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TCT 27 th Annual Scientific Symposium
Conference Review
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October 11-15, 2015, San Francisco, CA
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In this review:
ABSORB II: Absorb BVS, Xience give
similar outcomes at 2 years
ABSORB III: novel bioresorbable scaffold
as good as standard-of-care DES
BIOSOLVE-II: novel absorbable scaffold
safe, effective
LEADERS FREE: DES better than BMS
in high-risk PCI
MASTER: positive results seen for
bioresorbable-polymer DES in STEMI
PLATFORM: FFRCT reduces costs
compared with invasive coronary
angiography
Manual thrombectomy does not
improve outcomes in high-risk STEMI
TUXEDO: everolimus-eluting stent
superior to paclitaxel-eluting stent in
diabetes
SORT-OUT VI: 3-year data similar with
biolimus- and zotarolimus-eluting
stents
RESPECT confirms long-term safety,
efficacy of PFO closure for recurrent
stroke
Abbreviations used in this review:
BES = biolimus-eluting stent; BMS = bare metal stent;
DES = drug-eluting stent; EES = everolimus-eluting stent;
FFRCT = fractional flow reserve with computed tomography;
PES = paclitaxel-eluting stent; PFO = patent foramen ovale;
SES = sirolimus-eluting stent; ZES = zotarolimus-eluting stent.
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Welcome to this review of the Transcatheter Cardiovascular
Therapeutics (TCT) 27th Annual Scientific Symposium.
TCT specialises in interventional cardiovascular medicine and is the world’s largest and most important educational meeting
in this therapeutic area, showcasing the latest advances in current therapies and clinical research. Dr Sanjay Patel attended
the meeting and has chosen ten studies for inclusion in this review that he believes will be of particular interest to Australian
clinicians. The conference programme can be viewed here http://www.crf.org/tct
I hope you find this conference review interesting and useful in your clinical practice.
Kind Regards,
Dr Janette Tenne
Medical Research Advisor
[email protected]
First randomised comparison between the Absorb everolimus-eluting
bioresorbable vascular scaffold and the Xience everolimus-eluting stent:
2-year ABSORB II data
Authors: Chevalier B, et al.
Summary: This single-blind, multicentre, randomised trial, enrolled patients with myocardial ischaemia and one or two
de-novo native lesions in different epicardial vessels. Patients received either an everolimus-eluting bioresorbable scaffold
(Absorb BVS, n=335) or an everolimus-eluting metallic stent (Xience, n=166). The co-primary endpoints were vasomotion
and minimum lumen diameter at 3 years. The primary endpoint results are not yet available. At 2 years there were no
significant differences in clinical outcomes between the two arms. The patient oriented composite endpoint (all death,
MI and revascularisation) was 11.6% in the Absorb BVS group vs 12.8% in the Xience group (p=0.70). The device oriented
composite endpoint/target lesion failure (cardiac death, target vessel MI and target lesion revascularisation) was 7.0% in
the Absorb BVS group and 3.0% in the Xience group (p=0.07). The researchers noted that the exploratory observations
presented in this report are hypothesis generating and need to be confirmed in larger randomised trials such as ABSORB III.
Comment: Two year data from the ABSORB II study, that included 501 patients randomised 2:1 to receive Absorb
BVS or Xience, extended findings from ABSORB III, demonstrating again equivalent outcomes between the Absorb
everolimus-eluting bioresorbable scaffold and the Xience everolimus-eluting stent. However, this trial was not powered
for clinical outcomes and the 2-year data came from a non-prespecified interim analysis. Also, the study’s primary
endpoints of vasomotion and minimum lumen diameter at 3 years are not yet available. Notably, two cases of very late
definite stent thrombosis in Absorb BVS patients were reported. Both patients were on aspirin alone at the time of the
event, and possible causes included suboptimal expansion of the device, proximal stent malapposition, and incomplete
lesion coverage at the device’s edges. These findings emphasise the need for mandatory post-dilatation of these devices,
perhaps with intra-vascular imaging guidance.
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TCT 27th Annual Scientific Symposium
Conference Review
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Everolimus-Eluting Bioresorbable Scaffolds for
Coronary Artery Disease
Authors: Kereiakes DJ, et al.
