Comparison of 4 different strategies of DAPT after PCI in ACS real world population from a Northern Italy registry.

Aim of the study was to compare four different strategies of dual antiplatelet therapy (DAPT) in patients with acute coronary syndromes (ACS) treated with PCI. DAPT with Clopidogrel, Ticagrelor and Prasugrel has proved to be effective in patients with ACS treated with percutaneous coronary intervention (PCI) by reducing major adverse cardiovascular outcomes (MACE). However, the effect of the different strategies in a real-world population deserves further verification. A retrospective analysis of 2404 discharged ACS patients treated with PCI was performed, with a median follow-up of 1 year. The study population was stratified in four drug treatment cohorts: ASA + Clopidogrel (A-C), ASA + Plavix (A-PLx), ASA + Ticagrelor (A-T), ASA + Prasugrel (A-P). We assessed the incidence of net adverse cardiovascular events (NACE): all-cause death, myocardial infarction (MI), target vessel revascularization (TVR), stroke and bleeding during follow-up. At 1-year, the use of A-C and A-PLx was associated with the highest cumulative incidence of NACE in comparison with A-T and A-P therapies (respectively 14.8 and 29.6% vs. 9.2 and 6%). This difference was mainly driven by the mortality and TVR outcomes. Considering selection bias and differences in the patients baseline characteristics, the association of A-T and A-P seems to be superior in comparison with a DAPT strategy of A-C and A-PLx in low risk ACS-PCI patients from real world. In our Region the prescription is consistent with guidelines recommendations and Clopidogrel and Plavix are still predominantly used in older patients with more comorbidities, and this could partially explain the inferiority of this association.

Kawasaki disease: an epidemiological study in central Italy.

BACKGROUND: Kawasaki disease (KD) is a systemic vasculitis with an acute and self-limited course. The incidence of KD differs widely among ethnic groups and is higher in the Asian population. In Italy, no recent data are available. Our purpose is to define the epidemiology of Kawasaki disease in the years 2008-2013 in children aged < 14 years in the Italian regions of Tuscany and Emilia Romagna through administrative data. METHODS: We studied the epidemiology of KD in the years 2008-2013 in children 0-14 years old resident in Tuscany and in Emilia Romagna regions using hospital ICD-9 discharge codes with a thorough data cleaning for duplicates. RESULTS: The distribution of the KD patients across ages was similar for the two regions with a peak in the second year of life. When considering data of the two regions together, the rate of incidence was 17.6 for 100,000 children under 5 years. For both Regions the incidence rose slightly during the study period and had a seasonal distribution, with higher incidence in spring and winter. CONCLUSION: This is the first Italian study performed through the use of administrative data. Figures are in line but slightly higher than those published in other European countries.

Risk of Adverse Cardiac and Bleeding Events Following Cardiac and Noncardiac Surgery in Patients With Coronary Stent: How Important Is the Interplay Between Stent Type and Time From Stenting to Surgery?

BACKGROUND: Epidemiology and consequences of surgery in patients with coronary stents are not clearly defined, as well as the impact of different stent types in relationship with timing of surgery. METHODS AND RESULTS: Among 39 362 patients with previous coronary stenting enrolled in a multicenter prospective registry and followed for 5 years, 13 128 patients underwent 17 226 surgical procedures. The cumulative incidence of surgery at 30 days, 6 months, 1 year, and 5 years was 3.6%, 9.4%, 14.3%, and 40.0%, respectively, and of cardiac and noncardiac surgery was 0.8%, 2.1%, 2.6%, and 4.0% and 1.3%, 5.1%, 9.1%, and 31.7%, respectively. We assessed the incidence and the predictors of cardiac death, myocardial infarction, and serious bleeding event within 30 days from surgery. Cardiac death occurred in 438 patients (2.5%), myocardial infarction in 256 (1.5%), and serious bleeding event in 1099 (6.4%). Surgery increased 1.58× the risk of cardiac death during follow-up. Along with other risk factors, the interplay between stent type and time from percutaneous coronary intervention to surgery was independently associated with cardiac death/myocardial infarction. In comparison with bare-metal stent implanted >12 months before surgery, old-generation drug-eluting stent was associated with higher risk of events at any time point. Conversely, new-generation drug-eluting stent showed similar safety as bare-metal stent >12 months and between 6 and 12 months and appeared trendly safer between 0 and 6 months. CONCLUSIONS: Surgery is frequent in patients with coronary stents and carries a considerable risk of ischemic and bleeding events. Ischemic risk is inversely related with time from percutaneous coronary intervention to surgery and is influenced by stent type.

