Percutaneous coronary intervention outcomes based on American College of Cardiology/American Heart Association coronary lesion classification over 14 years - Melbourne interventional group (MIG) registry.

BACKGROUND: The American College of Cardiology / American Heart Association (ACC/AHA) introduced a coronary lesion classification in 1988 to stratify coronary lesions for probability of procedural success and complications after coronary angioplasty. Our aim is to assess the validity of the ACC/AHA lesion classification in predicting outcomes of percutaneous coronary intervention (PCI) in a contemporary cohort of patients. METHODS: Consecutive PCI procedures performed between 2005 and 2018, were divided into three periods. At each period, the ACC/AHA lesion classification (A, B1, B2, C) was analysed with respect to procedural characteristics, in-hospital and 30-day outcomes, as well as long-term mortality by linkage to the National Death Index (NDI). RESULTS: In total, 21,437 lesions were included with 7399 lesions (2005-2009), 6917 lesions (2010-2014) and 7121 lesions (2015-2018). There was a progressive increase in the number of complex lesions treated over time with ACC/AHA type C (15 %, 21 % and 26 %, p < 0.01). The rate of PCI procedural success decreased with increase in the complexity of lesions treated across all three periods (p < 0.01). Further, in-hospital and 30-day major adverse cardiovascular events (MACE), major adverse cardiac and cerebrovascular events (MACCE) increased across all three time periods (all p < 0.05). CONCLUSIONS: Our study validates the ACC/AHA lesion classification as a meaningful tool for prediction of PCI outcomes. Despite advances in PCI techniques and technology, complex lesion PCI defined by this classification continues to be associated with adverse outcomes.

Prevalence and outcomes of patients with SMuRF-less acute coronary syndrome undergoing percutaneous coronary intervention.

BACKGROUND: There is increasing awareness that patients without standard modifiable risk factors (SMuRFs; diabetes, hypercholesterolaemia, hypertension and smoking) may represent a unique subset of patients with acute coronary syndrome (ACS). We aimed to investigate the prevalence and outcomes of patients with SMuRF-less ACS undergoing percutaneous coronary intervention (PCI) compared with those with SMuRFs. METHODS: We analysed data from the Melbourne Interventional Group PCI Registry. Patients with coronary artery disease were excluded. The primary outcome was 30-day mortality. Secondary outcomes included in-hospital and 30-day events. Long-term mortality was investigated using Cox-proportional hazards regression. RESULTS: From 1 January 2005 to 31 December 2020, 2727/18 988 (14.4%) patients were SMuRF less, with the proportion increasing over time. Mean age was similar for patients with and without SMuRFs (63 years), and fewer females were SMuRF-less (19.8% vs 25.4%, p<0.001). SMuRF-less patients were more likely to present with cardiac arrest (6.6% vs 3.9%, p<0.001) and ST-elevation myocardial infarction (59.1% vs 50.8%, p<0.001) and were more likely to experience postprocedural cardiogenic shock (4.5% vs 3.6%, p=0.019) and arrhythmia (11.2% vs 9.9%, p=0.029). At 30 days, mortality, myocardial infarction, revascularisation and major adverse cardiac and cerebrovascular events did not differ between the groups. During median follow-up of 7 years, SMuRF-less patients had an adjusted 13% decreased rate of mortality (HR 0.87 (95% CI 0.78 to 0.97)). CONCLUSIONS: The proportion of SMuRF-less patients increased over time. Presentation was more often a devastating cardiac event compared with those with SMuRFs. No difference in 30-day outcomes was observed and SMuRF-less patients had lower hazard for long-term mortality.

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.

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.

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.

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.

Sex disparity in secondary prevention pharmacotherapy and clinical outcomes following acute coronary syndrome.

