A Diagnostics & Imaging Week

A study of nearly 18,000 patients with normal cholesterol but elevated levels of high sensitivity C-reactive protein (hsCRP), reported at this week's American Heart Association (AHA; Dallas) scientific sessions in New Orleans, has shown that a simple blood test can spot seemingly healthy people who are at increased risk for a heart attack or stroke.

In the randomized, double-blind study of 17,802 men and women, a lipid-lowering drug reduced heart attacks by 54% in people who had normal cholesterol but elevated levels of hsCRP. The JUPITER trial was presented as a late-breaking clinical trial. The study was simultaneously published in the New England Journal of Medicine.

"Compared to those who received placebo, patients receiving the drug rosuvastatin also had a 48% reduction in stroke, a 46% reduction in the need for interventions to reopen blocked blood vessels and a 20% drop in all-cause mortality," said Paul Ridker, MD, lead author of the study and director of the Center for Cardiovascular Disease Prevention at Brigham and Women's Hospital (Boston).

The trial included men over age 50 and women over age 60 with no history of cardiovascular disease, with LDL "bad" cholesterol levels below 130 mg/dL and hsCRP greater than or equal to 2 mg/L. to 190/100. They could have other risk factors for cardiovascular disease, such as high blood pressure up to 190/100, obesity, current smoking, abnormal glucose tolerance (but not diabetes) and/or the metabolic syndrome, and/or a family history of premature heart disease.

Overall, compared to placebo-treated participants in the trial, those given rosuvastatin had a 44% reduction in the primary endpoint of a first major cardiovascular event – a composite of heart attack, stroke, revascularization, hospitalization for unstable angina and cardiovascular death – the study authors noted. Hospitalizations for cardiac reasons were also reduced and the authors suggested that the strategy tested in JUPITER of treating elevated hsCRP patients with statin therapy could be cost-effective.

Ridker said one particularly striking finding was a 37% reduction in first events in men and women in the statin group who had no other risk factors except for elevated hsCRP, a sign of inflammation that can be associated with increased coronary disease risk.

The researchers found no increase in the number of patients with either muscle pain or cancer among those given rosuvastatin. As in almost all prior statin trials, they observed a small increase in reported diabetes, said Ridker, the Eugene Braunwald Professor of Medicine at Harvard Medical School (Boston).

Study participants, who were recruited from 1,300 sites in 26 countries, were randomly assigned to 20 milligrams of rosuvastatin a day or a daily placebo. The study's independent data and safety monitoring board ended the trial in March, more than two years ahead of schedule, when it determined that the study data indicated "unequivocal benefit of rosuvastatin" on coronary-related death and disability.

"Not only do we confirm that apparently healthy men and women with elevated hsCRP are at high risk of cardiovascular events, but we demonstrate that a simple therapy can reduce their risk of heart attack, stroke or cardiovascular death," Ridker said.

The study was sponsored by AstraZeneca (London).

In other news from the AHA conference:

• PGxHealth (Newton, Massachusetts) reported the launch of its new genetic test for arrhythmogenic right ventricular cardiomyopathy (ARVC), an inherited and often fatal heart condition.

The addition of the Familion ARVC test expands the company's Familion family of genetic tests for inherited cardiac syndromes. According to PgxHealth, the Familion tests detect genetic mutations that can cause cardiac channelopathies, such as Long QT syndrome, Brugada syndrome and catecholaminergic polymorphic ventricular tachycardia, or cardiomyopathies such as hypertrophic cardiomyopathy and ARVC in individuals and their families.

By detecting genetic mutations, the Familion tests can be used to recognize inherited forms of these syndromes, helping to guide treatment and reduce the incidence of deadly cardiac events associated with them, the company said.

When a cardiac channelopathy or cardiomyopathy has been diagnosed, the test can help doctors and patients make more informed treatment decisions and aid in uncovering other family members that may be at risk, even if asymptomatic, PgxHealth noted.

• GE Healthcare (Waukesha, Wisconsin) showcased new products, including three ultrasound devices: the Vivid E9, which it says is "making the promise of true 4-D heart imaging and opening the door to full cardiac studies in a completely 4-D environment"; Vivid q, which GE says adds "quantitative analysis to portable excellence, bringing even more diagnostic confidence into the equation while its intravascular ultrasound (ICE) imaging probe opens up an entirely new care area."

The company's diagnostic cardiology business also released new products at AHA, including the EMR Gateway, designed to deliver electrocardiogram (ECG) results and patient demographic data to virtually any Electronic Medical Records (EMR) system. GE said it would also announce a new electrocardiograph system in MAC 1600, Event Recording for advanced arrhythmia assessment and a new version of its ECG management system.

GE also said its ultrasound services team reported the availability of AcoustiCare, a package including as many as four, fully covered, transesophageal ultrasound probe repairs a year. Each repair consists of genuine, upgraded OEM parts and results in a like-new, remanufactured transducer probe.

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