Outcomes of thrombus aspiration during primary percutaneous coronary intervention for ST-elevation myocardial infarction.

BACKGROUND: Previous large multi-centre randomised controlled trials have not provided clear benefit with routine intracoronary thrombus aspiration (TA) as an adjunct to primary percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEMI). AIM: To determine whether there is a difference in outcomes with the use of manual TA prior to PCI, compared with PCI alone in a cohort of patients with STEMI. METHODS: We analysed data from 6270 consecutive patients undergoing primary PCI for STEMI prospectively enrolled in the Melbourne Interventional Group registry between 2007 and 2018. Multivariable analysis was performed to determine predictors of 30-day major adverse cardiovascular and cerebrovascular events (MACCE) and long-term mortality. RESULTS: We compared 1621 (26%) patients undergoing primary PCI with TA to 4649 (74%) patients undergoing PCI alone. Male gender (81% vs 78%; P < 0.01), younger age (61 vs 63 years; P = 0.03), GP-IIb/IIIa use (76% vs 58%, P < 0.01), and current smoking (40% vs 36%; P < 0.01) were more common in the TA group. TA was more likely to be used in patients with complex lesions (83% vs 66%; P < 0.01) with TIMI 0 flow (77% vs 56%; P < 0.01). No significant difference in post-procedural TIMI flow, stroke, 30-day mortality, or long-term mortality were identified. Multivariable analysis demonstrated a reduction in 30-day MACCE (hazard ratio (HR) 0.75; confidence interval (CI) 0.63-0.89; P < 0.01) in the TA group, but was not associated with long-term mortality (HR 0.98; CI 0.85-1.1; P = 0.73). CONCLUSION: The use of TA in patients undergoing primary PCI for STEMI was not associated with improved short or long-term mortality when compared with PCI alone.

Prognostic significance of suboptimal secondary prevention pharmacotherapy after acute coronary syndromes.

BACKGROUND: Optimal secondary prevention pharmacotherapy is the cornerstone of post-acute coronary syndrome (ACS) management. The prognostic impact of not receiving five guideline-recommended therapies is poorly described. AIM: To ascertain the prognostic significance of suboptimal pharmacotherapy in ACS survivors. METHODS: Consecutive patients with ACS from the Melbourne Interventional Group registry who were alive at 30 days following their index percutaneous coronary intervention were included. Patients were divided into three categories based on the number of secondary prevention medications prescribed. The optimal medical therapy (OMT), near-optimal medical therapy (NMT), suboptimal medical therapy (SMT) groups were prescribed 5, 4 and ≤ 3 medications, respectively. Primary endpoint was long-term mortality. Cox-proportional hazard modelling was undertaken to assess independent predictors of survival. RESULTS: Of the 9375 patients included, 5678 (60.6%) received OMT, 2903 (31.0%) received NMT and 794 (8.5%) received SMT. Patients receiving SMT were older, more likely to be female and had higher burden of comorbidities (renal impairment, congestive heart failure, diabetes, peripheral vascular disease; P < 0.01 for all). SMT was associated with higher long-term mortality at 3.9 ± 2.2 years when compared to NMT and OMT (16.8% vs 10.5% vs 8.2%, P < 0.001). Compared to OMT, SMT was an independent predictor of long-term mortality (hazard ratio, HR 1.62, 95% confidence interval, CI 1.30-2.02, P < 0.01) while NMT was associated with a clinically significant 14% mortality hazard (HR 1.14, 95% CI 0.97-1.34, P = 0.11). CONCLUSIONS: There is a graded long-term hazard associated with not receiving OMT after an ACS. Improvements in secondary prevention pharmacotherapy models of care are warranted to further decrease the long-term mortality.

Clinical Outcomes in Older Patients Undergoing Percutaneous Coronary Intervention for Non-ST-Elevation Acute Coronary Syndromes.

