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The registry-based randomized VALIDATE-SWEDEHEART trial (NCT02311231) compared bivalirudin vs. heparin in patients undergoing percutaneous coronary intervention (PCI) for myocardial infarction (MI). It showed no difference in the composite primary endpoint of death, MI, or major bleeding at 180 days. Here, we report outcomes at two years. Analysis of primary and secondary endpoints at two years of follow-up was prespecified in the study protocol. We report the study results for the extended follow-up time here. In total, 6006 patients were enrolled, 3005 with ST-segment elevation MI (STEMI) and 3001 with Non-STEMI (NSTEMI), representing 70 % of all eligible patients with these diagnoses during the study. The primary endpoint occurred in 14.0 % (421 of 3004) in the bivalirudin group compared with 14.3 % (429 of 3002) in the heparin group (hazard ratio [HR] 0.97; 95 % confidence interval [CI], 0.85–1.11; P = 0.70) at one year and in 16.7 % (503 of 3004) compared with 17.1 % (514 of 3002), (HR 0.97; 95 % CI, 0.96–1.10; P = 0.66) at two years. The results were consistent in patients with STEMI and NSTEMI and across major subgroups. Until the two-year follow-up, there were no differences in endpoints between patients with MI undergoing PCI and allocated to bivalirudin compared with those allocated to heparin. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02311231. • A large-scale trial involving 6006 MI patients compared the outcomes of bivalirudin and heparin. • Two-year outcomes show no significant difference in MI patients treated with bivalirudin vs. heparin. • Consistent results were observed in both STEMI and NSTEMI patient groups. • Long-term follow-up confirmed similar safety and efficacy profiles for both drugs. [ABSTRACT FROM AUTHOR]

This document is a reply from the authors of an article published in the New England Journal of Medicine. The authors clarify that in their trial, revascularization was considered unplanned when a patient was admitted to the hospital with persistent or increasing symptoms and a revascularization procedure was performed during the same hospitalization. They also mention that not all revascularizations that were not scheduled at discharge were defined as unplanned. The authors acknowledge that using a different definition of unplanned revascularization may yield different results, but they believe it would not change the overall outcome of the study. They suggest that future meta-analyses and individual patient data may help further understand the clinical relevance of complete revascularization. [Extracted from the article]

Objective: To determine the effects of oxygen therapy in myocardial infarction (MI) patients with and without diabetes.Research Design and Methods: In the Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction (DETO2X-AMI) trial, 6,629 normoxemic patients with suspected MI were randomized to oxygen at 6 L/min for 6-12 h or ambient air. In this prespecified analysis involving 5,010 patients with confirmed MI, 934 had known diabetes. Oxidative stress may be of particular importance in diabetes, and the primary objective was to study the effect of supplemental oxygen on the composite of all-cause death and rehospitalization with MI or heart failure (HF) at 1 year in patients with and without diabetes.Results: As expected, event rates were significantly higher in patients with diabetes compared with patients without diabetes (main composite end point: hazard ratio [HR] 1.60 [95% CI 1.32-1.93], P < 0.01). In patients with diabetes, the main composite end point occurred in 16.2% (72 of 445) allocated to oxygen as compared with 16.6% (81 of 489) allocated to ambient air (HR 0.93 [95% CI 0.67-1.27], P = 0.81). There was no statistically significant difference for the individual components of the composite end point or the rate of cardiovascular death up to 1 year. Likewise, corresponding end points in patients without diabetes were similar between the treatment groups.Conclusions: Despite markedly higher event rates in patients with MI and diabetes, oxygen therapy did not significantly affect 1-year all-cause death, cardiovascular death, or rehospitalization with MI or HF, irrespective of underlying diabetes, in line with the results of the entire study. [ABSTRACT FROM AUTHOR]