Summary: In this large, multicentre trial, patients with stable or unstable angina were
randomised to receive an everolimus-eluting bioresorbable vascular scaffold (Absorb, n=1322)
or an everolimus-eluting cobalt–chromium stent (Xience, n=686). The primary end point
was target lesion failure (cardiac death, target vessel MI, or ischaemia-driven target lesion
revascularisation) at 1 year. Target lesion failure at 1 year occurred in 7.8% of patients in
the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7%; 95% CI,
−0.5 to 3.9; p=0.007 for noninferiority and p=0.16 for superiority). There was no significant
difference between the Absorb group and the Xience group in rates of device thrombosis
within 1 year (1.5% vs 0.7%, respectively; p=0.13).
Comment: This multi-centre randomised controlled trial tested the performance of a
novel bioresorbable coronary scaffold (Absorb BVS) with an everolimus-eluting metallic
stent in over 2000 patients with evidence of coronary ischaemia. The major finding at
1 year was that target lesion failure was only slightly higher with the bioresorbable scaffold
versus the everolimus stent, and non-inferiority criteria were met. Notably also, there were
no significant differences in device thrombosis between arms. One limitation, however,
is that all patients had stable disease and results may therefore not be generalizable
to higher-risk patients and more complex disease. Nonetheless, this encouraging data
clearly demonstrates the Absorb scaffold performs similarly to current best practice
drug-eluting stents (DES) at one year, with anticipated benefits of this scaffold to be
seen at 3-5 years, post-implantation, after the scaffolds have completely disappeared.
Potential long term advantages include reductions in neoatherosclerosis, strut fracture
and polymer reactions, the unjailing of jailed side branches and fewer ‘full metal jackets.’
Abstract
Safety and performance of the second-generation
drug-eluting absorbable metal scaffold in patients
with de-novo coronary artery lesions (BIOSOLVE-II)
Authors: Haude M, et al.
Summary: This group assessed the safety and performance of a novel second-generation
drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary
artery lesions in a first-in-human prospective, multicentre, non-randomised, trial. Eligible
patients had stable or unstable angina or documented silent ischaemia, and a maximum of
two de-novo lesions. The primary endpoint was in-segment late lumen loss at 6 months.
123 patients were enrolled with 123 coronary target lesions. At 6 months, mean in-segment
late lumen loss was 0·27mm, and vasomotion was noted in 20 of 25 patients who were
tested (80%). Target lesion failure occurred in 4 patients (3%). No definite or probable scaffold
thrombosis was observed.
Comment: A drug-eluting absorbable metal scaffold offers favourable performance
and safety at 6 months, according to results from the first-in-human BIOSOLVE-II trial.
The prospective, multicentre non-randomised study recruited 123 patients with de novo
coronary artery stenosis in whom the DREAMS 2G device was implanted. This scaffold
consists of a refined magnesium alloy backbone and a polylactic acid polymer coating
with sirolimus, and completely resorbs by 12 months. Salient trial findings included a
significantly improved in-segment late lumen loss compared to its precursor devices,
documentation of vasomotion of the scaffolded vessel segment in 80% of patients at
6 months and no cases of definite or probable scaffold thrombosis. Moreover, rates
of target lesion failure and target lesion revascularisation were low and comparable to
other absorbable scaffolds and permanent DES. This device may potentially provide
some benefit over the Absorb scaffold, as its faster absorption time may decrease the
risk of late device thrombosis. However, this and other outcomes will need to be tested
in larger randomised studies.
Abstract
Independent commentary by Dr Sanjay Patel,
MB BS (Hons 1) PhD FRACP
Dr Patel is a Staff Specialist Cardiologist at Royal Prince Alfred
Hospital, a Visiting Medical Officer at Strathfield Private Hospital,
Senior Lecturer at the University of Sydney, and a National Heart
& Medical Council of Australia CJ Martin Fellow. Sanjay currently
practices as an interventional and general cardiologist. His clinical
interests include radial approach coronary intervention, as well as interventions
for structural heart disease and peripheral vascular disease. His other clinical
interests include management of patients with complex coronary artery disease
and difficult lipid profiles.
www.researchreview.com.au
improved
outcomes
start here*
*In patients with ACS, BRILINTA reduces the
risk of CV death, MI or stroke vs clopidogrel
at 12 months ( primary composite endpoint:
ARR 1.9%, RRR 16%; p<0.001).1,2
®
STREAMLINED AUTHORITY CODE 3879
PBS Information: Authority Required
( STREAMLINED ). Treatment of acute coronary
syndrome (myocardial infarction or unstable
angina) in combination with aspirin.
