CARDIOVASCULAR JOURNAL OF AFRICA • Vol 22, No 6, November/December 2011
AFRICA
345
coronary artery (on visual estimation of a
clinically indicated coronary angiogram)
and a target vessel for imaging with less
than 50% obstruction were randomised
in the trial. The clinical characteristics of
patients enrolled in SATURN are summa-
rised in Table 1.
Screening process
Patients who were not on a statin had to
have an LDL cholesterol higher than 2.6
mmol/l, while those on treatment were
required to have a level higher than 2.1
mmol/l. Patients with uncontrolled hyper-
tension, heart failure, renal dysfunction or
liver disease were excluded from the trial.
In the screening period, patients were
randomly assigned to either atorvasta-
tin 40 mg or rosuvastatin 20 mg daily
for two weeks to ascertain side effects
and compliance. Patients with an LDL
cholesterol less than 3 mmol/l and a
triglyceride level of less than 5.6 mmol/l
again underwent randomisation, this time
to a full dose of atorvastatin (80 mg daily)
or rosuvastatin (40 mg daily) for the two-
year study period, at the end of which a
second IVUS assessment of the originally
imaged target vessel was performed.
Clinical events were adjudicated
by members unaware of the treatment
assignments. Lipids were measured at six,
12, 18 and 24 months, while C-reactive
protein was measured annually.
After 104 weeks of treatment, 1 039
patients remained in the study (75%).
Of these, 519 were in the atorvastatin
and 520 in the rosuvastatin groups, with
no significant differences between the
two treatment groups. During treatment,
levels of LDL cholesterol were lower in
the rosuvastatin group (1.6 vs 1.8 mmol/l)
and HDL cholesterol levels were different
(1.25 mmol/l in the atorvastatin vs 1.3
mmol/l in the rosuvastatin group). There
was also a difference in the LDL:HDL
cholesterol ratio, with those in the rosu-
vastatin group having lower values than
those in the atorvastatin group. Median
C-reactive protein levels were similar.
Results
The results showed that the primary-
efficacy endpoint of percentage atheroma
volume was not significantly different
between the two treatment groups and
cardiovascular events were also similar
with regard to total atheroma volume.
With regard to the secondary-efficacy
evaluation, rosuvastatin treatment led to
a greater reduction in total atheroma
volume than in the atorvastatin-treated
group. The rate of abnormal laboratory
levels was low and glycated haemoglobin
levels did not change significantly in
either group during the two-year period.
‘The SATURN study has provided
strong validation for the benefits of high-
dose statins and, reassuringly, these doses
were well tolerated’, Dr Nicholls pointed
out.‘Thisunderscorestheclinicalapproach
of treating patients with higher doses of
statins to halt disease progression. In this
study, two-thirds of the patients showed
regression of atherosclerosis on higher
doses of statin therapy’, he concluded.
1.
Nicholls SJ,
et al
. Effect of 2 intensive
statin regimens on progression of CAD. Doi
10:1056/NEJMoa1110874
2.
Nicholls SJ, Borgman M, Nissen SE,
Raichlen JS,
et al
. Impact of statins on
progression of atherosclerosis: rationale and
design of SATURN (Study of Conorany
Atheroma by InTravascular Ultrasound:
effect of Rosuvastatin versus AtorvastatiN).
Curr Med Res Opin
2011;
27
(6): 1119–
1129. Epub 2011 Mar 30.
Raft of rivaroxaban good news from the USA, implications for
South African clinical practice
Rivaroxaban has been approved by the
US Food and Drug Administration (FDA)
for the prevention of stroke and systemic
embolism in non-valvular atrial fibrilla-
tion. From theAmericanHeartAssociation
(AHA) 2011 congress earlier this week,
the results of the ATLAS ACS 2-TIMI
51 trial have shown rivaroxaban improves
cardiovascular outcomes and reduces
cardiovascular and all-cause mortality
in acute coronary syndromes (ACS).
1,2
With the added recognised use of rivar-
oxaban in knee and hip arthroplasty and
in the prevention and treatment of venous
thromboembolism, deep-vein thrombosis
and pulmonary embolism,
3
South African
medicine regulators will need to widen
their assessment of the value of this factor
Xa inhibitor locally.
The ATLAS ACS 2-TIMI 51 trial
results were widely welcomed at the
AHA, with the lead investigator, Dr
Michael Gibson of Harvard Medical
School noting that rivaroxaban treatment
for about two years in ACS patients
resulted in a very robust reduction in the
primary endpoint of cardiovascular death,
myocardial infarction and stroke (RRR
of 16%). The risk of all-cause death was
reduced by 30% with the addition of rivar-
oxaban to the standard treatment of ACS.
‘Importantly, this benefit in reduced
deaths was also seen as a reduction in
sudden unwitnessed deaths, which we
know from autopsy studies is primarily
due to thrombotic events. Also rivaroxa-
ban reduced stent thrombosis by 31%.
These two aspects together give me confi-
dence that the benefits we are seeing are
due to the inhibition of thrombin genera-
tion. We now know we have a new target
of blocking thrombin production as an
important way of improving outcomes in
ACS’, Dr Gibson noted.
The beneficial results of rivaroxaban
treatment are very important to patient
care, as there is a large unmet need in
ACS management. This is seen in the fact
that despite the widespread use of dual
antiplatelet therapy, patients who have
had a recent ACS event continue to be
at increased risk of major cardiovascular
events, at an annual rate of 10%.
Dr Paul W Armstrong, Edmonton,
Canada was the discussant at the clinical
trial session and he noted that this study
is a welcome and transforming advance
in the management of ACS. In evaluat-
ing the ATLAS ACS 2-TIMI 51 trial, it is
important to note which patients benefit-
ted in this large multi-centre trial conduct-
ed in 766 sites in 44 countries. The more
than 15 000 adult patients included in
the study had symptoms of ACS and
were diagnosed with ST-segment eleva-
tion myocardial infarction (STEMI), non-