AIMS: We sought to investigate if sex disparity exists for secondary prevention pharmacotherapy following acute coronary syndrome (ACS) and impact on long-term clinical outcomes. METHODS AND RESULTS: We analysed data on medical management 30-day post-percutaneous coronary intervention (PCI) for ACS in 20 976 patients within the multicentre Melbourne Interventional Group registry (2005-2017). Optimal medical therapy (OMT) was defined as five guideline-recommended medications, near-optimal medical therapy (NMT) as four medications, sub-optimal medical therapy (SMT) as ≤3 medications. Overall, 65% of patients received OMT, 27% NMT and 8% SMT. Mean age was 64 ± 12 years; 24% (4931) were female. Women were older (68 ± 12 vs. 62 ± 12 years) and had more comorbidities. Women were less likely to receive OMT (61% vs. 66%) and more likely to receive SMT (10% vs. 8%) compared to men, P < 0.001. On long-term follow-up (median 5 years, interquartile range 2-8 years), women had higher unadjusted mortality (20% vs. 13%, P < 0.001). However, after adjusting for medical therapy and baseline risk, women had lower long-term mortality [hazard ratio (HR) 0.88, 95% confidence interval (CI) 0.79-0.98; P = 0.02]. NMT (HR 1.17, 95% CI 1.05-1.31; P = 0.004) and SMT (HR 1.79, 95% CI 1.55-2.07; P < 0.001) were found to be independent predictors of long-term mortality. CONCLUSION: Women are less likely to be prescribed optimal secondary prevention medications following PCI for ACS. Lower adjusted long-term mortality amongst women suggests that as well as baseline differences between gender, optimization of secondary prevention medical therapy amongst women can lead to improved outcomes. This highlights the need to focus on minimizing the gap in secondary prevention pharmacotherapy between sexes following ACS.

Long-term mortality in asymptomatic patients with stable ischemic heart disease undergoing percutaneous coronary intervention.

OBJECTIVES: Patients with stable ischemic heart disease (SIHD) may present with a variety of symptoms including typical angina, angina equivalents such as dyspnea or no symptoms. We sought to determine whether symptom status affects periprocedural safety and long-term mortality in patients undergoing PCI. METHODS: Prospectively enrolled consecutive patients undergoing PCI for SIHD at six hospitals in Australia between 2005 to 2018 as part of the Melbourne Interventional Group registry. Symptom status was recorded at the time of PCI and patients undergoing staged PCI were excluded. RESULTS: Overall, 11,730 patients with SIHD were followed up for a median period of 5 years (maximum 14.0 years, interquartile range 2.2-9.0 years) with 1,317 (11.2%) being asymptomatic. Asymptomatic patients were older, and more likely to be male, have triple-vessel disease, with multiple comorbidities including renal failure, diabetes and heart failure (all P < .01). These patients had significantly higher rates of periprocedural complications and major adverse cardiovascular events at 30-days. Long-term mortality was significantly higher in asymptomatic patients (27.2% vs 18.0%, P < .001). On cox regression for long-term mortality, after adjustment for more important clinical variables, asymptomatic status was an independent predictor (Hazard ratio (HR) 1.39 95% CI 1.16-1.66, P < .001). CONCLUSIONS: In a real-world cohort of patients undergoing revascularization for SIHD, absence of symptoms was associated with higher rates of periprocedural complications and, after adjustment for more important clinical variables, was an independent predictor of long-term mortality. As the primary goal of revascularization in SIHD remains angina relief, the appropriateness of PCI in the absence of symptoms warrants justification.

Differences in outcome of percutaneous coronary intervention between Indigenous and non-Indigenous people in Victoria, Australia: a multicentre, prospective, observational, cohort study.

BACKGROUND: Data on the patient characteristics and health outcomes of Indigenous Australians having revascularisation for treatment of coronary artery disease are scarce. The aim of this study was to assess differences in patient characteristics, presentations, and outcomes among Indigenous and non-Indigenous Australians having percutaneous coronary intervention (PCI) in urban and larger regional centres in Victoria, Australia. METHODS: In this multicentre, prospective, observational cohort study, data were prospectively collected from six government-funded tertiary hospitals in the state of Victoria, Australia. The Melbourne Interventional Group PCI registry was used to identify patients having PCI at Victorian metropolitan and large regional hospitals between Jan 1, 2005, and Dec 31, 2018. The primary outcome was long-term mortality. Secondary outcomes were 30 day mortality and 30 day major adverse cardiovascular events (MACE), defined as a composite endpoint of death, myocardial infarction, and target-vessel revascularisation. Regression analyses, adjusted for clinically relevant covariates and geographical and socioeconomic indices, were used to establish the influence of Indigenous status on these study outcomes. FINDINGS: 41 146 patient procedures were entered into the registry, of whom 179 (0·4%) were recorded as identifying as Indigenous Australian, 39 855 (96·9%) were not Indigenous Australian, and 1112 (2·7%) had incomplete data regarding ethnicity and were excluded. Compared with their non-Indigenous counterparts, Indigenous patients were younger, more often women, and more likely to have comorbidities. Indigenous Australians were also more likely to live in a regional community and areas of socioeconomic disadvantage. Procedural success and complication rates were similar for Indigenous and non-Indigenous patients having PCI. At 30 day follow-up, Indigenous Australians were more likely to be taking optimal medical therapy, although overall follow-up rates were lower and prevalence of persistent smoking was higher. Multivariable analysis showed that Indigenous status was independently associated with increased risk of long-term mortality (hazard ratio 2·49, 95% CI 1·79-3·48; p<0·0001), 30 day mortality (odds ratio 2·78, 95% CI 1·09-7·12; p=0·033), and 30-day MACE (odds ratio 1·87, 95% CI 1·03-3·39; p=0·039). INTERPRETATION: Indigenous Australians having PCI in urban and larger regional centres are at increased risk of mortality and adverse cardiac events. Clinically effective and culturally safe care pathways are urgently needed to improve health outcomes among Indigenous Australians who are having PCI. FUNDING: National Health and Medical Research Council, National Heart Foundation.