Introduction: Transcatheter aortic valve implantation (TAVI) is associated with a high incidence of new silent brain infarcts (SBIs) on postprocedural neuroimaging. A venous blood sample reflecting neuronal damage following TAVI could help identify patients with potential SBIs. We aimed to investigate if a biochemical marker of neuronal injury, neurofilament light chain (NFL), is elevated after TAVI. Methods: In this observational study, NFL was measured in plasma from 31 patients before and after TAVI. Multivariable regression analysis was performed to investigate any effect of clinical- and procedure-related factors on differences in NFL levels before and after TAVI. Results: Samples were collected 41 (14–81) days before and 44 (35–59) days after TAVI, median (interquartile range). Median age was 81 (77–84) years, and 35% were female. No patient had any overt procedure-related neurological complications. The geometric mean (95% confidence interval) of the NFL concentration was 30 (25–36) pg/mL before TAVI and 48 (39–61) pg/mL, after TAVI, p <0.001. None of the included variables in the multiple linear regression model were statistically significantly associated with the difference in levels before and after TAVI. Conclusions: NFL levels in plasma were higher after TAVI as compared with levels before, with a mean increase of 60% (18 pg/mL). Further studies including neuroimaging and cognitive outcomes are needed to understand the potential value of measuring NFL in relation to TAVI. [ABSTRACT FROM AUTHOR]

Background: The clinical effect of routine oxygen therapy in patients with suspected acute myocardial infarction who do not have hypoxemia at baseline is uncertain.Methods: In this registry-based randomized clinical trial, we used nationwide Swedish registries for patient enrollment and data collection. Patients with suspected myocardial infarction and an oxygen saturation of 90% or higher were randomly assigned to receive either supplemental oxygen (6 liters per minute for 6 to 12 hours, delivered through an open face mask) or ambient air.Results: A total of 6629 patients were enrolled. The median duration of oxygen therapy was 11.6 hours, and the median oxygen saturation at the end of the treatment period was 99% among patients assigned to oxygen and 97% among patients assigned to ambient air. Hypoxemia developed in 62 patients (1.9%) in the oxygen group, as compared with 254 patients (7.7%) in the ambient-air group. The median of the highest troponin level during hospitalization was 946.5 ng per liter in the oxygen group and 983.0 ng per liter in the ambient-air group. The primary end point of death from any cause within 1 year after randomization occurred in 5.0% of patients (166 of 3311) assigned to oxygen and in 5.1% of patients (168 of 3318) assigned to ambient air (hazard ratio, 0.97; 95% confidence interval [CI], 0.79 to 1.21; P=0.80). Rehospitalization with myocardial infarction within 1 year occurred in 126 patients (3.8%) assigned to oxygen and in 111 patients (3.3%) assigned to ambient air (hazard ratio, 1.13; 95% CI, 0.88 to 1.46; P=0.33). The results were consistent across all predefined subgroups.Conclusions: Routine use of supplemental oxygen in patients with suspected myocardial infarction who did not have hypoxemia was not found to reduce 1-year all-cause mortality. (Funded by the Swedish Heart-Lung Foundation and others; DETO2X-AMI ClinicalTrials.gov number, NCT01787110 .). [ABSTRACT FROM AUTHOR]

Background: Chronic angina is more common in patients with diabetes mellitus (DM) with poor glucose control. Ranolazine both treats chronic angina and improves glucose control.Objectives: This study sought to examine ranolazine's antianginal effect in relation to glucose control.Methods: The authors performed a secondary analysis of the RIVER-PCI (Ranolazine in Patients with Incomplete Revascularization after Percutaneous Coronary Intervention) trial, a clinical trial in which 2,604 patients with chronic angina and incomplete revascularization following percutaneous coronary intervention were randomized to ranolazine versus placebo. Mixed-effects models were used to compare the effects of ranolazine versus placebo on glycosylated hemoglobin (HbA1c) at 6- and 12-month follow-up. Interaction between baseline HbA1c and ranolazine's effect on Seattle Angina Questionnaire angina frequency at 6 and 12 months was tested.Results: Overall, 961 patients (36.9%) had DM at baseline. Compared with placebo, ranolazine significantly decreased HbA1c by 0.42 ± 0.08% (adjusted mean difference ± SE) and 0.44 ± 0.08% from baseline to 6 and 12 months, respectively, in DM patients, and by 0.19 ± 0.02% and 0.20 ± 0.02% at 6 and 12 months, respectively, in non-DM patients. Compared with placebo, ranolazine significantly reduced Seattle Angina Questionnaire angina frequency at 6 months among DM patients but not at 12 months. The reductions in angina frequency were numerically greater among patients with baseline HbA1c ≥7.5% than those with HbA1c <7.5% (interaction p = 0.07).Conclusions: In patients with DM and chronic angina with incomplete revascularization after percutaneous coronary intervention, ranolazine's effect on glucose control and angina at 6 months was proportionate to baseline HbA1c, but the effect on angina dissipated by 12 months. [ABSTRACT FROM AUTHOR]

