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.

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.

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.

Role of beta blockers following percutaneous coronary intervention for acute coronary syndrome.

AIMS: There is a paucity of evidence supporting routine beta blocker (BB) use in patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). The aim of this study was to evaluate BB use post PCI and its association with mortality. Furthermore, the study aimed to evaluate the association between BB and mortality in the subgroups of patients with left ventricular ejection fraction (LVEF) <35%, LVEF 35%-50% and LVEF >50%. METHODS: Using a large PCI registry, data from patients with ACS between January 2005 and June 2017 who were alive at 30 days were analysed. Those patients taking BB at 30 days were compared with those who were not taking BB. The primary outcome was all-cause mortality. The mean follow-up was 5.3±3.5 years. RESULTS: Of the 17 562 patients, 83.3% were on BB. Mortality was lower in the BB group (13.1% vs 19.5%, p=0.0001). Multivariable Cox proportional hazards model showed that BB use was associated with lower overall mortality (adjusted HR 0.87, 95% CI 0.78 to 0.97, p=0.014). In the subgroup analysis, BB use was associated with reduced mortality in LVEF <35% (adjusted HR 0.63, 95% CI 0.44 to 0.91, p=0.013), LVEF 35%-50% (adjusted HR 0.80, 95% CI 0.68 to 0.95, p=0.01), but not LVEF >50% (adjusted HR 1.03, 95% CI 0.87 to 1.21, p=0.74). CONCLUSION: BB use remains high and is associated with reduced mortality. This reduction in mortality is primarily seen in those with reduced ejection fraction, but not in those with preserved ejection fraction.

Incidence and risk factors for stroke following percutaneous coronary intervention.

BACKGROUND: Stroke rates and risk factors may change as percutaneous coronary intervention practice evolves and no data are available comparing stroke incidence after percutaneous coronary intervention to the general population. AIMS: This study aimed to identify the incidence and risk factors for inpatient and subsequent stroke following percutaneous coronary intervention with comparison to age-matched controls. METHODS: Data were prospectively collected from 22,618 patients undergoing percutaneous coronary intervention in the Melbourne Interventional Group registry (2005-2015). The cohort was compared to the North-East Melbourne Stroke Incidence Study population-based cohort (1997-1999) and predefined variables assessed for association with inpatient or outpatient stroke. RESULTS: Inpatient stroke occurred in 0.33% (65.3% ischemic, 28.0% haemorrhagic, and 6.7% cause unknown), while outpatient stroke occurred in 0.55%. Inpatient and outpatient stroke were associated with higher rates of in-hospital major adverse cardiovascular outcomes (p < 0.0001) and mortality (p < 0.0001), as well as 12-month mortality (p < 0.0001). Factors independently associated with inpatient stroke were renal impairment, ST-elevation myocardial infarction, previous stroke, left ventricular ejection fraction 30-45%, and female sex, while those associated with outpatient stroke were previous stroke, chronic lung disease, previous myocardial infarction, rheumatoid arthritis, female sex, and older age. Compared to the age-standardized population-based cohort, stroke rates in the 12 months following discharge were higher for percutaneous coronary intervention patients <65 years old, but lower for percutaneous coronary intervention patients ≥65 years old. CONCLUSIONS: Risk of inpatient stroke following percutaneous coronary intervention appears to be largely associated with clinical status at presentation, while outpatient stroke relates more to age and chronic disease. Compared to the general population, outpatient stroke rates following percutaneous coronary intervention are higher for younger, but not older, patients.

Long-term outcomes following percutaneous coronary intervention to an unprotected left main coronary artery in cardiogenic shock.

BACKGROUND: In cardiogenic shock with severe left main coronary artery stenosis (LM), limited information exists on short and longer-term outcomes. We sought to determine the outcomes of unprotected LM PCI in cardiogenic shock. METHODS: Excluding patients with previous CABG, consecutive patients undergoing PCI in cardiogenic shock from the Melbourne Intervention Group registry between 2005 and 2013 were analysed. Those post LM PCI were compared to those post non-LM PCI. Patient and procedural data were collected with 30-day and 12-month follow-up. Australian National Death Index linkage was performed for long-term mortality analysis. RESULTS: After excluding previous CABG, 18,069 procedures were performed during 1st January 2005 to 30th November 2013, 601 procedures in the setting of cardiogenic shock. Of these, 45 were performed to an isolated LM and 556 to a non-LM. Those with LM PCI were older and more likely to have a baseline left ventricular ejection fraction (LVEF) of <45%. The in-hospital, 30-day, 12-month and long-term mortality to 9 years in cardiogenic shock after LM PCI was 64.4%, 66.7%, 73.3% and 80.0% compared to 36.5%, 36.9%, 40.5% and 46.0%, after non-LM PCI (p < 0.001). On multivariate analysis, LM PCI was a significant independent predictor of long-term mortality (HR1.59, 95%CI 1.00-2.53, p = 0.048). Landmark analysis of survivors to discharge found the long-term mortality of LM PCI approaches 60% compared to 27% for those with non-LM PCI (p = 0.003). CONCLUSION: Long-term outcomes after PCI to LM in cardiogenic shock are poor, with much of the excess in mortality occurring early. However, reasonable long-term survival was found beyond the initial high-risk period.

