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 TenneMedical Research Advisorjanette.tenne@researchreview.com.au

First randomised comparison between the Absorb everolimus-eluting bioresorbable vascular scaffold and the Xience everolimus-eluting stent: 2-year ABSORB II dataAuthors: 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.

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

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* 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

improved outcomesstart here*

Please click here to review full product information before prescribing. Further information available on request from AstraZenecaACS=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

PBS Information: Authority Required (STREAMLINED). Treatment of acute coronary syndrome (myocardial infarction or unstable

angina) in combination with aspirin.

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Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery DiseaseAuthors: 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.

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Polymer-free drug-coated coronary stents in patients at high bleeding riskAuthors: Urban P, 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).

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.

Abstract

Safety and efficacy of a biodegradable polymer drug-eluting stent in the management of patients with acute STEMI: MASTER, a randomised studyAuthors: 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.

QOL and economic outcomes of assessing fractional flow reserve with computed tomography angiography: the PLATFORM studyAuthors: Hlatky MA, et al.

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: 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 non-invasive 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 trialAuthors: Jolly SS, et al.

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 diabetesAuthors: 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 target-vessel 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 first-generation 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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SORT-OUT VI: A prospective randomised trial of a durable-polymer zotarolimus-eluting stent versus abioabsorbable-polymer biolimus-eluting stent in patients with coronary artery disease – 3-year outcomesAuthors: 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 resultsAuthors: 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.

®

* 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

improved outcomesstart here*

Please click here to review full product information before prescribing. Further information available on request from AstraZenecaACS=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

PBS Information: Authority Required (STREAMLINED). Treatment of acute coronary syndrome (myocardial infarction or unstable

angina) in combination with aspirin.

STREAMLINED AUTHORITY CODE 3879