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Background/purpose: The COBRA Polyzene F™ NanoCoated Coronary Stent System (PzF coated stent) stent demonstrated favorable clinical outcomes at 9 months but late results have not been reported. We sought to assess the late safety and effectiveness of the PzF coated stent for treatment of de novo coronary artery lesions.Methods: Patients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a non-randomized, prospective clinical trial and followed for 5 years. The primary endpoint was target vessel failure (TVF, cardiac death, myocardial infarction [MI], or clinically-driven target vessel revascularization [TVR]) at 9 months. Secondary endpoints included major adverse clinical events (MACE, cardiac death, MI, or clinically driven TLR), clinically driven target lesion revascularization (TLR) and definite or probable stent thrombosis during 5-year follow-up. Endpoints at 5 years were analyzed as cumulative incidence accounting for competing risk of death.Results: Of 296 enrolled patients, 290 (98%) were evaluable at 5 years. By 5 years, MACE had occurred in 61 (21.3%), cardiac death in 11 (4.2%), MI in 25 (8.6%), and TLR in 34 (12.0%) subjects. Between follow-up years 1 and 5, a first MACE occurred in 17 (6.2%), including 10 (4.0%) cardiac death, 4 (1.6%) MI, and 7 (2.9%) TLR events. There were no definite or probable stent thromboses.Conclusions: The PzF coated stent demonstrated continued safety and effectiveness through 5 years with low to very low incident rates of MACE, MI, TLR and stent thrombosis between 1 and 5 years after stent placement. [ABSTRACT FROM AUTHOR]

Objectives: To assess feasibility, safety and efficacy of hybrid approach, consisting in a combination of modern drug-eluting stent (DES) and drug-eluting balloon (DCB), for treatment of de-novo diffuse coronary artery disease (CAD).Backgrounds: Contemporary DES are associated with a persistent risk of major cardiovascular events, due to in-stent thrombosis and restenosis. The hybrid approach, reducing the permanent metallic cage length, is supposed to mitigate the risk of device-related adverse events, especially in diffuse CAD.Methods: This is a prospective, non-randomized, observational, multicenter study intended to obtain data from 100 consecutive patients affected by de-novo diffuse CAD undergoing percutaneous coronary intervention with a hybrid approach, consisting in the combined use of DES and DCB in contiguous coronary segments. The study is recorded in ClinicalTrials.gov with the identifier: NCT03939468.Results: The primary endpoint is a device oriented composite end-point (DOCE) of cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) in DES- and/or DCB-treated segment. DOCE will be assessed at 12-months follow-up.Conclusions: This will be the first study investigating the feasibility, safety and efficacy of hybrid DES/DCB approach for the treatment of de-novo diffuse CAD. Here we describe the rationale and the design of the study. [ABSTRACT FROM AUTHOR]

Background: When comparing effects of on- versus off-pump coronary artery bypass grafting (CABG), it is important to assess the long-term clinical outcomes. However, most research conducted thus far has concentrated on short-term outcomes and ignored the long-term clinical outcomes, especially the 5-year outcomes of the largest randomized controlled trials.Objectives: The aim of this systematic review and meta-analysis was to investigate the long-term clinical outcomes of on- versus off-pump CABG.Methods: To identify potential studies systematic searches were carried out using various databases. The search strategy included the key concepts of cardiopulmonary bypass AND off-pump AND long term OR 5-year outcomes. This was followed by a meta-analysis investigating mortality, incidence of myocardial infarction, incidence of angina, need for revascularization, and incidence of stroke.Results: Six studies totaling 8,145 participants were analyzed. In the on-pump group mortality was 12.3%, compared with 13.9% in the off-pump group. The odds ratio (OR) for this comparison was 1.16 (95% confidence interval [CI]: 1.02 to 1.32; p = 0.03; 13.9% vs. 12.3%). In contrast, there were no differences in the incidence of myocardial infarction (OR: 1.06: 95% CI: 0.91 to 1.25; p = 0.45; 8.4% vs. 7.9%), incidence of angina (OR: 1.09; 95% CI: 0.75 to 1.57; p = 0.65; 2.3% vs. 2.1%), need for revascularization (OR: 1.15; 95% CI: 0.95 to 1.40; p = 0.16; 5.9% vs. 5.1%), and the incidence of stroke (OR: 0.78; 95% CI: 0.56 to 1.10; p = 0.16; 2.2% vs. 2.8%).Conclusions: Statistically, on-pump CABG appeared to offer superior long-term survival, although the clinical significance of this may be more uncertain. [ABSTRACT FROM AUTHOR]

