Health-related quality of life and mortality in patients with pulmonary embolism: a prospective cohort study in seven European countries.

PURPOSE: Little is known about the quality of life following pulmonary embolism (PE). The aim of the study was to assess the 12-month illness burden in terms of health-related quality of life (HrQoL) and mortality, in relation to differences in patient characteristics. METHODS: The PREFER in VTE registry, a prospective, observational study conducted in seven European countries, was used. Within 2 weeks following an acute symptomatic PE, patients were recruited and followed up for 12 months. Associations between patient characteristics and HrQoL (EQ-5D-5L) and mortality were examined using a regression approach. RESULTS: Among 1399 PE patients, the EQ-5D-5L index score at baseline was 0.712 (SD 0.265), which among survivors gradually improved to 0.835 (0.212) at 12 months. For those patients with and without active cancer, the average index score at baseline was 0.658 (0.275) and 0.717 (0.264), respectively. Age and previous stroke were significant factors for predicting index scores in those with/without active cancer. Bleeding events but not recurrences had a noticeable impact on the HrQoL of patients without active cancer. The 12-month mortality rate post-acute period was 8.1%, ranging from 1.4% in Germany, Switzerland, and Austria to 16.8% in Italy. Mortality differed between patients with active cancer and those without (42.7% vs. 4.7%). CONCLUSION: PE is associated with a substantial decrease in HrQoL at baseline which normalizes following treatment. PE is associated with a high mortality rate especially in patients with cancer, with significant country variation. Bleeding events, in particular, impact the burden of PE.

The impact of co-morbidity on the disease burden of VTE.

Venous thromboembolism (VTE) is often accompanied by co-morbidities, which complicate and confound data interpretation concerning VTE-related mortality, costs and quality of life. We aimed to assess the contribution of co-morbidities to the burden of VTE. The PREFER in VTE registry, across seven European countries, documented and followed acute VTE patients over 12 months. Patients with co-morbidities were grouped in major co-morbidity groups: cancer, cardiovascular (CV) comorbidity (other than VTE), CV risks, venous, renal, liver, respiratory, bone and joint diseases, and lower extremity paralysis. Mortality rates and health-related quality of life (HrQoL) utility values grouped per co-morbidity were compared to the UK general population. Regression analyses were performed to determine the impact of co-morbidities on mortality and HrQoL. VTE were analyzed together and separately as pulmonary embolism (PE) and deep vein thrombosis (DVT). In total, 3455 patients were included, 40.5% with PE and 59.5% with DVT. 13% and 16% of the PE and DVT patients had no co-morbidities and had a 12-month mortality rate of 1.8% and 1.7%, respectively. Frequency and severity of co-morbidities increased mortality rates up to 30%. The EQ-5D-5L index in patients without co-morbidities were 0.826 and 0.838 for PE and DVT. These scores decreased to 0.638 and 0.555 in the presence of co-morbidities. Co-morbidities in VTE patients are common. VTE had an impact on mortality and HrQoL, and additional impact of co-morbidities was seen. Awareness of the presence of co-morbidities is important when making VTE-related treatment decisions. The presence of co-morbidities in PE and DVT patients is common and their frequency and severity in VTE patients have a substantial impact on mortality rates and HrQoL. When adjusting for co-morbidities, the impact of VTE on mortality as well as health-related quality of life remains present. Assessing patients without consideration of co-morbidities might lead to misinterpretations of the disease burden of PE and DVT.

Do acute coronary events affect lipid management and cholesterol goal attainment in Germany? : Results from the Dyslipidemia International study II.