Same-day transfer for the invasive strategy of patients with non-ST-segment elevation acute coronary syndrome admitted to spoke hospitals: Data from the Emilia-Romagna Regional Network.

BACKGROUND: The service strategy (same-day transfer between spoke hospital and hub centre with catheterisation laboratory (cath-lab) facility to perform invasive procedures) has been suggested to improve the management of patients with non-ST-segment elevation acute coronary syndrome (NSTEACS) admitted to spoke hospitals. We used data from a large prospective Italian registry to describe application, performance and outcome of the service strategy in the daily clinical practice. METHODS: This study was based on an observational, post-hoc analysis of all consecutive NSTEACS patients admitted to spoke non-invasive hospitals of the Emilia-Romagna regional network and receiving coronary artery angiography (CAA)±percutaneous coronary intervention (PCI). We evaluated: application of service strategy, time to cath-lab access, hospital stay length, 30-days occurrence of adverse events. RESULTS: From January 2011-December 2012, 2952 NSTEACS consecutive patients were admitted to spoke non-invasive hospitals and received CAA. Overall, 1765 (60%) patients were managed with a service strategy. After multivariable analysis, service strategy emerged as independent predictor of faster access to cath-lab (within 72 h: hazard ratio (HR) 2.3, 95% confidence interval (CI) 1.9-2.7, p<0.0001; within 24 h: HR 2.8, 95% CI 2.2-3.3, p<0.0001, respectively). Service strategy significantly reduced hospital stay length (-5.5 days, p<0.0001). We estimated a mean of €1590 saved for each patient managed with service strategy. Thirty-day occurrence of adverse events did not differ between patients managed with or without a service strategy. CONCLUSIONS: In our daily clinical practice, a service strategy seems to be an effective approach to optimise the invasive management of NSTEACS patients admitted to spoke hospitals.

Incremental Value of the CRUSADE, ACUITY, and HAS-BLED Risk Scores for the Prediction of Hemorrhagic Events After Coronary Stent Implantation in Patients Undergoing Long or Short Duration of Dual Antiplatelet Therapy.

BACKGROUND: Multiple scores have been proposed to stratify bleeding risk, but their value to guide dual antiplatelet therapy duration has never been appraised. We compared the performance of the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines), ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy), and HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) scores in 1946 patients recruited in the Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study (PRODIGY) and assessed hemorrhagic and ischemic events in the 24- and 6-month dual antiplatelet therapy groups. METHODS AND RESULTS: Bleeding score performance was assessed with a Cox regression model and C statistics. Discriminative and reclassification power was assessed with net reclassification improvement and integrated discrimination improvement. The C statistic was similar between the CRUSADE score (area under the curve 0.71) and ACUITY (area under the curve 0.68), and higher than HAS-BLED (area under the curve 0.63). CRUSADE, but not ACUITY, improved reclassification (net reclassification index 0.39, P=0.005) and discrimination (integrated discrimination improvement index 0.0083, P=0.021) of major bleeding compared with HAS-BLED. Major bleeding and transfusions were higher in the 24- versus 6-month dual antiplatelet therapy groups in patients with a CRUSADE score >40 (hazard ratio for bleeding 2.69, P=0.035; hazard ratio for transfusions 4.65, P=0.009) but not in those with CRUSADE score ≤40 (hazard ratio for bleeding 1.50, P=0.25; hazard ratio for transfusions 1.37, P=0.44), with positive interaction (Pint=0.05 and Pint=0.01, respectively). The number of patients with high CRUSADE scores needed to treat for harm for major bleeding and transfusion were 17 and 15, respectively, with 24-month rather than 6-month dual antiplatelet therapy; corresponding figures in the overall population were 67 and 71, respectively. CONCLUSIONS: Our analysis suggests that the CRUSADE score predicts major bleeding similarly to ACUITY and better than HAS BLED in an all-comer population with percutaneous coronary intervention and potentially identifies patients at higher risk of hemorrhagic complications when treated with a long-term dual antiplatelet therapy regimen. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov. Unique identifier: NCT00611286.

[Quality indicators for the assessment of ST-segment elevation acute myocardial infarction (STEMI) networks. How hospital discharge records could be integrated with Emergency medical services data: the Emilia-Romagna STEMI network experience]. / Indicatori per la valutazione dei percorsi di rete dell'infarto miocardico acuto con sopraslivellamento del tratto ST: integrazione dei dati amministrativi provenienti dalle schede di dimissione ospedaliera e dal flusso emergenza-urgenza. Esperienza della Regione Emilia-Romagna.