Rescue PCI in the management of STEMI: Contemporary results from the Melbourne Interventional Group registry.

BACKGROUND: Fibrinolysis is an important reperfusion strategy in the management of ST-elevation myocardial infarction (STEMI) when timely access to primary percutaneous coronary intervention (PPCI) is unavailable. Rescue PCI is generally thought to have worse outcomes than PPCI in STEMI. We aimed to determine short- and long-term outcomes of patients with rescue PCI versus PPCI for treatment of STEMI. METHODS AND RESULTS: Patients admitted with STEMI (excluding out-of-hospital cardiac arrest) within the Melbourne Interventional Group (MIG) registry between 2005 and 2018 treated with either rescue PCI or PPCI were included in this retrospective cohort analysis. Comparison of 30-day major adverse cardiac events (MACE) and long-term mortality between the two groups was performed. There were 558 patients (7.1%) with rescue PCI and 7271 with PPCI. 30-day all-cause mortality (rescue PCI 6% vs. PPCI 5%, p = 0.47) and MACE (rescue PCI 10.3% vs. PPCI 8.9%, p = 0.26) rates were similar between the two groups. Rates of in-hospital major bleeding (rescue PCI 6% vs. PPCI 3.4%, p = 0.002) and 30-day stroke (rescue PCI 2.2% vs. PPCI 0.8%, p < 0.001) were higher following rescue PCI. The odds ratio for haemorrhagic stroke in the rescue PCI group was 10.3. Long-term mortality was not significantly different between the groups (rescue PCI 20% vs. PPCI 19%, p = 0.33). CONCLUSIONS: With contemporary interventional techniques and medical therapy, rescue PCI remains a valuable strategy for treating patients with failed fibrinolysis where PPCI is unavailable and it has been suggested in extenuating circumstances where alternative revascularisation strategies are considered.

Comparison of Long-Term Outcomes After Percutaneous Coronary Intervention in Patients With Insulin-Treated Versus Non-Insulin Treated Diabetes Mellitus.

There are conflicting data on whether patients with insulin-treated diabetes mellitus (ITDM) have poorer outcomes compared with non-insulin treated diabetic (non-ITDM) patients following percutaneous coronary intervention (PCI). We therefore compared clinical outcomes following PCI in ITDM versus non-ITDM patients. We prospectively collected data on 4,579 patients with diabetes underwent PCI between 2005 and 2014 in a large multicenter registry and dichotomized them as having ITDM (n = 1,111) or non-ITDM (n = 3,468). The non-ITDM group was further divided into diet control only (diet-DM; n = 786) and those taking oral hypoglycemic agents (OHG-DM; n = 2,639), and clinical outcomes were compared with ITDM patients. Median follow-up for long-term mortality was 4.2 years (IQR 2.0 to 6.6 years). ITDM patients were more likely to be female, obese, and have severe renal impairment (all p <0.001). Procedural characteristics were similar other than a greater use of drug-eluting stents in ITDM patients. On multivariable analysis, ITDM was an independent predictor of 12-month major adverse cardiovascular and cerebrovascular events (MACCE; OR 1.26, 95% CI 1.02 to1.55, p = 0.03). Dividing the non-ITDM group further by treatment, a progressively higher rate of 12-month MACCE across the 3 groups was observed (13.5% vs 17.9% vs 21.8%; p <0.001). Long-term mortality was similar in the diet-DM and OHG-DM groups, but significantly higher in the ITDM group on Kaplan-Meier analysis (log-rank p <0.001). In conclusion, there is a clear gradient of adverse outcomes with escalation of therapy from diet control to OHGs to insulin.

Temporal Trends in Patient Risk Profile and Clinical Outcomes Following Percutaneous Coronary Intervention.