OBJECTIVE: To document utilization of lipid-lowering therapy, attainment of low-density lipoprotein cholesterol target values, and cardiovascular outcomes in patients hospitalized for acute coronary syndrome in Germany. METHODS: The Dyslipidemia International Study II was a multicenter, observational study of the prevalence of dyslipidemia and lipid target value attainment in patients surviving any acute coronary syndrome event. Among patients on lipid-lowering therapy for ≥3 months, use of lipid-lowering therapy and lipid profiles were assessed at admission and again at 120 ± 15 days after admission (the follow-up time point). Multivariate logistic regression was used to identify variables predictive of low-density lipoprotein cholesterol target value attainment in patients using lipid-lowering therapy. RESULTS: A total of 461 patients hospitalized for acute coronary syndrome were identified, 270 (58.6%) of whom were on lipid-lowering therapy at admission. Among patients on lipid-lowering therapy, 90.7% and 85.9% were receiving statin monotherapy at admission and follow-up, respectively. Mean (SD) low-density lipoprotein cholesterol levels in patients on lipid-lowering therapy were 101 (40) mg/dl and 95 (30) mg/dl at admission and follow-up, respectively. In patients with data at both admission and follow-up (n = 61), low-density lipoprotein cholesterol target value attainment rates were the same (19.7%) at both time points. Smoking was associated with a 77% lower likelihood of attaining the low-density lipoprotein cholesterol target value. CONCLUSION: Hospitalization for an acute event does not greatly alter lipid management in acute coronary syndrome patients in Germany. Both lipid-lowering therapy doses and rates of low-density lipoprotein cholesterol target value attainment remained essentially the same several months after the event.

Prevalence of potential familial hypercholesteremia (FH) in 54,811 statin-treated patients in clinical practice.

BACKGROUND AND AIMS: Familial hypercholesterolemia (FH) is a life-threatening disease, characterized by elevated LDL-C levels and a premature, increased risk of coronary heart disease (CHD) that is globally underdiagnosed. The percentage of patients with possible or probable FH in various countries was examined in the Dyslipidemia International Study (DYSIS). METHODS: DYSIS is a multinational, cross-sectional observational study of 54,811 adult outpatients treated with statin therapy. The percentages of patients with high levels of LDL-C, and with possible or probable FH, were assessed using the Dutch scoring method for FH across 29 countries, in age subgroups for the analysis population and among diabetes patients. RESULTS: Despite statin therapy, 16.1% (range 4.4-27.6%) of patients had LDL-C >3.6 mmol/L (140 mg/dL) across countries and the prevalence of possible FH was 15.0% (range 5.5-27.8%) and 1.1% (range 0.0-5.4%) for probable FH. The highest percentages of probable FH occurred in Egypt (5.4%), the Baltic states (4.2%), Russia (3.2%), and Slovenia (3.1%), with the lowest rates in Israel (0.0%), Canada (0.2%), and Sweden (0.3%). Rates of FH were the highest in younger patients (45-54 years) for secondary prevention, regardless of the presence/absence of diabetes. CONCLUSIONS: Despite statin therapy, high LDL-C levels and rates of possible and probable FH were observed in some countries. The prevalence of FH was the highest in younger age patients, and >60% of patients with probable FH displayed CHD. Earlier diagnosis and treatment of patients with FH are needed to reduce CHD risk in these patients.

Fate of Patients With Coronary Perforation Complicating Percutaneous Coronary Intervention (from the Euro Heart Survey Percutaneous Coronary Intervention Registry).

Coronary perforation (CP) is a life-threatening complication that can occur during percutaneous coronary intervention (PCI). Little is known, however, about the incidence and clinical outcome of CP. We sought to investigate the occurrence of CP and its determinants and risk profile in a large-scale, prospective registry. From 2005 to 2008, unselected patients (n = 42,068) from 175 centers in 33 countries who underwent a PCI procedure were prospectively enrolled in the PCI registry of the Euro Heart Survey program. For the present analysis, patients experiencing CP during PCI (n = 124, 0.3%) were compared with those who underwent PCI without CP. Patients with CP were older, more often women, had more severe coronary disease, and underwent more complex types of coronary intervention. Independent factors associated with CP were the use of rotablation, intravascular ultrasound-guided PCI, bypass PCI, a totally occluded vessel, a type C lesion, peripheral arterial disease, and body mass index <25. More than 10% of the patients developed cardiac tamponade. In a small minority (3.3%), emergency bypass surgery had to be performed. The inhospital death rate was markedly elevated in patients with CP (7.3% vs 1.5%, p <0.001). After adjustment for the EuroHeart score, CP remained a strong predictor of hospital mortality (odds ratio 5.21, 95% confidence interval 2.34 to 11.60). In conclusion, in this real world, all-comers registry, the incidence of CP was low, occurred more often in patients who underwent more complex coronary interventions, and was associated with a fivefold higher hospital mortality.

