Preoperative Variables of 30-Day Mortality in Adults Undergoing Percutaneous Coronary Intervention: A Systematic Review.

BACKGROUND AND AIM: Risk adjustment following percutaneous coronary intervention (PCI) is vital for clinical quality registries, performance monitoring, and clinical decision-making. There remains significant variation in the accuracy and nature of risk adjustment models utilised in international PCI registries/databases. Therefore, the current systematic review aims to summarise preoperative variables associated with 30-day mortality among patients undergoing PCI, and the other methodologies used in risk adjustments. METHOD: The MEDLINE, EMBASE, CINAHL, and Web of Science databases until October 2022 without any language restriction were systematically searched to identify preoperative independent variables related to 30-day mortality following PCI. Information was systematically summarised in a descriptive manner following the Checklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies checklist. The quality and risk of bias of all included articles were assessed using the Prediction Model Risk Of Bias Assessment Tool. Two independent investigators took part in screening and quality assessment. RESULTS: The search yielded 2,941 studies, of which 42 articles were included in the final assessment. Logistic regression, Cox-proportional hazard model, and machine learning were utilised by 27 (64.3%), 14 (33.3%), and one (2.4%) article, respectively. A total of 74 independent preoperative variables were identified that were significantly associated with 30-day mortality following PCI. Variables that repeatedly used in various models were, but not limited to, age (n=36, 85.7%), renal disease (n=29, 69.0%), diabetes mellitus (n=17, 40.5%), cardiogenic shock (n=14, 33.3%), gender (n=14, 33.3%), ejection fraction (n=13, 30.9%), acute coronary syndrome (n=12, 28.6%), and heart failure (n=10, 23.8%). Nine (9; 21.4%) studies used missing values imputation, and 15 (35.7%) articles reported the model's performance (discrimination) with values ranging from 0.501 (95% confidence interval [CI] 0.472-0.530) to 0.928 (95% CI 0.900-0.956), and four studies (9.5%) validated the model on external/out-of-sample data. CONCLUSIONS: Risk adjustment models need further improvement in their quality through the inclusion of a parsimonious set of clinically relevant variables, appropriately handling missing values and model validation, and utilising machine learning methods.

Prevalence and Predictors of Emergency Medical Service Use in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction.

AIM: We aim to describe prevalence of Emergency Medical Service (EMS) use, investigate factors predictive of EMS use, and determine if EMS use predicts treatment delay and mortality in our ST-elevation myocardial infarction (STEMI) cohort. METHOD: We prospectively collected data on 5,602 patients presenting with STEMI for primary percutaneous coronary intervention (PCI) transported to PCI-capable hospitals in Victoria, Australia, from 2013-2018 who were entered into the Victorian Cardiac Outcomes Registry (VCOR). We linked this dataset to the Ambulance Victoria and National Death Index (NDI) datasets. We excluded late presentation, thrombolysed, and in-hospital STEMI, as well as patients presenting with cardiogenic shock and out-of-hospital cardiac arrest. RESULTS: In total, 74% of patients undergoing primary PCI for STEMI used EMS. Older age, female gender, higher socioeconomic status, and a history of prior ischaemic heart disease were independent predictors of using EMS. EMS use was associated with shorter adjusted door-to-balloon (53 vs 72 minutes, p<0.001) and symptom-to-balloon (183 vs 212 minutes, p<0.001) times. Mode of transport was not predictive of 30-day or 12-month mortality. CONCLUSIONS: EMS use in Victoria is relatively high compared with internationally reported data. EMS use reduces treatment delay. Predictors of EMS use in our cohort are consistent with those prevalent in prior literature. Understanding the patients who are less likely to use EMS might inform more targeted education campaigns in the future.

Clinical Outcomes of Renal Transplant Recipients Undergoing Percutaneous Coronary Intervention.