Short- and long-term outcomes of out-of-hospital cardiac arrest following ST-elevation myocardial infarction managed with percutaneous coronary intervention.

AIM: Out-of-hospital cardiac arrest (OHCA) is frequently associated with ST-elevation myocardial infarction (STEMI) and has a high mortality. We aimed to identify differences in characteristics and very long-term outcomes for STEMI patients with and without OHCA managed with percutaneous coronary intervention (PCI). METHODS: We analysed data from 12,637 PCI patient procedures for STEMI in the multi-centre Melbourne Interventional Group registry between January 2005 and December 2018. Multivariable models examined associations with OHCA presentation and 30-day mortality. Long-term outcomes were assessed through linkage with the Australian National Death Index. RESULTS: Compared with patients without OHCA (N = 11,580), patients with OHCA (N = 1057) were younger, more often male, had less cardiovascular risk factors, and more often presented with cardiogenic shock. OHCA preceded an increasing proportion of STEMI PCI cases from 2005 to 2018 (2.4% vs. 9.2%). Factors independently associated with OHCA presentation were younger age, male gender, prior valve surgery, multi-vessel disease, LAD culprit, small vessel diameter, and renal impairment on presentation. Patients with OHCA had lower procedural success, higher rates of bleeding and stroke, larger infarct size (measured by peak CK), and higher 30-day mortality (37% vs. 5%; all p < 0.05). Cardiogenic shock, renal impairment and lower ejection fraction were independently associated with 30-day mortality. Long-term mortality was 44% vs. 20% (median follow-up 4.6 years), with Cox regression analysis demonstrating no difference in survival if patients survived beyond 30 days (HR 1.18, 95% CI 0.95-1.47). CONCLUSIONS: OHCA has a high short-term mortality and precedes an increasing proportion of STEMI PCI cases. Thirty-day survivors have an excellent long-term prognosis.

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.

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.

The cost-effectiveness of guideline-driven use of drug-eluting stents: propensity-score matched analysis of a seven-year multicentre experience.

Background: In routine clinical practice, the implantation of a drug-eluting stent (DES) versus a bare metal stent (BMS) for percutaneous coronary intervention (PCI) has been guided by criteria for appropriate use. The cost-effectiveness (CE) of adopting these guidelines, however, is not clear, and was investigated from the perspective of the Australian healthcare payer.Methods and results: Baseline and 12-month follow-up data of 12,710 PCI patients enrolled in the Melbourne Interventional Group (MIG) registry between 2004 and 2011 were analysed. Costs inputs were derived from a clinical costing database and published sources. Propensity-score-matching was performed for DES and BMS groups within sub-groups. Incremental cost-effectiveness ratios (ICERs) were evaluated for all patients, and sub-groups of patients with '0', 1, 2, or ≥3 indications for a DES. The incremental cost per target vessel revascularization avoided for the overall population was $24,683, and for patients with 0, 1, and 2 indications for a DES was $44,635, $33,335, and $23,788, respectively. However, for those with >3 indications, DES compared with BMS was associated with cost savings. At willingness to pay thresholds of $45,000-$75,000, the probability of cost-effectiveness of DES for the overall cohort was 71-91%, '0' indications, 49-67%, 1 indication, 56-82%, 2 indications, 70-90%, and ≥3 indications, 97-99%.Conclusions: The cost-effectiveness of DES compared with BMS increased with increasing risk profile of patients from those who had 1, 2, to ≥3 indications for a DES. When compared with BMS, DES was least cost effective among patients with '0' indications for a DES. Based on these results, selective use of DES implantation is supported. These findings may be useful for evidence-based clinical decision-making.

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 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.

Re-examining the effect of door-to-balloon delay on STEMI outcomes in the context of unmeasured confounders: a retrospective cohort study.