Background: Thrombus aspiration during percutaneous coronary intervention (PCI) for the treatment of ST-segment-elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of thrombus aspiration during PCI in patients with ST-segment-elevation myocardial infarction.Methods: Included were large (n≥1000), randomized, controlled trials comparing manual thrombectomy and PCI alone in patients with ST-segment-elevation myocardial infarction. Individual patient data were provided by the leadership of each trial. The prespecified primary efficacy outcome was cardiovascular mortality within 30 days, and the primary safety outcome was stroke or transient ischemic attack within 30 days.Results: The 3 eligible randomized trials (TAPAS [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction], TASTE [Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia], and TOTAL [Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI]) enrolled 19 047 patients, of whom 18 306 underwent PCI and were included in the primary analysis. Cardiovascular death at 30 days occurred in 221 of 9155 patients (2.4%) randomized to thrombus aspiration and 262 of 9151 (2.9%) randomized to PCI alone (hazard ratio, 0.84; 95% confidence interval, 0.70-1.01; P=0.06). Stroke or transient ischemic attack occurred in 66 (0.8%) randomized to thrombus aspiration and 46 (0.5%) randomized to PCI alone (odds ratio, 1.43; 95% confidence interval, 0.98-2.10; P=0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure, or target vessel revascularization. In the subgroup with high thrombus burden (TIMI [Thrombolysis in Myocardial Infarction] thrombus grade ≥3), thrombus aspiration was associated with fewer cardiovascular deaths (170 [2.5%] versus 205 [3.1%]; hazard ratio, 0.80; 95% confidence interval, 0.65-0.98; P=0.03) and with more strokes or transient ischemic attacks (55 [0.9%] versus 34 [0.5%]; odds ratio, 1.56; 95% confidence interval, 1.02-2.42, P=0.04). However, the interaction P values were 0.32 and 0.34, respectively.Conclusions: Routine thrombus aspiration during PCI for ST-segment-elevation myocardial infarction did not improve clinical outcomes. In the high thrombus burden group, the trends toward reduced cardiovascular death and increased stroke or transient ischemic attack provide a rationale for future trials of improved thrombus aspiration technologies in this high-risk subgroup.Clinical Trial Registration: URLs: http://www.ClinicalTrials.gov http://www.crd.york.ac.uk/prospero/. Unique identifiers: NCT02552407 and CRD42015025936. [ABSTRACT FROM AUTHOR]

Aims: Standardized data definitions are necessary for the quantification of quality of care and patient outcomes in observational studies and randomised controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology (ESC) aims to create pan-European data standards for cardiovascular diseases and interventions, including transcatheter aortic valve implantation (TAVI). Methods and results: We followed the EuroHeart methodology for cardiovascular data standard development. A Working Group of 29 members representing 12 countries was established and included a patient representative, as well as experts in the management of valvular heart disease from the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Association of Cardiovascular Imaging (EACVI) and the Working Group on Cardiovascular Surgery. We conducted a systematic review of the literature and used a modified Delphi method to reach consensus on a final set of variables. For each variable, the Working Group provided a definition, permissible values, and categorized the variable as mandatory (Level 1) or additional (Level 2) based on its clinical importance and feasibility. In total, 93 Level 1 and 113 Level 2 variables were selected, with the level 1 variables providing the dataset for registration of patients undergoing TAVI on the EuroHeart IT platform. Conclusion: This document provides details of the EuroHeart data standards for TAVI processes of care and in-hospital outcomes. In the context of EuroHeart, this will facilitate quality improvement, observational research, registry-based RCTs and post-marketing surveillance of devices, and pharmacotherapies. One-sentence summary: The EuroHeart data standards for transcatheter aortic valve implantation (TAVI) are a set of internationally agreed data variables and definitions that once implemented will facilitate improvement of quality of care and outcomes for patients receiving TAVI. [ABSTRACT FROM AUTHOR]

The article highlights the routine oxygen supplementation in acute cardiovascular disease. Topics discussed include use of oxygen therapy in patients with acute stroke and other acute cardiovascular diseases; rationale behind increasing oxygen delivery to the ischemic heart, brain, or other organs; and potential risk-benefit ratio of oxygen treatment in acute cardiovascular conditions.