BACKGROUND: Distinguishing the subgroup of older, comorbid patients presenting with non-ST-elevation acute coronary syndromes (NSTEACS) who will benefit from percutaneous coronary intervention (PCI) remains challenging. Identifying risk factors for major adverse cardiac or cerebrovascular events (MACCE) post PCI may help define this cohort. The objective of this study was to describe contemporary outcomes of older patients with NSTEACS undergoing PCI and identify pre-procedural risk factors for MACCE. METHODS: We retrospectively reviewed data for 1,875 patients aged ≥80 years entered in the Victorian Cardiac Outcomes Registry (VCOR) who underwent PCI for NSTEACS between 1 January 2013 and 31 December 2017. MACCE was a composite outcome comprising 30-day mortality, myocardial infarction, stroke, major bleeding, target lesion revascularisation or target vessel revascularisation; in-hospital cardiogenic shock or stent thrombosis; and new requirement for dialysis. Patient demographic data and pre-procedural comorbidities were compared between the groups with and without a MACCE. RESULTS: The rate of MACCE at 30 days was 8.0% (n=150). Thirty-day (30-day) mortality was 3.0% (n=57). Pre-procedural left ventricular ejection fraction (LVEF)<45% (OR 2.32; 95% CI 1.47-3.68; p<0.001) and eGFR≤30 mL/min/1.73m2 or renal replacement therapy (OR 2.10; 95% CI 1.27-3.46; p<0.01) were independent predictors of a MACCE. CONCLUSIONS: Older patients presenting with NSTEACS who have left ventricular systolic dysfunction or renal impairment are at increased risk of MACCE post PCI. Randomised studies are required to determine if invasive management remains beneficial for these patents compared with medical therapy.

Clinical outcomes following ST-elevation myocardial infarction secondary to stent thrombosis treated by percutaneous coronary intervention.

OBJECTIVES: To assess the clinical outcomes of patients presenting with ST-elevation myocardial infarction (STEMI) secondary to stent thrombosis (ST) compared to those presenting with STEMI secondary to a de novo culprit lesion and treated by percutaneous coronary intervention (PCI). BACKGROUND: ST is an infrequent but serious complication of PCI with substantial associated morbidity and mortality, however with limited data. METHODS: We studied consecutive patients who underwent PCI for STEMI from 2005 to 2013 enrolled prospectively in the Melbourne Interventional Group registry. Patients were divided into two groups: the ST group comprised patients where the STEMI was due to ST and the de novo group formed the remainder of the STEMI cohort and all patients were treated by PCI. The primary endpoint was 30-day all-cause mortality. RESULTS: Compared to the de novo group (n = 3,835), the ST group (n = 128; 3.2% of STEMI) had higher rates of diabetes, hypertension and dyslipidemia, established cardiovascular diseases, myocardial infarction, and peripheral vascular disease, all p < .01. Within the ST group, very-late ST was the most common form of ST, followed by late and early ST (64, 19, and 17%, respectively). There was no significant difference in the primary outcome between the ST group and the de novo group (4.7 vs. 7.1%, p = .29). On multivariate analysis, ST was not an independent predictor of 30-day mortality (odds ratio: 0.62, 95% confidence interval: 0.07-1.09, p = .068). CONCLUSION: The short-term prognosis of patients with STEMI secondary to ST who were treated by PCI was comparable to that of patients with STEMI due to de novo lesions.

Outcomes of cardiogenic shock complicating acute coronary syndromes.

OBJECTIVES: We aimed to assess the outcomes of cardiogenic shock (CS) complicating acute coronary syndromes (ACS). BACKGROUND: CS remains the leading cause of mortality in patients presenting with ACS despite advances in care. METHODS: We studied 13,184 patients undergoing percutaneous coronary intervention (PCI) for all subtypes of ACS enrolled prospectively in a large multicentre Australian registry (Melbourne Interventional Group registry) from 2005 to 2013. All-cause mortality was obtained via linkage to the National Death Index. Patients were divided into those with and those without CS. RESULTS: Compared to the non-CS group (n = 12,548, 95.2%), the CS group (n = 636, 4.8%) had a higher proportion of out-of-hospital cardiac arrest (OHCA) (31.1 vs. 2.2%) and ST-elevation myocardial infarction (STEMI) presentation (89 vs. 34%), both p < .01. Patients in the CS group had higher rates of in-hospital (40.4 vs. 1.2%) and 30-day (41 vs. 1.7%) mortality compared to the non-CS group. Long-term mortality over a median follow-up of 4.2 years was higher in the CS group (50.6 vs. 13.8%), p < .001. Trends of in-hospital and 30-day mortality rates of CS complicating ACS were relatively stable from 2005 to 2013. Predictors of long-term NDI-linked mortality within the CS group include severe left ventricular systolic dysfunction (HR 3.0), glomerular filtration rate (GFR) <30 (HR 2.56), GFR 30-59 (HR 1.94), OHCA (HR 1.46), diabetes (HR 1.44), and age (HR 1.02), all p < .05. CONCLUSIONS: Rates of CS-related mortality complicating ACS have remained very high and steady over nearly a decade despite progress in STEMI systems of care, PCI techniques, and medical therapy.

