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Welcome to our review of the 9th Annual Australia and New Zealand Endovascular Therapies Meeting (ANZET15), held in Melbourne in August 2015.ANZET15 was conducted by the Interventional Council of The Cardiac Society of Australia and New Zealand. Selection and review of the research has been carried out independently by Associate Professor Con Aroney, University of Queensland.

We hope you enjoy these selections and look forward to your comments and feedback.

Kind Regards,

Dr Janette TenneMedical Research [email protected]

PCI: from balloon angioplasty to disappearing stentsAuthor: Haude M

Summary/Comment: Dr Haude traced the evolution of percutaneous coronary interventions (PCI) which began with the first balloon angioplasty by Andreas Grüntzig in 1977 followed by the first coronary wall stent in 1986 then the first balloon expandable Palmaz-Schatz stent in 1987 which eliminated recoil. He then explained that subacute stent thrombosis could be avoided with optimal stent deployment using intravascular ultrasound (IVUS) and appropriate dual antiplatelet therapy. The advent of drug-eluting stents which reduced neo-intimal proliferation was set back in 2006 when delayed arterial healing with the original Cypher and Taxus stents led to late stent thrombosis. The SYNTAX trial in 2009 demonstrated that in patients with a SYNTAX score of <23 there were equivalent outcomes of coronary stenting and coronary bypass surgery. More recent developments in coronary stenting have included changes in antiproliferative drugs, improvements in polymer material including biodegradable polymer, and the development of much thinner metal struts which have all led to an improvement in safety. The most recent development of a drug-eluting absorbable scaffold promises effective dilatation and capping of plaque with a return of coronary vasomotion, but is very expensive and requires evidence of clinical safety and superiority.

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ANZET 2015

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ACS = acute coronary syndromes; FFR = fractional flow reserve; IVUS = intravascular ultrasound; LAD = left anterior descending; PCI = percutaneous coronary intervention; STEMI = ST segment elevation myocardial infarction; TAVI = transcatheter aortic valve implantation.

In this review:

Abbreviations used in this review:

PCI evolution

Left main stem coronary disease

Left main stem bifurcations

Multivessel coronary disease: PCI or CABG?

Antiplatelet therapy and anticoagulation after PCI

Cardiac registry session

TAVI or surgery in the elderly?

Live cases from Vancouver and Melbourne

Future of TAVI

Mitral valve intervention

SYNTAX II trial

PCI for STEMI

Radiation protection

Bio-absorbable scaffoldsSelection and review of the research has been carried out independently by Associate Professor Con Aroney

Con Aroney graduated from the University of Queensland in 1979, and did his cardiology training at Royal Hobart, Royal Brisbane and Prince Charles Hospitals. He gained a Heart Foundation scholarship which allowed him to work as a clinical and research fellow at Harvard Medical School and the Massachusetts General Hospital. In 1991, he was awarded a Doctorate in Medicine from the University of Queensland for research in heart failure. He served as Director of the Coronary Care Unit at Prince Charles Hospital from 1990 till 2005, where he founded the first comprehensive Chest Pain Assessment Unit in Queensland. He is also an interventional cardiologist with a particular interest in the percutaneous treatment of structural heart disease, and has been an Australian pioneer of angioplasty using the radial artery, mitral and aortic balloon valvuloplasty, ASD and PFO closure, alcohol septal ablation, and most recently percutaneous aortic valve implantation (Corevalve, Edwards and Lotus) and mitral clip procedures. He is currently Director of Cardiac Services at Holy Spirit Northside Hospital, and a visiting cardiologist at Prince Charles Hospital. His academic position is Associate Professor of Medicine, University of Queensland.

Making Education Easy 11–13 August, 2015; Melbourne

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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.

STREAMLINED AUTHORITY CODE 3879


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ANZET 2015 Conference ReviewTM

Angiographic assessment of left main stem coronary disease is not enough for PCIAuthor: Yeung A

Summary/Comment: Dr Yeung stated that there are several limitations with the angiographic assessment of left main coronary stenting which include the lack of a true normal segment, overlap of the catheter with the left anterior descending (LAD) or circumflex arteries, incomplete mixing of blood and contrast as well as spillover of the contrast medium, all of which cause both over and underestimation of left main stenosis severity. He presented data showing a mismatch between angiographic and fractional flow reserve (FFR) assessment in almost 30% of patients. FFR itself is influenced by the patient’s myocardial mass with a larger mass more likely to cause a positive FFR for a given lesion. IVUS left main cross-sectional area of <4.5 mm² is strongly associated with ischaemia, whereas an area >6.0 mm² is not likely to be significant. FFR is particularly useful in patients with a cross-sectional area between 4.5–6.0 mm² and in those where the plaque extends into the proximal LAD or circumflex arteries. IVUS is particularly useful following left main stenting to confirm stent apposition, and jailing of the circumflex artery can be assessed with FFR. Left main stenting with incomplete revascularization of the other main vessels is associated with adverse outcomes.

