'Nuisance' Bleeds Don't Up CV Events in Non-ST-ACS

Shelley Wood

November 18, 2011

November 18, 2011 (Orlando, Florida) — A new analysis trying to tease out the prognostic significance of "nuisance" bleeding in non-ST-elevation acute coronary syndrome (non-ST-ACS) patients suggests that these types of bleeds do not increase the risk of more serious cardiovascular events.

Of note, however, people who have nuisance bleeding early on are twice as likely to have major cardiovascular events as are people who have nuisance bleeds after the 30-day mark.

Dr Usman Baber (Mount Sinai School of Medicine, New York, NY), who presented the findings earlier this week at the American Heart Association 2011 Scientific Sessions, points out that the association between major bleeding and cardiovascular events is well-established. By contrast, he told heartwire , the data on less severe, nuisance bleeding--bruising, nose bleeds, hematuria, and gastrointestinal bleeds that do not meet accepted definitions of major or minor bleeding--is much less clear.

"In clinical practice, we see patients who come in and say I'm having nose bleeds, should I stop my medicine, what does this mean?" he explained. "We know what a major bleed is, we know what a minor bleed is, how common they are, and how they correlate with events. But all these other ones in clinical practice, we're not as sure of their importance."

Baber et al reviewed the adverse-events database for the 12 562-patient CURE trial, extracting all bleeding events. They found that 682 patients had reported some kind of nuisance bleed, yielding an incidence of 5.4%--the most common type of bleeding in the trial. For comparison, the rate of minor bleeds was 3.6% and the rate of major bleeds was 3.2%.

Not surprisingly, bleeds were more common in patients randomized to clopidogrel plus aspirin than in patients randomized to aspirin plus placebo, and most occurred in the first six to eight weeks.

Of note, there was no difference in the rates of death, death or MI, or death/MI/stroke in patients who had nuisance bleeds vs those who did not.

Baber and colleagues then looked separately at event rates among patients who had nuisance bleeds within the first 30 days vs those who had bleeds after the 30-day mark. Here, rates of all three CV end points were twice as common among patients who'd had early nuisance bleeds than among those who'd had them later on.

"Clearly, the risk with nuisance bleeding is time-dependent," Baber said. "The question then is, with these people who are bleeding early on, is their risk only for the first 30 days, or is it sustained over time? And we found that even among those people who had nuisance bleeds early on, if you follow them over time, their risk diminishes. What that suggests to me is that nuisance bleeding in all likelihood is a marker of patients who are predisposed to adverse events, but it is not a mediator of adverse events or poor outcomes."

That's important, he added, since other data have shown that major bleeding is associated with a sustained risk of cardiovascular events over time.

Other patient characteristics likely account for the increased risk of nuisance bleeds and the increased risk of ischemic events, Baber said, saying the findings, "should not make us modify or change the way we practice."


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