Trends of Use and Outcomes Associated With Glycoprotein-IIb/IIIa Inhibitors in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention.

Background: Glycoprotein IIb/IIIa inhibitors (GPIs) are a treatment option in the management of acute coronary syndromes (ACSs). Evidence supporting the use of GPIs predates trials establishing the benefits of P2Y12 inhibitors, routine early invasive therapy, and thrombectomy devices in patients with ACS. Objective: The aim of this study was to determine trends in GPI use and their associated outcomes in contemporary practice. Methods: We assessed GPI use in patients with ACS undergoing percutaneous coronary intervention (PCI) from the Melbourne Interventional Group registry (2005-2013). The primary endpoint was the 30-day incidence of major adverse cardiovascular events (MACE). The safety endpoint was in-hospital major bleeding. Results: GPIs were used in 40.5% of 12 357 patients with ACS undergoing PCI. GPI use decreased over the study period (P for trend <0.0001). Patients were more likely to receive GPIs if they were younger, presented with a ST-elevation myocardial infarction (STEMI), had more complex (B2/C-type) lesions, and when thrombectomy devices were used (all P < 0.0001). MACE were higher in patients receiving GPI (4.9% vs 4.1%, P = 0.03). Propensity score matching revealed no difference in 30-day mortality and 30-day MACE (odds ratio [OR] = 1.00; 95% CI = 0.99-1.004 and OR = 1.01; 95% CI = 0.99-1.02, respectively). GPI use was associated with more bleeding complications (3.6% vs 1.8%, P < 0.0001). Conclusion and Relevance: GPI use in ACS patients undergoing PCI has declined, and use appears to be dictated by ACS type and lesion complexity, as opposed to high-risk comorbidities. GPI use was associated with a doubling in bleeding complications.

The Impact of Out-of-Hours Presentation on Clinical Outcomes in ST-Elevation Myocardial Infarction.

BACKGROUND: Systems of care have been established to ensure patients with ST-elevation myocardial infarction (STEMI) get timely access to primary percutaneous coronary intervention (PPCI). In this study, we evaluated whether patients undergoing PPCI both in-hours and out-of-hours experience similar care and clinical outcomes. METHODS: Of 9,865 patients who underwent PCI for STEMI from 2005 to 2016 and were enrolled in the multi-centre Melbourne Interventional Group registry, patients who had initially presented to a non-PCI capable hospital, received thrombolysis or presented >12hourspost-symptom onset were excluded. Our final study cohort of 4,590 patients were dichotomised by whether PPCI was performed in-hours or out-of-hours, and compared. The primary outcome was 30-day mortality. RESULTS: The in-hours group included 1,865 patients (40.6%) while 2,725 patients (59.4%) had out-of-hours PPCI. Patients presenting out-of-hours had longer median door-to-balloon time (DTBT; 83 [IQR 61-109] vs. 60 [IQR 41-88] mins, p<0.01) and were more likely to receive a drug-eluting stent (p=0.001). Procedural characteristics were otherwise similar although rates of radial access were low overall (18.4%). No differences in in-hospital, 30-day or 12-month mortality were observed between the groups (p=NS). On Cox proportional hazards modelling, out-of-hours presentation was not an independent predictor of 30-day mortality (HR 0.94, 95% CI 0.71-1.22). A landmark analysis of data from 2012 did not change the primary outcome. CONCLUSION: Despite a slightly longer DTBT, patients undergoing PPCI out-of-hours experienced similar care and clinical outcomes to the in-hours group. Given the majority of patients with STEMI present out-of-hours, these data have implications for STEMI systems of care.