Management of patients with ST-segment elevation or non-ST-segment elevation acute coronary syndromes in cardiac rehabilitation centers.

BACKGROUND: Current data on the management of patients in cardiac rehabilitation (CR) after an acute hospital stay due to ST-segment elevation or non-ST segment elevation acute coronary syndromes (STE-ACS or NSTE-ACS) are limited. We aimed to describe patient characteristics, risk factor management, and lipid target achievement of patients in CR in Germany and compare the 2 groups. HYPOTHESIS: With respect to the risk factor pattern and treatment effects during a CR stay, there are important differences between STE-ACS and NSTE-ACS patients. METHODS: Comparison of 7950 patients by STE-ACS or NSTE-ACS status in the Transparency Registry to Objectify Guideline-Oriented Risk Factor Management registry (2010) who underwent an inpatient CR period of about 3 weeks. RESULTS: STE-ACS patients compared to NSTE-ACS patients were significantly younger (60.5 vs 64.4 years, P < 0.0001), and had diabetes mellitus, hypertension, or any risk factor (exception: smoking) less often. At discharge, in STE-ACS compared to NSTE-ACS patients, the low-density lipoprotein cholesterol (LDL-C) <100 mg/dL goal was achieved by 75.3% and 76.2%, respectively (LDL-C <70 mg/dL by 27.7% and 27.4%), the high-density lipoprotein cholesterol goal of >50 mg/dL in women and >40 mg/dL in men was achieved by 49.3% and 49.0%, respectively, and the triglycerides goal of <150 mg/dl was achieved by 72.3% and 74.3%, respectively (all comparisons not significant). Mean systolic and diastolic blood pressure were 121/74 and 123/74 mm Hg, respectively (P < 0.0001 systolic, diastolic not significant). The maximum exercise capacity was 110 and 102 W, respectively (P < 0.0001), and the maximum walking distance was 581 and 451 meters, respectively (P value not significant). CONCLUSIONS: Patients with STE-ACS and NSTE-ACS differed moderately in their baseline characteristics. Both groups benefited from the participation in CR, as their lipid profile, blood pressure, and physical fitness improved.

Treatment patterns, risk factor control and functional capacity in patients with cardiovascular and chronic kidney disease in the cardiac rehabilitation setting.

BACKGROUND: Chronic kidney disease (CKD) is a frequent comorbidity among elderly patients and those with cardiovascular disease. CKD carries prognostic relevance. We aimed to describe patient characteristics, risk factor management and control status of patients in cardiac rehabilitation (CR), differentiated by presence or absence of CKD. DESIGN AND METHODS: Data from 92,071 inpatients with adequate information to calculate glomerular filtration rate (GFR) based on the Cockcroft-Gault formula were analyzed at the beginning and the end of a 3-week CR stay. CKD was defined as estimated GFR <60 ml/min/1.73 m(2). RESULTS: Compared with non-CKD patients, CKD patients were significantly older (72.0 versus 58.0 years) and more often had diabetes mellitus, arterial hypertension, and atherothrombotic manifestations (previous stroke, peripheral arterial disease), but fewer were current or previous smokers had a CHD family history. Exercise capacity was much lower in CKD (59 vs. 92 Watts). Fewer patients with CKD were treated with percutaneous coronary intervention (PCI), but more had coronary artery bypass graft (CABG) surgery. Patients with CKD compared with non-CKD less frequently received statins, acetylsalicylic acid (ASA), clopidogrel, beta blockers, and angiotensin converting enzyme (ACE) inhibitors, and more frequently received angiotensin receptor blockers, insulin and oral anticoagulants. In CKD, mean low density lipoprotein cholesterol (LDL-C), total cholesterol, and high density lipoprotein cholesterol (HDL-C) were slightly higher at baseline, while triglycerides were substantially lower. This lipid pattern did not change at the discharge visit, but overall control rates for all described parameters (with the exception of HDL-C) were improved substantially. At discharge, systolic blood pressure (BP) was higher in CKD (124 versus 121 mmHg) and diastolic BP was lower (72 versus 74 mmHg). At discharge, 68.7% of CKD versus 71.9% of non-CKD patients had LDL-C <100 mg/dl. Physical fitness on exercise testing improved substantially in both groups. When the Modification of Diet in Renal Disease (MDRD) formula was used for CKD classification, there was no clinically relevant change in these results. CONCLUSION: Within a short period of 3-4 weeks, CR led to substantial improvements in key risk factors such as lipid profile, blood pressure, and physical fitness for all patients, even if CKD was present.

