Objectives The aim of the present analysis was to compare 1-year mortality prediction of Bleeding Academic Research Consortium (BARC)-defined bleeding complications with existing bleeding definitions ...in patients with ST-segment elevation myocardial infarction (STEMI) and to investigate the prognostic value of the individual data elements of the bleeding classifications for 1-year mortality. Background BARC recently proposed a novel standardized bleeding definition. Methods The in-hospital occurrence of bleeding defined according to the BARC, TIMI (Thrombolysis In Myocardial Infarction), GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries), and ISTH (International Society on Thrombosis and Haemostasis) bleeding classifications was assessed in 2,002 STEMI patients undergoing primary percutaneous coronary intervention between January 1, 2003, and July 31, 2008. Results BARC types 2, 3, 4, and 5 bleeding occurred in 4.4%, 14.2%, 1.4%, and 0.3% of patients, respectively. By multivariable analysis, GUSTO- and ISTH-defined bleeding was not significantly associated with 1-year mortality, whereas TIMI major and BARC type 3b or 3c bleeding conferred a 2-fold higher risk of 1-year mortality (hazard ratios HRs: 2.00 95% confidence interval (CI): 1.32 to 3.01 and 1.84 95% CI: 1.23 to 2.77, respectively). Data elements most strongly associated with mortality were a hemoglobin decrease ≥5 g/dl (HR: 1.94 95% CI: 1.26 to 2.98), the use of vasoactive agents for bleeding (HR: 2.01 95% CI: 0.91 to 4.44), cardiac tamponade (HR: 2.38 95% CI: 0.56 to 10.1), and intracranial hemorrhage (HRs for 1-year mortality were not computable because there was only 1 patient with intracranial bleeding). Conclusions Both the BARC and TIMI bleeding classification identified STEMI patients at risk of 1-year mortality.
Background Supervised exercise therapy (SET) is recommended as the primary treatment for patients with intermittent claudication (IC). However, there is concern regarding the safety of performing SET ...because IC patients are at risk for untoward cardiovascular events. The Dutch physical therapy guideline advocates cardiac exercise testing before SET, if indicated. Perceived uncertainties concerning safety may contribute to the underuse of SET in daily practice. The objective of this review was to analyze the safety of supervised exercise training in patients with IC. Methods Two authors independently studied clinical trials investigating SET. Data were obtained from MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials. Complication rates were calculated and expressed as number of events per number of patient-hours. The usefulness of cardiac screening before SET was evaluated in a subanalysis. Results Our search strategy revealed 2703 abstracts. We selected 121 articles, of which 74 met the inclusion criteria. Studies represent 82,725 hours of training in 2876 IC patients. Eight adverse events were reported, six of cardiac and two of noncardiac origin, resulting in an all-cause complication rate of one event per 10,340 patient-hours. Conclusions SET can safely be prescribed in patients with IC because an exceedingly low all-cause complication rate was found. Routine cardiac screening before commencing SET is not required. Our results may diminish perceived uncertainties regarding safety and will possibly increase the use of SET in daily practice.
Patients with coronary artery disease (CAD) are at high risk of recurrent events. A healthy lifestyle can significantly reduce this risk. A previous trial, Randomized Evaluation of Secondary ...Prevention by Outpatient Nurse SpEcialists (RESPONSE), demonstrated that nurse-coordinated outpatient clinics improve drug treatment of cardiovascular risk factors. However, lifestyle-related risk factors, including smoking, overweight, and physical inactivity, were common and remained largely unchanged at follow-up in most patients (66%). The aim of the current study is to evaluate the impact of 3 community-based lifestyle programs in patients after hospitalization for CAD. We are conducting a multicenter (n = 15), randomized trial that will recruit 800 patients to test the efficacy of up to 3 widely available commercial lifestyle programs, aimed at patients and their partners, on top of usual care. These programs are aimed at smoking cessation (Luchtsignaal® ), weight loss (Weight Watchers® ), and improving physical activity (Philips DirectLife® ). Outcomes The primary outcome at 12 months is the proportion of patients in whom at least 1 lifestyle risk factor is improved without deterioration in any of the other 2, and a relative increase of at least 30% in this proportion is considered clinically relevant.
