Impact of angiographic coronary artery disease complexity on ischemic and bleeding risks and on the comparative effectiveness of zotarolimus-eluting vs. bare-metal stents in uncertain drug-eluting stent candidates.

BACKGROUND: The impact of coronary artery disease (CAD) extension/complexity on outcomes and on the comparative benefits/risks of zotarolimus-eluting stent (ZES) versus bare-metal stents (BMS) remains unclear in patients at high risk of bleeding or thrombosis or at low restenosis risk. METHODS: We performed a post-hoc analysis of the ZEUS trial. The impact of coronary anatomic complexity measured by the SYNTAX score on the differences in outcomes following ZES and BMS was assessed at 1 year. RESULTS: The mean SYNTAX score was 16.3 ±â€¯13.1 with a median of 12 (IQR: 7 to 22). We stratified patients according to SYNTAX tertiles (0-8: n = 563; >8-19 n = 532; >19: n = 511), and observed that the higher the score, the correspondingly higher was the rate of the primary endpoint of major adverse cardiovascular events (MACE) and other ischemic events, but not bleeding after adjustment. The superior efficacy of ZES versus BMS for MACE was consistent across SYNTAX tertiles (tertile 1: HR 0.71, 95% CI 0.44-1.13; tertile 2: HR 0.71, 95% CI 0.46-1.09; tertile 3: HR 0.83, 95% CI 0.61-1.10) without significant heterogeneity (p for trend = 0.55). This between-groups difference mainly reflected a reduction in MI and TVR without effect on mortality. There was no significant interaction between the SYNTAX score and allocated stent type with respect to ischemic and bleeding endpoints. CONCLUSIONS: The SYNTAX score was predictor of major adverse cardiovascular events but not bleeding and ZES provided superior efficacy and safety than BMS across the whole spectrum of CAD complexity. SYNTAX score may be routinely used for the assessment of the ischemic risk (but not bleeding) after PCI and should not guide the decision-making for DES versus BMS in patients undergoing PCI.

Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention?: A Pre-Specified Analysis From the ZEUS Trial.

OBJECTIVES: This study sought to investigate the ischemic and bleeding outcomes of patients fulfilling high bleeding risk (HBR) criteria who were randomized to zotarolimus-eluting Endeavor Sprint stent (E-ZES) or bare-metal stent (BMS) implantation followed by an abbreviated dual antiplatelet therapy (DAPT) duration for stable or unstable coronary artery disease. BACKGROUND: DES instead of BMS use remains controversial in HBR patients, in whom long-term DAPT poses safety concerns. METHODS: The ZEUS (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates) is a multinational, randomized single-blinded trial that randomized among others, in a stratified manner, 828 patients fulfilling pre-defined clinical or biochemical HBR criteria-including advanced age, indication to oral anticoagulants or other pro-hemorrhagic medications, history of bleeding and known anemia-to receive E-ZES or BMS followed by a protocol-mandated 30-day DAPT regimen. The primary endpoint of the study was the 12-month major adverse cardiovascular event rate, consisting of death, myocardial infarction, or target vessel revascularization. RESULTS: Compared with patients without, those with 1 or more HBR criteria had worse outcomes, owing to higher ischemic and bleeding risks. Among HBR patients, major adverse cardiovascular events occurred in 22.6% of the E-ZES and 29% of the BMS patients (hazard ratio: 0.75; 95% confidence interval: 0.57 to 0.98; p = 0.033), driven by lower myocardial infarction (3.5% vs. 10.4%; p < 0.001) and target vessel revascularization (5.9% vs. 11.4%; p = 0.005) rates in the E-ZES arm. The composite of definite or probable stent thrombosis was significantly reduced in E-ZES recipients, whereas bleeding events did not differ between stent groups. CONCLUSIONS: Among HBR patients with stable or unstable coronary artery disease, E-ZES implantation provides superior efficacy and safety as compared with conventional BMS. (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS]; NCT01385319).

Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates.