BACKGROUND: Patient selection and procedural characteristics continue to evolve in percutaneous coronary intervention (PCI). Australian data on long-term trends and outcomes are limited. This study aimed to identify long-term temporal trends in patient characteristics and outcomes in a large Australian PCI cohort. METHODS: We analysed data from 41,146 PCI procedures included in the multi-centre Melbourne Interventional Group registry to determine trends in patient characteristics, procedural practices and outcomes from 2005 to 2018. Procedures were divided into 2-yearly periods for trends analysis. RESULTS: Temporal trends in patient characteristics showed increases in age, proportion of males, rates of obesity, insulin-requiring diabetes mellitus, current smoking, obstructive sleep apnoea and prior PCI (all Ptrend < 0.01). Increases in the proportion of ST-elevation myocardial infarction, cardiogenic shock or out-of-hospital cardiac arrest (OHCA) were observed, and CathPCI National Cardiovascular Data Registry mortality risk scores increased over time (all Ptrend < 0.01). Use of radial access and drug-eluting stents increased, and lesions treated were more frequently ostial, left main or ACC/AHA type B2/C in recent years (all Ptrend < 0.01). In contrast, major bleeding and no reflow rates declined, however 30-day mortality, 12-month mortality and rates of stroke increased (all Ptrend < 0.01). Rates of vascular complications and 30-day target vessel revascularisation remained similar. In multivariable analysis, 2-yearly time periods were not independently associated with risk of 30-day mortality or 30-day MACE. CONCLUSIONS: Over the last 14 years, Australian PCI procedural complexity and patient risk profiles have increased. Higher mortality rates appear to relate to increased patient risk profile rather than procedural factors.

Outcomes of Percutaneous Coronary Intervention in Patients With Rheumatoid Arthritis.

Rheumatoid arthritis (RA) is the most common inflammatory arthritis and is associated with increased risk of cardiovascular events and mortality. Evidence regarding outcomes following PCI is limited. This study aimed to assess differences in outcomes following percutaneous coronary intervention (PCI) between patients with and without RA. The Melbourne Interventional Group PCI registry (2005 to 2018) was used to identify 756 patients with RA. Outcomes were compared with the remaining cohort (n = 38,579). Patients with RA were older, more often female, with higher rates of hypertension, previous stroke, peripheral vascular disease, obstructive sleep apnea, chronic lung disease, myocardial infarction, and renal impairment, whereas rates of dyslipidemia and current smoking were lower, all p <0.05. Lesions in patients with RA were more frequently complex (ACC/AHA type B2/C), requiring longer stents, with higher rates of no reflow, all p <0.05. Risk of long-term mortality, adjusted for potential confounders, was higher for patients with RA (hazard ratio 1.53, 95% confidence interval 1.30 to 1.80; median follow-up 5.0 years), whereas 30-day outcomes including mortality, major adverse cardiovascular events, bleeding, stroke, myocardial infarction, coronary artery bypass surgery, and target vessel revascularization were similar. In subgroup analysis, patients with RA and lower BMI (Pfor interaction < 0.001) and/or acute coronary syndromes (Pfor interaction = 0.05) had disproportionately higher risk of long-term mortality compared with patients without RA. In conclusion, patients with RA who underwent PCI had more co-morbidities and longer, complex coronary lesions. Risk of short-term adverse outcomes was similar, whereas risk of long-term mortality was higher, especially among patients with acute coronary syndromes and lower body mass index.

Colchicine in Patients With Acute Coronary Syndrome: The Australian COPS Randomized Clinical Trial.

BACKGROUND: Inflammation plays a crucial role in clinical manifestations and complications of acute coronary syndromes (ACS). Colchicine, a commonly used treatment for gout, has recently emerged as a novel therapeutic option in cardiovascular medicine owing to its anti-inflammatory properties. We sought to determine the potential usefulness of colchicine treatment in patients with ACS. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled trial involving 17 hospitals in Australia that provide acute cardiac care service. Eligible participants were adults (18-85 years) who presented with ACS and had evidence of coronary artery disease on coronary angiography managed with either percutaneous coronary intervention or medical therapy. Patients were assigned to receive either colchicine (0.5 mg twice daily for the first month, then 0.5 mg daily for 11 months) or placebo, in addition to standard secondary prevention pharmacotherapy, and were followed up for a minimum of 12 months. The primary outcome was a composite of all-cause mortality, ACS, ischemia-driven (unplanned) urgent revascularization, and noncardioembolic ischemic stroke in a time to event analysis. RESULTS: A total of 795 patients were recruited between December 2015 and September 2018 (mean age, 59.8±10.3 years; 21% female), with 396 assigned to the colchicine group and 399 to the placebo group. Over the 12-month follow-up, there were 24 events in the colchicine group compared with 38 events in the placebo group (P=0.09, log-rank). There was a higher rate of total death (8 versus 1; P=0.017, log-rank) and, in particular, noncardiovascular death in the colchicine group (5 versus 0; P=0.024, log-rank). The rates of reported adverse effects were not different (colchicine 23.0% versus placebo 24.3%), and they were predominantly gastrointestinal symptoms (colchicine, 23.0% versus placebo, 20.8%). CONCLUSIONS: The addition of colchicine to standard medical therapy did not significantly affect cardiovascular outcomes at 12 months in patients with ACS and was associated with a higher rate of mortality. Registration: URL: https://www.anzctr.org.au; Unique identifier: ACTRN12615000861550.