Please click here to review full product information
before prescribing. Further information available on
request from AstraZeneca
ACS=acute coronary syndromes; CV=cardiovascular; MI=myocardial infarction;
ARR=absolute risk reduction; RRR=relative risk reduction. References: 1. Wallentin
L et al. N Engl J Med 2009;361:1045–57. 2. BRILlNTA® Approved Product
Information. BRILINTA® is a registered trademark of the AstraZeneca group of
companies. Registered user AstraZeneca Pty Ltd. ABN 54 009 682 311. 5 Alma Road,
North Ryde NSW 2113. Medical Information:
1800 805 342. www.astrazeneca.com.au,
407584.022, WL287191, July 2015
a RESEARCH REVIEW publication
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TCT 27th Annual Scientific Symposium
Conference Review
TM
Polymer-free drug-coated coronary stents in
patients at high bleeding risk
QOL and economic outcomes of assessing fractional flow reserve
with computed tomography angiography: the PLATFORM study
Authors: Urban P, et al.
Authors: Hlatky MA, et al.
Summary: These researchers evaluated a polymer-free and carrier-free DES
that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus
analogue, into the vessel wall. In this randomised, double-blind trial, the DES was
compared with a similar bare metal stent (BMS) in 2466 patients with a high risk
of bleeding who underwent PCI. All patients received one month of dual antiplatelet
therapy. The primary safety endpoint was a composite of cardiac death, MI,
or stent thrombosis. The primary efficacy endpoint was clinically driven target
lesion revascularisation. At 390 days, the primary safety end point had occurred
in 112 patients (9.4%) in the DES group and in 154 patients (12.9%) in the BMS
group (HR 0.71; 95% CI 0.56 to 0.91; p<0.001 for noninferiority and p=0.005
for superiority). Clinically driven target lesion revascularisation was required by
59 patients (5.1%) and 113 patients (9.8%) in the respective groups (HR 0.50;
95% CI 0.37 to 0.69; p<0.001).
Summary: This study examined cost and QOL when using fractional flow reserve with computed tomography
(FFRCT) instead of usual care to evaluate symptomatic patients without known coronary disease. Such patients
were enrolled into two groups based on whether invasive or non-invasive diagnostic testing was planned. In each
group, consecutive observational cohorts were evaluated with either usual care or FFRCT and were followed up
for 90 days. Among 584 patients, 74% had atypical angina, and the pre-test probability of coronary disease was
49%. In the planned invasive group, mean costs were 32% lower in FFRCT patients than in usual care patients
($7343 vs $10,734; p<0.0001). In the non-invasive group, mean costs were not significantly different between
the FFRCT patients and the usual care patients ($2679 vs $2137; p=0.26). QOL was improved in the overall
study population (p<0.0001). In the non-invasive group, some QOL items improved significantly more in FFRCT
patients than in usual care patients, whereas in the invasive group, improvements in QOL were similar in the
FFRCT and usual care patients.
Comment: This randomised control trial tested the hypothesis that a
polymer-free stainless steel DES (BioFreedom) that holds drug in abluminal
surface structures would be superior to a standard BMS when implanted in
individuals at high bleeding risk, receiving only one month of dual antiplatelet
therapy. Notably, patients in the DES arm had a much lower rate of the primary
efficacy endpoint of clinically driven target lesion revascularisation at one year.
Also, BMS use was associated with higher rates of all secondary efficacy
endpoints including target lesion revascularisation and any revascularisation.
Additionally, rates of the primary composite safety endpoint (cardiac death, MI,
and definite/probable stent thrombosis) at one year were substantially lower
with DES compared with BMS. Bleeding outcomes were similar in both study
groups. This study, therefore, provides compelling evidence for use of this
novel DES in older patients at high bleeding risk, who can tolerate prolonged
dual antiplatelet therapy.