BACKGROUND: The use of drug-eluting stents (DES) in patients at high risk of bleeding or thrombosis has not been prospectively studied; limited data are available in patients who have a low restenosis risk. OBJECTIVES: This study sought to compare a hydrophilic polymer-based, second-generation zotarolimus-eluting stent (ZES) with a unique drug fast-release profile versus bare-metal stents (BMS) under similar durations of dual-antiplatelet therapy (DAPT). METHODS: We randomly assigned 1,606 patients with stable or unstable symptoms, and who on the basis of thrombotic bleeding or restenosis risk criteria, qualified as uncertain candidates for DES, to receive ZES or BMS. DAPT duration was on the basis of patient characteristics, rather than stent characteristics, and allowed for a personalized 1-month dual antiplatelet regimen. The primary endpoint was the risk of 1-year major adverse cardiovascular events (MACE), which included death, myocardial infarction (MI), or target vessel revascularization (TVR). RESULTS: Median DAPT duration was 32 days (interquartile range [IQR]: 30 to 180 days) and did not differ between the groups. In the ZES group, 140 patients (17.5%) reached the primary endpoint, compared with 178 patients (22.1%) in the BMS group (hazard ratio: 0.76; 95% confidence interval: 0.61 to 0.95; p = 0.011) as a result of lower MI (2.9% vs. 8.1%; p < 0.001) and TVR rates (5.9% vs.10.7%; p = 0.001) in the ZES group. Definite or probable stent thrombosis was also significantly reduced in ZES recipients (2.0% vs. 4.1%; p = 0.019). CONCLUSIONS: Compared with BMS, DES implantation using a stent with a biocompatible polymer and fast drug-eluting characteristics, combined with an abbreviated, tailored DAPT regimen, resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantation. (Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS] Study; NCT01385319).

Attitudes of healthcare professionals involved in cardiology practice towards key points of contemporary guidelines on resuscitation.

Hellenic J Cardiol. 2014; 55: 378-385. At the request of the authors, the name of the second author of this Original Research article has been changed from Athanasios Patialakas to Athanasios Patialiakas.

Attitudes of healthcare professionals involved in cardiology practice towards key points of contemporary guidelines on resuscitation.

INTRODUCTION: Cardiopulmonary resuscitation (CPR) is not always executed in compliance with contemporary guidelines and the quality of CPR may differ among hospitals within the same country or among categories of healthcare providers and medical specialties. The aim of this study was to assess attitudes of cardiology healthcare professionals towards CPR guidelines. METHODS: An anonymous questionnaire was posted online during 2009. Responders were asked about their age, gender, occupation, and training/experience in CPR. Responders' attitudes towards CPR were assessed using 7 questions regarding the accuracy of their opinions about the automated external defibrillator, public defibrillation programs, CPR performance, and therapeutic hypothermia. A score (0 to 7) was formed by assigning grade 1 to answers that accorded with European Resuscitation Council (ERC) guidelines and grade 0 to all other answers. The reliability analysis for this score yielded a Cronbach's alpha of 0.78. RESULTS: There were 544 responders (158 females), median age 34 years (30, 40). Median score was 5 (3, 6). Attending an ERC resuscitation course (beta=0.33, SE beta=0.05, p<0.001), age (beta=-0.15 SE beta=0.05, p=0.002), involvement in >10 CPRs /year (beta=0.19, SE beta=0.05, p<0.001), and being a physician (beta=0.17, SE beta=0.05, p=0.001) were all independent predictors of score. Attendance at an ERC course (OR: 2.7 [1.5 to 4.7]), being a physician (OR: 2 [1.3 to 5]) and involvement in >10 CPRs /year (OR: 1.7 [1.1 to 2.7]) were also independent predictors for attitudes that accorded with contemporary guidelines regarding therapeutic hypothermia. CONCLUSIONS: Attending an ERC resuscitation course, frequent involvement in CPR attempts, younger age, and being a physician were all independent predictors for more positive attitudes towards the guidelines. These factors, with the exception of age, were also associated with positive attitudes towards the implementation of therapeutic hypothermia.

Low total testosterone levels are associated with the metabolic syndrome in elderly men: the role of body weight, lipids, insulin resistance, and inflammation; the Ikaria study.