Background Bleeding limits anticoagulant treatment in patients with acute coronary syndromes (ACS). Objectives We investigated whether background concomitant antiplatelet therapy influences the effects of apixaban after ACS. Methods This study examined high-risk ACS patients who were treated with aspirin or aspirin plus clopidogrel and who were randomized to apixaban 5 mg twice daily or placebo. In a post-hoc analysis, we assessed whether the effect of apixaban on efficacy and safety outcomes varied by the concomitant antiplatelet regimen by using simple Cox modeling and marginal structural models with propensity scores and antiplatelet therapy as a time-dependent covariate. Results At baseline, of 7,364 patients, 16.3% (n = 1,202) were on aspirin alone, and 79.0% (n = 5,814) were on aspirin plus clopidogrel. A total of 19.2% (n = 1,415) switched antiplatelet therapy during follow-up. No differential effect of apixaban versus placebo was observed for the composite endpoint of cardiovascular death, myocardial infarction, and ischemic stroke in patients taking aspirin (12.21 per 100 patient-years vs. 13.21 per 100 patient-years; adjusted hazard ratio [HR]: 0.91; 95% confidence interval [CI]: 0.62 to 1.32) or aspirin plus clopidogrel (13.22 vs. 14.24; adjusted HR: 0.95; 95% CI: 0.78 to 1.14; p interaction = 0.84). Compared with placebo, apixaban increased Thrombolysis In Myocardial Infarction major bleeding in patients taking aspirin (1.48 vs. 0.25; adjusted HR: 6.62; 95% CI: 0.75 to 51.73) and in patients taking aspirin plus clopidogrel (2.58 vs. 1.02; adjusted HR: 2.44; 95% CI: 1.34 to 4.45; p interaction = 0.41). Similar results were obtained with marginal structural models and in patients treated with and without percutaneous coronary intervention. Conclusions Post-ACS treatment with apixaban versus placebo showed no efficacy, but it increased bleeding regardless of concomitant therapy with aspirin alone or aspirin plus clopidogrel. (Apixaban for Prevention of Acute Ischemic Events 2 [APPRAISE-2]; NCT00831441 ) [ABSTRACT FROM AUTHOR]

Randomized clinical trials provide the foundation of clinical evidence to guide physicians in their selection of treatment options. Importantly, randomization is the only reliable method to control for confounding factors when comparing treatment groups. However, randomized trials have limitations, including the increasingly prohibitive costs of conducting adequately powered studies. Local and national regulatory requirements, delays in approval, and unnecessary trial processes have led to increased costs and decreased efficiency. Another limitation is that clinical trials involve selected patients who are treated according to protocols that might not represent real-world practice. A possible solution is registry-based randomized clinical trials. By including a randomization module in a large inclusive clinical registry with unselected consecutive enrolment, the advantages of a prospective randomized trial can be combined with the strengths of a large-scale all-comers clinical registry. We believe that prospective registry-based randomized clinical trials are a powerful tool for conducting studies efficiently and cost-effectively. [ABSTRACT FROM AUTHOR]

