Feasibility and Safety of Erythropoietin (EPO) Administration in Patients with Acute Myocardial...

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ABSTRACTS Heart, Lung and Circulation Abstracts S173 2008;17S:S1–S209 Conclusions: This prospective multicentre registry demonstrates that eptifibatide was safe and effective on introduction into clinical practice, was commonly used for off-label indications and for time periods different to man- ufacturer’s recommendations. Monitoring introduction of a new drug through a cooperative multicentre registry is a useful tool for quality assurance and assessment of clinical standards of care. doi:10.1016/j.hlc.2008.05.410 410 A 2 × 2 Factorial Design Randomised Control Trial Assessing the Efficacy of High Pressure Coronary Stent Deployment and Post-dilation to Achieve Relative Over- size Compared to Nominal Stent Deployment and Sizing in Patients at High Risk for Re-stenosis Using the Endeavor Drug-eluting Stent Versus Bare Metal Stents: The HEADROOM trial—Report of the First 100 Patients Joseph Matthews 1,2,3,4,, Mark Pitney 1,2,3,4 , Nigel Jepson 1,2,3,4 , Robert Giles 1,2,3,4 , Daniel Friedman 1,2,3,4 , Roger Allan 1,2,3,4 , Warren Walsh 1,2,3,4 , Antony Lau 1,2,3,4 , Sze-yuan Ooi 1,2,3,4 1 Eastern Heart Clinic, Randwick, Australia; 2 Prince of Wales, Randwick, Australia; 3 Sutherland Heart Clinic, Sutherland, Australia; 4 The Sutherland Hospital, Sutherland, Australia Background: The use of drug eluting stents in “inter- mediate” restenosis risk patients remains controversial. Over-sizing a stent to reduce restenosis is unproven. This study aimed to investigate these practices. We report on progress of the first 100 patients. Methods: Five hundred patients will be enrolled across two centres into a 2 × 2 factorial design randomised trial. For inclusion patients must have two risks for restenosis from a list of either clinical (diabetes, acute coronary syn- drome) or angiographic (ostial, length > 18 mm, calcium, width 2.5 mm, lesion B2/C) criteria. Randomisation is into either over-size (OS) vs. nominal-size, and then drug eluting (endeavour) vs. bare metal. Oversize is defined as a final target lesion diameter 10–20% greater than ref- erence vessel diameter. A maximum of 2 planned stents per patient is permitted. The primary endpoint is clini- cally driven target lesion revascularisation (TLR) over 12 months. Secondary endpoints include MACE and stent thrombosis. Procedural results: In the 1st 100 pts, 52 were randomised to received endeavour stents and 48 bare metal. A total of 118 lesions were treated with an average reference ves- sel diameter of 2.95 = 0.6 mm. Lesion length was 18 mm. All lesions were successfully stented with no procedural MACE. Over-sizing did not increase periprocedural Tp elevation (mean 10h Trop I 0.6). Follow up Results: 70(%) patients follow up of over 6 months, TLR has occurred in 5/48 bare metal patients vs. 0/52 endeavour (p = 0.02). No stent thrombosis has occurred. Conclusion: Early results suggest reduction in TLR with endeavour in this group. doi:10.1016/j.hlc.2008.05.411 411 Feasibility and Safety of Erythropoietin (EPO) Adminis- tration in Patients with Acute Myocardial Infarction to Improve Cardiac Function and Remodelling: Pilot Study Joseph Matthews 1,2,3,, Mark Pitney 1,2,3 , Jason Kovacic 1,2,3 , Robert Lindeman 1,2,3 , Eugene Loh 1,2,3 , Nigel Jepson 1,2,3 , Greg Cranney 1,2,3 , Sze-yuan Ooi 1,2,3 1 Eastern Heart Clinic, Randwick, Australia; 2 Prince Of Wales, Randwick, Australia; 3 St. Vincents Hospital, Sydney, Australia Background: Research into the cardio-protective effects of EPO in animal models of myocardial infarction is an area of increasing interest, with studies reporting a reduction in infarct size, cell apoptosis and improved neo- vascularization. We now report the results of a safety trial administering EPO to humans during the post infarct period. Methods: This was a single centre safety trial conducted with Ethics committee and TGA approval. Initially inclu- sion criteria were patients with EF < 40% within 24 h of primary angioplasty for AMI, this was increased to EF < 50% within 48 h to improve enrolment. Exclusion cri- teria included any previous history of LV dysfunction. All patients received a single intravenous dose of Eprex 10,000 i.u. within 48 h of primary angioplasty. Bloods were collected at baseline, day 7, 14, 30, 3 months and 6 months. Endpoints included mortality and hyper-viscosity events and MACE at six months. Results: Fourteen patients were enrolled from July 2006 to October 2007, with to date 6-month follow-up for 11/14. 13/14 were LAD infarcts, 1/14 RCA, with mean EF 44%. There was no significant change in red cell or reticulocyte count or haematocrit. There were no significant adverse events. Conclusion: A 10,000 u dose of IV Eprex given to patients with large myocardial infarcts in the period immediately after primary angioplasty is safe and feasible. Dose escala- tion and phase II studies are required to measure efficacy of EPO therapy for myocardial infarction. doi:10.1016/j.hlc.2008.05.412 412 Complications of Coronary Angiography in a Real-World Setting: 8-year Experience Namal Wijeisnghe , Christopher Nunn, Cherian Sebastian, Spencer Heald, Hugh McAlister, Gerard Devlin Waikato Hospital, Hamilton, New Zealand Background: The risk of major complications during coro- nary angiography is not well documented in New Zealand. The aim of this study was to evaluate the incidence of