Trends and predictors of recurrent acute coronary syndrome hospitalizations and unplanned revascularization after index acute myocardial infarction treated with percutaneous coronary intervention.

BACKGROUND: Repeat hospitalizations for recurrent acute coronary syndrome (ACS) or unplanned revascularization after acute myocardial infarction (MI) are common, costly and potentially preventable. We aim to describe 10-year trends and identify independent risk factors of these repeat hospitalizations. METHODS: We analyzed data from 9615 patients from the Melbourne Interventional Group registry (2005-2014) who underwent percutaneous coronary intervention (PCI) for their index MI and survived to discharge. Patients with ≥1 hospitalization for recurrent ACS events and/or unplanned revascularization in the year after discharge were included in the recurrent coronary hospitalization group. We assessed yearly trends of recurrent coronary events and identified independent predictors using multivariate analysis. RESULTS: Recurrent coronary hospitalization occurred in 1175 (12.2%) patients. There was a significant decrease in the rate of recurrent ACS hospitalization (15.3%-7.6%, P for trend <.001) and unplanned revascularization (4.2%-2.1%, P for trend = .01), but not in all-cause re-hospitalizations (P for trend = .28). On multivariate analysis, female gender, diabetes mellitus, previous coronary bypass surgery, previous PCI, reduced ejection fraction, heart failure, multi-vessel coronary disease and obstructive sleep apnea were independent predictors of recurrent coronary hospitalizations (all P < .05). CONCLUSIONS: Recurrent hospitalization for ACS or unplanned revascularization has decreased significantly over the past decade. Risk factors for such events are numerous and largely non-modifiable, however they identify a cohort of patients in whom non-culprit vessel PCI in multi-vessel disease, optimization of left ventricular dysfunction and diabetes management may improve outcomes.

Outcomes in patients with peripheral vascular disease following percutaneous coronary intervention.

OBJECTIVES: To evaluate the clinical characteristics and outcomes of patients with peripheral vascular disease (PVD) undergoing percutaneous coronary intervention (PCI) in a contemporary setting, and to determine whether use of drug-eluting stents (DESs) improves outcomes. BACKGROUND: PVD was an independent risk factor for adverse outcomes following PCI in the bare-metal stent (BMS) era. It is not known whether outcomes in these patients have improved with advances in interventional techniques and stent technology, as they have for the general population. METHODS: Eighteen thousand three hundred and eighty patients undergoing PCI from an Australian registry between 2005 and 2013 were studied. Clinical and procedural data, 30-day and 12-month outcomes were compared in those with and without a reported history of PVD. Outcomes were also compared between patients with PVD who received DES and those who received BMS. Long-term mortality was compared using Australian National Death Index (NDI) linkage. RESULTS: Patients with PVD (n = 1,251, 6.8%) were older and had more prevalent diabetes, hypertension, cerebrovascular disease, heart failure, renal impairment, ostial lesions, left main, and multi-vessel disease (p < 0.001). Patients with PVD had significantly higher rates of major adverse cardiovascular events (MACEs) compared with those without PVD, in-hospital (5.7% vs. 4.1%, p < 0.008), at 30-days (8.6% vs. 5.8%, p < 0.001) and at 12-months (24.6% vs. 13.2%, p < 0.001). At 4.9 ± 2.6 years follow-up, there was significantly greater mortality in the PVD group. PVD patients who received DES experienced significantly less MACE than PVD patients treated with BMS at 30-days (4.8 vs. 10.1%, p < 0.001) and 12-months (19.4 vs. 26.4%, p < 0.005). CONCLUSIONS: PVD is an independent predictor of adverse outcomes in patients undergoing PCI. PVD patient who received DES had improved outcomes compared with those receiving BMS.

Comparison of short-term clinical outcomes of proximal versus nonproximal lesion location in patients treated with primary percutaneous coronary intervention for ST-elevation myocardial infarction: The PROXIMITI study.