Literature studying the door-to-balloon time-outcome relation in coronary intervention is limited by the potential of residual biases from unobserved confounders. This study re-examines the time-outcome relation with further consideration of the unobserved factors and reports the population average effect. Adults with ST-elevation myocardial infarction admitted to one of the six registry participating hospitals in Australia were included in this study. The exposure variable was patient-level door-to-balloon time. Primary outcomes assessed included in-hospital and 30 days mortality. 4343 patients fulfilled the study criteria. 38.0% (1651) experienced a door-to-balloon delay of >90 minutes. The absolute risk differences for in-hospital and 30-day deaths between the two exposure subgroups with balanced covariates were 2.81 (95% CI 1.04, 4.58) and 3.37 (95% CI 1.49, 5.26) per 100 population. When unmeasured factors were taken into consideration, the risk difference were 20.7 (95% CI -2.6, 44.0) and 22.6 (95% CI -1.7, 47.0) per 100 population. Despite further adjustment of the observed and unobserved factors, this study suggests a directionally consistent linkage between longer door-to-balloon delay and higher risk of adverse outcomes at the population level. Greater uncertainties were observed when unmeasured factors were taken into consideration.

Risk-Adjusting Key Outcome Measures in a Clinical Quality PCI Registry: Development of a Highly Predictive Model Without the Need to Exclude High-Risk Conditions.

OBJECTIVES: This study sought to determine the most risk-adjustment model for 30-day all-cause mortality in order to report risk-adjusted outcomes. The study also explored whether the exclusion of extreme high-risk conditions of cardiogenic shock, intubated out-of-hospital cardiac arrest (OHCA), or the need for mechanical ventricular support affected the model's predictive accuracy. BACKGROUND: Robust risk-adjustment models are a critical component of clinical quality registries, allowing outcomes to be reported in a fair and meaningful way. The Victorian Cardiac Outcomes Registry encompasses all 30 hospitals in the state of Victoria, Australia, that undertake percutaneous coronary intervention. METHODS: Data were collected on 27,544 consecutive percutaneous coronary intervention procedures from 2014 to 2016. Twenty-eight patient risk factors and procedural variables were considered in the modeling process. The multivariable logistic regression analysis considered derivation and validation datasets, along with a temporal validation period. RESULTS: The model included risk-adjustment for cardiogenic shock, intubated OHCA, estimated glomerular filtration rate, left ventricular ejection fraction, angina type, mechanical ventricular support, ≥80 years of age, lesion complexity, percutaneous access site, and peripheral vascular disease. The C-statistic for the derivation dataset was 0.921 (95% confidence interval: 0.905 to 0.936), with C-statistics of 0.931 and 0.934 for 2 validation datasets reflecting the 2014 to 2016 and 2017 periods. Subgroup modeling excluding cardiogenic shock and intubated OHCA provided similar risk-adjusted outcomes (p = 0.32). CONCLUSIONS: Our study has developed a highly predictive risk-adjustment model for 30-day mortality that included high-risk presentations. Therefore, we do not need to exclude high-risk cases in our model when determining risk-adjusted outcomes.

Association of Body Mass Index and Extreme Obesity With Long-Term Outcomes Following Percutaneous Coronary Intervention.

Background Previous studies have reported a protective effect of obesity compared with normal body mass index (BMI) in patients undergoing percutaneous coronary intervention (PCI). However, it is unclear whether this effect extends to the extremely obese. In this large multicenter registry-based study, we sought to examine the relationship between BMI and long-term clinical outcomes following PCI, and in particular to evaluate the association between extreme obesity and long-term survival after PCI. Methods and Results This cohort study included 25 413 patients who underwent PCI between January 1, 2005 and June 30, 2017, who were prospectively enrolled in the Melbourne Interventional Group registry. Patients were stratified by World Health Organization-defined BMI categories. The primary end point was National Death Index-linked mortality. The median length of follow-up was 4.4 years (interquartile range 2.0-7.6 years). Of the study cohort, 24.8% had normal BMI (18.5-24.9 kg/m2), and 3.3% were extremely obese (BMI ≥40 kg/m2). Patients with greater degrees of obesity were younger and included a higher proportion of diabetics (P<0.001). After adjustment for age and comorbidities, a J-shaped association was observed between different BMI categories and adjusted hazard ratio (HR) for long-term mortality (normal BMI, HR 1.00 [ref]; overweight, HR 0.85, 95% CI 0.78-0.93, P<0.001; mild obesity, HR 0.85, 95% CI 0.76-0.94, P=0.002; moderate obesity, HR 0.95, 95% CI 0.80-1.12, P=0.54; extreme obesity HR 1.33, 95% CI 1.07-1.65, P=0.01). Conclusions An obesity paradox is still apparent in contemporary practice, with elevated BMI up to 35 kg/m2 associated with reduced long-term mortality after PCI. However, this protective effect appears not to extend to patients with extreme obesity.