Comment: CT coronary angiography provides anatomic information, and is highly sensitive, but does not
define the functional significance of lesions. Fractional flow reserve can now be estimated from standard CT
angiography data. Accordingly, the PLATFORM study was designed to test the diagnostic utility of FFRCT in
patients with stable symptoms, without documented CAD, who were referred for either planned invasive or noninvasive evaluation. In previously presented results, PLATFORM demonstrated that use of FFRCT was associated
with a 61% reduction in the rate of invasive angiography in those patients without a finding of obstructive
CAD. Further analysis now demonstrates that the use of FFRCT is associated with lower costs versus invasive
coronary angiography and with greater improvement in QOL versus usual non-invasive testing in symptomatic
patients with intermediate probability CAD. This study is limited by its non-randomised design, but nevertheless
demonstrates the potential economic benefit of FFRCT in reducing unnecessary invasive angiography.
Abstract
Outcomes after thrombus aspiration for STEMI: 1-year follow-up of
the prospective randomised TOTAL trial
Authors: Jolly SS, et al.
Abstract
Safety and efficacy of a biodegradable polymer
drug-eluting stent in the management of patients
with acute STEMI: MASTER, a randomised study
Authors: Moris de la Tassa C, et al.
Summary: In this multicentre, single-blind trial, patients with acute STEMI were
randomised to receive the Ultimaster sirolimus-eluting stent (SES, Terumo; n=375),
which is coated with a bioresorbable polymer, or the Kaname BMS (Terumo; n=125).
The three primary endpoints were: safety at 1 month (composite of all-cause death,
recurrent MI, unplanned infarct-related artery revascularisation, stroke, definite
stent thrombosis or major bleeding); efficacy at 6 months (in-stent late loss) and
safety/efficacy at 12 months (target vessel failure defined as cardiac death or MI
not clearly attributable to a non-target vessel and clinically driven target vessel
revascularisation). The safety event rate at 1 month was 3.5% with the SES and
7.2% with the BMS (p=0.13). At 6 months, the efficacy endpoint of in-stent late
loss was also met (0.10mm vs 0.87mm, respectively; p=0.0072). In-segment
late loss also was lower with SES (0mm vs 0.55mm; p<0.001). Patients with
SES had reduced percent diameter stenosis, both in-stent (15.1% vs 42.2%) and
in-segment (22.2% vs 42.9%), as well as greater mean lumen diameter, both
in-stent (2.44mm vs 1.61mm) and in-segment (2.2mm vs 1.56mm; p<0.001 for
all). Data for the third primary endpoint of 12-month target vessel failure are not
yet available. However, analysis at 6 months indicated superior outcomes for SES
in terms of clinically driven target lesion revascularisation (1.9% vs 5.6%; p=0.05),
definite or probable stent thrombosis (1.3% vs 4.8%; p=0.03) and the composite
of all-cause death, MI and coronary revascularisation (7.7% vs 14.4%; p=0.03).
Comment: The multicentre, randomised single-blind MASTER trial compared a
bioresorbable-polymer DES (Ultimaster SES) with a Kaname BMS in 500 acute
STEMI patients and demonstrated similar safety at 1 month and better efficacy
at 6 months with the SES. MASTER had three primary endpoints: safety
at 1 month, efficacy at 6 months (in-stent late loss) and safety/efficacy at
12 months (target vessel failure). Data for the third primary endpoint of 12-month
target vessel failure are not yet available. However, analysis at 6 months
indicated superior outcomes for the SES in terms of clinically driven target
lesion revascularisation, stent thrombosis and the composite of all-cause
death, MI and coronary revascularisation. In summary, the SES showed superior
efficacy and favourable safety compared with BMS implantation, suggesting
that DES with a bioresorbable polymer could be a valuable feature in STEMI
intervention, however the full 12-month follow-up for target vessel failure is
required to confirm this hypothesis.
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Summary: Two previous large trials have reported contradictory results at 1 year after thrombus aspiration in
STEMI. The trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL,
n=10,732) aimed to clarify the longer-term benefits, in a 1-year follow-up of the largest randomised trial of thrombus
aspiration. Adult patients from 87 hospitals in 20 countries were randomised within 12 hours of symptom onset
to receive routine manual thrombectomy with PCI or PCI alone. The primary outcome was cardiovascular death,
MI, cardiogenic shock, or heart failure at 1 year. The composite primary outcome occurred in 7.8% of both groups
(p=NS). Cardiovascular death within 1 year occurred in 4% of each group and stroke within 1 year occurred in
1·2% of the thrombectomy group and 0·7% of the PCI group (p=NS for both outcomes). These results show that
thrombus aspiration can no longer be recommended as a routine strategy in STEMI.