BACKGROUND: The assessment of the regional network for ST-segment elevation acute myocardial infarction (STEMI) is fundamental for quality assurance. Since 2011 all Italian Health Authorities, in addition to hospital discharge records (HDR), must provide a standardized information flow (ERD) about emergency department (ED) and emergency medical system (EMS) activities. The aim of this study was to evaluate whether data integration of ERD with HDR may allow the development of appropriate quality indicators. METHODS: Patients admitted to coronary care units (CCU) for STEMI between January 1 to December 31, 2013, were identified from the regional HDR database. All data were linked to those of the regional ERD database. Four quality indicators were defined: 1) rates of EMS activation, 2) rates of EMS direct transfer to the catheterization laboratory (Cath-lab), 3) transfer rates from a Spoke to a Hub hospital with angioplasty facilities, and 4) median time spent in ED. RESULTS: In 2013, 2793 patients with STEMI were admitted to the CCU. Of these, 1684 patients (60%) activated EMS and were transported to Spoke or Hub hospitals; 955 (57%) entered directly in CCU/Cath-lab; 677 were transferred directly to a Hub hospital ED without being admitted to a Spoke hospital. The median ED time in Hub hospital was 47 min (IQR 24-136) and in Spoke hospital 53 min (IQR 30-131). CONCLUSIONS: The integration among administrative data banks (i.e., HDR with ERD) allowed the assessment of the regional STEMI network and the identification of potentially useful quality indicators. Their easy availability should enable comparisons with local, national and international standards, and may favor quality improvement.

Repeated Aortic Balloon Valvuloplasty in Elderly Patients With Aortic Stenosis Who Are Not Candidates for Definitive Treatment.

AIMS: A sizable group of patients with symptomatic aortic stenosis can undergo neither surgical aortic valve replacement nor transcatheter aortic valve implantation. The aim of this study was to assess the potential role of repeated balloon aortic valvuloplasty (BAV) in these patients. METHODS: Within our local prospective BAV registry, we retrospectively selected 105 patients who underwent ≥2 BAV procedures between 2005 and 2012 because of persisting contraindications to definitive treatment after first BAV. In-hospital outcome and incidence of adverse events at 1, 2, and 3 years were assessed. Mean age was 84 ± 6 years, mean logistic EuroSCORE was 23.6 ± 13.4%. RESULTS: No intraprocedural deaths occurred. In-hospital events for the 224 BAV procedures were: myocardial infarction, 4%; stroke, 0.9%; vascular complications, 8% (1.8% major); and bleedings, 5.9% (life threatening, 0.9%; major, 1.8%). Acute aortic regurgitation occurred in 6 cases and was always resolved during procedures. Median follow-up was 785 days. Second BAVs showed fewer vascular complications (P<.001) and bleedings (P<.001). Bleedings (odds ratio [OR], 6.88; 95% confidence interval [CI], 1.58-29.88) and vascular complications (OR, 4.8; 95% CI, 1.19-19.31) occurring after the first procedure were independent predictors for subsequent adverse events. All-cause mortality at 1, 2, and 3 years was 15.2%, 41.3%, and 57.2%. Hospital readmission for heart failure was 40.7% at 1-year follow-up, 61.7% at 2-year follow-up, and 77.6% at 3-year follow-up. CONCLUSION: BAV is associated with poor long-term clinical outcome. However, when no other therapeutic options are feasible, a strategy of repeated palliative BAV appears to be safe and is potentially associated with improved clinical outcomes.

Self-controlled case-series study to verify the effect of adherence to Beta-blockers in secondary prevention of myocardial infarction.

BACKGROUND: Beta-blockers (BB) are recommended in secondary prevention of acute myocardial infarction (AMI), but adherence to prescription medication is a recognized problem. Most literature on the consequences of poor adherence to prescribed BB is limited by the possibility of "healthy adherer bias" and better-designed studies have been advocated. METHODS AND RESULTS: We investigated the association between adherence to BB prescription and risk of subsequent AMIs using the self-controlled case series design, which allows improved control of interpersonal confounding, being based on intrapersonal comparisons. From all the 30 089 patients hospitalized for AMI in the years 2009-2011 in an Italian region we selected those that suffered subsequent AMIs at days 31 to 365 from discharge (1328), and then the 1207 that had at least one BB prescription collected at any of the regional pharmacies. Using information on prescriptions, each individual's observation time was then divided into periods exposed or unexposed to BB and the relative AMI incidence rate ratios (IRR) of BB exposure were estimated by conditional Poisson regression. The IRR (rate of recurrent AMI in exposed versus unexposed periods) was 0.79 (95% CI 0.69 to 0.90, P=0.001). Various sensitivity analyses confirmed the robustness to possible failure of assumptions, ie, considering only first recurrences (IRR 0.76, 95% CI 0.66 to 0.88, P<0.001), excluding cardiovascular fatalities (IRR 0.76, 95% CI 0.65 to 0.89, P<0.001), and excluding individuals with long hospital admissions (IRR 0.60, 95% CI 0.43 to 0.83, P=0.002). CONCLUSIONS: Adherence to recommended BB therapy was associated with a 20% reduction of recurrent AMIs, consistently with previous research, but with decreased concerns about healthy-adherer bias.