BACKGROUND: Clinical outcomes of patients with renal transplant (RT) undergoing percutaneous coronary intervention (PCI) remain poorly elucidated. METHOD: Between 2014 and 2021, data were analysed for the following three groups of patients undergoing PCI enrolled in a multicentre Australian registry: (1) RT recipients (n=226), (2) patients on dialysis (n=992), and (3) chronic kidney disease (CKD) patients (estimated glomerular filtration rate [eGFR], 30‒60 mL/min per 1.73 m2) without previous RT (n=15,534). Primary outcome was 30-day major adverse cardiac and cerebrovascular events (MACCEs)-composite of mortality, myocardial infarction, stent thrombosis, target vessel revascularisation, and stroke. RESULTS: RT recipients were younger than dialysis and patients with CKD (61±10 vs 68±12 vs 78±8.2 years, p<0.001). Patients with RT less frequently had severe left ventricular dysfunction compared with dialysis and CKD groups (6.7% vs 14% and 8.5%); however more, often presented with acute coronary syndrome (58% vs 52% and 48%), especially STEMI (all p<0.001). Patients with RT and CKD had lower rates of 30-day MACCE (4.4% and 6.8% vs 11.6%, p<0.001) than the dialysis group. Three-year survival was similar between RT and CKD groups, however was lower in the dialysis group (80% and 83% vs 60%, p<0.001). After adjustment, dialysis was an independent predictor of 30-day MACCE (odds ratio [OR] 1.90, 95% confidence interval [CI] 1.44‒2.50, p<0.001), however RT was not (OR 0.91, CI 0.42‒1.96, p=0.802). Both RT (hazard ratio [HR] 2.07, CI 1.46‒2.95, p<0.001) and dialysis (HR 1.35, CI 1.02‒1.80, p=0.036) heightened the hazard of long-term mortality. CONCLUSIONS: RT recipients have more favourable clinical outcomes following PCI compared with patients on dialysis. However, despite having similar short-term outcomes to patients with CKD, the hazard of long-term mortality is significantly greater for RT recipients.

No-Reflow Prediction in Acute Coronary Syndrome During Percutaneous Coronary Intervention: The NORPACS Risk Score.

BACKGROUND: Suboptimal coronary reperfusion (no reflow) is common in acute coronary syndrome percutaneous coronary intervention (PCI) and is associated with poor outcomes. We aimed to develop and externally validate a clinical risk score for angiographic no reflow for use following angiography and before PCI. METHODS: We developed and externally validated a logistic regression model for prediction of no reflow among adult patients undergoing PCI for acute coronary syndrome using data from the Melbourne Interventional Group PCI registry (2005-2020; development cohort) and the British Cardiovascular Interventional Society PCI registry (2006-2020; external validation cohort). RESULTS: A total of 30 561 patients (mean age, 64.1 years; 24% women) were included in the Melbourne Interventional Group development cohort and 440 256 patients (mean age, 64.9 years; 27% women) in the British Cardiovascular Interventional Society external validation cohort. The primary outcome (no reflow) occurred in 4.1% (1249 patients) and 9.4% (41 222 patients) of the development and validation cohorts, respectively. From 33 candidate predictor variables, 6 final variables were selected by an adaptive least absolute shrinkage and selection operator regression model for inclusion (cardiogenic shock, ST-segment-elevation myocardial infarction with symptom onset >195 minutes pre-PCI, estimated stent length ≥20 mm, vessel diameter <2.5 mm, pre-PCI Thrombolysis in Myocardial Infarction flow <3, and lesion location). Model discrimination was very good (development C statistic, 0.808; validation C statistic, 0.741) with excellent calibration. Patients with a score of ≥8 points had a 22% and 27% risk of no reflow in the development and validation cohorts, respectively. CONCLUSIONS: The no-reflow prediction in acute coronary syndrome risk score is a simple count-based scoring system based on 6 parameters available before PCI to predict the risk of no reflow. This score could be useful in guiding preventative treatment and future trials.

Electrocardiographic patterns and clinical outcomes of acute coronary syndrome cardiogenic shock in patients undergoing percutaneous coronary intervention - A propensity score analysis.

OBJECTIVES: To determine the influence of presenting electrocardiographic (ECG) changes on prognosis in acute coronary syndrome cardiogenic shock (ACS-CS) patients undergoing percutaneous coronary angiography (PCI). BACKGROUND: The effect of initial ECG changes such as ST-elevation myocardial infarction (STEMI) versus non-STEMI among patients ACS-CS on prognosis remains unclear. METHODS: We analysed data from consecutive patients with ACS-CS enrolled in the Victorian Cardiac Outcomes registry between 2014 and 2020. Inverse probability of treatment weighting analysis (IPTW) was used to assess the effect of ECG changes on 30-day mortality. RESULTS: Of 1564 patients with ACS-CS who underwent PCI, 161 had non-STEMI and 1403 had STEMI on ECG. The mean age was 66 ± 13 years, and 74 % (1152) were males. Patients with non-STEMI compared to STEMI were older (70 ± 12 vs 65 ± 13 years), had higher rates of diabetes (34 % vs 21 %), prior coronary artery bypass graft surgery (14 % vs 3.3 %), peripheral arterial disease (10.6 % vs 4.1 %, p < 0.01), and lower baseline eGFR (53.8 [37.1, 75.4] vs 65.3 [46.3, 87.8] ml/min/1.73m2), all p ≤ 0.01. Non-STEMI patients were more likely to have a culprit left circumflex artery (29 % vs 20 %) and more often underwent multivessel percutaneous coronary intervention (30 % vs 20 %) but had lower rates of out-of-hospital cardiac arrest (21 % vs 39 %), all p ≤ 0.01. Propensity score analysis with IPTW confirmed that non-STEMI ECG was associated with lower odds for 30-day all-cause mortality (OR 0.47 [0.32, 0.69], p < 0.001), and 30-day major adverse cardiovascular and cerebrovascular events (OR 0.48 [0.33, 0.70]). CONCLUSIONS: In patients undergoing PCI, Non-STEMI as compared to STEMI on index ECG was associated with approximately half the relative risk of both 30-day mortality and 30-day MACCE and could be a useful variable to integrate in ACS-CS risk scores.