Transcript of Feasibility and Safety of Erythropoietin (EPO) Administration in Patients with Acute Myocardial...

Page 1: Feasibility and Safety of Erythropoietin (EPO) Administration in Patients with Acute Myocardial Infarction to Improve Cardiac Function and Remodelling: Pilot Study

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Heart, Lung and Circulation Abstracts S1732008;17S:S1–S209

Conclusions: This prospective multicentre registrydemonstrates that eptifibatide was safe and effective onintroduction into clinical practice, was commonly used foroff-label indications and for time periods different to man-ufacturer’s recommendations. Monitoring introductionof a new drug through a cooperative multicentre registryis a useful tool for quality assurance and assessment ofclinical standards of care.

doi:10.1016/j.hlc.2008.05.410

410A 2 × 2 Factorial Design Randomised Control TrialAssessing the Efficacy of High Pressure Coronary StentDeployment and Post-dilation to Achieve Relative Over-size Compared to Nominal Stent Deployment and Sizingin Patients at High Risk for Re-stenosis Using theEndeavor Drug-eluting Stent Versus Bare Metal Stents:The HEADROOM trial—Report of the First 100 Patients

Joseph Matthews 1,2,3,4,∗, Mark Pitney 1,2,3,4, NigelJepson 1,2,3,4, Robert Giles 1,2,3,4, Daniel Friedman 1,2,3,4,Roger Allan 1,2,3,4, Warren Walsh 1,2,3,4, Antony Lau 1,2,3,4,Sze-yuan Ooi 1,2,3,4

1 Eastern Heart Clinic, Randwick, Australia; 2 Prince of Wales,Randwick, Australia; 3 Sutherland Heart Clinic, Sutherland,Australia; 4 The Sutherland Hospital, Sutherland, Australia

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Conclusion: Early results suggest reduction in TLR withendeavour in this group.

doi:10.1016/j.hlc.2008.05.411

411Feasibility and Safety of Erythropoietin (EPO) Adminis-tration in Patients with Acute Myocardial Infarction toImprove Cardiac Function and Remodelling: Pilot Study