Impact of lunar phase on outcomes following ST-elevation myocardial infarction.

BACKGROUND: There is a long-held belief in the association between the full moon and extremes of human behaviour and adverse health consequences. Small-scale studies are conflicting; however, most suggest no clear association between lunar phase and occurrence of acute coronary syndromes. AIMS: To evaluate the impact of the lunar phase, and in particular, the full moon phase, on the incidence and outcomes among ST-elevation myocardial infarction (STEMI) cases undergoing percutaneous coronary intervention (PCI). METHODS: We conducted a multi-centre retrospective study from the Melbourne Interventional Group registry, including 7570 STEMI cases from six tertiary centres over a 12-year study period in Victoria, Australia, and performed statistical analysis using Stata software. Primary outcomes studied were the incidence of STEMI, the occurrence of major adverse cardiac and cerebrovascular events and mortality at 1 and 5 years in cases of STEMI undergoing primary or rescue percutaneous coronary intervention during the full moon between 2005 and 2017 in Victoria, Australia. RESULTS: This study demonstrated neither significant difference in STEMI incidence (P = 0.61) nor of major adverse cardiovascular events across all lunar phases. Subgroup analysis confirmed no difference in outcomes during the full moon compared to a composite of other lunar phases.Kaplan-Meier survival estimates showed similar 30-day outcomes across lunar phases (P = 0.35) and when comparing full moon to a composite of other lunar phases (P = 0.45). Similarly, there was no significant difference in survival at 1 and 5 years between lunar phases (P = 0.68) or compared to the full moon phase (P = 0.51). CONCLUSIONS: This study showed no significant difference in the incidence or cardiovascular outcomes and survival in patients with STEMI undergoing primary or rescue percutaneous coronary intervention during the lunar phases.

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.

Medium-Term Bioresorbable Scaffold Outcomes Utilising Data From an Australian Clinical Quality Registry.

BACKGROUND: Bioresorbable scaffolds (BRS) are a novel technology in coronary intervention. However, recent trials demonstrate higher rates of device failure compared to contemporary drug-eluting stents. This study sought to utilise a clinical quality registry to assess the medium-term safety of the Abbott Absorb BRS (Abbott Vascular, Santa Clara, CA, USA), in an Australian context. METHODS: A prospective, observational study of 192 BRS percutaneous coronary interventions (PCI) compared to 31,773 non-BRS PCIs entered in the Victorian Cardiac Outcomes Registry from 2013 to 2017. The main outcome measure was patient-oriented composite endpoint (POCE) events comprising all-cause mortality, any myocardial infarction (MI), and any revascularisation. RESULTS: Bioresorbable scaffolds patients (mean age 61.6±10.5 years, 79% male) were younger, had less comorbidity, less prior PCI, fewer ST elevation myocardial infarction (STEMI) presentations, lower rates of multi-lesion disease and more adjuvant devices compared to non-BRS PCI (all p<0.01). All-cause mortality was 2.1%, myocardial infarction (MI) 2.1%, scaffold thrombosis 3.1% and any revascularisation 14.1% (mean follow-up 27.4±8.9 months). POCE events occurred in 11.5% at 1 year and 16.9% at 2 years, comparable to pooled-trial data. Multivariate predictors of POCE were >1 scaffold used (odds ratio [OR] 4.6, 95% confidence interval [CI] 1.9-11.4, p<0.01) and scaffold diameter ≤2.5 mm (OR 3.3, 95% CI 1.4-7.6, p=0.02). Over 95% guideline adherence was achieved in six of eight patient selection criteria and four of six device deployment criteria. CONCLUSION: In an Australian setting, BRS were used in non-complex patients. Most guidelines for use were adhered to and outcomes were comparable to pooled trial data. Clinical quality registries are effective in assessing novel treatments and technologies when potential safety concerns develop.