Comparison of Characteristics and Outcomes in Patients With Acute Decompensated Heart Failure Admitted Under General Medicine and Cardiology Units.

BACKGROUND: Acute decompensated heart failure (ADHF) is a leading cause of cardiovascular disease hospitalisations associated with significant morbidity and mortality. In hospitals, HF patients are typically managed by cardiology or physician teams, with differences in patient demographics and clinical outcomes. This study utilises contemporary HF registry data to compare patient characteristics and outcomes in those with ADHF admitted into General Medicine and Cardiology units. METHODS: The Victorian Cardiac Outcomes Registry was utilised to identify patients hospitalised with ADHF 30-day period in each of four consecutive years. We compared patient characteristics, pharmacological management and outpatient follow-up of patients admitted to General Medicine and Cardiology units. Primary outcome measures included in-hospital mortality, 30-day readmission, and 30-day mortality. RESULTS: Between 2014 and 2017, a total of 1,253 patients with ADHF admissions were registered, with 53% admitted in General Medicine units and 47% in Cardiology units. General Medicine patients were more likely to be older (82 vs 71 years; p<0.001), female (51% vs 34%; p<0.001), and have higher prevalence of comorbidities and preserved left ventricular function (p<0.001). There were no differences in primary outcome measures between General Medicine and Cardiology in terms of: in-hospital mortality (5.0% vs 3.9%; p=0.35), 30-day readmission (23.4% vs 23.6%; p=0.93), and 30-day mortality (10.0% vs 8.0%; p=0.21). CONCLUSIONS: Hospitalised patients with HF continue to have high mortality and rehospitalisation rates. The choice of treatment by General Medicine or Cardiology units, based on the particular medical profile and individual needs of the patients, provides equivalent outcomes.

Associations Between Metabolic Syndrome and Long-Term Mortality in Patients who underwent Percutaneous Coronary Intervention: An Australian Cohort Analysis.

Metabolic syndrome (MetS) provides significant risk for coronary disease, however long-term prognosis after percutaneous coronary intervention (PCI) has been understudied. We assessed the prevalence and outcomes of patients with MetS from an Australian PCI cohort. We retrospectively examined data from the Melbourne Interventional Group multicenter PCI registry using a modified definition for MetS including ≥3 of the following: hypertension, diabetes mellitus, dyslipidemia, and body mass index ≥30 kg/m2. Thirty-day outcomes and long-term mortality were compared with patients without MetS. Cox regression methods were used to assess the multivariable effect of MetS on long-term mortality. Of 41,146 patients, 12,228 (34%) had MetS. Patients with MetS experienced greater 30-day myocardial infarction (2.2% vs 1.8%, p = 0.013), whereas patients without MetS had a trend for greater 30-day mortality (3.0% vs 3.4%, p = 0.051) and greater in-hospital major bleeding (1.7% vs 2.4%, p <0.001). After a median follow-up of 5.62 years (Q1 2.03, Q3 8.89), patients with MetS experienced greater mortality (24% vs 19%, p <0.001). After adjustment, MetS was not an independent predictor of long-term mortality (hazard ratio 0.95 confidence interval 0.86 to 1.05, p = 0.35). In sensitivity analyses, MetS-Diabetic patients had the highest, and MetS-NonDiabetic obese patients had the lowest long-term mortality. One in 3 patients who underwent all-comer PCI presented with MetS and experienced greater long-term mortality compared with others. However, this association was lost after adjustment for baseline confounders, highlighting that MetS is a marker of risk after PCI. Our findings support the obesity paradox and confirm robust associations between diabetes mellitus and long-term mortality.

