Anselm K. Gitt

Gender Differences in the Management and Clinical Outcome of Stable Angina

Background— We sought to examine the impact of gender on the investigation and subsequent management of stable angina and to assess gender differences in clinical outcome at 1 year. Methods and Results— The Euro Heart Survey of Stable Angina enrolled patients with a clinical diagnosis of stable angina on initial assessment by a cardiologist. Baseline clinical details and cardiac investigations planned or performed within a 4-week period of the assessment were recorded, and follow-up data were collected at 1 year. A total of 3779 patients were included in the survey; 42% were female. Women were less likely to undergo an exercise ECG (odds ratio, 0.81; 95% CI, 0.69 to 0.95) and less likely to be referred for coronary angiography (odds ratio, 0.59; 95% CI, 0.48 to 0.72). Antiplatelet and statin therapies were used significantly less in women than in men, both at initial assessment and at 1 year, even in those in whom coronary disease had been confirmed. Women with confirmed coronary disease were less likely to be revascularized than their male counterparts and were twice as likely to suffer death or nonfatal myocardial infarction during the 1-year follow-up period (hazard ratio, 2.09; 95% CI, 1.13 to 3.85), even after multivariable adjustment for age, abnormal ventricular function, severity of coronary disease, and diabetes. Conclusions— Significant gender bias has been identified in the use of investigations and evidence-based medical therapy in stable angina. Women were also less likely to be revascularized. The observed bias is of particular concern in light of the adverse prognosis observed among women with stable angina and confirmed coronary disease.

Effects of Prandial Versus Fasting Glycemia on Cardiovascular Outcomes in Type 2 Diabetes: The HEART2D trial

OBJECTIVE—Hyperglycemia and Its Effect After Acute Myocardial Infarction on Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus (HEART2D) is a multinational, randomized, controlled trial designed to compare the effects of prandial versus fasting glycemic control on risk for cardiovascular outcomes in patients with type 2 diabetes after acute myocardial infarction (AMI). RESEARCH DESIGN AND METHODS—Patients (type 2 diabetes, aged 30–75 years) were randomly assigned within 21 days after AMI to the 1) prandial strategy (PRANDIAL) (three premeal doses of insulin lispro targeting 2-h postprandial blood glucose <7.5 mmol/l) or the 2) basal strategy (BASAL) (NPH twice daily or insulin glargine once daily targeting fasting/premeal blood glucose <6.7 mmol/l). RESULTS—A total of 1,115 patients were randomly assigned (PRANDIAL n = 557; BASAL n = 558), and the mean patient participation after randomization was 963 days (range 1–1,687 days). The trial was stopped for lack of efficacy. Risks of first combined adjudicated primary cardiovascular events in the PRANDIAL (n = 174, 31.2%) and BASAL (n = 181, 32.4%) groups were similar (hazard ratio 0.98 [95% CI 0.8–1.21]). Mean A1C did not differ between the PRANDIAL and BASAL groups (7.7 ± 0.1 vs. 7.8 ± 0.1%; P = 0.4) during the study. The PRANDIAL group showed a lower daily mean postprandial blood glucose (7.8 vs. 8.6 mmol/l; P < 0.01) and 2-h postprandial blood glucose excursion (0.1 vs. 1.3 mmol/l; P < 0.001) versus the BASAL group. The BASAL group showed lower mean fasting blood glucose (7.0 vs. 8.1 mmol/l; P < 0.001) and similar daily fasting/premeal blood glucose (7.7 vs. 7.3 mmol/l; P = 0.233) versus the PRANDIAL group. CONCLUSIONS—Treating diabetic survivors of AMI with prandial versus basal strategies achieved differences in fasting blood glucose, less-than-expected differences in postprandial blood glucose, similar levels of A1C, and no difference in risk for future cardiovascular event rates.

The European cardiac resynchronization therapy survey

AIMS The European cardiac resynchronization therapy (CRT) survey is a joint initiative taken by the Heart Failure Association and the European Heart Rhythm Association of the European Society of Cardiology. The primary aim of this survey is to describe current European practice associated with CRT implantations. METHODS AND RESULTS A total of 140 centres from 13 European countries contributed data from consecutive patients successfully implanted with a CRT device with or without an ICD between November 2008 and June 2009. The total number of patients enrolled was 2438. The median age of the patients was 70 years (IQR 62-76) and 31% were > or =75 years. It was found that 78% were in NYHA functional class III or IV and 22% in I or II. The mean ejection fraction was 27% +/- 8 and the mean QRS duration 157 ms +/- 32. The QRS duration was <120 ms in 9%. Atrial fibrillation was reported in 23%. It was found that 26% of patients had a previously implanted permanent pacemaker or ICD; 76% of procedures were performed by an electrophysiologist; 82% had an elective admission for implantation and the median duration of hospitalization was 3 days (IQR 2-7); and 73% received a CRT-D device which was more often implanted in men, younger patients, and with ischaemic aetiology. The mean QRS duration was reduced to 133 ms +/- 27 (P < 0.0001) at discharge. Peri-procedural complication rates were comparable to the rates reported in randomized trials. CONCLUSION This CRT survey provides important information describing current European practice with regard to patient demographics, selection criteria, procedural routines, and status at discharge. These data should be useful for benchmarking individual patient management and national practice against wider experience.