Incidence and predictors of hypoglycaemia in type 2 diabetes - an analysis of the prospective DiaRegis registry.

BACKGROUND: Hypoglycaemia is a serious adverse effect of antidiabetic drug therapy. We aimed to determine incidence rates of hypoglycaemia in type-2 diabetic patients and identify predictors of hypoglycaemia when treatment is intensified. METHODS: DiaRegis is a prospective German registry that follows 3810 patients with type-2 diabetes referred for treatment intensification because of insufficient glycaemic control on one or two oral antidiabetic drugs. RESULTS: Out of a total of 3347 patients with data available for the present analysis 473 (14.1%) presented any severity hypoglycaemia over a follow-up of 12 months. 0.4% were hospitalized (mean of 1.3±0.6 episodes), 0.1% needed medical assistance (1.0±0.0), 0.8% needed any help (1.1±0.5) and 10.1% no help (3.4±3.7), and 8.0% had no specific symptoms (3.6±3.5). Patients with incident hypoglycaemia had longer diabetes duration, higher HbA1c and a more frequent smoking history; more had co-morbid disease conditions such as coronary artery disease, peripheral arterial disease, amputation, heart failure, peripheral neuropathy, diabetic retinopathy and clinically relevant depression at baseline. Multivariable adjusted positive predictors of incident hypoglycaemia over the follow-up were prior anamnestic hypoglycaemia, retinopathy, depression, insulin use and blood glucose self-measurement, but not sulfonylurea use as previously reported for anamnestic or recalled hypogylcaemia. On the contrary, glitazones, DPP-4 inhibitors and GLP-1 analogues were associated with a reduced risk of hypoglycaemia. CONCLUSIONS: Hypoglycaemia is a frequent adverse effect in ambulatory patients when antidiabetic treatment is intensified. Particular attention is warranted in patients with prior episodes of hypoglycaemia, microvascular disease such as retinopathy and in patients receiving insulin. On the other hand glitazones, DPP-4 inhibitors and GLP-1 analogues are associated with a reduced risk.

Treatment patterns and risk factor control in patients with and without metabolic syndrome in cardiac rehabilitation.

