Cardiovascular Trials Review Cardiovascular Trials Review - Diegori.it

MIRACL
Myocardial Ischemia Reduction with Aggressive Cholesterol
Lowering (Substudy)
(continued)
Results
Conclusions
The end point of this substudy was the incidence of fatal
and nonfatal stroke. At study entry, the lipid levels between
the two groups were similar; the mean level of total cholesterol
was 206 mg/dL, 124 mg/dL for LDL cholesterol, 46
mg/dL for HDL cholesterol, and 182 mg/dL for triglycerides.
The total and LDL cholesterol had increased slightly in the
placebo group at the end of the study. LDL cholesterol had
increased 12% in the placebo group, and decreased by 40%
in the atorvastatin group. Nonfatal stroke occurred in 22
patients in the placebo group and 9 in the atorvastatin
group (relative risk [RR] 0.40; 95% CI=0.19–0.88; p=0.02).
Fatal and nonfatal stroke occurred in 24 patients in the
placebo group and 12 in the atorvastatin group (RR 0.49;
95% CI=0.24–0.98, p=0.04). 3 strokes were classified as
hemorrhagic; all were in the placebo group. 8 strokes were
classified as either hemorrhagic or undetermined; 5 of these
were in the placebo group. All other strokes were either
thrombotic or embolic. Patients who developed stroke
were older than those who did not, were more likely to be
women, and more likely to have a history of heart failure,
cerebrovascular disease, or MI. Lipid levels at baseline were
similar in patients who developed stroke and those who did
not. Cox proportional hazards analysis revealed that 2 variables
were associated with an increased risk of nonfatal
stroke: history of cerebrovascular disease (RR 3.44; 95%
CI=1.50–7.87; p=0.004); and previous MI (RR 1.99; 95%
CI=0.96–4.15; p=0.065). Treatment with atorvastatin had a
RR of 0.41 (95% CI=0.19–0.89; p=0.024) and current smoking
had a RR of 0.28 (95% CI=0.08–0.92; p=0.36). However,
further analysis showed that current smokers in the study
were younger and less likely to have diabetes, hypertension,
history of heart failure, or previous coronary revascularization,
which may account for this finding.
Aggressive lowering of lipid levels with atorvastatin in
patients with an acute coronary syndrome was associated
with a significantly reduced risk of stroke in the shortterm
(16 weeks) follow-up period.
840 8. Lipid-Lowering Studies