Background: Limited data are available on the relative performances between different types of drug-eluting stents (DES) for obstructive left main coronary artery disease (LMCAD).Objectives: This study sought to compare effectiveness and safety profiles of various second-generation DES for LMCAD in real-world clinical practice.Methods: Among 4,470 patients in 3, multicenter, prospective registries (IRIS-DES [Interventional Cardiology Research Incorporation Society-Drug-Eluting Stents] registry, the IRIS-MAIN [Interventional Cardiology Research Incorporation Society-Left MAIN Revascularization] registry, and the PRECOMBAT [PREmier of Randomized COMparison of Bypass Surgery versus AngioplasTy Using Drug-Eluting Stent in Patients with Left Main Coronary Artery Disease] study) treated between July 2007 and July 2015, the authors identified 2,692 patients with significant LMCAD who received second-generation DES; 1,254 with cobalt-chromium everolimus-eluting stents (CoCr-EES), 232 with biodegradable polymer biolimus-eluting stents (BP-BES), 616 with platinum-chromium EES (PtCr-EES), and 590 with Resolute zotarolimus-eluting stent (Re-ZES). The primary outcome was target-vessel failure.Results: The observed 3-year rates of target-vessel failure were not significantly different for the different types of DES (16.7% for the CoCr-EES, 13.2% for the BP-BES, 18.7% for the PtCr-EES, and 14.7% for the Re-ZES; p = 0.15). In multiple treatment propensity score analysis, the adjusted hazard ratios (HRs) for target-vessel failure were similar in between-group comparisons of the different DES, except for the PtCr-EES versus the BP-BES (reference; HR: 1.60; 95% confidence interval: 1.01 to 2.54; p = 0.046). There were no significant differences in risk of composite of all-cause death, any myocardial infarction, or any revascularization and its individual components according to the different types of DES. Although the 3-year incidence of stent thrombosis was considerably low (≤1.0%) for all types of DES, between-group differences were observed, generally favoring the EES platforms.Conclusions: In this pooled analysis of 3 prospective registries involving unrestricted use of various second-generation DES for LMCAD, we found no significant between-group differences in 3-year risk of target-vessel failure, except for a higher risk of primary outcome with PtCr-EES compared to BP-BES. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133). [ABSTRACT FROM AUTHOR]

Purpose: To investigate cardiac toxicity associated with breast radiation therapy (RT) at 10-year follow-up in BCIRG-001, a phase 3 trial comparing adjuvant anthracycline chemotherapy (fluorouracil, doxorubicin, and cyclophosphamide) with anthracycline-taxane chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) in women with lymph node-positive early breast cancer.Methods and Materials: Prospective data from all 746 patients in the control arm (fluorouracil, doxorubicin, and cyclophosphamide) of BCIRG-001 at 10-year follow-up were obtained from Project Data Sphere. Cardiac toxicities examined included myocardial infarction (MI), heart failure (HF), arrhythmias, and relative and absolute left ventricular ejection fraction decrease of >20% from baseline. Toxicities were compared between patients who received RT versus no RT, left-sided RT versus no RT, and internal mammary nodal RT versus no RT.Results: Of the 746 patients, 559 (75%) received RT to a median dose of 50 Gy. Myocardial infarction occurred in 3 RT patients (0.5%) versus 6 no-RT patients (3%) (P=.01). Heart failure was seen in 15 RT patients (2.7%) versus 3 no-RT patients (1.6%) (P=.6). Among these, 35 RT patients (18%) had a left ventricular ejection fraction relative decrease of >20% baseline versus 7 (10%) who did not receive RT (P=.1). Arrhythmias were more common in RT patients (3.2%) versus no-RT patients (0%) (P=.01). On univariable and multivariable analysis HF was not significantly associated with RT, and MI was negatively associated with RT.Conclusions: In this retrospective analysis of prospective toxicity outcomes, there is an increased risk of arrhythmias but no clear evidence of significantly increased risk of MI or HF at 10 years in lymph node-positive women treated with breast RT and uniform adjuvant doxorubicin-based chemotherapy. Given the low incidence of these outcomes, studies with larger numbers are needed to confirm our findings. [ABSTRACT FROM AUTHOR]

Background: Cardiac troponin (T and I) are considered the standard markers for detection of myocardial damage and the diagnosis of acute coronary syndrome (ACS) among patients who present to an emergency department with chest pain. However, these markers can be released in other situations and may be associated with short- and long-term clinical outcomes. In this study, we examine late mortality rates among patients presenting with a suspected ACS due to an unstable coronary plaque and those patients having a non-ACS.Methods: 4388 patients were hospitalised with suspected ACS, between 14 and 27 May 2012 in the Australia and New Zealand SNAPSHOT ACS study. Those patients were categorised in five diagnostic groups: 1) ST elevation MI (n=419); 2) non-ST elevation MI (n=1012); 3) unstable angina (n=925); 4) non-ACS diagnoses (n=837); and 5) chest pain considered unlikely ischaemic (not otherwise specified, n=1195).Result: The respective mortality rates at 18 months in these groups were 16.2%, 16.3%, 6.8%, 12.8%, and 4.8%; Pearson χ2=110 p<0.001. Among non-ACS diagnoses patients (group 4) those with the highest mortality rates (cardiac (14.4%), respiratory (18.2%), sepsis (15.4%) and neoplastic (67%) diagnoses) had the highest rates of elevated troponin levels (48%, 31%, 38% and 67% respectively). By contrast, those with the lowest mortality rates (musculoskeletal (2.9%), gastrointestinal disorders (3.9%) and non-specific chest pain (7.4%)) had the lowest rate of elevated troponin levels (9%, 18% and 15.8% respectively). However, after adjusting for baseline clinical and demographic characteristics, the mortality rate at 18 months for patients with elevated troponin was similar for ACS or non-ACS diagnoses (Hazard Ratio, 95% C.I.0.98-1.07, p=0.333).Conclusions: Among patients in the 2012 SNAPSHOT ACS study, non-ACS diagnoses characterised by high rates of elevated troponin levels had high mortality rates similar to those diagnosed with ACS. Therapies known to be effective in ACS patients, including early invasive management, should be examined in these non-ACS patients with troponin elevations within adequately powered randomised trials. [ABSTRACT FROM AUTHOR]