AIM: Metabolic syndrome (MetS) is a clustering of factors that are associated with increased cardiovascular risk. We aimed to investigate the proportion of patients with MetS in patients undergoing cardiac rehabilitation (CR), and to describe differences between patients with MetS compared to those without MetS with regard to (1) patient characteristics including demographics, risk factors, and comorbidities, (2) risk factor management including drug treatment, and (3) control status of risk factors at entry to CR and discharge from CR. METHODS: Post-hoc analysis of data from 27,904 inpatients (Transparency Registry to Objectify Guideline-Oriented Risk Factor Management registry) that underwent a CR period of about 3 weeks were analyzed descriptively in total and compared by their MetS status. RESULTS: In the total cohort, mean age was 64.3 years, (71.7% male), with no major differences between groups. Patients had been referred after a ST elevation of myocardial infarction event in 41.1% of cases, non-ST elevation of myocardial infarction in 21.8%, or angina pectoris in 16.7%. They had received a percutaneous coronary intervention in 55.1% and bypass surgery (coronary artery bypass graft) in 39.5%. Patients with MetS (n = 15,819) compared to those without MetS (n = 12,085) were less frequently males, and in terms of cardiac interventions, more often received coronary artery bypass surgery. Overall, statin use increased from 79.9% at entry to 95.0% at discharge (MetS: 79.7% to 95.2%). Patients with MetS compared to those without MetS received angiotensin converting enzyme inhibitors, angiotensin receptor blockers, oral antidiabetics, and insulin at entry and discharge more frequently, and less frequently clopidogrel and aspirin/clopidogrel combinations. Mean blood pressure was within the normal range at discharge, and did not differ substantially between groups (124/73 versus 120/72 mmHg). Overall, between entry and discharge, levels of total cholesterol, low density lipoprotein cholesterol, and triglycerides were substantially lowered, in particular in MetS patients. Thus, control rates of lipid parameters improved substantially, with the exception of high density lipoprotein cholesterol. Low density lipoprotein cholesterol rates <100 mg/dL increased from 38.7% at entry to 73.8% at discharge (MetS: from 39.4% to 74.6%) and triglycerides control rates (<150 mg/dL) from 58.1% to 70.4% (MetS: 43.7% to 62.2%). Physical fitness on exercise testing improved substantially in both groups. CONCLUSION: Patients with and without MetS benefited substantially from the participation in CR, as their lipid profile, blood pressure, and physical fitness improved. Treatment effects were similar in the two groups.

Effects of a secondary prevention combination therapy with an aspirin, an ACE inhibitor and a statin on 1-year mortality of patients with acute myocardial infarction treated with a beta-blocker. Support for a polypill approach.

OBJECTIVE: Large randomized clinical trials have shown the efficacy of aspirin, ACE (angiotensin converting enzyme) inhibitors and statins as secondary prevention measures in patients after an acute coronary syndrome with and without ST elevations. Therefore we aimed to determine the effect of a combination therapy with these three drugs on 1-year mortality after acute myocardial infarction (AMI). METHODS: We prospectively followed 9998 survivors of acute myocardial infarction treated with a beta-blocker for 1 year. Patients were divided into three groups according to their therapy with aspirin, ACE inhibitors and statins: 3 drugs, 2 drugs or 0-1 drug. RESULTS: The majority of patients (n = 6260, 62.6%) were treated with 3 drugs, 2986 (29.9%) with 2 drugs and 752 (7.5%) with 0-1 drug. In the univariate analysis 1-year mortality was 4.9%, 9.7% and 13.6%, respectively. After adjusting for confounding factors in the propensity score analysis the odds ratios for 1-year mortality were significantly increased with 0-1 drug (odds ratio 1.67, 95% CI 1.24-2.27) and with 2 drugs (odds ratio 1.54, 95% CI 1.26-1.87) in comparison with the group treated with all 3 drugs. However, in the ACOS registry the treatment was left to the discretion of the physician. This could lead to a selection bias, which cannot be fully eliminated by using multiple regression analysis. CONCLUSIONS: A combination therapy with aspirin, an ACE inhibitor and a statin reduces 1-year mortality in patients after AMI. Therefore a polypill approach with these three agents should be considered to increase drug compliance and reduce mortality after acute myocardial infarction.

Effect of an invasive strategy on in-hospital outcome and one-year mortality in women with non-ST-elevation myocardial infarction.

