NAPLES II: High dose atorvastatin reduces non Q-wave myocardial infarction following PCI through pleiotropic effects
Giving 80 mg of atorvastatin within 24 hours of a percutaneous
coronary intervention (PCI) reduces the incidence of non Q-wave myocardial infarction
(MI) after PCI, according to research presented during the i2 Summit at the American
College of Cardiology's 58th annual scientific session.
An earlier trial, Novel Approaches for Preventing or
Limiting Events (NAPLES) I, showed that 40 mg of atorvastatin administered at
least seven days before PCI reduced the rate of periprocedural non Q-wave MI.
NAPLES II sought to determine whether a high loading dose of atorvastatin given
in the 24 hours before an intervention would also be protective.
"One of the complications after stent implantation is
the rise in troponin and CK-MB, which may occur in up to 30 percent of patients,
even though their procedure has been completely successful. This rise is associated
with worse outcomes after PCI. There are many data to support that statins administered
one week before stenting can prevent CK-MB and troponin increase," said Carlo
Briguori, M.D., PhD of Clinica Mediterranea, Naples, Italy. "We wanted to learn
if giving a high dose of atorvastatin right before stenting would have a similar
protective effect."
NAPLES II randomly assigned 668 patients scheduled for
elective PCI who were not on statin therapy to atorvastatin 80 mg (n = 338) or
no atorvastatin (n = 330). The primary endpoint was the incidence of periprocedural
MI as assessed by analysis of creatine kinase myocardial enzyme (CK-MB) and cardiac
troponin I before and at intervals of six and 12 hours after the intervention.
Periprocedural MI was defined as a CK-MB elevation greater
than three times the upper limit of normal (ULN) alone or associated with chest
pain or ST segment or T-wave abnormalities.
The incidence of periprocedural MI was 9.5 percent in
the atorvastatin group and 15.8 percent in the control group (P = 0.014; odds
ratio, 0.56). The incidence of troponin elevation greater than three times ULN
was 26.6 percent in the atorvastatin group and 39.1 percent in the control group
(P < 0.001; odds ratio, 0.56).
"These findings support the concept that statins prevent
periprocedural necrosis," Dr. Brigouri said.
"The fact that atorvastatin was effective when we started
it at a very high dose 24 hours before PCI suggests that the major mechanism by
which statins are effective is through their pleiotropic effects - interference
with the inflammatory and thrombotic pathways that may be involved in the CK-MB
increase following stenting."
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