Background: In patients with a myocardial infarction (MI) 1 to 3 years earlier, treatment with ticagrelor + low-dose aspirin (ASA) reduces the risk of cardiovascular (CV) death, MI, or stroke compared with low-dose aspirin alone, but at an increased risk of major bleeding.Objectives: The authors evaluated cost-effectiveness of ticagrelor + low-dose ASA in patients with prior MI within the prior 3 years.Methods: The authors performed a prospective economic substudy alongside the PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis In Myocardial Infarction 54) trial, which randomized 21,162 patients to ASA alone, ticagrelor 60 mg twice daily + low-dose ASA, or ticagrelor 90 mg twice daily + low-dose ASA. Medical resource use data were collected over a median 33-month follow-up. Costs were assessed from the U.S. health care system perspective. In-trial data relating to survival, utility, and costs were combined with lifetime projections to evaluate lifetime cost-effectiveness of the Food and Drug Administration-approved lower-dose ticagrelor regimen (60 mg twice daily).Results: Hospitalization costs were similar for ticagrelor 60 mg and placebo ($2,262 vs. $2,333; 95% confidence interval for difference -$303 to $163; p = 0.54); after inclusion of a daily ticagrelor 60 mg cost of $10.52, total costs were higher for ticagrelor ($10,016 vs. $2,333; 95% CI: $7,441 to $7,930; p < 0.001). In-trial quality-adjusted life-years (QALYs) were similar (2.28 vs. 2.27; p = 0.34). Over a lifetime horizon, ticagrelor was associated with QALY gains of 0.078 and incremental costs of $7,435, yielding an incremental cost-effectiveness ratio (ICER) of $94,917/QALY gained. Several high-risk groups had more favorable ICERs, including patients with >1 prior MI, multivessel disease, diabetes, renal dysfunction (all with ICERs $50,000 to $70,000/QALY gained), patients age <75 years (ICER = $44,779/QALY gained), and patients with peripheral artery disease (ICER = $13,427/QALY gained).Conclusions: For patients with a history of MI >1 year previously, long-term treatment with ticagrelor 60 mg + low-dose ASA yields a cost-effectiveness ratio suggesting intermediate value based on current guidelines. Ticagrelor appears to provide higher value for patients in several recognized high-risk subgroups. (Prevention of Cardiovascular Events [e.g., Death From Heart or Vascular Disease, Heart Attack, or Stroke] in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin [PEGASUS]; NCT01225562). [ABSTRACT FROM AUTHOR]

Background: Spontaneous coronary artery dissection (SCAD) is the most common cause of pregnancy-associated myocardial infarction and remains poorly characterized.Objectives: This study sought to assess presentation, clinical factors, and outcomes of pregnancy-associated spontaneous coronary artery dissection (P-SCAD) compared with spontaneous coronary artery dissection not associated with pregnancy (NP-SCAD).Methods: A Mayo Clinic registry was established in 2010 to include comprehensive retrospective and prospective SCAD data. Records were reviewed to identify women who were pregnant or ≤12 weeks postpartum at time of SCAD. Complete records were available for 323 women; 54 women met criteria for P-SCAD (4 during pregnancy) and they were compared with 269 women with NP-SCAD.Results: Most events occurred within the first month postpartum (35 of 50). Compared with NP-SCAD, P-SCAD patients more frequently presented with ST-segment elevation myocardial infarction (57% vs. 36%; p = 0.009), left main or multivessel SCAD (24% vs. 5%; p < 0.0001; and 33% vs. 14%; p = 0.0027, respectively), and left ventricular function ≤35% (26% vs. 10%; p = 0.0071). Among women with imaging of other vascular territories, P-SCAD was less likely with a diagnosis of fibromuscular dysplasia and extracoronary vascular abnormalities (42% vs. 64%; p = 0.047; and 46% vs. 77%; p = 0.0032, respectively). Compared with U.S. birth data, women with P-SCAD were more often multiparous (p = 0.0167), had a history of infertility therapies (p = 0.0004), and had pre-eclampsia (p = 0.001). On long-term follow-up (median 2.3 years) recurrent SCAD occurred in 51 patients, with no difference in the Kaplan Meier 5-year recurrence rates (10% vs. 23%; p = 0.18).Conclusions: P-SCAD patients had more acute presentations and high-risk features than women with NP-SCAD did. The highest frequency of P-SCAD occurred during the first postpartum month and P-SCAD patients less often had extracoronary vascular abnormalities. Hormonal, hemodynamic variations, and yet-undefined mechanisms might be significant contributors to P-SCAD. (The "Virtual" Multicenter Spontaneous Coronary Artery Dissection [SCAD] Registry [SCAD]; NCT01429727; Genetic Investigations in Spontaneous Coronary Artery Dissection [SCAD]; NCT01427179). [ABSTRACT FROM AUTHOR]