BACKGROUND: Subgroup analyses from randomized studies show inconsistent results regarding an early invasive approach in women with non-ST-elevation myocardial infarction (NSTEMI). We sought to investigate the impact of an invasive strategy in clinical practice, analyzing data from the German Acute Coronary Syndromes registry (ACOS). METHODS: Overall 1986 consecutive women were enrolled in the registry between June 2000 and November 2002 and were divided into two groups: 1215 (61.2%) underwent coronary angiography, 771 (38.8%) received conservative treatment. In the invasive group percutaneous coronary intervention was performed in 40.7% within 48 h and in 16.4% after 48 h, whereas 8.3% underwent coronary artery bypass grafting within hospital stay. RESULTS: In-hospital death (3.2% vs 10.5%, p<0.0001), in-hospital death/myocardial infarction (MI) (7.1% vs 14.9%, p<0.0001) and one-year death (8.1% vs 24%) occurred significantly less often in patients with invasive strategy. After adjustment of the confounding factors in the propensity score analysis the invasive strategy showed no significant benefit for in-hospital death (OR 0.86, 95% CI 0.51-1.44) or death/MI (OR 0.70, 95% CI 0.47-1.04) but remained superior for mortality (OR 0.47, 95% CI 0.3-0.7) and death/MI one year after discharge (OR 0.47, 95% CI 0.33-0.68). CONCLUSIONS: In clinical practice women presenting with NSTEMI have a long-term benefit from an invasive therapeutic strategy with a significant reduction in mortality as well as the composite endpoint of death/MI.

Prevalence and overlap of different lipid abnormalities in statin-treated patients at high cardiovascular risk in clinical practice in Germany.

BACKGROUND: In line with current guideline recommendations, patients at high cardiovascular risk are usually treated with statins for secondary as well as for primary prevention. While many studies investigated treatment goal achievement with regards to low-density lipoprotein (LDL-C) and total cholesterol (TC) there is paucity of data regarding high density lipoprotein (HDL-C), and/or triglycerides (TG). SETTING: Prospective, cross-sectional study (Dyslipidemia International Survey, DYSIS) with data provided by 748 office-based physicians throughout Germany. METHODS: Consecutive patients were eligible for participation, if they were at least 45 years old, currently treated with a statin and had had a documented lipid profile (at least 1 parameter) within the last 6 months. Besides descriptive analyses, logistic regression was performed with backward selection to assess predictors for lipid abnormalities (non-attainment of goals for TC, LDL-C, low HDL-C or elevated TG) classified according to current European Society of Cardiology guidelines. RESULTS: The 4,282 documented patients (98.6% Caucasian, 56.4% male; 86.6% at high cardiovascular risk) were predominantly treated with simvastatin (83.9%), pravastatin (7.7%) or atorvastatin (3.9%), usually with doses equivalent to simvastatin 20-40 mg daily. Non-statins were used in at most 12% of patients. No lipid abnormalities were found in 21.0% of patients, one abnormality in 38.5%, two in 31.9%, and all three in 8.5%. LDL-C goals were not attained in 58.1%, elevated TC was found in 66.6%, low HDL-C in 22.7%, and elevated TG in 47.3%. In the multivariate logistic regression model, non-attainment of LDL-C levels was predicted by hypertension (odds ratio, OR 1.4), current smoking (OR 1.3), sedentary lifestyle (OR 1.3), and female gender (OR 1.3). On the other hand, a reduced risk for missing LDL-C targets was noted in the presence of ischemic heart disease (OR 0.6), diabetes (0.5), higher statin doses, ezetimibe treatment, or specialist care, respectively. CONCLUSION: A substantial proportion of statin-treated patients not only missed targets for LDL-C, but also did not attain the normal levels for HDL-C and/or TG. There is a large disconnect between high prevalence of HDL and/or TG disorders, with or without elevated LDL-C, and utilization of therapies targeting these lipids. Particularly in high-risk patients, additional efforts should be made to improve their lipid profile.

Chronic total coronary occlusions in patients with stable angina pectoris: impact on therapy and outcome in present day clinical practice.