Adherence to agents acting on the renin-angiotensin system in secondary prevention of non-fatal myocardial infarction: a self-controlled case-series study.

AIMS: In accordance with current guidelines, patients discharged after acute myocardial infarction (AMI) are usually prescribed agents acting on the renin-angiotensin system (ACE-I/ARB). However, adherence to prescribing medications is a recognized problem and most studies demonstrating the value of adherence were limited by their non-randomized design and by 'healthy-adherer' bias. Herein we sought to evaluate the relationship between adherence to ACE-I/ARB and risk of subsequent AMIs, by using the self-controlled case-series design which virtually eliminates interpersonal confounding, being based on intrapersonal comparisons. METHODS AND RESULTS: We linked data from three longitudinal registries containing information about hospitalizations, drug prescriptions, and vital status of all residents in an Italian region. From 30 089 patients hospitalized for AMI in the years 2009-11, we enrolled the 978 with non-fatal re-AMIs at Days 31-365 after discharge, receiving at least one ACE-I/ARB prescription collected at any of the regional pharmacies. Using information on prescriptions, each individual's observation time was then divided into periods exposed or unexposed to ACE-I/ARB. The relative re-AMI incidence rate ratios (IRRs) of ACE-I/ARB exposure were estimated by conditional Poisson regression. During drug-covered periods, the risk of AMI recurrence was ∼20% lower, i.e. the IRR (rate of recurrent AMI in exposed versus unexposed periods) was 0.79 (95% CI 0.66-0.96, P = 0.001). The benefit of ACE-I/ARB was confirmed also by sensitivity analyses considering only first recurrences, excluding cases with AMI within previous 3 years, or with long, not AMI, hospital re-admission. CONCLUSIONS: Poor adherence to ACE-I/ARB prescription medication was associated with a 20% increased risk of recurrent AMI. This was consistent with previous research, but the SCSS study design, even if not randomized, eased previous concerns about healthy-adherer bias.

New-generation drug-eluting stents reduce stent thrombosis and myocardial infarction: a propensity-score-adjusted analysis from the multicenter REAL registry (REgistro Regionale AngiopLastiche Dell'Emilia-Romagna).

OBJECTIVES: The aim of this study was to compare long-term clinical outcomes in patients treated with new-generation drug-eluting stent (DES) or early-generation DES in a real-world registry. BACKGROUND: New-generation DESs have proved to be more effective and safer than early-generation DES in randomized trials. However, the effects of new-generation DES versus early-generation DES in everyday clinical practice deserve further verification. METHODS: A propensity-score and inverse-probability weighted analysis of 5,332 patients undergoing DES implantation (2,557 new-generation and 2,775 early-generation) between January 1, 2007 and June 30, 2011 was performed, with a median follow-up of 3 years. We assessed the incidence of major adverse cardiovascular events (MACE: all-cause death, nonfatal myocardial infarction [MI], and target vessel revascularization [TVR]), and angiographic stent thrombosis (ST) during follow-up. RESULTS: At 3-years, new-generation DES in comparison with early-generation DES were associated with a reduced risk of MI (5% versus 7.4%, hazard ratio [HR]=0.65, 95% confidence interval [CI]=0.51-0.82, P=0.0004) and angiographic ST (0.5% vs. 1.1%, HR=0.35, 95% CI 0.17-0.72, P=0.004), whereas, the risk of TVR (10.9% vs. 13.5%; HR 0.99, 95% CI 0.84-1.16, P=0.99) and overall MACE was not significantly different (19.2% vs. 22.4%, HR=0.94, 95% CI=0.83-1.07, P=0.35). CONCLUSIONS: Our data from a large all-comers multicenter registry confirm that, in comparison with early-generation DES, the use of new-generation DES is associated with similar efficacy and increased long-term safety, because of a reduced risk of ST and MI.

Association of bleeding, mortality and sex in acute coronary syndromes: the missing triangle.