Comment: Performing manual thrombectomy routinely prior to primary PCI in STEMI patients does not improve
outcomes at 1 year, according to data from the TOTAL trial. At 1 year, the composite rate of cardiovascular
death, heart failure, recurrent MI or cardiogenic shock (primary outcome) was 7.8% in both groups. Individual
components of the primary outcome were also similar. However, combined stroke or transient ischaemic
attack also was more common with manual thrombectomy. Additional analyses failed to find benefit of manual
thrombectomy in any patient subgroup, even those with the highest thrombus burden. Based on TOTAL’s 1-year
outcomes, manual thrombectomy can no longer be recommended as a routine strategy for STEMI patients.
Abstract
Paclitaxel-eluting versus everolimus-eluting coronary stents
in diabetes
Authors: Kaul U, et al.
Summary: In this study (TUXEDO-India), patients with diabetes and CAD who were undergoing PCI received either
a paclitaxel-eluting stent (PES) or an everolimus-eluting stent (EES) (n=1830). The primary endpoint was targetvessel failure at 1 year, defined as a composite of cardiac death, target-vessel MI, or ischaemia-driven target-vessel
revascularisation. At 1 year, PES did not meet the criterion for noninferiority to EES (rate of target-vessel failure,
5.6% vs 2.9%; p=0.38 for noninferiority). There was a significantly higher rate of target vessel failure at 1-year
in the PES group than in the EES group (p=0.005), and also of spontaneous MI (3.2% vs 1.2%, p=0.004), stent
thrombosis (2.1% vs 0.4%, p=0.002), target-vessel revascularisation (3.4% vs 1.2%, p=0.002), and target-lesion
revascularisation (3.4% vs 1.2%, p=0.002).
Comment: Patients with diabetes and CAD fare significantly better in the first year after PCI if they receive
an EES rather than a PES, according to results of the TUXEDO-India trial. The trial, conducted at 46 centres in
India randomised 1830 patients with diabetes and either stable CAD or ACS to PCI with PES or EES. Although
Taxus stents are now rarely used in the US, Europe and Australia, there was conflicting data regarding as to
which stent performed better in the setting of diabetes. This trial definitively answers this question while also
raising questions about the results of FREEDOM, BARI-2D and SYNTAX, which compared CABG with firstgeneration stents, and on which guidelines on PCI and CABG in patients with diabetes are based. The findings
of TUXEDO-India and other studies pointing to the superiority of EES over PES do not invalidate the results of
earlier PCI versus CABG trials but do suggest that the advantage of CABG in diabetics might not be as great as
previously believed. Nonetheless, CABG remains the treatment of choice in diabetic patients with high Syntax
scores and very diffuse coronary disease while more focal disease could be treated equally well by surgery or PCI.
Abstract
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TCT 27th Annual Scientific Symposium
Conference Review
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SORT-OUT VI: A prospective randomised trial of a
durable-polymer zotarolimus-eluting stent versus a
bioabsorbable-polymer biolimus-eluting stent in patients
with coronary artery disease – 3-year outcomes
Authors: Raungaard B, et al.
Summary: This open-label, non-inferiority trial (SORT-OUT IV) randomised patients with
stable CAD or ACS and at least one coronary artery lesion to receive either a durable-polymer
zotarolimus-eluting stent (ZES) or a biodegradable-polymer biolimus-eluting stent (BES).
The primary endpoint was a composite of safety (cardiac death and MI not clearly attributable to
a non-target lesion) and efficacy (target-lesion revascularisation) at 12 months. The 12-month
primary endpoint was met by 79 patients (5·3%) in the ZES group and 75 patients (5·0%) in
the BES group (p=0·004 for noninferiority). At 3 years (n=2999), the composite endpoint
was similar with ZES and BES (8.6% vs 9.6%; p=0.36).