OBJECTIVES: The objective of this study was to investigate the association of proximal and nonproximal location of culprit coronary lesions with clinical outcomes of patients presenting with ST-elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PCI). BACKGROUND: Proximal culprit lesion location in patients presenting with STEMI is associated with increased mortality when compared to distal culprit lesions in the thrombolytic era. The impact of lesion location on clinical outcomes in the era of PCI remains unclear. METHODS: We analyzed 3,283 patients with STEMI who enrolled in the Victorian Cardiac Outcomes Registry. We compared outcomes in those with proximal lesion location versus patients with nonproximal location. RESULTS: Of 3,283 participants, 1,376 (41.9%) had a proximal lesion location. Patients with proximal lesion location presented with greater rates of cardiogenic shock and out-of-hospital cardiac arrest, and left ventricular systolic dysfunction, all P < .01. Procedural success rates were similar (96% vs. 95%, P = .08). Patients with proximal lesion location had higher rates of in-hospital and 30-day mortality, major adverse cardiac events (MACE; mortality, myocardial infarction, stent thrombosis, and unplanned revascularization) and major adverse cardiac and cerebrovascular events (MACCE; MACE, and stroke) compared to the nonproximal group, all P < .001. However, on multivariable regression analysis, proximal lesion location was not independently associated with MACE during in-hospital stay or at 30-days (OR 1.32, 95% CI 0.95-1.83, P = .09 and OR 1.23, 95% CI 0.92-1.65, P = .15) respectively. CONCLUSIONS: Patients with proximal lesion location had greater hemodynamic instability and higher-risk features; however, proximal lesions per se were not independently associated with worse clinical outcomes compared to nonproximal lesions.

Temporal Changes in Characteristics, Treatment and Outcomes of Heart Failure Patients Undergoing Percutaneous Coronary Intervention Findings From Melbourne Interventional Group Registry.

BACKGROUND: Limited data exist on whether outcomes of patients with heart failure (HF) undergoing percutaneous coronary intervention (PCI) have improved over time. The purpose of this study was to assess temporal trends in patient characteristics, treatment and outcomes of patients with HF undergoing PCI. METHODS: Using data from the Melbourne Interventional Group (MIG), we evaluated temporal trends of procedure volume, major adverse cardiac events (MACE; a composite of all-cause mortality, myocardial infarction and target vessel revascularisation) and rates of cardiovascular readmission, all-cause death and cardiovascular death in consecutive patients with HF undergoing PCI. Change over time was assessed by Box-Jenkins autoregressive integrated moving average (ARIMA) models. RESULTS: Data from 1,604 patients were analysed. In our cohort, there were no significant changes in the number of procedures performed annually and patient characteristics between January 2005 and December 2014. Optimal use of HF therapy has improved over the study period. Planned clopidogrel therapy of more than 12 months increased in tandem with increasing use of drug-eluting stents (DES). Procedural success was high (≥90%). However, the rates of MACE, cardiovascular readmission, all-cause death and cardiovascular death remained unchanged throughout the study period. CONCLUSIONS: Clinical outcomes in HF patients undergoing PCI have remained unchanged despite improvement in medical technology and contemporary therapeutic measures.

Utility of the ACC/AHA lesion classification as a predictor of procedural, 30-day and 12-month outcomes in the contemporary percutaneous coronary intervention era.

BACKGROUND: Correlations between the ACC/AHA coronary lesion classification and clinical outcomes in the contemporary percutaneous coronary intervention (PCI) era are not well established. METHODS: We analyzed clinical characteristics and outcomes according to ACC/AHA lesion classification (A, B1, B2, C) in 13,701 consecutive patients from the Melbourne Interventional Group (MIG) registry. Patients presenting with STEMI, cardiogenic shock and out-of-hospital cardiac arrest were excluded. The primary endpoints were 30-day and 12-month mortality. Secondary endpoints were procedural success as well as 30-day and 12-month major adverse cardiac events. RESULTS: Of the 13,701 patients treated, 1,246 (9.1%) had type A lesions, 5,519 (40.3%) had type B1 lesions, 4,449 (32.5%) had Type B2 lesions and 2,487 (18.2%) had Type C lesions. Patients with type C lesions were more likely to be older and have impaired renal function, diabetes, previous myocardial infarction, peripheral vascular disease and prior bypass graft surgery (all P < 0.01). They were also more likely to require rotational atherectomy, drug-eluting stents and longer stent lengths (all P < 0.01). Increasing lesion complexity was associated with lower procedural success (99.6% vs. 99.1% vs. 96.6% vs. 82.7%, P < 0.001) and worse 30-day (0.2% vs. 0.3% vs. 0.7% vs. 0.6%, P < 0.001) and 12-month mortality (2.2% vs. 2.0% vs. 3.2% vs. 2.9%, P <0.01). Kaplan Meier analysis showed complex lesions (type B2 and C) had lower survival at 12-months (P = 0.003). CONCLUSIONS: PCI to more complex lesions continues to be associated with lower procedural success rates as well as inferior medium-term clinical outcomes. Thus the ACC/AHA lesion classification should still be calculated preprocedure to predict acute PCI success and clinical outcomes.