We studied the association between taking part in a long distance ski race and cancer incidence to address the hypothesis that a lifestyle involving a high degree of physical activity (PA) lowers cancer incidence with a pattern that is different by cancer site. Cancer incidence was estimated in a large cohort of skiers (n = 185,412) participating in the Vasaloppet long distance ski race in Sweden 1989–2010 and non-participants in the ski race, randomly selected from the Swedish general population (n = 184,617). Data include race finishing times as a measurement of physical fitness. Hazard ratios (HRs) and net probability of cancer over twenty years of follow-up were estimated for all invasive cancer, and separately for prostate, breast, colo-rectal and lung cancer, and groups of cancers with presumed relation to lifestyle. Participating in Vasaloppet was associated with a relative risk reduction for all invasive cancer of 6% (95% confidence interval 2–9%) and a relative risk reduction of 32% (95% confidence interval 28–37%) of cancer sites where there is epidemiological evidence that smoking, bodyweight, regular PA and consumption of fruit and vegetables are aetiological factors. For skin cancer the risk was increased, as for prostate cancer. Skiers with shorter finishing times had lower incidence of cancer. This study indicates that it is unrealistic to reduce overall population cancer incidence drastically with life style. However, cancers that are epidemiologically associated with life style factors were significantly reduced by what presumably is a blend of non-smoking, normal body weight, sound dietary habits and PA. Our data thus provide additional support for present days' recommendations about life style prevention. Higher health awareness is associated with attendance to screening, which may explain our results for prostate cancer. University fund, independent funds from an insurance company and a private foundation. [ABSTRACT FROM AUTHOR]

Objective: To examine the relationship between country of birth and the utilization of coronary angiography, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) after a first-time myocardial infarction (MI). Design, setting and patients: 117 494 MI patients of all ages who were admitted to coronary care units between 2001 and 2009 in Sweden were followed-up for three months after admission. Main outcome measures: Undergoing coronary angiography, PCI or CABG after first-time MI. Results: proportion of patients undergoing angiography and PCI increased whereas proportion of patients undergoing CABG also delay time for all three procedures decreased over the study period. The proportion of women undergoing any of the three procedures was markedly lower and delay time longer than those of men regardless of study period and migration background. Overall foreign-born first MI patients had higher rate of angiography (HR = 1.30, 95% CI: 1.27-1.33), PCI (HR = 1.27, 95% CI: 1.24-1.30) and CABG (HR = 1.21, 95% CI: 1.15-1.28) compared with Sweden born first MI patients. After controlling for potential confounding factors in multivariable models, the overall differences vanished for angiography and reduced markedly for PCI and CABG. However, multivariable stratified analysis by specific country of birth yielded higher rate of angiography among men born in Uganda (HR = 2.11, 95% CI: 1.00-4.43) and Peru (HR = 1.98, 95% CI: 1.07-3.68) and lower rate among men born in Croatia (HR = 0.71, 95% CI: 0.52-0.99) and women born in Thailand (HR = 0.49, 95% CI: 0.35-0.94). PCI adjusted rates were higher among women born in Palestine state (HR = 2.44, 95% CI: 1.15-5.16), Iraq (HR = 1.34, 95% CI: 1.04-1.74) and Poland (HR = 1.21, 95% CI: 1.02-1.44) and rate of CABG was higher among immigrants from some parts of Asia, including men born in Sri Lanka (HR = 3.19, 95% CI: 1.43-7.12), India (HR = 1.95, 95% CI: 1.21-3.14), Vietnam (HR = 2.65, 95% CI: 1.32-5.33), Palestine State (HR = 2.11, 95% CI: 1.06-4.24), and women born in Syria (HR = 2.36, 95% CI: 1.25-4.45), Iraq (HR = 1.74, 95% CI: 1.02-2.94), and Turkey (HR = 1.70, 95% CI: 1.03-2.79). Conclusions: The observed high rate of CABG for immigrants and particularly those born in some Asian countries was not explained by the potential confounding factors. A more severe coronary disease in this population might explain this high rate but needs further research. Awareness and subsequent intervention at earlier stage of coronary disease among immigrants could prolong their life and reduce the healthcare costs. [ABSTRACT FROM AUTHOR]