Background: Lipid-rich plaque (LRP) is thought to be a precursor to cardiac events. However, its clinical significance in coronary arteries has never been systematically investigated.Objectives: This study investigated the prevalence and clinical significance of LRP in the nonculprit region of the target vessel in patients undergoing percutaneous coronary intervention (PCI).Methods: The study included 1,474 patients from 20 sites across 6 countries undergoing PCI, who had optical coherence tomography (OCT) imaging of the target vessel. Major adverse cardiac events (MACE) were defined as a composite of cardiac death, acute myocardial infarction, and ischemia-driven revascularization. Patients were followed for up to 4 years (median of 2 years).Results: Lipid-rich plaque was detected in nonculprit regions of the target vessel in 33.6% of patients. The cumulative rate of nonculprit lesion-related MACE (NC-MACE) over 48 months in patients with LRP was higher than in those without LRP (7.2% vs. 2.6%, respectively; p = 0.033). Acute coronary syndrome at index presentation (risk ratio: 2.538; 95% confidence interval [CI]: 1.246 to 5.173; p = 0.010), interruption of statin use ≥1 year (risk ratio: 4.517; 95% CI: 1.923 to 10.610; p = 0.001), and LRP in nonculprit regions (risk ratio: 2.061; 95% CI: 1.050 to 4.044; p = 0.036) were independently associated with increased NC-MACE. Optical coherence tomography findings revealed that LRP in patients with NC-MACE had longer lipid lengths (p < 0.001), wider maximal lipid arcs (p = 0.023), and smaller minimal lumen areas (p = 0.003) than LRPs in patients without MACE.Conclusions: Presence of LRP in the nonculprit regions of the target vessel by OCT predicts increased risk for future NC-MACE, which is primarily driven by revascularization for recurrent ischemia. Lipid-rich plaque with longer lipid length, wider lipid arc, and higher degree of stenosis identified patients at higher risk of future cardiac events. (The Massachusetts General Hospital Optical Coherence Tomography Registry; NCT01110538). [ABSTRACT FROM AUTHOR]

Background: To determine the rate of all cause and cardiac death, new myocardial infarction (MI) or coronary revascularisation at over three years from index visit in emergency department chest pain patients without known coronary artery disease (CAD) at index presentation who had a negative electrocardiogram (ECG) and biomarker workup for acute coronary syndrome (ACS).Methods: An unplanned sub-study of a prospective observational study of consecutive adult patients presenting to the ED with atraumatic chest pain (or equivalents). The primary outcome of interest was the predictive performance of a negative ECG and biomarker work-up for ACS for all cause and cardiac mortality over more than three years' follow-up in patients not known to have pre-existing CAD presenting to the ED with chest pain. Secondary outcomes were rate of new MI or revascularisation not related to the index visit.Results: 237 patients were studied. Median age was 52 years (IQR 42 - 62) and 55.3% were male. Median follow-up was 48 months. There were seven deaths (3%, 95% CI 1.4 - 6%), one of which was potentially cardiac in origin with cause of death given as pulmonary hypertension and cardiac failure (0.4%, 95% CI 0.02 - 2.3%). There was one confirmed MI (0.6%, 95% CI 0.03 - 3.8%). The rate of revascularisation not related to the index visit was 3.1% (95% CI 1.1 - 7.4%).Conclusion: Patients who present to ED with potentially cardiac chest pain but who do not have known CAD, and have non-ischaemic ECGs and troponin assays below the 99th percentile are at low risk of cardiac death or MI in long-term follow-up. This challenges the recommendation for routine functional or anatomic testing. [ABSTRACT FROM AUTHOR]

Background: First-generation drug-eluting coronary stents (DES) were introduced in 2003 to 2004, and their use resulted in a considerable reduction in the development of in-stent restenosis at the cost of an increased risk of late stent thromboses.Objectives: This study followed clinical outcomes of patients included in a large randomized trial for 10 years to enable detection of late changes in annual event rates that could necessitate medical attention.Methods: A total of 2,098 unselected all-comer patients (50% with acute coronary syndrome) were randomly assigned to have a first-generation DES implanted. This study recorded the occurrence of a major adverse cardiac event (MACE) assessed as the composite of cardiac death, myocardial infarction, and target vessel revascularization. Stent thromboses were also assessed.Results: Of the 2,098 unselected patients, 73.1% were still alive after 10 years. During the follow-up period, MACE occurred in 346 (32.5%) in the group receiving a sirolimus-eluting stent and in 342 (33.1%) in the group receiving a paclitaxel-eluting stent (hazard ratio: 0.96; 95% confidence interval: 0.83 to 1.11; p = 0.60), with a steady annual rate of 2.6% after the first year. Definite, probable, and possible stent thrombosis appeared in 279 patients (13.3%), with no difference between stent types and with a steady annual rate of 1.3% after the first year.Conclusions: Among the surviving patients, the long-term annual MACE rate and the stent thrombosis rate appeared constant for both stent types, with no apparent late changes. Although there is no need for extraordinary medical attention for these patients, the absence of declines in annual event rates calls for continuous surveillance. (Danish Organization on Randomized Trials With Clinical Outcome II [SORT OUT II]; NCT00388934). [ABSTRACT FROM AUTHOR]