Pretreatment with dual antiplatelet therapy in patients with ST-elevation myocardial infarction.

BACKGROUND: The optimal time to administer P2Y12 inhibitors in patients with ST-elevation myocardial infarction (STEMI) remains to be defined. We sought to assess whether a pretreatment strategy was associated with improved coronary reperfusion and clinical outcomes. METHODS: Consecutive patients from the Melbourne Interventional Group registry (2005-2014) who presented with STEMI and underwent primary PCI were included. Those who received any P2Y12 inhibitor prior to arrival in the cardiac catheterisation laboratory were included in the pretreatment group. The primary endpoints were the proportion of patients with initial TIMI flow grade <3 and in-hospital bleeding. The secondary endpoints were 12-month mortality and major adverse cardiovascular events (MACE). RESULTS: Of the 2,807 patients included, 892(31.8%) received pretreatment. Clopidogrel was the most common P2Y12 inhibitor used (79.6%). Pretreatment was associated with less thromboaspiration and GPIIb/IIIa inhibitor use (both P < 0.01). Pretreatment was not associated with lower rates of TIMI flow <3 on initial angiogram (78.0% vs. 80.7%, P = 0.18) nor with increased in-hospital bleeding (3.6% vs. 3.9%, P = 0.67). Pretreatment was associated with lower 12-month mortality (4.7% vs. 7.0%, P = 0.02) but similar MACE rate (13.0% vs. 14.1%, P = 0.43). Multivariate analysis revealed pretreatment was not an independent predictor of 12-month mortality (OR 0.79; 95% CI 0.5-1.3, P = 0.32). CONCLUSION: Pretreatment with a P2Y12 inhibitor in patients with STEMI was not routine practice in our Australian cohort and was not associated with improved coronary reperfusion or clinical outcomes. Larger studies are required to definitively ascertain the risk/benefit ratio of dual antiplatelet therapy pretreatment in STEMI.

Does Statin Benefits Patients with Heart Failure Undergoing Percutaneous Coronary Intervention? Findings from the Melbourne Interventional Group Registry.

PURPOSE: The effectiveness of statins in improving clinical outcomes among patients with heart failure (HF) undergoing percutaneous coronary intervention (PCI) is unclear. We examined the association between use of statins and clinical outcomes in patients with HF included in the Melbourne Interventional Group registry. METHODS: Patients were followed from 30 days to 1 year post-PCI for a primary composite outcome of all-cause mortality and hospitalisation for cardiovascular (CV) causes. Secondary outcomes included major adverse cardiac events (MACE, a composite of all-cause mortality, myocardial infarction and target vessel revascularisation) and hospitalisation for CV causes. Outcomes were compared between statin-treated and non-statin-treated patients (at 30 days post-PCI) using propensity scores to balance for risk factors. RESULTS: Among 991 patients included in the inverse probability-weighted Cox model, statin use had no significant effect on the primary composite outcome [adjusted hazard ratio (aHR), 1.03; 95% confidence interval (CI), 0.68 to 1.56; p = 0.89], nor MACE (aHR, 0.99; 95% CI, 0.54 to 1.84; p = 0.99) or hospitalisation for CV causes (HR, 1.13; 95% CI, 0.74 to 1.72; p = 0.57). CONCLUSIONS: Our results suggest that statin therapy may confer no significant benefits in patients with HF undergoing PCI. However, prospective randomised controlled trials are needed to provide more definitive answers.

The Establishment of the Victorian Cardiac Outcomes Registry (VCOR): Monitoring and Optimising Outcomes for Cardiac Patients in Victoria.

