Big Shoulders

The American Heart Association’s annual scientific session in Chicago offered insights on the latest therapies and practices, from statin treatments and screening tools to readmissions and communications. Here is a roundup of presentations from the Nov. 15-19 event.

PCSK9 inhibitor safe, effective in statin-intolerant patients

Treatment with a monoclonal antibody designed to reduce low-density lipoprotein (LDL) cholesterol in at-risk patients who were statin intolerant lowered lipid levels and improved adherence compared with statins in the ODYSSEY ALTERNATIVE study.

“I don’t think people realize how complex these patients are,” says lead investigator Patrick M. Moriarty, MD, director of clinical pharmacology at the University of Kansas Medical Center in Kansas City. He presented safety and efficacy results for alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, during a late-breaking clinical trial session.

The study enrolled patients who were very high-, high- or moderate-risk who had a history of statin intolerance, which was defined as the inability to tolerate at least two different statins because of skeletal-muscle symptoms. During a single-blind run-in period, all patients received placebo subcutaneous injections and placebo pills. Those who reported muscle-related adverse events were excluded.

The remaining 314 patients were randomized to alirocumab 75 mg and a daily oral placebo (126 patients); a placebo subcutaneous injection and daily oral ezetimibe 10 mg, a recommended option for statin-intolerant patients (125 patients); or a placebo subcutaneous injection and daily oral atorvastatin 20 mg (63 patients). The study also included a three-year open-label treatment period. 

At 24 weeks, the alirocumab group experienced a greater change in LDL cholesterol from baseline compared with the ezetimibe group and more patients in the alirocumab group reached target lipid levels. For safety, fewer patients in the alirocumab group reported skeletal-muscle-related treatment-emergent adverse events than in the ezetimibe group and the atorvastatin group and fewer discontinued treatment as a result.

Almost 90 percent of patients continued on the open-label study. Discontinuation due to adverse events dropped to 1.4 percent in the open-label period. “[Alirocumab] is safer, more efficacious than ezetimibe and more potent,” Moriarty says. He calls it a win-win for patients with the potential to dramatically change treatment for statin-intolerant patients.

Warfarin plus antiplatelet therapy may raise dementia risk

Patients with atrial fibrillation who often are over-anticoagulated on warfarin and receive antiplatelet therapy may be at increased risk of developing dementia. “Of all the variables in multivariate analysis, the only ones that truly predicted dementia risk in the population was over-anticoagulation percent time [of 25 percent of more] vs. over-anticoagulation that was good, or less than 10 percent,” says presenter Thomas Jared Bunch, MD. “It is quite a strong marker for dementia risk.”

Bunch, director of electrophysiology research at the Intermountain Medical Center Heart Institute in Murray, Utah, and colleagues have proposed that repetitive cerebral injury from microbleeds or small clots from under- or over-anticoagulation may contribute to dementia. In this study, they focused on patients with no history of clinical dementia who received antiplatelet agents in addition to warfarin. The study included 1,031 patients receiving antiplatelet therapy and warfarin at the center, with a follow-up of 4.5 years.

Patients with international normalized ratios (INRs) of 3 on 25 percent or more of their blood tests were more than twice as likely to be diagnosed with dementia as patients with INRs of 3 on 10 percent of tests, they determined.

N.J.'s mandatory newborn pulse-ox screening shows success

Critical screening for newborns in New Jersey bears fruit: 13 more babies were identified with critical congenital heart defects than had been previously identified through prenatal screening or physical exam, according to one study.

Secondarily, babies with other kinds of congenital heart defects and serious medical conditions were identified solely through the mandatory pulse oximetry program.

In June of 2011, New Jersey enacted legislation that required all hospitals and birthing centers in the state to evaluate all live births using noninvasive pulse oximetry screening to determine infant risks for critical congenital heart defects. The screening is designed to capture the small percentage of newborns who appear healthy at birth and are not identified through prenatal screening or physical exam. These infants may be discharged from the hospital but need extra care.