Background Evidence suggesting important ethnic differences in chronic kidney disease (CKD) prevalence comes mainly from the United States, and data among various ethnic groups in Europe are lacking. ...We therefore assessed differences in CKD in 6 ethnic groups living in the Netherlands and explored to what extent the observed differences could be accounted for by differences in conventional cardiovascular risk factors (smoking, physical activity, obesity, hypertension, diabetes, and hypercholesterolemia). Study Design Cross-sectional analysis of baseline data from the Healthy Life in an Urban Setting (HELIUS) cohort study. Setting & Participants A random sample of 12,888 adults (2,129 Dutch, 2,273 South Asian Surinamese, 2,159 African Surinamese, 1,853 Ghanaians, 2,255 Turks, and 2,219 Moroccans) aged 18 to 70 years living in Amsterdam, the Netherlands. Predictors Ethnicity. Outcomes & Measurements CKD status was defined using the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) severity of CKD classification. CKD was defined as albumin-creatinine ratio ≥ 3 mg/mmol (category ≥ A2) or glomerular filtration rate < 60 mL/min/1.73 m2 (category ≥ G3). Comparisons among groups were made using prevalence ratios (PRs). Results The age-standardized prevalence of CKD was higher in all ethnic minority groups, ranging from 4.6% (95% CI, 3.8%-5.5%) in African Surinamese to 8.0% (95% CI, 6.7%-9.4%) in Turks, compared with 3.0% (95% CI, 2.3%-3.7%) in Dutch. Adjustment for conventional risk factors reduced the PR substantially, but ethnic differences remained for all ethnic minority groups except African Surinamese, with the PR ranging from 1.48 (95% CI, 1.12-1.97) in Ghanaians to 1.75 (95% CI, 1.33-2.30) in Turks compared with Dutch. Similar findings were found when CKD was stratified into a moderately increased and a combined high/very high risk group. Among the combined high/very high CKD risk group, conventional risk factors accounted for most of the ethnic differences in CKD except for South Asian Surinamese (PR, 2.60; 95% CI, 1.26-5.34) and Moroccans (PR, 2.33; 95% CI, 1.05-5.18). Limitations Cross-sectional design. Conclusions These findings suggest ethnic inequalities in CKD for most groups even after adjustment for conventional risk factors. These findings highlight the need for further research to identify other potential factors contributing to the ethnic inequalities in CKD.
Abstract Background Cholesterol and blood pressure (BP) can be effectively and safely lowered with statin drugs and BP-lowering drugs, reducing major cardiovascular (CV) events by 20%-30% within 5 ...years in high-risk individuals. However, there are limited data in lower-risk populations. The H eart O utcomes P revention E valuation-3 (HOPE-3) trial is evaluating whether cholesterol lowering with a statin drug, BP lowering with low doses of 2 antihypertensive agents, and their combination safely reduce major CV events in individuals at intermediate risk who have had no previous vascular events and have average cholesterol and BP levels. Methods A total of 12,705 women 65 years or older and men 55 years or older with at least 1 CV risk factor, no known CV disease, and without any clear indication or contraindication to the study drugs were randomized to rosuvastatin 10 mg/d or placebo and to candesartan/hydrochlorothiazide 16/12.5 mg/d or placebo (2 × 2 factorial design) and will be followed for a mean of 5.8 years. The coprimary study outcomes are the composite of CV death, nonfatal myocardial infarction (MI), and nonfatal stroke and the composite of CV death, nonfatal MI, nonfatal stroke, resuscitated cardiac arrest, heart failure, and arterial revascularization. Results Participants were recruited from 21 countries in North America, South America, Europe, Asia, and Australia. Mean age at randomization was 66 years and 46% were women. Conclusions The HOPE-3 trial will provide new information on cholesterol and BP lowering in intermediate-risk populations with average cholesterol and BP levels and is expected to inform approaches to primary prevention worldwide (HOPE-3 ClinicalTrials.gov NCT00468923 ).
Background The OASIS-5 (Organization to Assess Strategies in Ischemic Syndromes-5) trial demonstrated that fondaparinux was noninferior to enoxaparin while reducing the risk of bleeding by 50%. The ...objectives of our study were to assess the effects of fondaparinux compared to enoxaparin in patients stratified by their Global Registry of Acute Coronary Events (GRACE) score and to examine the ability of the GRACE score to predict bleeding in patients with acute coronary syndromes (ACS). Methods We analyzed efficacy and safety according to the GRACE admission risk score. Results The impact of fondaparinux versus enoxaparin on the primary outcome of death, myocardial infarction, and refractory ischemia at 180 days was similar in the low-, intermediate-, and high-risk groups: 7.0% versus 7.7% (hazard ratio HR 0.90, 95% confidence interval CI 0.75-1.08), 10.2% versus 11.3% (HR 0.89, 95% CI 0.77-1.03), and 20.1% versus 21.1% (HR 0.95, 95% CI 0.85-1.06). Major bleeding rates were higher with increasing GRACE risk scores: 2.2%, 3.2%, and 4.1% in the low, intermediate, and high-risk groups. Six-month mortality was 2.2%, 4.2%, and 12.3% in the 3 groups. The risk of major bleeding was substantially lower with fondaparinux in all groups: 1.6% versus 2.9% (HR 0.55, 95% CI 0.39-0.77), 2.2% versus 4.1% (HR 0.53, 95% CI 0.40-0.70), 2.8% versus 5.5% (HR 0.50, 95% CI 0.38-0.64). Conclusion The GRACE score predicted both bleeding and mortality in patients with ACS. The efficacy and safety of fondaparinux were consistent in all risk groups supporting its use in a broad range of ACS patients.