AIMS: Percutaneous coronary intervention (PCI) and antithrombotic drugs are the standard therapy for patients with acute coronary syndromes (ACS), but their impact on bleeding and mortality in women has not been adequately investigated. METHODS: This was a prospective observational cohort study of ACS patients, who were referred to 6 of the 13 centres belonging to the REgistro regionale AngiopLastiche dell'Emilia-Romagna programme in Emilia-Romagna for coronary angiography and PCI between June 2010 and November 2011. The aim of the study was to verify whether the incidence of Global Registry of Acute Coronary Events-defined in-hospital bleeding after an ACS is significantly higher in women than in men, and to evaluate its impact on short and long-term mortality. RESULTS: The analysis involved a total of 1686 patients (511 women and 1175 men). The women were older and more frequently affected by hypertension, congestive heart failure and single-vessel disease; however, none of the clinical or procedural variables was significantly different between the sexes after statistical adjustment. There was a significantly higher rate of in-hospital bleeding among the women [8.6 vs. 5.8%; adjusted odds ratio 1.73, 95% confidence interval (CI) 1.19-2.52, P = 0.004], but the adjusted hazard ratio for short and long-term all-cause mortality was not significantly different. After optimal adjustment, bleeding, but not female sex, was identified as a predictor of short-term all-cause mortality (hazard ratio 2.68, 95% CI 1.21-5.93, P = 0.01), but this was not confirmed in the case of long-term mortality (hazard ratio 1.57, 95% CI 0.91-2.71, P = 0.10). CONCLUSION: After optimal adjustment for baseline differences, the findings of this contemporary Italian PCI registry study showed that women experience bleeding more frequently, but do not have worse mortality outcomes than men. Bleeding was confirmed as an independent predictor of short-term mortality.

Combining therapeutic hypothermia and emergent coronary angiography in out-of-hospital cardiac arrest survivors: Optimal post-arrest care for the best patient.

BACKGROUND: Aggressive post-resuscitation care, in particular combining mild therapeutic hypothermia (MTH) with early coronary angiography (CAG) and percutaneous coronary intervention (PCI), may improve prognosis after out-of-hospital cardiac arrest (OHCA). OBJECTIVES: The study aims to assess the value of immediate CAG or PCI in comatose survivors after OHCA treated with MTH and their association with outcomes. METHODS: Observational, prospective analysis of all comatose, resuscitated patients treated with MTH at a tertiary centre and undergoing CAG or PCI ≤6 hours after OHCA, or non-invasively managed. Primary outcomes were 30-day and 1-year survival. RESULTS: From March 2004-December 2012, 141 (51%) out of 278 comatose patients after cardiac OHCA were treated with MTH (median age: 64.5 (interquartile range 55-73) years, males: 67%, first shockable rhythm: 70%, witnessed OHCA: 94%, interval OHCA-resuscitation ≤20 min: 81%). Ninety-seven patients (69%) underwent early CAG, and 45 (32%) of them PCI. Patients undergoing CAG or PCI had a more favourable risk profile than subjects non-invasively managed. PCI treated patients had more bleedings, but no stent thrombosis occurred. Thirty-day and one-year unadjusted total mortality rates were 50% and 72% for non-invasively managed patients, 26% and 38.7% for patients submitted only to CAG and 32% and 36.6% for patients treated with PCI (p=0.0435 for early death, and p<0.0001 for one-year mortality, respectively). However, a propensity-matched score analysis did not confirm the survival advantage of invasive management (p=0.093). At multivariable analysis, clinical and OHCA-related variables as well as CAG, but not PCI, were associated with outcomes. CONCLUSIONS: Comatose patients cooled after OHCA and submitted to emergency CAG or PCI are a favourable outcome population that receives optimal post-arrest care.

Coronary artery surgery versus percutaneous coronary intervention in octogenarians: long-term results.

BACKGROUND: The aim of this study was to compare 7-year rates of all-cause death, cardiac death, myocardial infarction, target vessel revascularization, and stroke in a large cohort of octogenarians with left main coronary artery or multivessel disease, treated with coronary artery bypass grafting or percutaneous coronary intervention. METHODS: Two propensity score-matched cohorts of patients undergoing revascularization procedures at regional public and private centers of Emilia-Romagna, Italy, from July 2002 to December 2008 were used to compare long-term outcomes of percutaneous coronary intervention (947 patients) and coronary artery bypass grafting (441 patients). RESULTS: There were no significant differences between groups in 30-day mortality. In the follow-up the overall and the matched percutaneous coronary intervention population experienced significantly worse outcomes in terms of cardiac mortality, myocardial infarction, and target vessel revascularization. No difference was found for stroke between treatment groups. Percutaneous coronary intervention was an independent predictor of increased death at long-term follow-up. The subgroups in which coronary artery bypass grafting reduced more clearly the risk of death were age 80 to 85 years, previous myocardial infarction, history of cardiac heart failure, chronic renal failure, peripheral vascular disease, and patients with three-vessel disease associated with the left main coronary artery. CONCLUSIONS: In this real-world setting, surgical coronary revascularization remains the standard of care for patients with left main or multivessel disease. The long-term outcomes of current percutaneous coronary intervention technology in octogenarians are yet to be determined with adequately powered prospective randomized studies.

