Search

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: 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]

Abstract: Background: The incidence and treatment strategies of acute coronary syndrome (ACS) vary by region. Additionally, the clinical spectrum of ACS is changing and outcomes are improving. Aim: We assessed the incidence, treatment strategies, and outcomes of ACS for a well-defined population within a well-established network of percutaneous coronary intervention (PCI) centers and non-PCI centers. Methods: The CZECH-2 registry included 1221 consecutive patients (mean age: 68±13years; 63.4% males) admitted for suspected ACS to 32 hospitals (including 4 PCI centers) within four Czech counties (total population: 2,370,841 inhabitants) during a 2-month period. Results: The estimated incidence of confirmed ACS was 2149cases/million/year. In 374 (31%) patients, ACS was ruled out during the hospital stay. Coronary angiography (CAG) was performed in 60% of the patients overall and PCI was performed in 59% of the confirmed ACS patients. Killip classifications II–IV on admission were more common in patients with final diagnosis of non ST-elevation myocardial infarction (NSTEMI) than ST-elevation myocardial infarction (STEMI) (37.1% vs. 22.8%; p<0.001). The 30-day mortality rate was 5.7% for the whole study group, 7.3% for STEMI patients, 8.4% for NSTEMI patients, and 1.6% for patients with unstable angina pectoris (UAP), respectively. Conclusions: Almost one-third of the patients admitted for suspected ACS had a different final diagnosis. Among those with confirmed ACS, the use of CAG, PCI, CABG, and effective medications is rational. Outcome in NSTEMI patients was equivalent to those in STEMI patients, mainly due to the high-risk population in this group. [Copyright &y& Elsevier]

Abstract: Objective: Ascertain platelet inhibition and patient outcomes (PLATO) trial conduct. Methods: We examined information from the FDA complete response review. Results: FDA Medical Review indicated that (1) patients on ticagrelor monitored by the study sponsor had a lower odds ratio for the primary endpoint (p=0.0004) versus ticagrelor patients monitored by a third party Clinical Research Organisation (CRO) independent of the study sponsor, (2) a significant interaction existed between ticagrelor and regions monitored by the study sponsor for all cause mortality through study end in favor of ticagrelor (p=0.006), (3) ticagrelor faired worse than clopidogrel when regions were monitored independent of the study sponsor by a third party Contract Research Organisation (United States, Russia and Georgia), (OR=1.21, 95% CI: 0.91 to 1.59, p=0.2022), (4) 46% of all primary endpoint events favoring ticagrelor came from just two countries (Poland and Hungary), (5) PLATO was easy to unblind by breaking open a clopidogrel/dummy clopidogrel tablet with at least 452 patients being unblinded prior to the database lock, (6) significantly more cardiac events submitted for clopidogrel counted in the primary analysis as a myocardial infarction (MI) compared to those submitted for ticagrelor (p<0.0001), (7) significantly more ticagrelor subjects hospitalized after an index event/hospitalization were not being reported as having a primary event compared to clopidogrel (p=0.002 in favor of ticagrelor), (8) site-reported MI was not significantly reduced with ticagrelor versus clopidogrel, (9) an estimated 23 definite or possible cardiovascular events or deaths on ticagrelor were either not submitted for adjudication, inactivated, deleted or were downgraded to “softer” endpoints (this was not shown in the FDA review for clopidogrel), and (10) four FDA reviewers voted for non-approval of ticagrelor. Discussion: The FDA report highlights what appear to be multiple serious deficiencies in the reporting of the PLATO results, which clinicians will not have gleaned from the primary publication alone. Individual clinicians may therefore wish to carefully reconsider their practice of ticagrelor prescription for this indication. Guideline bodies should also evaluate the information in its totality. [Copyright &y& Elsevier]

Abstract: Leukocyte count predicted the risk of first-time myocardial infarction and ischemic stroke. The aim of this study was to determine the role of elevated leukocyte count in non-diabetic patients admitted for acute first-ever ischemic stroke on clinical presentation and 3-year mortality. We studied 462 patients with acute first-ever ischemic stroke without diabetes mellitus or active infection at admission. Patients were classified into 2 groups according to their leukocyte count. A white blood cell (WBC) count ≥10,000/μL was defined as an elevated leukocyte count, otherwise as normal. Clinical presentation, risk factors for stroke, laboratory data, co-morbidities, and outcomes were recorded. 64 patients (13.9%) had elevated leukocytes. Multivariate logistic regression showed that an elevated platelet count was positively associated with the elevated leukocyte count, while a low serum sodium level was negatively associated with an elevated leukocyte count (P =0.008, P =0.003, respectively). An elevated leukocyte count was associated with a higher risk of a stroke in evolution (P =0.021). Multivariate Cox regression analysis revealed that an elevated leukocyte count is a significant predictor of 3-year mortality [P =0.010, HR=3.26 (1.33–7.98)]. In conclusion, higher leukocyte counts during the acute stroke stage are associated with increased risk of 3-year mortality in patients with acute, first-ever ischemic stroke. [Copyright &y& Elsevier]

Abstract: Aim: To examine the impact of primary stent implantation versus balloon angioplasty on long-term outcome (median 8 years) in 117 patients with ST-elevation myocardial infarction (STEMI) from randomized trials. Methods: Enrolled patients were those presenting with STEMI within 12 h of symptom onset. Patients were randomized to either Palmaz–Schatz stent implantation (N =25) or balloon angioplasty (N =23) between January and November 1996; or Palmaz–Schatz (N =26), or Cordis coil stent implantation (N =24) or balloon angioplasty (N =19) between February 1998 and March 1999. Results: Patients (67±11 years) arrived to the hospital within median 2.5 h of symptom onset with Killip 1/2/3/4 grade (72/19/7/2%, respectively). The culprit lesion was located in the left anterior descending (50%), right (39%), or left circumflex coronary artery (11%) with TIMI 0/1/2/3 flow (81/5/12/2%, respectively). Clinical/angiographic features were comparable between the 2 groups. During follow-up, there was a significant reduction in cardiac mortality in the stent group (5%) compared to the angioplasty group (17%, log-rank test p =0.04). In addition, the stent group had a lower target lesion revascularization rate (28% versus 52%, p =0.008), and a significantly lower major adverse cardiac event rate (37% versus 67%, p =0.005), than the angioplasty group. Conclusion: Compared to balloon angioplasty, primary stenting resulted in a sustained beneficial effect on cardiac mortality at 8 years. [Copyright &y& Elsevier]

Abstract: Objectives: Estimation of long-term outcome for patients suffering from acute myocardial infarction treated with primary angioplasty in an alsatian public center. Patients and methods: Two-hundred and ninety-eight patients who underwent an urgent coronarography in a non-university center, with a view to immediate angioplasty, between January 1999 and December 2001. Results: Two-hundred and sixty-four patients (88.6%) were actually treated with urgent angioplasty, which has been successful in 87.1% of cases. Hospital mortality was of 7.7%. The population was composed of 16.4% patients older than 75 and of 11.7% patients with Killip 3 or 4 at admission. Mean follow-up was 34 months, lost to follow-up rate was of 4.7%. The global survival rate was of 78.9% and eventless survival rate of 41.9%. Conclusion: Our results confirm the efficiency of angioplasty in real-life conditions as well at short-term as at long-term. [Copyright &y& Elsevier]