BACKGROUND: Chronic total coronary occlusions (CTOs) represent a subgroup of coronary lesions with a low procedural success and high recurrence rate. However, there is evidence for a prognostic benefit of revascularizing a CTO. OBJECTIVE: This study assessed the prevalence of CTOs among patients with stable angina pectoris and its impact on therapeutic strategies. METHODS: Between 2001 and 2003, a survey was conducted in 64 sites to analyze the outcome of the first diagnostic angiography in patients presenting with stable angina pectoris (STAR registry). The clinical characteristics, initial angiographic findings, therapeutic strategy and outcome within the first year were analyzed. RESULTS: A total of 2,002 patients were entered into the registry. One-third had at least one CTO. At 1 year, the mortality in patients with a CTO was significantly higher than in those without a CTO (5.5 vs. 3.1%; P = 0.009). This excess mortality was related to a higher prevalence of confounding factors in patients with a CTO such as diabetes and more severe LV dysfunction. Patients with a CTO were more likely to undergo surgery or being treated medically, whereas patients without a CTO were more likely to undergo PCI. If a CTO was treated by PCI the periprocedural and long-term outcome was similar to those with PCI for a non-occlusive lesion. However, periprocedural MACE was higher for patients treated for a non-occlusive lesion without first treating the CTO. CONCLUSIONS: The prevalence of CTOs in patients with stable angina pectoris is high, and it influences the clinical outcome within the first year. The therapeutic strategy is influenced towards a rather conservative approach and lower rates of interventional therapy.

Effect of an invasive strategy on in-hospital outcome in elderly patients with non-ST-elevation myocardial infarction.

AIMS: We sought to investigate the impact of an invasive treatment in elderly patients presenting with non-ST elevation myocardial infarction (NSTEMI) in clinical practice. METHODS AND RESULTS: We analysed data of consecutive elderly patients (> or =75 years) with NSTEMI who were prospectively enrolled in the German Acute Coronary Syndromes registry between July 2000 and November 2002. Overall 1936 patients were divided into two groups: 1005 (51.9%) underwent coronary angiography and/or revascularization, 931 (48.1%) received conservative treatment. In the invasive group, percutaneous coronary intervention was performed in 37.5% within 48 h and in 17.6% after 48 h, whereas 9.8% underwent coronary artery bypass grafting within the hospital stay. In-hospital death (12.5 vs. 6.0%, P < 0.0001) and death/myocardial infarction (17.3 vs. 9.6%, P < 0.0001) occurred significantly less often in patients with invasive strategy. After adjustment of the confounding factors in the propensity score analysis the invasive strategy remained superior for mortality (OR 0.55, 95% CI 0.35-0.86) and death and non-fatal myocardial infarction (OR 0.51, 95% CI 0.35-0.75) and 1 year mortality (OR 0.56, 95% CI 0.38-0.81). Major bleeding complications tended to be more frequent in the invasive group (8.8 vs. 5.8%, P = 0.07). CONCLUSION: In clinical practice, in elderly patients with NSTEMI, an invasive strategy is associated with an improved in-hospital and 1 year outcome but a trend towards more bleeding complications.

Actual clinical practice of exercise testing in consecutive patients after non-ST-elevation myocardial infarction: results of the acute coronary syndromes registry.

BACKGROUND: Exercise testing has been advocated for risk stratification and determination of therapeutic strategies after acute myocardial infarction. Frequency and therapeutic impact of exercise testing after non-ST-elevation myocardial infarction (NSTEMI) in actual clinical practice, however, is not known. METHODS AND RESULTS: From the German acute coronary syndrome (ACOS) registry patients with acute NSTEMI (n = 5281) were evaluated: 20.8% of patients (1097/5281) had predischarge exercise testing, and from these tests 33.5% (367/1097) were positive. The strongest predictors for renunciation of predischarge exercise testing were ejection fraction under 40%, age over 70 years and stroke history. In-hospital coronary angiographies or percutaneous coronary interventions were not associated with a lower rate of exercise testing. During 1-year follow-up all-cause mortality was 13.6% in patients without and 5.1% in patients with exercise test respectively (P < 0.0001). In patients with positive exercise test 1-year mortality was 6.5%, in patients with negative exercise test 4.4% (P = 0.13). During follow-up no significant difference was found in the rate of coronary revascularizations between patients either with positive or negative exercise tests. Furthermore, no significant difference was found in the rate of death and revascularizations comparing different groups of exercise capacity. CONCLUSIONS: After NSTEMI in Germany the majority of patients do not get predischarge exercise testing, although this group appears to be of special risk for fatality during follow-up. Furthermore, in actual clinical practice, neither exercise induced signs of ischemia nor exercise capacity have a significant impact on the rate of revascularization procedures during follow-up.