BACKGROUND: The Victorian Cardiac Outcomes Registry (VCOR) was established in 2012 to ensure the safety and quality of cardiac based therapies across Victoria. As a clinical quality registry, VCOR monitors the performance of health services in both the public and private sectors, by measuring and reporting on trends in the quality of patient care over time, within individual hospitals, comparatively with other hospitals, and aggregated at the state level. The current paper describes the VCOR registry aims, methods, governance structure and progress to date. METHODS: Primary management of the registry is undertaken at Monash University in association with the Victorian Cardiac Clinical Network, Department of Health and Human Services Victoria. RESULTS: The Victorian Cardiac Outcomes Registry has currently collected data on more than 33,000 cardiac patients across three separate areas of interest in 35 hospitals. These include percutaneous coronary intervention (PCI), the early treatment of acute myocardial infarction in rural and regional settings, and data relating to in-hospital management of heart failure. CONCLUSIONS: The Victorian Cardiac Outcomes Registry is a clinical cardiac registry that commenced data collection in 2013, providing a detailed description of selected aspects of contemporary cardiology clinical practice in a majority of Victorian hospitals. This information enables hospitals and cardiac units to benchmark their practice, clinical outcomes and quality of care to other similar units and hospitals across the state. If replicated by other states in Australia, there will be the potential for important national comparisons, with the goal to foster continuous improvement in patient care and outcomes across the entire Australian health system.

Acupuncture for analgesia in the emergency department: a multicentre, randomised, equivalence and non-inferiority trial.

OBJECTIVES: This study aimed to assess analgesia provided by acupuncture, alone or in combination with pharmacotherapy, to patients presenting to emergency departments with acute low back pain, migraine or ankle sprain. DESIGN: A pragmatic, multicentre, randomised, assessor-blinded, equivalence and non-inferiority trial of analgesia, comparing acupuncture alone, acupuncture plus pharmacotherapy, and pharmacotherapy alone for alleviating pain in the emergency department. Setting, participants: Patients presenting to emergency departments in one of four tertiary hospitals in Melbourne with acute low back pain, migraine, or ankle sprain, and with a pain score on a 10-point verbal numerical rating scale (VNRS) of at least 4. MAIN OUTCOME MEASURES: The primary outcome measure was pain at one hour (T1). Clinically relevant pain relief was defined as achieving a VNRS score below 4, and statistically relevant pain relief as a reduction in VNRS score of greater than 2 units. RESULTS: 1964 patients were assessed between January 2010 and December 2011; 528 patients with acute low back pain (270 patients), migraine (92) or ankle sprain (166) were randomised to acupuncture alone (177 patients), acupuncture plus pharmacotherapy (178) or pharmacotherapy alone (173). Equivalence and non-inferiority of treatment groups was found overall and for the low back pain and ankle sprain groups in both intention-to-treat and per protocol (PP) analyses, except in the PP equivalence testing of the ankle sprain group. 15.6% of patients had clinically relevant pain relief and 36.9% had statistically relevant pain relief at T1; there were no between-group differences. CONCLUSION: The effectiveness of acupuncture in providing acute analgesia for patients with back pain and ankle sprain was comparable with that of pharmacotherapy. Acupuncture is a safe and acceptable form of analgesia, but none of the examined therapies provided optimal acute analgesia. More effective options are needed. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12609000989246.

Incidence, Predictors and Outcomes of Major Bleeding in Patients Following Percutaneous Coronary Interventions in Australia.