Objective: To examine the impact of androgen deprivation therapy (ADT) and primary treatment modality on cardiovascular and skeletal-related events and to investigate potential effect modification in a contemporary cohort of patients treated for clinically localized prostate cancer.Subjects and Methods: We conducted a retrospective cohort study using Surveillance, Epidemiology, and End Results-Medicare linked databases for men aged 65-79 years who underwent radical prostatectomy or radiotherapy for cT1 or cT2 prostate cancer from 2000 to 2008. We categorized treatment according to primary therapy and receipt of ADT. We described the cumulative incidence of cardiovascular and skeletal-related events.Results: Among 60,156 men, 14,403 underwent surgery and 45,753 underwent radiotherapy. Median follow-up was 6.0 years. After adjusting for baseline differences, treatments with radiotherapy (adjusted hazard ratios [aHR] 1.16-1.28, P <.0001-.04) and ADT (aHR 1.18-1.32, P <.0001-.008) were each independently associated with increased risk of coronary heart disease, sudden cardiac death, fracture, and fracture requiring hospitalization. Radiotherapy was associated with an increased risk of myocardial infarction (aHR 1.20, P = .02), whereas ADT was not (P = .5). We did not identify a significant statistical interaction between primary and hormonal treatment.Conclusion: Care for cardiovascular and skeletal-related events is an important part of the survivorship phase for a significant proportion of patients with localized prostate cancer. Increasing use of ADT for patients with localized disease undergoing radiotherapy and the observed higher prevalence of these events in these patients should be considered when discussing the risks and benefits of treatment for localized prostate cancer and when formulating a survivorship plan. [ABSTRACT FROM AUTHOR]

Background: Acute heart failure (HF) associated with an acute coronary syndrome (ACS) predicts adverse outcome. There have been important recent improvements in ACS management. Our aim was to describe the management and outcomes in those with and without HF in a contemporary ACS cohort.Methods: Consecutive patients presenting with ACS between 2007 and 2011 were enrolled in the All New Zealand Acute Coronary Syndrome Quality Improvement (ANZACS-QI) registry. Outcomes and medication dispensing were obtained using anonymised linkage to national data sets. A summary pharmacotherapy measure of "quadruple therapy" was defined as dispensing of at least one agent from each of the four evidence-based classes - anti-platelet, statin, angiotensin converting enzyme inhibitor/angiotensin receptor blocker and beta blocker.Results: Of 3743 ACS patients 14% had acute HF. Acute heart failure patients were older (69.2±12.6 vs 62.3±12.8 years, p<0.001), less likely to have coronary angiography (66% vs 86%, p<0.001) and revascularisation (46% vs 62%, p<0.001). Immediate post-discharge quadruple therapy was higher for those with than without HF (61% vs 55%, p=0.02) but fell to similar levels by one-year (45% vs 53%, p=0.55). At four years follow-up nearly half of those presenting with ACS and HF had died. After adjustment, HF remained a strong predictor of death within 28 days (OR 2.9, 95%CI 1.5 - 5.5) and beyond 28 days (HR 1.8, 95%CI 1.5 - 2.3).Conclusion: Acute heart failure complicating ACS is associated with heightened risk of short-term and long-term mortality. One in three ACS patients with HF did not have coronary angiography and less than half received quadruple therapy a year after presentation. [ABSTRACT FROM AUTHOR]

Background: Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited and additional interventional approaches are required.Objectives: This study sought to report the safety and performance data from the feasibility study with a novel direct annuloplasty system.Methods: Seventy-one patients with moderate to severe FMR (mean 67.7 ± 11.3 years of age, left ventricular [LV] ejection fraction 34.0 ± 8.3%), on stable medical heart failure medication were prospectively enrolled.Results: Device success rate was 70.4% (n = 50 of 71). No intraprocedural death occurred. In patients receiving implants, 4 patients (8.9%) experienced cardiac tamponade. Thirty-day (n = 45) and 6-month (n = 41) rates for all-cause mortality, stroke, and myocardial infarction were 4.4%, 4.4%, and 0.0% and 12.2%, 4.9%, and 0%, respectively. At 6 months, nonurgent mitral surgery was performed in 1 patient (2.4%) and nonurgent percutaneous repair in 7 patients (17.1%). Echocardiographic core analysis after 6 months showed mitral regurgitation reduction in 50% of treated patients by a mean of 1.3 grades. Concerning mitral valve (MV) annular geometry, we found significant reduction of anterior-posterior (-0.31 ± 0.4 cm) and septal-lateral dimensions (-0.21 ± 0.3 cm), a decreased MV-tenting area (-0.57 ± 1.1 cm(2)) and increase in MV coaptation length (0.13 ± 0.2 cm). Transthoracic echocardiography indicated reverse LV remodeling with reduction of LV end-diastolic diameter (-0.20 ± 0.4 mm) and volume (-22 ± 39 ml). Treatment was associated with significant improvement in 6-min walking distances (56.5 ± 92.0 m) and improvements in New York Heart Association functional class III/IV at 6 months from 53.3% to 23.3%.Conclusions: Percutaneous direct annuloplasty is feasible and safe in high-risk FMR patients. This treatment initiates LV reverse remodeling, and provides clinical improvement during 6 months after treatment. (Mitralign Percutaneous Annuloplasty First in Man Study; NCT01852149). [ABSTRACT FROM AUTHOR]