Long-term outcome in patients with ST segment elevation myocardial infarction and multivessel disease treated with culprit-only, immediate, or staged multivessel percutaneous revascularization strategies: Insights from the REAL registry.

OBJECTIVES: To examine the differences in cardiac outcomes for patients with ST-elevation myocardial infarction (STEMI) and multivessel disease (MVD) as a function of whether they underwent culprit-only primary percutaneous coronary intervention (PPCI) or multivessel PCI, either during PPCI or as a staged procedure. BACKGROUND: MVD occurs in about 40% of patients presenting with STEMI, and it has been associated with a worse outcome compared to single-vessel disease. The most favorable PCI strategy for dealing with significant nonculprit lesions has to be established. METHODS: A total of 2061 STEMI patients with MVD undergoing PPCI, prospectively enrolled in the REAL Registry between July 2002 and December 2010, were considered: 706 underwent culprit-only PPCI; 367 multivessel PCI during the index procedure; 988 had a staged PCI within 60 days. Mortality and outcomes were calculated at 30 days and 2 years. RESULTS: At multivariate analysis, culprit-only PPCI was associated with higher rates of cardiac outcomes as compared to staged multivessel PCI, taken as reference [Hazard Ratio (HR): 2.81, 95% confidence interval (CI): 1.34-5.89, P = 0.006 for 30-day mortality, and HR: 1.93, 95% CI: 1.35-2.74, P = 0.0002 for 2-year mortality, respectively]. Short-term mortality rates were higher in multivessel PCI group as compared to staged PCI group (HR: 2.58, 95% CI: 1.06-6.26, P = 0.03); no differences were observed at 2-year follow-up (HR: 1.08, 95% CI: 0.64-1.82, P = 0.76). CONCLUSIONS: Our findings support the current guidelines recommendation to perform culprit-only PPCI in STEMI patients with MVD without hemodynamic compromise, followed by a staged PCI of noninfarct-related significant lesions.

Recent temporal trends for first-time hospitalization for acute myocardial infarction. Treatment patterns and clinical outcome in a large cohort study.

BACKGROUND: The objective was to report recent trends in the incidence, adoption of evidence-based treatment, and clinical outcomes for first-time hospitalization for acute myocardial infarction. METHODS: This is a large retrospective population-based cohort study using medical administrative data (International Classification of Diseases, Ninth Revision, Clinical Modification, codes) performed in the Emilia-Romagna Region of Italy (approximately 4.5 million inhabitants). We identified 60,673 patients with a first hospitalization for acute myocardial infarction from 2002 through 2009. RESULTS: The standardized incidence rate per 100,000 person-years of acute myocardial infarction increased from 173 cases in 2002 to a peak of 197 cases in 2004 and then decreased each year thereafter to 167 cases in 2009. The proportion of patients who underwent coronary angiography and angioplasty in the acute phase increased over time, respectively, from 45.4% and 27.1% to 72.3% and 57.2% (P < .001). Medication use within 12 months of discharge increased for aspirin, ß-blockers, and statins. A reduction in crude and adjusted in-hospital all-cause (16.1% in 2002 vs 12.8% in 2009, P < .001) and cardiovascular mortality (13.6% in 2002 vs 9.5% in 2009, P < .001) was observed over time. At 1 year after hospital discharge, no significant variations occurred in adjusted risk for all-cause mortality or cardiovascular mortality. Notably, crude and adjusted risk for in-hospital and postdischarge bleeding showed a significant increment. CONCLUSIONS: The utilization of evidence-based treatments in patients with myocardial infarction increased between 2002 and 2009. These changes in practice over time favored a reduction in early case fatality at the cost of a significant increase in bleeding.

Incidence and outcome of high on-treatment platelet reactivity in patients with non-ST elevation acute coronary syndromes undergoing percutaneous coronary intervention (from the VIP [VerifyNow and Inhibition of Platelet Reactivity] study).