Predicting prognosis in stable angina—results from the Euro heart survey of stable angina: prospective observational study

Abstract Objectives To investigate the prognosis associated with stable angina in a contemporary population as seen in clinical practice, to identify the key prognostic features, and from this to construct a simple score to assist risk prediction. Design Prospective observational cohort study. Setting Pan-European survey in 156 outpatient cardiology clinics. Participants 3031 patients were included on the basis of a new clinical diagnosis by a cardiologist of stable angina with follow-up at one year. Main outcome measure Death or non-fatal myocardial infarction. Results The rate of death and non-fatal myocardial infarction in the first year was 2.3 per 100 patient years; the rate was 3.9 per 100 patient years in the subgroup (n = 994) with angiographic confirmation of coronary disease. The clinical and investigative factors most predictive of adverse outcome were comorbidity, diabetes, shorter duration of symptoms, increasing severity of symptoms, abnormal ventricular function, resting electrocardiogaphic changes, or not having any stress test done. Results of non-invasive stress tests did not significantly predict outcome in the population who had tests done. A score was constructed using the parameters predictive of outcome to estimate the probability of death or myocardial infarction within one year of presentation with stable angina. Conclusions A score based on the presence of simple, objective clinical and investigative variables makes it possible to discriminate effectively between very low risk and very high risk patients and to estimate the probability of death or non-fatal myocardial infarction over one year.

Comparison of clinical benefits of Clopidogrel therapy in patients with acute coronary syndromes taking Atorvastatin versus other statin therapies

In clinical practice, we found no significant difference between atorvastatin therapy or other statin therapies in the clinical outcomes of patients with acute coronary syndromes receiving clopidogrel therapy. In patients receiving atorvastatin therapy, clopidogrel therapy was associated with a significant decrease in mortality and stroke during univariate analysis and a moderate trend of reduced mortality and stroke without statistical significance in the multivariate analysis.

Persistent lipid abnormalities in statin-treated patients and predictors of LDL-cholesterol goal achievement in clinical practice in Europe and Canada

Background: The prevalence of persistent lipid abnormalities in patients receiving statins in primary and secondary care is needed to formulate recommendations for future treatment. Studies associating cardiovascular risk factors with lipid target goal achievement are lacking. Design: A cross-sectional, observational study that assessed the prevalence of persistent dyslipidemia in patients treated with statins and analyzed predictors of lipid target achievement. Methods: Serum lipid values of 22,063 statin-treated patients were studied in the context of their cardiovascular risk factors, and the potency and composition of their lipid-lowering treatment. European Society of Cardiology recommendations were used to classify patient risk, and to define LDL-cholesterol goal and normal levels for HDL-cholesterol and triglycerides. Results: Overall, 48.2% of patients did not achieve the therapeutic goal for LDL-cholesterol, either as a single lipid anomaly or associated with low HDL-cholesterol, elevated triglycerides, or both. Lack of goal achievement was more prevalent among low-risk patients (55.8%) than high-risk patients (46.8%). Serum LDL-cholesterol levels were lower in high-risk patients. Predictors associated with LDL-cholesterol goal achievement were higher statin dose (odds ratio (OR): 0.35), specialist treatment (OR: 0.74), or combined lipid-lowering therapy (OR: 0.80). Conclusions: Nearly half of statin-treated patients missed their therapeutic LDL-cholesterol goal, highlighting a gap between recommendations and clinical practice. Better achievement of LDL-cholesterol therapeutic goal was found among patients at high cardiovascular risk, those on high statin doses or using combination therapy, and patients managed by specialists. Results suggest that residual dyslipidemia in statin-treated patients at low cardiovascular risk may be reduced by increasing statin dose.

The role of cardiac registries in evidence-based medicine.

Cardiovascular disease remains the primary cause of mortality, and a major cause of disability in the developed world.1 This significant burden necessitates ongoing improvements in patient management, to minimize the impact of cardiovascular conditions on both patients and healthcare systems. These improvements in cardiovascular care are promoted by an evidence-based approach, shaped by comprehensive clinical guidelines. The scientific basis of recommendations is an important feature of clinical guidelines, and influences the degree to which they are followed in clinical practice.2 Recent studies have assigned the highest evidence grading to randomized controlled trials (RCTs) that are clinically important, and representative of the clinical population covered by the guideline recommendation.3 For example, this highest grading was assigned to a recommendation based on a meta-analysis of RCTs showing low-dose diuretics to be the most effective first-line treatment for cardiovascular event prevention in hypertensive patients. This study reviewed data from 42 RCTs which were, crucially, representative of the population that the recommendation was made for (i.e. hypertensive patients).3,4 The importance of the applicability of evidence to recommendations highlights the need to consider evidence from clinically relevant situations, not all of which have been assessed by RCTs. This evidence can originate from expert consensus, as well as non-randomized prospective studies. Although generally providing a lower evidence-level than RCTs,3,5 observational studies can make an important contribution to the evidence base when the study outcomes are clinically important, and the populations involved are representative. Indeed, information from several registries was considered in the recent American Heart Association Acute Coronary Care in the Elderly Scientific Statement.6 Non-randomized prospective registries document the treatment and outcomes for consecutive patients in clinical practice. Therefore, data are gained from a ‘real-world’ selection of patients, many of whom would be excluded from RCTs, …

The European CRT Survey: 1 year (9-15 months) follow-up results

The European CRT Survey is a joint initiative of the Heart Failure Association (HFA) and the European Heart Rhythm Association (EHRA) of the European Society of Cardiology evaluating the contemporary implantation practice of cardiac resynchronization therapy (CRT) in Europe.