Complex coronary interventions – left main stem and bifurcationsAuthors: Jepson N and Pitney M

Summary/Comment: Drs Jepson and Pitney performed live cases from Prince of Wales Hospital, Sydney. They demonstrated the use of multimodality imaging and FFR assessment in cases of complex coronary artery disease including IVUS of left main lesions and the use of optimal coherence tomography post PCI to assess stent apposition. The use of a provisional versus a two stent strategy for simple bifurcational lesions was advocated. A bio-absorbable scaffold was placed in the mid LAD with the use of aggressive predilatation. The use of this scaffold would then not preclude a future possible implantation of an internal mammary graft to the LAD. Patient selection using the SYNTAX score and frailty indices were discussed.

Multivessel coronary disease can be equally well treated by PCI or CABGAuthors: Banning A and Taggart D

Summary/Comment: This debate principally centred on the SYNTAX trial which used an anatomical rather than a functional coronary assessment, employed the obsolete Taxus stent and cases were performed using femoral rather than radial access. The SYNTAX patients were an unusually high risk population for a randomised clinical trial; PCI was often performed with incomplete revascularization by often inexperienced operators at one sitting whereas surgery was performed by experienced surgeons and with very high rates of arterial revascularization. The point was made that despite this, stented patients with low SYNTAX score (<23) had similar outcomes to surgical patients. The contradictory view discussed the continuing separation of outcomes favouring bypass surgery beyond five years, and that there was far too much incomplete revascularization with PCI. Surgery has the benefit of downstream revascularization which is protective against progressive disease. Commentator Dr Haude said that complex cases would be best managed with a Heart Team discussion. He stated that despite advice to do otherwise, many patients preferred PCI over bypass surgery.


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Antiplatelet therapy and anticoagulation after PCIAuthor: Chieffo A

Summary/Comment: Dr Chieffo first discussed the historical context of dual antiplatelet therapy reducing the risk of myocardial infarction and stent thrombosis, but said that for every stent thrombosis prevented there was approximately two clinical bleeds. This problem has also been demonstrated in the recent Pegasus study with long-term ticagrelor therapy. She presented evidence showing a very low risk of stent thrombosis with contemporary thin strut drug-eluting metallic stent technology and that after a mandatory three to six month period of dual antiplatelet therapy all factors related to ischaemic and bleeding risks should be considered in making a decision for more prolonged treatment. She also presented evidence on the APPRAISE-2 trial which showed no benefit of additional apixaban in acute coronary syndromes (ACS) patients and of the ATLAS ACS trial where rivaroxaban was associated with reduced events but at the expense of increased bleeding.

Cardiac registry sessionAuthors: Brieger D, et al

Summary/Comment: Dr Brieger discussed ACOR (Australasian Cardiac Outcomes Registry) which is rolling out nationwide and will provide 30-day and one-year outcomes. There is also a government funded devices registry as a part of ACOR. The ANZACS-QI (All New Zealand Acute Coronary Syndrome Quality Improvement) registry was presented by Dr Devlin from New Zealand which has been active for some years and is already productive in clinical research and in providing feedback on outcomes to hospital and operators. In this registry, patients with previous cardiovascular disease represented only 13% of the population but were responsible for 47% of cardiac procedures. VCOR (Victorian Cardiac Outcomes Registry), presented by Dr Lefkovits, found that 75% of stents used were drug-eluting and 70% of ST segment elevation myocardial infarction (STEMI) infarcts were achieving a door-to-balloon time of <90 minutes. Thirty-seven percent of STEMI patients were managed with a radial intervention but there was a wide variation between centres. Dr Yeung gave the US perspective demonstrating that more sophisticated electronic medical records facilitated data input and were now widely used. Dr Haude gave the European example where reimbursement of transcatheter aortic valve implantation (TAVI) was linked with submission of registry data, leading to a reporting rate of 100%.

TAVI is challenging surgery as gold standard in elderly patientsAuthor: Thomas M

Summary/Comment: Dr Thomas gave a talk asking whether TAVI or surgical aortic valve replacement is the gold standard treatment for elderly patients with aortic stenosis. He made the point that the results for TAVI are superior to surgery with lower mortality and stroke rates. Contemporary methods for implantation also lead to low pacemaker rates which were previously due to oversizing and low implants. He stated that durability is excellent at five years which is more than adequate for patients in their late 80s. Longer durability will only be an issue if the implants are considered for younger patients. During this session Dr Gurvitch from Melbourne demonstrated a case with CT evidence of marked protrusion of calcium at the aortic annular level which has been considered a risk factor for annular rupture. He demonstrated the deployment of an Edwards Sapien 3 device with under-filling and post-implant balloon dilatation leading to an excellent result.

Live cases from St Paul’s Hospital, Vancouver and The Alfred Hospital, MelbourneAuthors: Webb J, et al

Summary/Comment: Dr Webb from St Paul’s Hospital in Vancouver demonstrated the use of an Edwards Sapien 3 valve implant in a degenerated Carpentier-Edwards valve using a 14F sheath with an excellent result. Dr Duffy from The Alfred Hospital in Melbourne demonstrated the use of the Medtronic Evolut R valve implanted under conscious sedation with an excellent outcome. Dr Walton from The Alfred demonstrated percutaneous closure of an aortic paravalvular leak, with initial implantation of a small plug being changed to a larger device with an excellent result.