High residual platelet reactivity (RPR) on clopidogrel treatment has been associated with increased risk for ischemic events during follow-up in patients with acute coronary syndromes. The aim of this study was to assess the incidence, predictors, and clinical consequences of high RPR in a large population of patients with non-ST-segment elevation acute coronary syndromes who underwent percutaneous coronary intervention and stenting. Overall, 833 patients received point-of-care testing of platelet inhibition 30 days after percutaneous coronary intervention. High RPR was diagnosed on the basis of P2Y12 reaction units >230. The incidence and predictors of death, myocardial infarction, stroke, and serious bleeding events were assessed up to 1 year from the day of testing. P2Y12 reaction units were normally distributed, and 264 patients were classified as poor responders (31.7%). Independent predictors of response to clopidogrel were male gender (odds ratio [OR] 1.51), age (OR 0.96), diabetes mellitus (OR 0.51), and use of proton pump inhibitors (OR 0.59). At 1 year, poor responders showed higher rates of death (4.6% vs 1.9%, p = 0.032) and serious bleeding events (4.9% vs 1.8%, p = 0.009) compared with good responders. After adjustment for confounders, high RPR did not emerge as an independent predictor of mortality (OR 0.57, 95% confidence interval [CI] 0.23 to 1.42, p = 0.23) or serious bleeding events (OR 0.61, 95% CI 0.25 to 1.52, p = 0.29). The results did not change using the a cut-off value for P2Y12 reaction units of 208. In conclusion, 1/3 of patients with acute coronary syndromes who underwent percutaneous coronary intervention and stenting showed high on-treatment RPR on bedside monitoring. They had a worse prognosis, but the level of platelet inhibition was not independently associated with the incidence of ischemic or bleeding events.

Coronary artery bypass grafting vs percutaneous coronary intervention in a 'real-world' setting: a comparative effectiveness study based on propensity score-matched cohorts.

OBJECTIVES: Most studies comparing coronary artery bypass grafting (CABG) and percutaneous coronary interventions (PCI) showed that fewer patients who had undergone CABG required repeat revascularizations , but no difference in survival, with the exception of some subgroups of patients. However, long-term real-world evidence on patients in whom both procedures are technically feasible is yet not available. The aim of this study was to compare 5-year rates of death, myocardial infarction (MI), target vessel revascularization (TVR) and stroke in a large cohort of patients with left main coronary artery (LMCA) or multivessel disease, treated with CABG or PCI (with or without DES) or PCI with DES only. METHODS: Two propensity score (PS)-matched cohorts of patients undergoing revascularization procedures at the regional public and private centres of Emilia-Romagna over the period July 2002-December 2008 were used to compare long-term outcomes of PCI (6246 patients) and CABG (5504 patients). RESULTS: PCI was associated with higher risk of death (HR = 1.6; 95% CI 1.4-1.8, P < 0.0001), MI (HR = 3.3; 95% CI 2.7-4.0, P < 0.0001) and TVR (HR = 4.5; 95% CI 3.8-5.2, P < 0.0001) at 5 years. No significant difference was shown for stroke (HR = 1.1; 95% CI 0.9-1.4, P = 0.43). CABG benefit was more evident in the risk of death in patients with two-vessel disease plus LMCA and in those with three-vessel disease, LVEF <35%, congestive heart failure and diabetes. Adjusted comparison with PS between PCI with DES only and CABG confirmed significant differences in favour of CABG for mortality, MI and TVR rates. Competing risk analysis showed that the difference in the mortality rate was due to higher rate of MI in PCI. CONCLUSIONS: In the 'real-world' setting of this study, CABG was associated with significantly lower rates of death, MI and TVR in patients with LMCA or multivessel disease, so it remains the standard of care, particularly for patients with more extensive coronary disease and diabetes.

Emerging indications, in-hospital and long-term outcome of balloon aortic valvuloplasty in the transcatheter aortic valve implantation era.