“If a baby with critical congenital heart defects goes undetected, later detection could result in significant disability or death for the infant,” explains Kim Van Naarden Braun, PhD, of the Centers for Disease Control and Prevention in Atlanta and the New Jersey Health Department. “There are significant implications for late diagnosis.”

Since the legislation was enacted, screening was successfully performed on 99.6 percent of live births in the state. The program identified 13 infants with congenital heart defects, 11 with noncritical congenital heart defects and six with other serious medical conditions.

EHR method helps define CI readmission factors

Using novel methods to extract data from EHRs, researchers at two Boston hospitals identified three factors that potentially may predict PCI readmissions.

The 30-day readmission rate for PCIs reached nearly 12 percent in 2011, according to an analysis of the National Cardiovascular Data Registry’s CathPCI registry. These readmissions add costs for Medicare and private insurers and burden patients. Jason H. Wasfy, MD, of Massachusetts General Hospital in Boston, and colleagues wanted to predict prospectively patients at risk of readmissions as a way to lower cost and improve care.

Using the EHR and high-volume PCI centers at Massachusetts General and Brigham and Women’s hospitals, they extracted unstructured and semi-structured data on nearly 9,300 PCIs. In an analysis that matched 888 readmitted patients and 1,776 patients who were not readmitted, they determined that anticoagulation, the number of previous emergency room visits and anxiety were independently associated with readmission.

Anxiety may offer physicians a golden opportunity to reduce readmission rates because it is modifiable and actionable, according to Wasfy, who also is co-chair of the Acute Myocardial Infarction Clinical Care Redesign Committee at Massachusetts General’s Institute for Heart, Vascular and Stroke Care. “To do a good PCI is not to just to do the procedure right,” he says. “We need to educate patients about what it means to have heart artery disease and make sure they have the resources to manage their conditions and good ways to access their physicians to ask questions.”

Their next steps include testing the new variables in a risk model prospectively to evaluate whether they improve the model’s predictive ability.

Readmission penalties hit inner-city hospitals hardest

Medicare penalties on 30-day readmissions for MI, heart failure and pneumonia disproportionately ding inner-city hospitals with disadvantaged patients, according to Arshad A. Javed, MD, chief medical resident at John D. Dingell V.A. Medical Center in Detroit, and colleagues.  

They compared readmission penalties for 2013 and 2014 in hospitals in large cities for all states except Maryland and also evaluated census and socioeconomic data. The 2013 results were based on data from 2008 to 2011, with 2014 results reflecting 2012 and 2013 data.

They found that safety-net hospitals in larger cities received higher penalties. Five hospitals in Detroit and three in Newark, N.J., had the highest penalties, at 0.9 percent. Indianapolis, by comparison, had a rate below 0.2 percent. They reported a moderate correlation of readmission penalties with a low level of education for people in the city and a significant positive correlation with the rate of unemployment in a city.

“Level of education, unemployment and low household income were significantly associated with readmission penalties,” Javed notes. “If they [Centers for Medicare & Medicaid Services] adjust them [penalties] according to those three factors, it will make a huge difference.”

The buzz on second-hand smoke from pot

According to one study, endothelial function was just as impaired in rats exposed to second-hand smoke from marijuana as cigarettes. Blood vessel function remained impaired even when the marijuana contained none of the compound that produces the feeling of intoxication in humans.

“The take home message is that smoke is smoke,” says researcher Matthew L. Springer, PhD, of the Center for Tobacco Control Research & Education at the University of California, San Francisco. “Whether you’re getting it from tobacco or marijuana, you’re getting smoke. If you’re smoking it yourself, you’re getting smoke. If you’re a bystander exposed to someone else’s second-hand smoke, you’re getting smoke.”

Using rat models, Springer and colleagues found that arterial function was impaired by 50 percent to 70 percent when exposed to marijuana second-hand smoke for about 30 minutes. While tobacco second-hand smoke impairment typically resolves after 30 minutes after exposure, marijuana exposure took much longer.

Springer warns that more and more nonsmokers will be exposed to greater quantities as laws on marijuana use change—particularly, if public smoking laws aren’t written broadly enough to ensure marijuana is included.