Early eptifibatide improves TIMI 3 patency before primary percutaneous coronary intervention for acute ST elevation myocardial infarction: results of the randomized integrilin in acute myocardial infarction (INTAMI) pilot trial.

AIMS: Adjunctive therapy with glycoprotein IIb/IIIa inhibitors has been shown to reduce ischaemic complications and improve clinical outcome in patients with primary percutaneous coronary intervention (PCI) for acute ST elevation myocardial infarction. Little is known about the use of eptifibatide in this setting. METHODS AND RESULTS: One hundred and two patients with ST elevation myocardial infarction <12 h scheduled for primary percutaneous intervention were randomly assigned to early eptifibatide given in the emergency room (early) or optional eptifibatide at the time of PCI (late or no). Primary endpoint was the patency of the infarct vessel before PCI. Patients in the early group received their first eptifibatide bolus, a mean of 45 min before angiography. TIMI 3 patency before PCI was observed in 34% in the early group and 10% in late or no group (P=0.01). The incidence of complete ST resolution 1 h after PCI was 61% in early group and 66% in the late or no group, respectively (P=n.s.). There were no significant differences in the rates of TIMI 3 flow after PCI, death, reinfarction, stroke, and major bleeding complications until day 30. CONCLUSION: In this pilot trial, double bolus eptifibatide given in the emergency room improved TIMI 3 grade flow of the infarct-related coronary artery before PCI. These results should be confirmed in a larger trial and whether this advantage translates into an improvement in clinical outcome should be tested in a trial with primary clinical endpoints.

The initial management of stable angina in Europe, from the Euro Heart Survey: a description of pharmacological management and revascularization strategies initiated within the first month of presentation to a cardiologist in the Euro Heart Survey of Stable Angina.

AIMS: In order to assess adherence to guidelines and international variability in management, the Euro Heart Survey of Newly Presenting Angina prospectively studied medical therapy, percutaneous coronary intervention (PCI), and surgery in patients with new-onset stable angina in Europe. METHODS AND RESULTS: Consecutive patients, 3779 in total, with a clinical diagnosis of stable angina by a cardiologist were enrolled. After initial assessment by a cardiologist, 78% were treated with aspirin, 48% with a statin, and 67% with a beta-blocker. ACE-inhibitors were prescribed by the cardiologist in 37% overall. Revascularization rates were low, with only 501 (13%) patients having PCI or coronary bypass surgery performed or planned. However, when restricted to patients with coronary disease documented within 4 weeks of assessment, over 50% had revascularization performed or planned. Among other factors, the national rate of angiography and availability of invasive facilities significantly predicted the likelihood of revascularization, OR 2.4 and 2.0, respectively. CONCLUSION: This survey shows a shortfall between guidelines and practice with regard to the use of evidence-based drug therapy and evidence that revascularization rates are strongly influenced by non-clinical, in addition to clinical, factors.

Women and heart disease: the role of diabetes and hyperglycemia.

Cardiovascular disease (CVD) is the primary cause of death in women, and women with type 2 diabetes mellitus are at greater risk of CVD compared with nondiabetic women. The increment in risk attributable to diabetes is greater in women than in men. The extent to which hyperglycemia contributes to heart disease risk has been examined in observational studies and clinical trials, although most included only men or did not analyze sex differences. The probable adverse influence of hyperglycemia is potentially mediated by impaired endothelial function, and/or by other mechanisms. Beyond high blood glucose level, a number of other common risk factors for CVD, including hypertension, dyslipidemia, and cigarette smoking, are seen in women with diabetes and require special attention. Presentation and diagnosis of CVD may differ between women and men, regardless of the presence of diabetes. Recognizing the potential for atypical presentation of CVD in women and the limitations of common diagnostic tools are important in preventing unnecessary delay in initiating proper treatment. Based on what we know today, treatment of CVD should be at least as aggressive in women-and especially in those with diabetes-as it is in men. Future trials should generate specific data on CVD in women, either by design of female-only studies or by subgroup analysis by sex.