Joseph Matthews 1,2,3,∗, Mark Pitney 1,2,3, JasonKovacic 1,2,3, Robert Lindeman 1,2,3, Eugene Loh 1,2,3,Nigel Jepson 1,2,3, Greg Cranney 1,2,3, Sze-yuan Ooi 1,2,3

1 Eastern Heart Clinic, Randwick, Australia; 2 Prince Of Wales,Randwick, Australia; 3 St. Vincents Hospital, Sydney, Australia

Background: Research into the cardio-protective effectsof EPO in animal models of myocardial infarction isan area of increasing interest, with studies reporting areduction in infarct size, cell apoptosis and improved neo-vascularization. We now report the results of a safety trialadministering EPO to humans during the post infarctperiod.Methods: This was a single centre safety trial conductedwith Ethics committee and TGA approval. Initially inclu-sion criteria were patients with EF < 40% within 24 hof primary angioplasty for AMI, this was increased toEF < 50% within 48 h to improve enrolment. Exclusion cri-tA1cEaRO1TceCwato

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ackground: The use of drug eluting stents in “inter-ediate” restenosis risk patients remains controversial.ver-sizing a stent to reduce restenosis is unproven. This

tudy aimed to investigate these practices. We report onrogress of the first 100 patients.ethods: Five hundred patients will be enrolled across

wo centres into a 2 × 2 factorial design randomised trial.or inclusion patients must have two risks for restenosisrom a list of either clinical (diabetes, acute coronary syn-rome) or angiographic (ostial, length > 18 mm, calcium,idth ≤2.5 mm, lesion B2/C) criteria. Randomisation is

nto either over-size (OS) vs. nominal-size, and then drugluting (endeavour) vs. bare metal. Oversize is defineds a final target lesion diameter 10–20% greater than ref-rence vessel diameter. A maximum of 2 planned stentser patient is permitted. The primary endpoint is clini-ally driven target lesion revascularisation (TLR) over 12onths. Secondary endpoints include MACE and stent

hrombosis.rocedural results: In the 1st 100 pts, 52 were randomised

o received endeavour stents and 48 bare metal. A totalf 118 lesions were treated with an average reference ves-el diameter of 2.95 = −0.6 mm. Lesion length was 18 mm.ll lesions were successfully stented with no proceduralACE. Over-sizing did not increase periprocedural Tp

levation (mean 10 h Trop I 0.6).ollow up Results: 70(%) patients follow up of over 6onths, TLR has occurred in 5/48 bare metal patients

s. 0/52 endeavour (p = 0.02). No stent thrombosis hasccurred.

eria included any previous history of LV dysfunction.ll patients received a single intravenous dose of Eprex

0,000 i.u. within 48 h of primary angioplasty. Bloods wereollected at baseline, day 7, 14, 30, 3 months and 6 months.ndpoints included mortality and hyper-viscosity eventsnd MACE at six months.esults: Fourteen patients were enrolled from July 2006 toctober 2007, with to date 6-month follow-up for 11/14.

3/14 were LAD infarcts, 1/14 RCA, with mean EF 44%.here was no significant change in red cell or reticulocyteount or haematocrit. There were no significant adversevents.onclusion: A 10,000 u dose of IV Eprex given to patientsith large myocardial infarcts in the period immediately

fter primary angioplasty is safe and feasible. Dose escala-ion and phase II studies are required to measure efficacyf EPO therapy for myocardial infarction.

oi:10.1016/j.hlc.2008.05.412

12omplications of Coronary Angiography in a Real-Worldetting: 8-year Experience

amal Wijeisnghe ∗, Christopher Nunn, Cherianebastian, Spencer Heald, Hugh McAlister, Gerardevlin

Waikato Hospital, Hamilton, New Zealand

ackground: The risk of major complications during coro-ary angiography is not well documented in New Zealand.he aim of this study was to evaluate the incidence of