CARDIOVASCULAR JOURNAL OF AFRICA • Vol 22, No 6, November/December 2011
344
AFRICA
Drug Trends in Cardiology
Dramatic reductions in plaque volumes on maximum statin therapy
Largest IVUS trial shows equal plaque regression with atorvastatin and rosuvastatin
The SATURN trial, which evaluated the
extent of plaque regression in patients
with symptomatic coronary artery disease
(CAD) over a two-year period using
maximum doses of atorvastatin and rosu-
vastatin, showed no difference between
these two statins with regard to the prima-
ry endpoint of percentage reduction of
atheroma volume.
1
‘The extent of regression with both
statins at maximum dose was unprec-
edented in our experience and relates
well to the very low event rate seen in
this clinical trial’, Dr Stephen Nicholls
from the Cleveland Clinic, USA and
principal investigator of this Astrazeneca-
sponsored study noted (Fig. 1).
The SATURN study (Study of
Coronary Atheroma by InTravascular
Ultrasound: Effect of Rosuvastatin versus
AtorvastatiN), a prospective randomised,
multicentre, double-blind study, is the
largest imaging study in cardiovascular
medicine to date and adds to the collec-
tive experience of using intravascular
ultrasound (IVUS) to detect changes in
coronary atheroma volume (Fig. 2).
The primary-efficacy parameter
of the SATURN trial was set as the
change in percentage atheroma volume
in matched coronary artery segments
performed at baseline and at the end
of the 104-week treatment period.
2
The
secondary endpoints included the change
in total atheroma volume on therapy,
change in lipid and lipoprotein values,
and a safety evaluation, including analysis
of adverse events and laboratory data. The
incidence of major adverse cardiovascular
events was explored in the total patient
cohort as a function of changes in IVUS
variables, but did not have the power to
directly compare the treatment groups
with regard to clinical events.
A total of 1 385 subjects aged 18
years and older with at least 20% or
more lumen stenosis in a native epicardial
TABLE 1. CLINICAL CHARACTERISTICS OF PATIENTS
Parameter
Cohort (
n
=
1 385)
n
(%)
Age (years)
57.6
±
8.6
Males
998 (72)
BMI (kg/m
2
)
29.3
±
5.3
Overweight (BMI
≤
25 to
<
30 kg/m
2
617 (45)
Obese (BMI
≥
30 kg/m
2
522 (38)
Previous MI
329 (24)
Previous PCI
303 (22)
Previous CVA/TIA
34 (2)
Hypertension
945 (69)
Diabetes
207 (15)
Current smoking
442 (32)
Peripheral artery disease
85 (8)
Baseline aspirin use
1114 (80)
Baseline statin use
823 (59)
Baseline beta-blocker use
923 (67)
Baseline ACE inhibitor use
582 (42)
Baseline ARB use
180 (13)
Continuous data presented as mean (
±
80) and categorical data as
n
(%). Baseline medications
included selected medication that was taken within 90 days of consent.
ACE, angiotensin converting enzymes; ARB, angiotensin receptor blocker; BMI, body mass
index; CVA, cerebrovascular accident; MI, myocardial infarction; PCI, percutaneous coronary
intervention; TIA, transient ischaemic attack.
Fig. 1. Primary IVUS efficacy parameter.
0.0
–0.5
–1.0
–1.5
Change percent atheroma volume
Atorvastatin
Rosuvastatin
p
<
0.001*
†
comparison between groups
* comparison from baseline
Median change percent atheroma volume
–0.99
p
<
0.001*
–1.22
p
=
0.17
†
Fig. 2. LCL-C and disease progression.
2
1
0
–1
–2
Median change percent
atheroma volume
1
1.5
2
2.5
3
Amended from AHA data
Mean LDL-C (mmol/l)
REVERSAL
Pravastatin
CAMELOT
Placebo
STRADIVARIUS
Placebo
REVERSAL
Atorvastatin
A-PLUS
Placebo
ILLUSTRATE
Atorvastatin + placebo
ASTEROID
Rosuvastatin
SATURN
Atorvastatin
SATURN
Rosuvastatin