Reperfusion strategy in Europe: temporal trends in performance measures for reperfusion therapy in ST-elevation myocardial infarction

AIMS The rate and type of reperfusion, as well as time delays to reperfusion are directly associated with mortality and are established as performance measures (PMs) in the treatment of ST elevation myocardial infarction (STEMI). To date, little information exists about PMs for reperfusion in clinical practice in Europe and their temporal changes. METHODS AND RESULTS Using the Euro Heart Survey ACS-III data set (2 years of inclusions between 2006 and 2008, 138 centres in 21 countries), we selected patients with STEMI eligible for reperfusion therapy. Recorded variables corresponded to the CARDS data set. The rate and type of reperfusion, as well as door to needle and door to artery times were assessed and compared between periods. Timely reperfusion was defined as a door to needle time < 30 min, or a door to artery time < 90 min. We assessed changes in PMs for reperfusion over the 2 years of recruitment. Among 19 205 patients included in the registry, 7655 had STEMI, and 6481 were admitted within the first 12 h and eligible for reperfusion. The rate of patients who underwent reperfusion increased from 77.2 to 81.3%, with an increase in the use of primary percutaneous coronary intervention (P-PCI). The door to needle and door to artery times decreased significantly during the study period, from 20 to 15 min (P = 0.0011) and from 60 to 45 min (P < 0.0001) respectively. As a result, the number of eligible patients receiving reperfusion therapy in a timely manner increased from 53.1 to 63.5% (P < 0.0001). In parallel, over the 2-year period, in-hospital mortality decreased from 8.1 to 6.6% (P = 0.047). CONCLUSION In centres participating in the Euro Heart Survey ACS III, PMs for reperfusion in STEMI improved significantly between 2006 and 2008, with greater use of PCI. Similarly, the rate of patients reperfused in a timely manner also increased, with a significant reduction in door to needle and door to artery times.

In-hospital time to treatment of patients with acute ST elevation myocardial infarction treated with primary angioplasty: determinants and outcome. Results from the registry of percutaneous coronary interventions in acute myocardial infarction of the Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte

Objective: To determine the predictors of time between presentation and primary angioplasty and the influence of this delay time on in-hospital mortality in clinical practice. Design: Analysis of data from the registry of percutaneous coronary interventions in acute myocardial infarction of the Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte (ALKK). Patients: Data of 4815 patients registered at 80 hospitals between 1994 and 2000 were analysed. Results: Mean age of the patients was 61.4 (12.5) years. Cardiogenic shock was present in 14.1%. Mean time from admission to primary angioplasty (“door to angiography” time) was 83 (122) minutes. Logistic regression analysis showed the presence of a bundle branch block (odds ratio (OR) 1.95, 95% confidence interval (CI) 1.15 to 3.29), prior coronary artery bypass grafting (OR 1.67, 95% CI 1.08 to 2.59), pre-hospital delay > 3 hours (OR 1.61, 95% CI 1.37 to 1.89), and female sex (OR 1.21, 95% CI 1.01 to 1.45) to be independently associated with longer door to angiography times, whereas a higher hospital volume of performing primary angioplasty (OR 0.53, 95% CI 0.46 to 0.62) and the year of the investigation (OR 0.96, 95% CI 0.92 to 1.00) were independently associated with shorter door to angiography times. Independent predictors of in-hospital mortality were cardiogenic shock (41.6% v 4.0% without cardiogenic shock, p < 0.0001), technical success (29.2% with TIMI (thrombolysis in myocardial infarction) flow < 3 v 6.5% with TIMI flow 3, p < 0.0001), age (16.5% ⩾ 70 years v 6.6% < 70, p < 0.0001), three vessel disease (16.5% v 6.8% with < 3 vessel disease, p < 0.0001), anterior location of infarction (12% v 7.4% without anterior infarction, p < 0.0001), year of inclusion (adjusted OR 0.92 per year, p  =  0.011), and volume of primary angioplasty at the hospital (11% for < 20 angioplasty procedures/year v 8.3% for ⩾ 20/year, p  =  0.027) but not the door to angiography time (adjusted OR 1.14 per tertile, p  =  0.397). Conclusions: In current clinical practice in Germany median door to angiography time is quite short (83 (122) minutes). Some patients and hospital factors are independently associated with a longer door to angiography time. Within the observed short in-hospital delays door to angiography time did not influence in-hospital mortality. However, efforts to keep them as short as possible should be continued.