Real-world long-term survival after non-emergent percutaneous coronary intervention to unprotected left main coronary artery - From the Melbourne Interventional Group (MIG) registry.

BACKGROUND: Current evidence suggests that percutaneous coronary intervention for unprotected left main coronary artery disease (LMPCI) in selected patients is a safe alternative to coronary artery bypass grafting. However, real-world long-term survival data is limited. METHODS: We analyzed 24,644 patients from the MIG (Melbourne Interventional Group) registry between 2005 and 2020. We compared baseline clinical and procedural characteristics, in-hospital and 30-day outcomes, and long-term survival between unprotected LMPCI and non-LMPCI among patients without ST-segment elevation myocardial infarction, cardiogenic shock, or cardiac arrest. RESULTS: Unprotected LMPCI patients (n = 185) were significantly older (mean age 72.0 vs. 64.6 years, p < 0.001), had higher prevalence of impaired ejection fraction (EF <50 %; 27.3 % vs. 14.9 %, p < 0.001) and lower estimated glomerular filtration rate < 60 ml/min/1.73m2 (40.9 % vs. 21.5 %, p < 0.001), and had greater use of intravascular ultrasound (21 % vs. 1 %, p < 0.001) and drug-eluting stents (p < 0.001). LMPCI was associated with longer hospital stay (4 days vs. 2 days, p < 0.001). There was no significant difference in other in-hospital outcomes, 30-day mortality (0.6 % vs. 0.6 %, p = 0.90), and major adverse cardiac events (1.7 % vs. 3 %, p = 0.28). Although the unadjusted Kaplan-Meier survival to 8 years was significantly less with LMPCI compared to non-LMPCI (p < 0.01), LMPCI was not a predictor of long-term survival up to 8 years after Cox regression analysis (HR 0.67, 95 % CI 0.40-1.13, p = 0.13). CONCLUSION: In this study, non-emergent unprotected LMPCI was uncommonly performed, and IVUS was underutilized. Despite greater co-morbidities, LMPCI patients had comparable 30-day outcomes to non-LMPCI, and LMPCI was not an independent predictor of long-term mortality.

Sex Differences in Pharmacotherapy and Long-Term Outcomes in Patients With Ischaemic Heart Disease and Comorbid Left Ventricular Dysfunction.

BACKGROUND: Left ventricular (LV) dysfunction and ischaemic heart disease (IHD) are common among women. However, women tend to present later and are less likely to receive guideline-directed medical therapy (GDMT) compared with men. METHODS: We analysed prospectively collected data (2005-2018) from a multicentre registry on GDMT 30 days after percutaneous coronary intervention in 13,015 patients with LV ejection fraction <50%. Guideline-directed medical therapy was defined as beta blocker, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker±mineralocorticoid receptor antagonist. Long-term mortality was determined by linkage with the Australian National Death Index. RESULTS: Women represented 20% (2,634) of the total cohort. Mean age was 65±12 years. Women were on average >5 years, with higher body mass index and higher rates of hypertension, diabetes, renal dysfunction, prior stroke, and rheumatoid arthritis. Guideline-directed medical therapy was similar between sexes (73% vs 72%; p=0.58), although women were less likely to be on an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (80% vs 82%; p=0.02). Women were less likely to be on statin therapy (p<0.001) or a second antiplatelet agent (p=0.007). Women had higher unadjusted long-term mortality (25% vs 19%; p<0.001); however, there were no differences in long-term mortality between sexes on adjusted analysis (hazard ratio 0.99; 95% confidence interval 0.87-1.14; p=0.94). CONCLUSIONS: Rates of GDMT for LV dysfunction were high and similar between sexes; however, women were less likely to be on appropriate IHD secondary prevention. The increased unadjusted long-term mortality in women was attenuated in adjusted analysis, which highlights the need for optimisation of baseline risk to improve long-term outcomes of women with IHD and comorbid LV dysfunction.

Natural History and Clinical Outcomes After ST-Segment Elevation Myocardial Infarction Without Stent Insertion.