Background: Mineralocorticoid receptor antagonists (MRA) improve outcome in the setting of post-myocardial infarction (MI) heart failure (HF).Objectives: The study sought to assess the benefit of an early MRA regimen in acute MI irrespective of the presence of HF or left ventricular (LV) dysfunction.Methods: We randomized 1,603 patients to receive an MRA regimen with a single intravenous bolus of potassium canrenoate (200 mg) followed by oral spironolactone (25 mg once daily) for 6 months in addition to standard therapy or standard therapy alone. The primary outcome of the study was the composite of death, resuscitated cardiac arrest, significant ventricular arrhythmia, indication for implantable defibrillator, or new or worsening HF at 6-month follow-up. Key secondary/safety outcomes included death and other individual components of the primary outcome and rates of hyperkalemia at 6 months.Results: The primary outcome occurred in 95 (11.8%) and 98 (12.2%) patients in the treatment and control groups, respectively (hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.73 to 1.28). Death occurred in 11 (1.4%) and 17 (2.1%) patients in the treatment and control groups, respectively (HR: 0.65; 95% CI: 0.30 to 1.38). In a non-pre-specified exploratory analysis, the odds of death were reduced in the treatment group (3 [0.5%] vs. 15 [2.4%]; HR: 0.20; 95% CI: 0.06 to 0.70) in the subgroup of ST-segment elevation MI (n = 1,229), but not in non-ST-segment elevation MI (p for interaction = 0.01). Hyperkalemia >5.5 mmol/l(-1) occurred in 3% and 0.2% of patients in the treatment and standard therapy groups, respectively (p < 0.0001).Conclusions: The study failed to show the benefit of early MRA use in addition to standard therapy in patients admitted for MI. (Aldosterone Lethal effects Blockade in Acute myocardial infarction Treated with or without Reperfusion to improve Outcome and Survival at Six months follow-up; NCT01059136). [ABSTRACT FROM AUTHOR]

Background: Prompt reperfusion in patients with ST-segment elevation myocardial infarction (STEMI) reduces infarct size and improves survival. However, the intuitive link between infarct size and prognosis has not been convincingly demonstrated in the contemporary era.Objectives: This study sought to determine the strength of the relationship between infarct size assessed early after primary percutaneous coronary intervention (PCI) in STEMI and subsequent all-cause mortality, reinfarction, and hospitalization for heart failure.Methods: We performed a pooled patient-level analysis from 10 randomized primary PCI trials (total 2,632 patients) in which infarct size was assessed within 1 month after randomization by either cardiac magnetic resonance (CMR) imaging or technetium-99m sestamibi single-photon emission computed tomography (SPECT), with clinical follow-up for ≥ 6 months.Results: Infarct size was assessed by CMR in 1,889 patients (71.8%) and by SPECT in 743 patients (28.2%). Median (25th, 75th percentile) time to infarct size measurement was 4 days (3, 10 days) after STEMI. Median infarct size (% left ventricular myocardial mass) was 17.9% (8.0%, 29.8%), and median duration of clinical follow-up was 352 days (185, 371 days). The Kaplan-Meier estimated 1-year rates of all-cause mortality, reinfarction, and HF hospitalization were 2.2%, 2.5%, and 2.6%, respectively. A strong graded response was present between infarct size (per 5% increase) and subsequent mortality (Cox-adjusted hazard ratio: 1.19 [95% confidence interval: 1.18 to 1.20]; p < 0.0001) and hospitalization for heart failure (adjusted hazard ratio: 1.20 [95% confidence interval: 1.19 to 1.21]; p < 0.0001), independent of age, sex, diabetes, hypertension, hyperlipidemia, current smoking, left anterior descending versus non-left anterior descending infarct vessel, symptom-to-first device time, and baseline TIMI (Thrombolysis In Myocardial Infarction) flow 0/1 versus 2/3. Infarct size was not significantly related to subsequent reinfarction.Conclusions: Infarct size, measured by CMR or technetium-99m sestamibi SPECT within 1 month after primary PCI, is strongly associated with all-cause mortality and hospitalization for HF within 1 year. Infarct size may, therefore, be useful as an endpoint in clinical trials and as an important prognostic measure when caring for patients with STEMI. [ABSTRACT FROM AUTHOR]

Background: Patients with acute coronary syndrome (ACS), especially those receiving medical management without revascularization, are at high risk for spontaneous myocardial infarction (MI), but its frequency and predictors are unknown.Objectives: This study sought to characterize spontaneous MI events in a randomized population during 30 months of follow-up and develop a prediction model for spontaneous MI to assign risk of spontaneous MI events in ACS populations.Methods: We analyzed data from the randomized TRILOGY ACS (TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medically manage Acute Coronary Syndromes) trial of aspirin plus prasugrel or clopidogrel following ACS. The trial included 9,326 patients with non-ST-segment elevation myocardial infarction (NSTEMI)/unstable angina (UA) who were managed medically without planned revascularization. Our study population included 9,294 patients. A multivariable Cox proportional hazards model was developed to determine predictors of time to first spontaneous MI event through 30 months. After model validation, we developed a calculator for model implementation.Results: Among 9,294 patients, 695 spontaneous MI events occurred over a median of 17 months, representing 94% of adjudicated MI events (n = 737). The Kaplan-Meier event rate of spontaneous MI through 30 months was 10.7%. The strongest predictors of spontaneous MI were older age, NSTEMI versus UA as index event, diabetes mellitus, no pre-randomization angiography, and higher baseline creatinine values. The model exhibited good predictive capabilities (c-index = 0.732) and had good calibration, especially for patients with low-to-moderate risk of spontaneous MI.Conclusions: Spontaneous MI following a medically managed UA/NSTEMI event is common. Baseline characteristics can be used to predict subsequent risk of spontaneous MI in this population. These findings provide insight into the long-term natural history of medically managed UA/NSTEMI patients and could be used to optimize risk stratification and treatment of these patients. (A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects [TRILOGY ACS]; NCT00699998). [ABSTRACT FROM AUTHOR]