Comment: Remnants of polymer materials on DES may trigger chronic inflammatory
responses that can lead to impaired endothelialisation of stent struts, malapposition,
and increased risk of stent thrombosis. Accordingly, the SORT-OUT VI trial compared a
biodegradable-polymer BES with a permanent-polymer ZES in patients with stable CAD or
ACS, and demonstrated that both stents offered low rates of major adverse cardiovascular
events at up to 3 years post-implantation. These results show that both devices have
excellent long-term safety and efficacy profile, indicating that a biodegradable polymer
can be as safe and efficacious as a durable polymer.
RESPECT: A prospective randomised trial of PFO closure
in patients with cryptogenic stroke – long-term results
improved
outcomes*
start here
*In patients with ACS, BRILINTA reduces the
risk of CV death, MI or stroke vs clopidogrel
at 12 months ( primary composite endpoint:
ARR 1.9%, RRR 16%; p<0.001).1,2
*BRILINTA is initiated with a single 180mg
dose and then continued at 90mg twice daily
in combination with aspirin.2
Authors: Carroll JD, et al.
Summary: The main RESPECT trial, published in the NEJM in 2013, showed superiority
of patent foramen ovale (PFO) closure in patients assigned to the Amplatzer PFO Occluder
(n=499) compared with guideline-directed medical therapy with one or more antiplatelet
medications or warfarin (n=481) for reducing the risk of recurrent cryptogenic stroke in
prespecified per-protocol and as-treated analyses. However, it found no significant benefit
in the primary intention-to-treat analysis. This summary provides follow-up of 5.5 years for
the PFO occlusion arm and 4.9 years for the medical-therapy arm. In the intention-to-treat
population, the relative risk for recurrent cryptogenic stroke was reduced by 54% after PFO
closure (p=0.042). Additionally, PFO closure reduced the relative risk of recurrent cryptogenic
stroke by 70% compared with medical therapy (p=0.004). In a sensitivity analysis limiting
the intention-to-treat population to patients aged <60 years, there was still a 52% relative
reduction in all-cause stroke risk with PFO closure versus medical management (p=0.035).
PFO closure also resulted in a 75% reduction in relative risk for cryptogenic stroke among
patients with atrial septal aneurysms and substantial right-to-left shunts (p=0.007). Rates
of major vascular complications (0.9%) and device explantation (0.4%) were very low.
Comment: Extended follow-up results of the RESPECT trial support the safety and
efficacy of PFO closure over medical management for reducing the risk of recurrent
cryptogenic stroke. The main RESPECT trial showed superiority of PFO closure in patients
assigned to the Amplatzer PFO Occluder compared with guideline-directed medical
therapy in pre-specified per-protocol and as-treated analyses, but it found no significant
benefit in the primary intention-to-treat analysis. Findings at a follow-up of 5.5 years
for the PFO occlusion arm and 4.9 years for the medical-therapy arm have now been
presented. In the intention-to-treat population, the relative risk for recurrent cryptogenic
stroke was significantly reduced by more than half after PFO closure. Additionally, PFO
closure reduced the relative risk of recurrent cryptogenic stroke by 70% compared
with medical therapy. Lastly, procedure and device safety was extremely low, with no
evidence of intra-procedural stroke, device embolization/thrombosis/erosion. Rates of
major vascular complications and device explantation also were very low.
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®
STREAMLINED AUTHORITY CODE 3879
PBS Information: Authority Required
( STREAMLINED ). Treatment of acute coronary
syndrome (myocardial infarction or unstable
angina) in combination with aspirin.
Please click here to review full product information
before prescribing. Further information available on
request from AstraZeneca
ACS=acute coronary syndromes; CV=cardiovascular; MI=myocardial infarction;
ARR=absolute risk reduction; RRR=relative risk reduction. References: 1. Wallentin
L et al. N Engl J Med 2009;361:1045–57. 2. BRILlNTA® Approved Product
Information. BRILINTA® is a registered trademark of the AstraZeneca group of
companies. Registered user AstraZeneca Pty Ltd. ABN 54 009 682 311. 5 Alma Road,
North Ryde NSW 2113. Medical Information:
1800 805 342. www.astrazeneca.com.au,
407584.022, WL287191, July 2015
a RESEARCH REVIEW publication
© 2015 RESEARCH REVIEW
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