Intensive exercise protects against telomere shortening, according to an intriguing new study appearing in Circulation. German researchers studied young professional runners, middle-aged athletes, and age-matched controls who did not exercise regularly.

“The most significant finding of this study is that physical exercise of the professional athletes leads to activation of the important enzyme telomerase and stabilizes the telomere,” said Ulrich Laufs, the study’s lead author from Saarland University in Homburg, Germany, in an AHA press release.
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Using a new, highly sensitive assay for cardiac troponin T, investigators from the PEACE trial have been able to demonstrate that nearly all patients with stable CAD have detectable levels of troponin T, and that these levels may predict death and heart failure. Somewhat surprisingly, however, troponin T levels were not significantly associated with MI in the study. The results appear in a report in the New England Journal of Medicine by Torbjørn Omaland and other PEACE Trial investigators, led by Eugene Braunwald.
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High volume primary PCI centers are faster and deliver more evidence-based care than their lower-volume counterparts, but in recent years there is no discernible difference in mortality, according to a new study from the Get With the Guidelines Program appearing in JAMA.
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Merck may have been aware of the heightened cardiovascular risk of rofecoxib (Vioxx) years before it withdrew the drug from the market in 2004, according to an article appearing in the Archives of Internal Medicine.

Joseph Ross and colleagues analyzed data available to the manufacturer from 30 randomized trials and enrolling over 20,000 subjects. As early as December 2000, only a year and a half after the drug’s approval in May 1999, the data from the trials available at the time gave a strong cardiovascular safety signal (RR= 2.18, CI=0.93-5.81, p=0.07). The signal grew increasingly convincing, reaching significance (p=0.05) by June 2001 with a 35% increased risk of cardiovascular thromboembolic events or death. The signal continued to grow stronger: by September 2004 the use of rofecoxib was associated with a highly significant 43% elevated risk (RR=1.43, CI=1.16-1.76, p<0.001).
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Following a similar earlier communication today from the European Medicines Agency, the FDA late this afternoon announced an ongoing safety review of Meridia (sibutramine). The FDA announcement includes some details not contained in the EMEA communication.

According to the FDA announcement (see below), preliminary data from the SCOUT trial (Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event) suggest that patients taking sibutramine may have a higher risk of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients taking placebo. The FDA reported that the rate of cardiovascular events was 11.4% in the sibutramine arm versus 10% in the placebo arm.
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EINSTEIN-Extension, which will be presented as a late-breaking clinical trial at the American Society of Hematology meeting in New Orleans on December 8, demonstrates that rivaroxaban (Xarelto), the direct oral factor Xa inhibitor, is effective in the long-term prevention of recurrent venous thromboembolism. But a high bleeding rate may dampen enthusiasm for the new oral anticoagulant.

The trial randomized 1,197 patients who had already completed 6-12 months of anticoagulant treatment for a first acute episode of VTE to either rivaroxaban or placebo for an additional 6-12 months. Symptomatic recurrent VTE occurred in  42 (7.1%) of placebo patients and 8 (1.3%) of rivaroxaban patients, representing a highly significant 82% relative risk reduction. When therapy was stopped, after a mean duration of 190 days, there were 6 new events in each group in the following month.
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The AHA, ACC, and SCAI have released focused updates to existing STEMI and PCI guidelines. New to the guidelines are recommendations regarding prasugrel, left main stenting, and DES vs BMS for primary PCI, among others.

Here are some of the highlights:
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Updated: The FDA has issued a public health advisory to highlight updated safety information regarding an interaction between clopidogrel (Plavix) and omeprazole. The label change, which was made on Friday, was reported first by CardioBrief yesterday.

An FDA official explained that the label changes were based on data from a new study performed by the sponsor: Here are the study details as written in the new label:
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Early repolarization, long thought to be benign, is associated with an increased risk of death from cardiac causes, according to a new study presented here at the AHA and published online in the New England Journal of Medicine. Finnish investigators examined the ECGs of 1,864 middle-aged people to assess the prognostic significance over 30 years of early repolarization (defined as an elevation of the QRS-ST junction– J point– in leads other than V1 through V3).
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[Updated. See bottom of story for postscript on CNBC TV reporter Mike Huckman's embargo break.]

The early release of the ARBITER 6 trial on Sunday was a roller coaster ride in more ways than one. In addition to the drama in the newsroom at the AHA as the embargo was lifted, the hastily assembled news conference couldn’t get underway until one very important participant could be summoned from a family outing at Disney’s Animal Kingdom.
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Biventricular pacing may prevent the adverse left ventricular modeling and reduction in LV function often seen with RV pacing, according to results of the PACE Trial presented at the AHA and published online in the New England Journal of Medicine.

Chinese investigators randomized 177 patients with bradycardia and preserved LV function to biventricular pacing or RV apical pacing. At 12 months, LV EF was 54.8% in the RV pacing group compared to 62.2% in the Biventricular pacing group, a highly significant difference (p<0.001). LV end systolic volume was 35.7ml vs 27.6 ml, a relative difference of 25% that was highly significant.
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Results from the 8,430 STEMI patients enrolled in the PLATO trial (presented last summer at the ESC and published simultaneously in the Lancet) are consistent with the main 18,000 patient trial and show that ticagrelor reduced the primary endpoint of MI, stroke or vascular death without causing an increase in major bleeding complications when compared to clopidogrel. The trial was presented by Philippe Gabriel Steg at the AHA.
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Arbiter-6 is big news. CNBC will be reporting live from the convention hall on Monday when the results are released. Just in the last day or so the New York Times and the Wall Street Journal have discussed the significance– or lack of it– of the trial. On the one hand, most cardiologists I speak with don’t believe the trial is a big deal. On Wall Street, on the other hand, the feeling is very different, since analysts believe the trial might further threaten the embattled multibillion dollar Vytorin/Zetia franchise (and perhaps give a boost to Abbot’s niacin franchise).

At first glance, ARBITER-6 just isn’t important. From a purely scientific perspective ARBITER 6 doesn’t have much going for it. It’s a small trial with a surrogate endpoint. It won’t definitively answer any relevant clinical questions. So we might actually agree with the Merck PR person who asked CNBC reporter Mike Huckman: ”Why are you making this such a big deal? It’s a 200-patient study.”
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