After restoration of coronary perfusion in patients presenting with ST-segment elevation myocardial infarction (STEMI), discrete severe stenotic coronary lesions are not always apparent. There remains ambiguity whether drug-eluting stent (DES) insertion or initial medical management is best practice. We sought to assess short-term clinical outcomes in patients presenting with STEMI without initial stent insertion. Patients who underwent percutaneous coronary intervention for STEMI between 2014 and 2020 were prospectively enrolled and assessed for inclusion. Patients presenting with in-stent restenosis or stent thrombosis, or who did not survive to hospital discharge were excluded. Of 13,871 patients presenting, 456 (3.3%) were treated without initial stenting. These patients were older than those treated with DES (66.1 ± 13.6 vs 62.3 ± 12.4 years, p <0.001), had higher rates of diabetes (23.5% vs 16.0%, p <0.001) and previous revascularization with either percutaneous coronary intervention (14.0% vs 7.3%, p <0.001) or coronary artery bypass graft (3.5% vs 1.8%, p = 0.008). Thirty-day mortality was elevated in patients treated without stenting compared to those receiving DES (4.2% vs 0.9%, p <0.001), as were rates of myocardial infarction (1.3% vs 0.5%, p = 0.026) and major adverse cardiac events (10.5% vs 2.4%, p <0.001). After propensity matching, a trend toward increased mortality remained (4.2% vs 2.0%, p = 0.055). In conclusion, a no-stenting initial strategy, compared with DES insertion, is associated with increased 30-day mortality in those presenting with STEMI without severe stenosis. These data suggest when appropriate, current-generation DES insertion should be undertaken.

Impact of Preprocedural Diastolic Blood Pressure on Outcomes in Patients Undergoing Percutaneous Coronary Intervention.

BACKGROUND: Recent US guidelines recommend lower blood pressure (BP) targets in hypertension, but aggressive lowering of diastolic BP (DBP) can occur at the expense of myocardial perfusion, particularly in the presence of coronary artery disease. We sought to establish the long-term impact of low DBP on mortality among patients undergoing percutaneous coronary intervention with well-controlled systolic BP. METHODS: We analyzed data from 12 965 patients undergoing percutaneous coronary intervention between 2009 and 2018 from the Melbourne Interventional Group registry who had a preprocedural systolic BP of ≤140 mm Hg. Patients with ST-elevation myocardial infarction, cardiogenic shock, and out-of-hospital arrest were excluded. Patients were stratified into 5 groups according to preprocedural DBP: <50, 50 to 59, 60 to 69, 70 to 79, and ≥80 mm Hg. The primary outcome was long-term, all-cause mortality. Mortality data were derived from the Australian National Death Index. RESULTS: Patients with DBP<50 mm Hg were older with higher rates of diabetes, renal impairment, prior myocardial infarction, left ventricular dysfunction, peripheral and cerebrovascular disease (all P<0.001). Patients with DBP<50 mm Hg had higher 30-day (2.5% versus 0.7% for the other 4 quintiles; P<0.0001) and long-term mortality (median, 3.6 years; follow-up, 29% versus 11%; P<0.0001). Cox-regression analysis revealed that DBP<50 mm Hg was an independent predictor of long-term mortality (hazard ratio [HR], 1.55 [95% CI, 1.20-2.00]; P=0.001). CONCLUSIONS: In patients with well-controlled systolic BP undergoing percutaneous coronary intervention, low DBP (<50 mm Hg) is an independent predictor of long-term mortality.

Effect of Concomitant Cardiac Arrest on Outcomes in Patients With Acute Coronary Syndrome-Related Cardiogenic Shock.

Patients with acute coronary syndrome (ACS)-related cardiogenic shock (CS) with or without concomitant CA may have disparate prognoses. We compared clinical characteristics and outcomes of patients with CS secondary to ACS with and without cardiac arrest (CA). Between 2014 and 2020, 1,573 patients with ACS-related CS with or without CA who underwent percutaneous coronary intervention enrolled in a multicenter Australian registry were analyzed. Primary outcome was 30-day major adverse cardiovascular and cerebrovascular events (MACCE) (composite of mortality, myocardial infarction, stent thrombosis, target vessel revascularization and stroke). Long-term mortality was obtained through linkage to the National Death Index. Compared with the no-CA group (n = 769, 49%), the CA group (n = 804, 51%) was younger (62 vs 69 years, p <0.001) and had fewer comorbidities. Patients with CA more frequently had ST-elevation myocardial infarction (92% vs 86%), occluded left anterior descending artery (43% vs 33%), and severe preprocedural renal impairment (49% vs 42%) (all p <0.001). CA increased risk of 30-day MACCE by 45% (odds ratio 1.45, 95% confidence interval 1.05 to 2.00, p = 0.024) after adjustment. CA group had higher 30-day MACCE (55% vs 42%, p <0.001) and mortality (52% vs 37%, p <0.001). Three-year survival was lower for CA compared with no-CA patients (43% vs 52%, p <0.001). In Cox regression, CS with CA was associated with a trend toward greater long-term mortality hazard (hazard ratio 1.19, 95% confidence interval 1.00 to 1.41, p = 0.055). In conclusion, concomitant CA among patients with ACS-related CS conferred a particularly heightened short-term risk with a diminishing legacy effect over time for mortality. CS survivors continue to exhibit high sustained long-term mortality hazard regardless of CA status.