Aims The OASIS-6 trial demonstrated the benefit of fondaparinux in patients with ST-segment elevation myocardial infarction (STEMI) not undergoing primary percutaneous coronary intervention. Elderly ...compared to younger patients are at higher risk of bleeding and could have a different balance of benefits and risks when treated with antithrombotic therapy. Methods and Results We explored the efficacy and safety of fondaparinux compared to control according to age tertiles in 12,092 patients with STEMI in the OASIS-6 trial. Death or myocardial infarction rates were reduced by fondaparinux in tertile I (age <56 years, 4.5% vs 4.8%, hazard ratio HR 0.94, 95% CI 0.71-1.25), in tertile II (age 56-68 years, 7.9% vs 9.7%, HR 0.80, 0.65-0.98), and in tertile III (age ≥69 years, 17.2% vs 19.8%, HR 0.87, 95% CI 0.75-1.01, P for heterogeneity = 0.87). Severe hemorrhage rates were reduced in tertile I (0.5% vs 0.6%, HR 0.94, 95% CI 0.41-2.12), in tertile II (0.9% vs 1.5%, HR 0.63, 95% CI 0.35-1.11), and in tertile III (2.1% vs 2.4%, HR 0.86, 95% CI 0.56-1.33, P for heterogeneity = 0.86). Death, myocardial infarction, or severe hemorrhage rates were reduced in tertile I (4.8% vs 5.0%, HR 0.95, 95% CI 0.72-1.25), in tertile II (8.1% vs 10.1%, HR 0.79, 95% CI 0.65-0.97), and in tertile III (17.6% vs 20.4%, HR 0.86, 95% CI 0.74-1.00, P for heterogeneity = 0.77). Conclusion The balance of benefits and risks of fondaparinux is consistent across age tertiles, supporting its use across the age spectrum of patients with STEMI who do not undergo primary percutaneous coronary intervention.
Background Loss of body tissue resulting in undernutrition can be caused by reduced food intake, altered metabolism, ageing, and physical inactivity. The predominant cause of undernutrition before ...cardiac operations is unknown. First, we explored the association of reduced food intake and inactivity with undernutrition in patients before elective cardiac operations. Second, we assessed if adding these reversible, cause-based items to the nutritional screening process improved diagnostic accuracy. Methods A prospective observational study was performed. Undernutrition was defined by low fat-free mass index (LFFMI) measured by bioelectrical impedance spectroscopy and/or unintended weight loss (UWL). Reduced food intake was defined as the patient having a decreased appetite over the previous month. Patients admitted to hospital preoperatively were assumed to be less physically active than patients awaiting cardiac operations at home. Using these data, we developed a new tool and compared this with an existing cardiac surgery–specific tool (Cardiac Surgery–Specific Malnutrition Universal Screening Tool CSSM). Results A total of 325 patients who underwent open cardiac operations were included. Reduced food intake and inactivity were associated with undernutrition (odds ratio OR, 4.2; 95% confidence interval CI, 2.1–8.5 and OR, 2.0; 95% CI, 1.0–4.0). Reduced food intake and inactivity were integrated with body mass index (BMI) and UWL into a new scoring system: the Cardiac Surgery–Specific Undernutrition Screening Tool (CSSUST). Sensitivity in identification of undernourished patients was considerably higher with the CSSUST (90%) than with the CSSM (71%) (receiver operating characteristic ROC curve–based area under the curve AUC, 0.79; 95% CI, 0.73–0.86 and ROC AUC, 0.71; 95% CI, 0.63–0.80). Conclusions Results suggest that reduced food intake and inactivity partly explain undernutrition before cardiac operations. Our new cause-based CSSUST, which includes reduced food intake and inactivity, is superior to existing tools in identifying undernutrition in patients undergoing cardiac operations.
OBJECTIVE—Recently, polymorphisms in thrombospondin (THBS) genes coding for THBS-1 (N700S), THBS-2 (T>G substitution in 3′-untranslated region), and THBS-4 (A387P) genes were proposed to modulate the ...risk of premature coronary artery disease (CAD) or myocardial infarction (MI). It was our objective to verify this hypothesis in an independent cohort.
METHODS AND RESULTS—We performed a case-control study among patients (n=503) referred to our institution for symptomatic CAD that occurred before the age of 50 years and a group of age- and sex-matched population-based controls free of CAD (n=1071). The THBS-1 variant allele was not associated with an altered risk of premature CAD or MI. Homozygosity for the THBS-2 variant allele and the THBS-4 variant (387P) allele was significantly associated with a reduced risk of premature MI compared with wild-type individuals (OR=0.44, 0.24 to 0.84 and OR=0.43, 0.22 to 0.85, respectively). The latter observation is in contrast with a previous report, although confidence intervals overlap.
CONCLUSIONS—We conclude that a relationship between the THBS-1 N700S polymorphism and premature CAD is unlikely. For the THBS-4 A387P polymorphism, additional studies are required to elucidate its role in premature CAD. Finally, we conclude that the THBS-2 polymorphism is associated with a reduced risk of premature MI.
PDF