Impact of Gender and Door-to-Balloon Times on Long-Term Mortality in Patients Presenting With ST-Elevation Myocardial Infarction.

Guidelines mandate emergent revascularization in patients presenting with ST-elevation myocardial infarction (STEMI) irrespective of gender. We sought to compare the door-to-balloon times and the impact of timely reperfusion on clinical outcomes in women compared with men presenting with STEMI undergoing primary percutaneous coronary intervention (PPCI). We analyzed data from 6,179 consecutive patients presenting with STEMI undergoing PPCI from the Melbourne Interventional Group registry (2005 to 2017). The primary outcome was long-term mortality. Of the 6,179 patients included 1,258 (20.3%) were female. Female patients were older (69 ± 13 vs 62 ± 12 years; p < 0.001), had more co-morbidities and had longer median symptom-to-balloon times (204 [interquartile range {IQR} 154 to 294] vs 181 [IQR 139 to 258] minutes; p < 0.001) and longer median door-to-balloon times (81 [IQR 55 to 102] vs 75 [IQR 51 to 102)] minutes; p < 0.001), while receiving less drug-eluting stents (39% vs 43%; p = 0.01) and having less radial access for PPCI (15% vs 21%; p < 0.001). Furthermore, female patients received less guideline-directed medical therapy than men with less prescription of aspirin (93.4% vs 95.4%; p = 0.02), statins (96.5% vs 97.6%; p < 0.05), and beta blockers (84.3% vs 89.4%; p < 0.001). Unadjusted in-hospital and 30-day mortality rates were higher in women (8.8% vs 6.2%, 9.8% vs 6.9%; p < 0.001). However, on Cox-proportional hazards modeling, gender was not an independent predictor of long-term mortality (hazards ratio 0.99, 95% confidence interval 0.83 to 1.18; p = 0.92) at a mean follow-up of 4.8 ± 3.5 years. In conclusion, in this large multicenter registry of patients with STEMI, women had longer ischemic times, higher risk profiles, and differing interventional approaches compared with men. Addressing these gender inequalities with early identification of symptoms, adherence to guideline-directed medical therapy, as well as higher rates of radial access and use of drug-eluting stents has the potential to further improve outcomes in women with STEMI.

Impact of Pre-Procedural Blood Pressure on Long-Term Outcomes Following Percutaneous Coronary Intervention.

BACKGROUND: High systolic blood pressure (SBP) increases cardiac afterload, whereas low diastolic blood pressure (DBP) may lead to impaired coronary perfusion. Thus, wide pulse pressure (high systolic, low diastolic [HSLD]) may contribute to myocardial ischemia and also be a predictor of adverse cardiovascular events. OBJECTIVES: The purpose of this study was to determine the relationship between pre-procedural blood pressure and long-term outcome following percutaneous coronary intervention (PCI). METHODS: The study included 10,876 consecutive patients between August 2009 and December 2016 from the Melbourne Interventional Group registry undergoing PCI with pre-procedural blood pressure recorded. Patients with ST-segment elevation myocardial infarction, cardiogenic shock, and out-of-hospital cardiac arrest were excluded. Patients were divided into 4 groups according to SBP (high ≥120 mm Hg, low <120 mm Hg) and DBP (high >70 mm Hg, low ≤70 mm Hg). RESULTS: Mean pulse pressure was 60 ± 21 mm Hg. Patients with HSLD were older and more frequently women, with higher rates of hypercholesterolemia, renal impairment, diabetes, and multivessel and left main disease (all p ≤ 0.0001). There was no difference in 30-day major adverse cardiac events, but at 12 months the HSLD group had a greater incidence of myocardial infarction (p = 0.018) and stroke (p = 0.013). Long-term mortality was highest for HSLD (7.9%) and lowest for low systolic, high diastolic (narrow pulse pressure) at 2.1% (p = 0.0002). Cox regression analysis demonstrated significantly lower long-term mortality in the low systolic, high diastolic cohort (hazard ratio: 0.50; 99% confidence interval: 0.25 to 0.98; p = 0.04). CONCLUSIONS: Pulse pressure at the time of index PCI is associated with long-term outcomes following PCI. A wide pulse pressure may serve as a surrogate marker for risk following PCI and represents a potential target for future therapies.

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.