BACKGROUND: The prevalence of the metabolic syndrome (MetS) increases with age. Among other changes, testosterone levels decline with age. The relationship between testosterone levels and MetS components in older subjects has not been clearly defined until today. OBJECTIVES: The aim of this work was to evaluate the relationship between total serum testosterone levels and MetS and its components. METHODS: The working sample consisted of 467 elderly individuals (mean age 75 ± 6 years old, n = 220 men) from Ikaria Island, Greece. MetS was defined according to the NCEP ATPIII criteria. RESULTS: MetS prevalence was 52% in men and 64% in women. Those with MetS had lower testosterone levels; a 10 ng/dl increase in testosterone was associated with a 3% reduction in odds of having MetS in men (95% CI: 0.95-0.99), but not in women. This remained the result after various adjustments had been made, including daily hours of sleep. Testosterone was inversely associated with abnormal waist circumference, high-sensitivity C-reactive protein (hs-CRP), insulin, and HDL cholesterol levels in men only. When lipid categories, hs-CRP, BMI, and insulin resistance levels were taken into account, testosterone lost its significance in predicting MetS (p < 0.20), suggesting that these markers possess a mediating effect. CONCLUSIONS: In elderly men, low serum testosterone was associated with MetS. Lipids, BMI, inflammation, and insulin resistance levels seem to explain this relationship, suggesting a potential mediating effect. This finding may support a research hypothesis relating serum testosterone to cardiovascular disease, which requires further research.

Randomized comparison of Zotarolimus-Eluting Endeavor Sprint versus bare-metal stent implantation in uncertain drug-eluting stent candidates: rationale, design, and characterization of the patient population for the Zotarolimus-eluting Endeavor Sprint stent in uncertain DES candidates study.

BACKGROUND: The use of drug-eluting stent (DES) instead of bare-metal stent (BMS) in patients at high stent thrombosis or bleeding risk as well as in those at low restenosis risk (ie, uncertain DES candidates) remains a matter of debate. Zotarolimus-Eluting Endeavor Sprint stent (E-ZES) (Santa Rosa, CA) is a hydrophilic polymer-based second-generation device with unique drug fast-release profile, which may allow for a shorter dual antiplatelet therapy (DAPT) duration without safety concerns. HYPOTHESIS: The primary objective is to assess whether E-ZES implantation followed by a shorter than currently recommended course of DAPT will decrease the incidence of 12-month major adverse cardiovascular events as compared with BMS in undefined DES recipients. Actual duration of DAPT regimen will be dictated by patients' characteristics and not by stent type and, as such, can be as short as 30 days after intervention in both stent groups. STUDY DESIGN: The ZEUS study is an open-label randomized clinical trial conducted at 20 clinical sites in Italy, Switzerland, Portugal, and Hungary. With 1,600 individuals, this study will have 85% power to detect a 33% difference in the primary end point consisting of the composite of death, nonfatal myocardial infarction, or target vessel revascularization. SUMMARY: The ZEUS trial aims to assess whether the use of E-ZES, followed by a DAPT duration regimen based on patients' characteristics and not by stent type, is superior to conventional BMS implantation in undefined DES recipients who qualify for the presence of high thrombosis, bleeding, or low restenosis risk criteria.

In-hospital worsening renal function is an independent predictor of one-year mortality in patients with acute myocardial infarction.

BACKGROUND: We investigated the incidence, clinical predictors and prognostic value of worsening renal function (WRF) regarding 1-year mortality in patients with acute myocardial infarction (AMI). METHODS: We collected in-hospital data from 447 patients hospitalized for AMI in our institute within 12h of symptoms' onset. WRF was defined as a 25% or more decrease in estimated glomerural filtration rate during hospital stay. From blood samples obtained on admission and throughout hospitalization hemoglobin, white blood cell count, C-reactive protein, B-type natriuretic peptide, plasma glucose, troponin I and baseline and peak creatinine levels were measured. Ejection fraction was calculated on admission with 2D echocardiography. All patients underwent coronary arteriography and the revascularization status (complete or not) was also recorded. The end point was all-cause mortality after one-year of follow-up. RESULTS: WRF was detected in 63 pts (16.7%) and age, ejection fraction and white blood cell count emerged as the only independent predictors. The incidence of 1-year mortality was 10.7% (48 deaths). Patients with WRF exhibited higher 1-year mortality (37.5% vs. 6.3%, log rank p<0.001) and were characterized by more severe and less completely treated coronary artery disease, greater degree of myocardial necrosis and marked neurohormonal activation. By applying multivariate Cox regression analysis WRF, B-type natriuretic peptide, ejection fraction and admission diastolic blood pressure were identified as the only independent predictors of death. CONCLUSIONS: WRF is associated with adverse 1-year outcome in patients with AMI. Close monitoring of renal function in the acute phase of MI may substantially contribute to long-term risk stratification.