Background: Our previous study showed that patients with acute myocardial infarction (AMI) had lower levels of vaspin than patients without AMI. The aim of this study was to investigate the clinical significance of vaspin in patients with AMI.Methods: A total of 80 patients with AMI were enrolled. Plasma vaspin levels, clinical parameters, lipid profile, C reactive protein (CRP) were measured. All the patients were followed-up for 24±2 months for the occurrence of major adverse major cardiac events (MACEs).Results: During the follow-up, 48 patients experienced a MACE. The plasma vaspin concentrations in the MACEs-positive group were lower than those in the MACEs-negative group (0.156 ± 0.015 vs 0.314 ± 0.229ng/mL, p<0.001). Receiver operating characteristic curves showed that circulating vaspin concentration significantly differentiated patients with MACEs (p<0.001). The optimal cutoff value for predicting MACE was 0.259ng/mL. Then the patients were divided into vaspin>0.259ng/mL group and vaspin<0.259ng/mL group according to the plasma vaspin levels. Forty-five patients (74%) in the vaspin<0.259ng/mL group and three (16%) patients in the vaspin>0.259ng/mL group experienced a MACE. Multivariate survival analyses showed that the vaspin level (hazard ratio, HR 0.423) independently predicted the occurrence of MACEs. Compared with the results of echocardiography at admission, the improvement of LVEF in the vaspin>0.259ng/mL group was significant (54.3±7.6% to 61.2±4.7%, p<0.001), but the change of LVEF in the low vaspin group was not significant (51.3±9.7% to 52.5±10.9%).Conclusions: Vaspin might be a useful predictive biomarker in patients with AMI, and patients with low vaspin levels might have a high risk of a MACE. In addition, vaspin might have protective effects on the improvement of LVEF after AMI. [ABSTRACT FROM AUTHOR]

Background: Whether cyclosporine A (CsA) has beneficial effects in reperfused myocardial infarction (MI) is debated.Objectives: This study investigated whether CsA improved ST-segment resolution in a randomized, multicenter phase II study.Methods: The authors randomly assigned 410 patients from 31 cardiac care units, age 63 ± 12 years, with large ST-segment elevation MI within 6 h of symptom onset, Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 to 1 in the infarct-related artery, and committed to primary percutaneous coronary intervention, to 2.5 mg/kg intravenous CsA (n = 207) or control (n = 203) groups. The primary endpoint was incidence of ≥70% ST-segment resolution 60 min after TIMI flow grade 3. Secondary endpoints included high-sensitivity cardiac troponin T (hs-cTnT) on day 4, left ventricular (LV) remodeling, and clinical events at 6-month follow-up.Results: Time from symptom onset to first antegrade flow was 180 ± 67 min; a median of 5 electrocardiography leads showed ST-segment deviation (quartile [Q]1 to Q3: 4 to 6); 49.8% of MIs were anterior. ST-segment resolution ≥70% was found in 52.0% of CsA patients and 49.0% of controls (p = 0.55). Median hs-cTnT on day 4 was 2,160 (Q1 to Q3: 1,087 to 3,274) ng/l in CsA and 2,068 (1,117 to 3,690) ng/l in controls (p = 0.85). The 2 groups did not differ in LV ejection fraction on day 4 and at 6 months. Infarct site did not influence CsA efficacy. There were no acute allergic reactions or nonsignificant excesses of 6-month mortality (5.7% CsA vs. 3.2% controls, p = 0.17) or cardiogenic shock (2.4% CsA vs. 1.5% controls, p = 0.33).Conclusions: In the CYCLE (CYCLosporinE A in Reperfused Acute Myocardial Infarction) trial, a single intravenous CsA bolus just before primary percutaneous coronary intervention had no effect on ST-segment resolution or hs-cTnT, and did not improve clinical outcomes or LV remodeling up to 6 months. (CYCLosporinE A in Reperfused Acute Myocardial Infarction [CYCLE]; NCT01650662; EudraCT number 2011-002876-18). [ABSTRACT FROM AUTHOR]

Background: Cohort studies of STEMI patients have reported that over 30% receive no reperfusion. Barriers to greater use of reperfusion in STEMI patients require further elucidation.Methods: We collected data on STEMI patients with no reperfusion as part of the SNAPSHOT ACS Registry, which recruited consecutive ACS patients in 478 hospitals throughout Australia and New Zealand during 14-27 May 2012.Results: Of 4387 patients enrolled, 419 were diagnosed with STEMI. Primary PCI (PPCI) was performed in 160 (38.2%), fibrinolysis was used in 105 (25.1%), and 154 (36.7%) had no reperfusion. Patients with no reperfusion had a mean age of 70.3±15.0 years compared with 63.1±13.5 in the reperfusion group (p<0.0001). There were more females in the no reperfusion group (37.1% v 23.0% p=0.002) and they were significantly more likely to have prior PCI or CABG, heart failure, atrial fibrillation, chronic kidney disease and other vascular disease, and to be nursing home residents (all p<0.05). Patients without reperfusion had a significantly higher mortality in hospital (11.7% v 4.9%, p=0.011). In 370 patients who presented within 12hours, 28 had early angiography without PCI, which was considered an attempt at reperfusion. Therefore reperfusion was attempted in 293 of 370 eligible patients (79.2%).Conclusion: Of consecutive STEMI patients, 36.7% did not receive any reperfusion and they had a higher risk of death in hospital. In eligible patients, reperfusion was attempted in 79.2%. National strategies to encourage earlier medical contact and greater use of reperfusion in eligible patients may lead to better outcomes. [ABSTRACT FROM AUTHOR]