Estimating the cost-effectiveness and return on investment of the Victorian Cardiac Outcomes Registry in Australia: a minimum threshold analysis.

OBJECTIVES: We sought to establish the minimum level of clinical benefit attributable to the Victorian Cardiac Outcomes Registry (VCOR) for the registry to be cost-effective. DESIGN: A modelled cost-effectiveness study of VCOR was conducted from the Australian healthcare system and societal perspectives. SETTING: Observed deaths and costs attributed to coronary heart disease (CHD) over a 5-year period (2014-2018) were compared with deaths and costs arising from a hypothetical situation which assumed that VCOR did not exist. Data from the Australian Bureau of Statistics and published sources were used to construct a decision analytic life table model to simulate the follow-up of Victorians aged ≥25 years for 5 years, or until death. The assumed contribution of VCOR to the proportional change in CHD mortality trend observed over the study period was varied to quantify the minimum level of clinical benefits required for the registry to be cost-effective. The marginal costs of VCOR operation and years of life saved (YoLS) were estimated. PRIMARY OUTCOME MEASURES: The return on investment (ROI) ratio and the incremental cost-effectiveness ratio (ICER). RESULTS: The minimum proportional change in CHD mortality attributed to VCOR required for the registry to be considered cost-effective was 0.125%. Assuming this clinical benefit, a net return of $A4.30 for every dollar invested in VCOR was estimated (ROI ratio over 5 years: 4.3 (95% CI 3.6 to 5.0)). The ICER estimated for VCOR was $A49 616 (95% CI $A42 228 to $A59 608) per YoLS. Sensitivity analyses found that the model was sensitive to the time horizon assumed and the extent of registry contribution to CHD mortality trends. CONCLUSIONS: VCOR is likely cost-effective and represents a sound investment for the Victorian healthcare system. Our evaluation highlights the value of clinical quality registries in Australia.

Characteristics of Radial Artery Coronary Bypass Graft Failure and Outcomes Following Subsequent Percutaneous Coronary Intervention.

BACKGROUND: When patients with prior coronary artery bypass grafting (CABG) undergo percutaneous coronary intervention (PCI), targeting the native vessel is preferred. Studies informing such recommendations are based predominantly on saphenous vein graft (SVG) PCI. There are few data regarding arterial graft intervention, particularly to a radial artery (RA) graft. OBJECTIVES: The aim of this study was to report the characteristics of arterial graft stenoses and evaluate the feasibility of RA PCI. METHODS: This study included 2,780 consecutive patients with prior CABG undergoing PCI between 2005 and 2018 who were prospectively enrolled in the MIG (Melbourne Interventional Group) registry. Data were stratified by PCI target vessel. RA graft PCI was compared with both native vessel (native PCI) and SVG PCI. Internal mammary graft PCI data were reported. The primary outcome was 3-year mortality. RESULTS: Overall, 1,928 patients (69.4%) underwent native PCI, 716 (25.6%) SVG PCI, 86 (3.1%) RA PCI, and 50 (1.8%) internal mammary graft PCI. Compared with SVG PCI, the RA PCI cohort presented earlier after CABG, less frequently had acute coronary syndrome, and more commonly had ostial or distal anastomosis intervention (P < 0.005 for all). Compared with patients who underwent native PCI, those who underwent RA PCI were more likely to have diabetes and peripheral vascular disease (P < 0.001 for both) and to present with non-ST-segment elevation myocardial infarction (P = 0.010). The RA PCI group had no perforations or in-hospital myocardial infarctions, though no significant difference was found in periprocedural outcomes compared with either native or SVG PCI. No differences were found between RA PCI and either native or SVG PCI in 30-day outcomes or 3-year mortality. CONCLUSIONS: Presenting and lesion characteristics differed between patients undergoing arterial compared with SVG PCI, implying a varied pathogenesis of graft stenosis. RA PCI appears feasible, safe, and where anatomically suitable, may be a viable alternative to native PCI.

Trends in Intra-Aortic Balloon Pump Use in Cardiogenic Shock After the SHOCK-II Trial.

