ARMYDA-RELOAD study finds benefit in giving patients with acute coronary syndrome a loading dose of clopidogrel even when they are already taking it
Patients with acute coronary syndrome who take clopidogrel
achieve significant benefit from a 'reloading' dose prior to angioplasty, according
to a late-breaking clinical trial presented at the annual meeting of the American
College of Cardiology.
Patients typically take 75 mg clopidogrel daily; in the
Antiplatelet Therapy for Reduction of Myocardial Damage During Angioplasty-RELOAD
(ARMYDA-RELOAD) study, such patients who were about to undergo angioplasty for
an acute coronary syndrome event were given a 'reloading' dose of 600 mg.
Researchers found that the extra medication was associated with a nearly two
thirds reduction in post procedural major adverse coronary event rate (combination
of death, myocardial infarction, or repeat revascularization) without increase
in risk for bleeding.
Prior to the current trial, no study has ever specifically examined the effect
of clopidogrel reloading on patients with acute coronary syndrome.
"The implications of the study are self-evident: When a patient with acute
coronary syndrome is undergoing percutaneous coronary intervention and has been
taking clopidogrel before, it is a very good idea to give a further loading dose
of 600 mg prior to the procedure. This will protect against ischemic complications,
without fear of more bleeding," said Germano Di Sciascio, MD, professor and chairman
of cardiology at Campus Biomedico, University of Rome, Italy.
"In patients with stable syndromes, ongoing preexisting clopidogrel may supply
sufficient anti-platelet effect to safely undergo the procedure."
Researchers recruited 436 patients who had been taking clopidogrel for more
than 10 days before their procedure. Of these, 167 (38 percent) had acute coronary
syndrome. Patients were randomized to receive an additional 600-mg loading dose
of clopidogrel or placebo four to eight hours before their procedure. Blood tests
confirmed that platelet reactivity was significantly lower in the reload group
compared with the placebo group in patients with acute coronary syndrome.
After 30 days, the overall rates of major adverse cardiac events were the same
in the two groups: 7 percent in patients who received clopidogrel reloading versus
9 percent in the placebo group. A similar finding was observed in patients with
stable chest pain (8 percent versus 4 percent, respectively).
However, in patients with acute coronary syndromes, clopidogrel reloading
significantly reduced the major adverse cardiac event rate (7 percent versus 18
percent, respectively). There was no difference in the rates of bleeding (5 percent
in both groups).
Fundamental differences in the cardiovascular conditions that characterize
acute and stable chest pain may explain the effectiveness of clopidogrel reloading
in patients with acute coronary syndrome, Dr. Di Sciascio said.
"Patients with acute coronary syndrome have higher platelet reactivity, higher
inflammatory status and more intracoronary thrombus," he said. "This may make
them more prone to benefit from clopidogrel reloading."
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