Background: Acute myocardial infarction (AMI) has poorer outcomes in disadvantaged populations such as those in regional and remote locations. We compared long-term outcomes associated with presentation to regional or remote hospitals among AMI patients.Methods and Results: Administrative claims data from New South Wales (27% regional and remote residents) was used to identify patients >18 years admitted to any NSW hospital with a principal diagnosis of AMI (ICD10 codes: I21·0-I21·4) between 01/07/2004 and 30/06/2008. Hospital of presentation location with a population of <250,000 was defined as regional and remote while hospitals with a population >250,000 were deemed urban. Receipt of revascularisation and mortality were analysed and adjusted for age, comorbidities and previous revascularisation. Patients were censored at death or end of the follow-up period (31 December 2009). 39,798 patients were identified with 9,393 (23.6%) regional and remote presenters. In multivariable models, regional and remote presentation was associated with reduced rates of revascularisation (OR 0.30 95%CI 0.28-0.32; p<0.001), no impact on overall mortality (HR 1.04 95%CI 0.99-1.02; p=0.11), but with increased mortality for patients presenting with STEMI (HR 1.14; 95% CI 1.06-1.23; p<0.001). The propensity analysis was consistent with these findings.Conclusions: Presentation to a regional and remote hospital was associated with lower revascularisation rates following AMI, but with a higher long-term mortality if presenting with ST segment elevation. [ABSTRACT FROM AUTHOR]

Background: Complete revascularization may improve outcomes compared with an infarct-related artery (IRA)-only strategy in patients being treated with primary percutaneous coronary intervention (PPCI) who have multivessel disease presenting with ST-segment elevation myocardial infarction (STEMI). However, there is concern that non-IRA PCI may cause additional non-IRA myocardial infarction (MI).Objectives: This study sought to determine whether in-hospital complete revascularization was associated with increased total infarct size compared with an IRA-only strategy.Methods: This multicenter prospective, randomized, open-label, blinded endpoint clinical trial evaluated STEMI patients with multivessel disease having PPCI within 12 h of symptom onset. Patients were randomized to either IRA-only PCI or complete in-hospital revascularization. Contrast-enhanced cardiovascular magnetic resonance (CMR) was performed following PPCI (median day 3) and stress CMR at 9 months. The pre-specified primary endpoint was infarct size on pre-discharge CMR. The study had 80% power to detect a 4% difference in infarct size with 100 patients per group.Results: Of the 296 patients in the main trial, 205 participated in the CMR substudy, and 203 patients (98 complete revascularization and 105 IRA-only) completed the pre-discharge CMR. The groups were well-matched. Total infarct size (median, interquartile range) was similar to IRA-only revascularization: 13.5% (6.2% to 21.9%) versus complete revascularization, 12.6% (7.2% to 22.6%) of left ventricular mass, p = 0.57 (95% confidence interval for difference in geometric means 0.82 to 1.41). The complete revascularization group had an increase in non-IRA MI on the pre-discharge CMR (22 of 98 vs. 11 of 105, p = 0.02). There was no difference in total infarct size or ischemic burden between treatment groups at follow-up CMR.Conclusions: Multivessel PCI in the setting of STEMI leads to a small increase in CMR-detected non-IRA MI, but total infarct size was not significantly different from an IRA-only revascularization strategy. (Complete Versus Lesion-Only Primary PCI Pilot Study [CvLPRIT]; ISRCTN70913605). [ABSTRACT FROM AUTHOR]

Background: To investigate the efficacy and safety of low-dose tirofiban in elderly patients undergoing primary percutaneous coronary intervention (PPCI) for acute myocardial infarction (AMI).Methods: One hundred and four patients aged 70 years and above undergoing PPCI for AMI were divided into control (n=52) and study (n=52) groups. All patients received bolus intracoronary injection of tirofiban (10μg/kg), which was followed by intravenous infusion at 0.15μg/kg/min in the control group and at 0.075μg/kg/min in the study group for 24h.Results: There was no statistically significant difference between the study group and the control group in patients with complete ST segment resolution (84.2% vs. 85.7%, P=0.851), peak high-sensitive cardiac troponin T level (5.1±1.9 vs. 5.8±2.6μg/L, P=0.123), scores of thrombus in the infarct-related artery (0.98±0.51 vs. 1.12±0.59, P=0.214), and patients with TIMI grade 3 flow (86.0% vs. 88.2%, P=0.737) after PPCI. There were no statistically significant differences between the two groups in left ventricular ejection fraction (57.1±6.3 vs. 57.7±6.1, P=0.611) and composite major adverse cardiovascular events rate (P =0.778) at 90 days after PCI. The total bleeding rate in the study group was lower than in the control group (P=0.048).Conclusion: In elderly patients with AMI undergoing primary PCI, low and standard dose of tirofiban exerts similar effects on platelet aggregation, coronary flow, infarct size, left ventricular systolic function and short-term clinical outcomes. Low dose regimen is associated with a lower bleeding rate than the standard dose. [ABSTRACT FROM AUTHOR]