Myocardial infarction complicated by cardiogenic shock (MI-CS) has a poor prognosis, even with early revascularization. Previously, intra-aortic balloon pump (IABP) use was thought to improve outcomes, but the IABP-SHOCK-II (Intra-aortic Balloon Pump in Cardiogenic Shock-II study) trial found no survival benefit. We aimed to determine the trends in IABP use in patients who underwent percutaneous intervention over time. Data were taken from patients in the Melbourne Interventional Group registry (2005 to 2018) with MI-CS who underwent percutaneous intervention. The primary outcome was the trend in IABP use over time. The secondary outcomes included 30-day mortality and major adverse cardiovascular and cerebrovascular events (MACCEs). Of the 1,110 patients with MI-CS, IABP was used in 478 patients (43%). IABP was used more in patients with left main/left anterior descending culprit lesions (62% vs 46%), lower ejection fraction (<35%; 18% vs 11%), and preprocedural inotrope use (81% vs 73%, all p <0.05). IABP use was associated with higher bleeding (18% vs 13%) and 30-day MACCE (58% vs 51%, both p <0.05). The rate of MI-CS per year increased over time; however, after 2012, there was a decrease in IABP use (p <0.001). IABP use was a predictor of 30-day MACCE (odds ratio 1.6, 95% confidence interval 1.18 to 2.29, p = 0.003). However, IABP was not associated with in-hospital, 30-day, or long-term mortality (45% vs 47%, p = 0.44; 46% vs 50%, p = 0.25; 60% vs 62%, p = 0.39). In conclusion, IABP was not associated with reduced short- or long-term mortality and was associated with increased short-term adverse events. IABP use is decreasing but is predominately used in sicker patients with greater myocardium at risk.

Harmonising Individual Patient Level Cardiac Registry Data Across the Asia Pacific Region-A Feasibility Study of In-Hospital Outcomes of STEMI Patients From the Asia Pacific Evaluation of Cardiovascular Therapies (ASPECT) Network.

OBJECTIVE: The Asia-Pacific Evaluation of Cardiovascular Therapies (ASPECT) collaboration was established to inform on percutaneous coronary intervention (PCI) in the Asia-Pacific Region. Our aims were to (i) determine the operational requirements to assemble an international individual patient dataset and validate the processes of governance, data quality and data security, and subsequently (ii) describe the characteristics and outcomes for ST-elevation myocardial infarction (STEMI) patients undergoing PCI in the ASPECT registry. METHODS: Seven (7) ASPECT members were approached to provide a harmonised anonymised dataset from their local registry. Patient characteristics were summarised and associations between the characteristics and in-hospital outcomes for STEMI patients were analysed. RESULTS: Six (6) participating sites (86%) provided governance approvals for the collation of individual anonymised patient data from 2015 to 2017. Five (5) sites (83%) provided >90% of agreed data elements and 68% of the collated elements had <10% missingness. From the registry (n=12,620), 84% were male. The mean age was 59.2±12.3 years. The Malaysian cohort had a high prevalence of previous myocardial infarction (34%), almost twice that of any other sites (p<0.001). Adverse in-hospital outcomes were the lowest in Hong Kong whilst in-hospital mortality varied from 2.7% in Vietnam to 7.9% in Singapore. CONCLUSIONS: Governance approvals for the collation of individual patient anonymised data was achieved with a high level of data alignment. Secure data transfer process and repository were established. Patient characteristics and presentation varied significantly across the Asia-Pacific region with this likely to be a major predictor of variations in the clinical outcomes observed across the region.

Temporal Change in the Remaining Life Expectancy in People Who Underwent Percutaneous Coronary Intervention.

Whether percutaneous coronary intervention (PCI) is effective in improving long-term survival in an Australian PCI cohort remains unclear. We aimed to examine the change in the remaining life expectancy for patients who underwent PCI over the past decade. Patient data from the Melbourne Interventional Group were divided into four 3-year periods (2005 to 2007, 2008 to 2010, 2011 to 2013, and 2014 to 2016) for survival analysis. The primary outcome was time to death after PCI. Kaplan-Meier survival curves for overall survival were constructed to estimate the 5-year survival. To extrapolate the overall survival curve to the lifetime time horizon, 6 parametric survival distributions were fitted to the individual patient-level data against the Kaplan-Meier curve. The best fit distribution was selected based on goodness-of-fit statistics and expert opinion. The combination of annual mortality post-PCI from the parametric survival analysis and the background mortality by age informed the overall mortality rate. The life expectancy was compared with the general Australians. In addition, the utility weight of post-PCI patients was used to estimate the quality-adjusted life years gained. A total of 27,301 patients with a mean age of 64.4 ± 12 years were included. The base-case results showed that over the 4 time periods, the remaining life expectancy for patients aged 64.4 years on average at the time of PCI remained relatively stable except for period 4: 18.12 years (2005 to 2007), 17.56 years (2008 to 2010), 18.39 years (2011 to 2013), and 17.25 years (2014 to 2016), respectively. The quality-adjusted life years gained showed a similar trend: 14.86 (2005 to 2007), 14.40 (2008 to 2010), 15.07 (2011 to 2013), and 14.13 (2014 to 2016) separately. In conclusion, the widened gap in life expectancy in post-PCI patients versus the general Australian over the 2014 to 2016 period suggests the need for improved implementation of prevention strategies for coronary heart disease. Enhanced disease management after PCI that lowers residual mortality risk is recommended to extend the survival of patients with coronary heart disease.