BACKGROUND: Major bleeding is a serious complication of percutaneous coronary intervention (PCI). We set out to investigate the incidence of major bleeding and its impact on hospitalisation and long-term mortality. METHOD: We examined seven years of registry data encompassing 16,860 PCI procedures. RESULTS: Between 2005 and 2011 major bleeding increased from 1.3% to 3.4%. In patients with ST elevated myocardial infarction (STEMI), the rate increased from 2.3% to 6.4%. The increase remained significant after adjusting for patient and procedural characteristics (OR=1.09/year, p=0.001). Bleeding risk was highest in patients presenting with out-of-hospital cardiac arrest and cardiogenic shock (CS). Women, STEMI patients, those aged over 70yrs or weighing <60kg were at higher risk. Glycoprotein IIb/IIIa-inhibitor use more than doubled the risk of bleeding (OR=2.28, p=<0.001). Mortality rates at one year were 4.18% overall and 7.9% in STEMI. Bleeding was a strong predictor of mortality after adjusting for potential confounders (HR=2.92, 95% CI: 2.08, 4.09). Bleeding significantly increased length of stay (med four days vs seven days) and rehospitalisation at 12 months (OR=1.36, 95% CI: 1.08, 1.70). CONCLUSIONS: Major bleeding rates post-PCI appear to be increasing in Australia. Bleeding increases hospitalisation and is associated with poor clinical outcomes.

Monosomal karyotype predicts inferior survival independently of a complex karyotype in patients with myelodysplastic syndromes.

BACKGROUND: Conflicting data exist about the impact of a monosomal karyotype (MK) on overall survival (OS) for patients with myelodysplastic syndromes (MDSs) and particularly for those with a complex karyotype (CK). This study was aimed at determining whether an MK is associated with OS independently of the number of cytogenetic abnormalities (CAs) in a population-based MDS cohort. METHODS: Cancer registry data on incident MDS cases were linked with cytogenetic data and hospital administrative data from 2000 to 2010 for the Australian state of Victoria. RESULTS: Between 2000 and 2010, 1404 incident MDS cases with cytogenetic results were identified. A CK, defined as 3 or more abnormalities, was present in 126 (9%). A very complex karyotype (vCK), defined as 5 or more abnormalities, was present in 95 (7%). An MK was associated with worse OS in the whole cohort (median 6 vs 39 months, P < 0.001) including those with a coexisting CK (6 vs 17 months, P < 0.001) or vCK (6 vs 9 months, P = 0.02). After adjustments for the number of CAs, an MK remained independently associated with OS, although its effect size decreased with increasing cytogenetic complexity (hazard ratio for an MK, 4.81; 95% confidence interval, 3.08-7.52; hazard ratio for the number of CAs, 1.22; 95% confidence interval, 1.15-1.30; and hazard ratio for the interaction between an MK and CAs, 0.83; 95% confidence interval, 0.77-0.89). CONCLUSIONS: These results support the clinical utility of an MK as an independent predictor of adverse outcomes for MDS patients, even among CK and vCK groups, although its prognostic effect decreases with increasing cytogenetic complexity.

Utility of rotational atherectomy and outcomes over an eight-year period.

OBJECTIVES: To evaluate outcomes of patients undergoing rotational atherectomy (RA) in a multicenter percutaneous coronary intervention (PCI) registry. BACKGROUND: RA remains an important technique for plaque modification in PCI, particularly with complex calcification. METHODS: The study population consisted of consecutive patients undergoing PCI in nine major Australian hospitals, who were treated over an 8-year period (June 2004 to June 2012). RESULTS: Of 16,577 PCI's, 1.0% of patients n = 167 (214 lesions) underwent RA. Patients undergoing RA were more likely to be older (71.0 ± 9.7 vs. 64.4 ±11.9 years, P < 0.01), with greater incidence of diabetes (37.7% vs. 23.8%, P < 0.01) and renal impairment. There was no significant difference in procedural success (94.6% vs. 95.5%, P = 0.57), dissection (6.1% vs. 4.8%, P = 0.39), transient no reflow (4.4% vs. 2.8%, P = 0.23), or persistent no reflow (0% RA vs. 0.7% non-RA, P = 0.23). Those undergoing RA had a low but increased risk of death at 12 months (6.6 vs. 3.6%, P = 0.04). There was no significant difference in 12 month major adverse cardiovascular outcomes (MACE) between groups following adjustment for univariate predictors (OR 1.00, 95%CI; 0.93-1.08). Additionally, there was no significant difference in 30-day MACE (6.0% vs. 5.1%, P = 0.62) or 30-day mortality (2.4% vs. 1.8%, P = 0.54) between groups. CONCLUSIONS: In this large multicenter registry, RA continues to be used to treat complex lesions with low procedural complications and MACE rates. It is essential for interventional cardiologists to maintain skills in RA to enable effective percutaneous treatment of certain complex lesions.