AIMS: The introduction of transcatheter aortic valve implantation (TAVI) has generated a renewed interest in the treatment of high-risk patients with severe aortic stenosis. This study describes the indications and long-term outcome of balloon aortic valvuloplasty (BAV) in recent years. METHODS AND RESULTS: Between 2000 and 2010, 415 consecutive patients at our institution underwent BAV. The number of BAV per year increased sharply after the introduction of TAVI. Patients were 77.5±10.9 years old and showed important comorbidities (average logistic EuroSCORE=23.9±15.3%). We identified four cohorts according to the indications: 1) bridge for TAVI (B-TAVI; n=162); 2) bridge for aortic valve replacement (B-AVR, n=97); 3) cardiogenic shock (n=23); 4) palliation (n=133). Baseline characteristics were significantly different among groups. In-hospital mortality was 5.1%, and occurred predominantly in patients who underwent BAV in the setting of cardiogenic shock (56.5% vs. around 2% in the other subgroups). Other major events were stroke (0.5%), major vascular complications (2.2%), and life-threatening bleedings (1.5%). The cumulative one-year and two-year mortality rates were 33.2% and 57.4%, respectively, with the highest incidence in the shock group (70.7% and 80.4%) and the lowest in the B-AVR group (21.7% and 38.4%). Rehospitalisation for heart failure was 26.3% at one-year and 47.2% at two-year follow-up. CONCLUSIONS: The number of BAV is increasing, mainly due to increased referral of high-risk patients and to the emerging indication of bridge for TAVI. In this complex population, BAV is relatively safe but two-year survival remains poor, and more effective and definitive treatments should be pursued in a timely fashion.

Baseline white blood cell count is an independent predictor of long-term cardiovascular mortality in patients with non-ST-segment elevation acute coronary syndrome, but it does not improve the risk classification of the GRACE score.

OBJECTIVES: To investigate the prognostic significance of baseline white blood cell count (WBCc) in non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and its additive predictive value beyond the Global Registry of Acute Coronary Events (GRACE) score. METHODS: We included 1,315 consecutive NSTE-ACS patients. Patients were divided in quartiles according to the WBCc (cells per 1 mm(3)) i.e. Q1 <6,850, Q2 = 6,850-8,539, Q3 = 8,540-10,857 and Q4 ≥10,858. The study end point was 3-year cardiovascular death (CVD). RESULTS: The median age of the study population was 76 years. Overall, 335 patients (25.5%) died with 211 of these (16%) suffering from CVD. Patients in Q4 showed a higher cumulative probability of CVD compared to patients in Q1-Q3. On multivariable analysis, patients in Q4 were at higher risk of CVD [hazard ratio (HR) = 1.47, 95% confidence interval (CI) 1.09-1.98, p = 0.011]. WBCc as a continuous variable was also independently associated with the study end point (HR = 1.043; 95% CI 1.02-1.07; p = 0.001). However, the incorporation of WBCc into the GRACE score did not improve either prediction of risk (C-index = 0.796 for GRACE score with or without WBCc) or classification of risk [relative integrated discrimination improvement = 0.0154, 95% CI) -0.029 to 0.0618; continuous net reclassification improvement = -0.0676, 95% CI -0.2149-0.0738). CONCLUSIONS: WBCc was an independent predictor of 3-year CVD in patients with NSTE-ACS. However, it did not add prognostic information beyond the GRACE score.

Impact of COPD on long-term outcome after ST-segment elevation myocardial infarction receiving primary percutaneous coronary intervention.

BACKGROUND: There are limited data describing the long-term outcome of patients with concomitant COPD who develop ST-segment elevation myocardial infarction (STEMI). METHODS: A total of 11,118 consecutive patients with STEMI enrolled in the web-based Registro Regionale Angioplastiche Emilia-Romagna (REAL) registry were followed-up and stratified according to COPD presence or not. At 3-year follow-up, mortality and hospital readmissions due to myocardial infarction (MI), heart failure (HF), coronary revascularization (CR), serious bleeding, and COPD were assessed. RESULTS: According to our criteria, 2,032 patients (18.2%) had a diagnosis of COPD. Overall, 1,829 patients (16.5%) died. COPD was an independent predictor of mortality (hazard ratio [HR], 1.4; 95% CI, 1.2-1.6). Hospital readmissions for recurrent MI (10% vs 6.9%, P < .01), CR (22% vs 19%, P < .01), HF (10% vs 6.9%, P < .01), and SB (10% vs 6%, P < .01) were significantly more frequent in patients with COPD as compared with those without. Also, hospital readmissions for COPD were more frequent in patients with a previous history of COPD as compared with those without (19% vs 3%; P < .01, respectively). Patients with a hospital readmission for COPD showed a fourfold increased risk of death (HR, 4.2; 95% CI, 3.4-5.2). Finally, hospital readmissions for COPD emerged as a strong independent risk factor for recurrence of MI (HR, 2.1; 95% CI, 1.4-3.3), HF (HR, 5.8; 95% CI, 4.6-7.5), and SB (HR, 3; 95% CI, 2.1-4.4). CONCLUSIONS: Patients with STEMI and concomitant COPD are at greater risk for death and hospital readmissions due to cardiovascular causes (eg, recurrent MI, HF, bleedings) than patients without COPD.