LidocAine Versus Opioids In MyocarDial infarction: the AVOID-2 randomized controlled trial.

AIMS: Opioid analgesia has been shown to interfere with the bioavailability of oral P2Y12 inhibitors prompting the search for safe and effective non-opioid analgesics to treat ischaemic chest pain. METHODS AND RESULTS: The lidocAine Versus Opioids In MyocarDial infarction trial was a prospective, Phase II, prehospital, open-label, non-inferiority, randomized controlled trial enrolling patients with suspected STEACS with moderate to severe pain [numerical rating scale (NRS) at least 5/10]. Intravenous lidocaine (maximum dose 300 mg) or intravenous fentanyl (up to 50 µg every 5 min) were administered as prehospital analgesia. The co-primary end points were prehospital pain reduction and adverse events requiring intervention. Secondary end points included peak cardiac troponin I, cardiac MRI (cMRI) assessed myocardial infarct size and clinical outcomes to 30 days. A total of 308 patients were enrolled. The median reduction in pain score (NRS) was 4 vs. 3 in the fentanyl and lidocaine arms, respectively, for the primary efficacy end point [estimated median difference -1 (95% confidence interval -1.58, -0.42, P = 0.5 for non-inferiority, P = 0.001 for inferiority of lidocaine)]. Adverse events requiring intervention occurred in 49% vs. 36% of the fentanyl and lidocaine arms which met non-inferiority and superiority favouring lidocaine (P = 0.016 for superiority). No significant differences in myocardial infarct size and clinical outcomes at 30 days were seen. CONCLUSION: IV Lidocaine did not meet the criteria for non-inferiority with lower prehospital pain reduction than fentanyl but was safe and better tolerated as analgesia in ST-elevation myocardial infarction (STEMI). Future trials testing non-opioid analgesics in STEMI and whether opioid avoidance improves clinical outcomes are needed. TRIAL REGISTRATION: CTRN12619001521112p.

Impact of prehospital opioid dose on angiographic and clinical outcomes in acute coronary syndromes.

BACKGROUND: An adverse interaction whereby opioids impair and delay the gastrointestinal absorption of oral P2Y12 inhibitors has been established, however the clinical significance of this in acute coronary syndrome (ACS) is uncertain. We sought to characterise the relationship between prehospital opioid dose and clinical outcomes in patients with ACS. METHODS: Patients given opioid treatment by emergency medical services (EMS) with ACS who underwent percutaneous coronary intervention (PCI) between 1 January 2014 and 31 December 2018 were included in this retrospective cohort analysis using data linkage between the Ambulance Victoria, Victorian Cardiac Outcomes Registry and Melbourne Interventional Group databases. Patients with cardiogenic shock, out-of-hospital cardiac arrest and fibrinolysis were excluded. The primary end point was the risk-adjusted odds of 30-day major adverse cardiac events (MACE) between patients who received opioids and those that did not. RESULTS: 10 531 patients were included in the primary analysis. There was no significant difference in 30-day MACE between patients receiving opioids and those who did not after adjusting for key patient and clinical factors. Among patients with ST-elevation myocardial infarction (STEMI), there were significantly more patients with thrombolysis in myocardial infarction (TIMI) 0 or 1 flow pre-PCI in a subset of patients with high opioid dose versus no opioids (56% vs 25%, p<0.001). This remained significant after adjusting for known confounders with a higher predicted probability of TIMI 0/1 flow in the high versus no opioid groups (33% vs 11%, p<0.001). CONCLUSIONS: Opioid use was not associated with 30-day MACE. There were higher rates of TIMI 0/1 flow pre-PCI in patients with STEMI prescribed opioids. Future prospective research is required to verify these findings and investigate alternative analgesia for ischaemic chest pain.