Future of TAVIAuthor: Meredith I

Summary/Comment: Dr Meredith discussed the evolution of TAVI and predicts a four-fold growth in worldwide volume in the next 10 years. The results for TAVI are built on the original evidence base of the PARTNER trials where a first generation device led to identical five year results as valve surgery. He also presented the pivotal CoreValve trial showing superior results to surgery at two years including a lower stroke rate. All contemporary trials have shown similar excellent results and low adverse event rates but issues remain with paravalvular leaks in particular in patients with marked annular calcification. The use of seals, cuffs and skirts have led to a major improvement in this problem. Long-term trial and registry results are leading to a move to TAVI implants in younger and intermediate-risk patients.

Mitral valve intervention – present and futureAuthor: Yeo K

Summary/Comment: Dr Yeo began his talk with a summary of the use of the MitraClip with its use shifting from degenerative to functional mitral regurgitation. The clip is considered a Class 2b indication in the US where it is only authorized for the treatment of degenerative mitral regurgitation. He stated that patient selection is the most important decision to be made with regard to implantation of this device and that treatment of patients with exceedingly poor left ventricular function and prohibitive risk is not advisable. He pointed out that the implantation is technically demanding with a significant learning curve. Dr Yeo briefly discussed the Mitralign, Cardioband and Millipede devices and was particularly enthusiastic about the Tendyne mitral valve implant which is already undergoing clinical trials in Australia and elsewhere. This device is implanted from the left ventricular apex and has supporting attachments from the valve to the left ventricular apex.

SYNTAX II, coronary physiology and multivessel coronary diseaseAuthor: Banning A

Summary/Comment: Dr Banning began his lecture with the results of the BARI and ARTS trials as well as the original SYNTAX trial. He made the point that both decision making and PCI hardware have significantly improved since 2005 and the use of FFR now leads to more appropriate decision making regarding revascularization. The SYNTAX II trial employs a functional assessment which includes instantaneous wave-free ratio (iFR) assessment. It will also employ state of the art stents with thinner struts and bio-absorbable polymer and the use of IVUS to facilitate stent apposition. These techniques should result in superior selection and results in the stent arm. Cardiac surgery will again employ state of the art arterial revascularization, although surgical techniques have not changed significantly in the past 10 years. FFR assessment will also be considered following PCI to assess adequacy of revascularization and will be used for determining graft placement in patients having bypass surgery.

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Research Review

Conference Reviews are prepared with an independent commentary from relevant specialists.To become a reviewer please email [email protected] Review Australia Pty Ltd is an independent Australian publisher. Research Review receives funding from a variety of sources including Government depts., health product companies, insurers and other organisations with an interest in health. Journal content is created independently of sponsor companies with assistance from leading local specialists. Privacy Policy: Research Review will record your email details on a secure database and will not release them to anyone without your prior approval. Research Review and you have the right to inspect, update or delete your details at any time. Disclaimer: This publication is not intended as a replacement for regular medical education but to assist in the process. The reviews are a summarised interpretation of the published study and reflect the opinion of the writer rather than those of the research group or scientific journal. It is suggested readers review the full trial data before forming a final conclusion on its merits. Research Review publications are intended for Australian health professionals.

®

* 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


4


4© 2015 RESEARCH REVIEW


State of the art in PCI for STEMIAuthor: Jolly S

Comment: Dr Jolly outlined the history of management of STEMI with the first coronary care unit in 1965, the use of streptokinase and aspirin in 1988 and following this the adoption of the pharmaco-invasive approach with transfer following lytic administration. He outlined the benefits of radial versus femoral access which have resulted in reduced major bleeding and mortality. He summarized the thrombectomy trials from the initially successful TAPAS trial to the TOTAL trial which showed no benefits from routine versus bailout thrombectomy and a 31% increase in stroke. He discussed the use of future trials including the COMPLETE trial which examined complete revascularization of multivessel disease in STEMI.

Radiation protection in interventional suiteAuthor: Jolly S

Comment: Dr Jolly outlined the dangers of radiation including reports of increased brain tumour rates in interventional cardiologists and radiologists. He discussed techniques to reduce radiation including programming changes to radiation equipment which can lead to a 50% reduction in dose and include using 7.5 frames per second acquisition, radiation skirts and shields, head protection and radiation monitoring and feedback. Radial access is not a problem for high volume operators but he recommends taking a step back during acquisition and preferentially having the arm beside the body rather than angulated. He also showed evidence for the use of a pelvic lead drape which reduced scatter and radiation dose to the operator.

Bio-absorbable scaffolds: exciting future or delusional folly?Authors: Haude M and Banning A

Comment: The bio-absorbable scaffolds are currently considered an early generation device with very large strut thicknesses compared with contemporary metal stents. They have major theoretical advantages in terms of return of vasospasm and ability to address the artery with non-invasive imaging or future surgery if required. Other scaffolds such as magnesium stents are also in evolution. The ABSORB III and IV trials are underway and will be presented in the next few years and it was recommended that operators should await trial evidence of safety and efficacy before their widespread clinical use could be advocated.

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