Background We studied the association between taking part in a long distance ski race and cancer incidence to address the hypothesis that a lifestyle involving a high degree of physical activity (PA) lowers cancer incidence with a pattern that is different by cancer site. Methods Cancer incidence was estimated in a large cohort of skiers ( n = 185,412) participating in the Vasaloppet long distance ski race in Sweden 1989–2010 and non-participants in the ski race, randomly selected from the Swedish general population ( n = 184,617). Data include race finishing times as a measurement of physical fitness. Hazard ratios (HRs) and net probability of cancer over twenty years of follow-up were estimated for all invasive cancer, and separately for prostate, breast, colo-rectal and lung cancer, and groups of cancers with presumed relation to lifestyle. Findings Participating in Vasaloppet was associated with a relative risk reduction for all invasive cancer of 6% (95% confidence interval 2–9%) and a relative risk reduction of 32% (95% confidence interval 28–37%) of cancer sites where there is epidemiological evidence that smoking, bodyweight, regular PA and consumption of fruit and vegetables are aetiological factors. For skin cancer the risk was increased, as for prostate cancer. Skiers with shorter finishing times had lower incidence of cancer. Interpretation This study indicates that it is unrealistic to reduce overall population cancer incidence drastically with life style. However, cancers that are epidemiologically associated with life style factors were significantly reduced by what presumably is a blend of non-smoking, normal body weight, sound dietary habits and PA. Our data thus provide additional support for present days’ recommendations about life style prevention. Higher health awareness is associated with attendance to screening, which may explain our results for prostate cancer. Funding University fund, independent funds from an insurance company and a private foundation. [ABSTRACT FROM AUTHOR]

In the PLATelet inhibition and patient Outcomes (PLATO) study of patients with acute coronary syndromes, ticagrelor reduced mortality compared to clopidogrel but the mechanisms for this mortality reduction remain uncertain. We analysed adverse events (AEs) consistent with either pulmonary infection or sepsis, and subsequent mortality, in 18,421 PLATO patients treated with ticagrelor or clopidogrel. AEs occurring within 7 days of last dose of study medication were defined as 'on-treatment'. Serial measurements of blood leukocyte counts, C-reactive protein and interleukin-6 were performed. Fewer on-treatment pulmonary AEs occurred in the ticagrelor compared to the clopidogrel group (275 vs. 331 respectively; p = 0.019), with fewer deaths following these AEs (33 vs. 71; p < 0.001), particularly in those who remained on study medication three days after AE onset (10 vs. 43; p < 0.001). There were fewer deaths attributed to sepsis in the ticagrelor group (7 vs. 23; p = 0.003). Leukocyte counts were lower in the clopidogrel group during treatment ( p < 0.0001 at 1, 3 and 6 months) but not at 1 month post-discontinuation. C-reactive protein increased more at discharge in the ticagrelor group (28.0 ± 38.0 vs. 26.1 ± 36.6 mg/l; p < 0.001) and interleukin-6 remained higher during the first month of treatment with ticagrelor. We conclude that the mortality risk following pulmonary AEs and sepsis in acute coronary syndrome patients appears to be lower during ticagrelor compared to clopidogrel therapy. Further work should assess whether ticagrelor and clopidogrel have differential effects on immune signalling. [ABSTRACT FROM AUTHOR]

Objective Coeliac disease ( CD) has been linked to an increased risk of ischaemic heart disease ( IHD). We examined the risk of IHD in first-degree relatives and spouses to coeliac patients to ascertain the genetic contribution to IHD excess risk. Study design and setting Coeliac disease was defined as having a biopsy-verified villous atrophy (Marsh grade 3) in 1969-2008 ( n = 29 096). Coeliac patients were matched to 144 522 controls. Through Swedish registers, we identified all first-degree relatives and spouses to coeliac patients and their controls, in total 87 622 unique coeliac relatives and 432 655 unique control relatives. Our main outcome measure was IHD defined according to relevant international classification of disease codes in the Swedish Inpatient Registry or in the Cause of Death Registry. Hazard ratios ( HR) and confidence intervals ( CI) were estimated through Cox regression adjusted for sex, age-group and calendar year at study entry of the relative. Result During a median follow-up of 10·8 years, 2880 coeliac relatives and 13 817 control relatives experienced IHD. First-degree relatives of coeliac patients were at increased risk of IHD ( HR = 1·05; 95% CI = 1·00-1·09, P-value = 0·04), while spouses were at no increased risk ( HR = 0·99; 95% CI = 0·87-1·12). The excess risk of IHD in coeliac first-degree relatives aged 40-59 years was 70/100 000 person-years. Conclusion First-degree relatives to coeliac patients seem to be at an increased risk of IHD but the excess risk is so small that it has little clinical relevance. [ABSTRACT FROM AUTHOR]

Objective: Information is limited on the prognostic implications of cardiac troponin I (cTnI) changes during the first days of non-ST elevation acute coronary syndrome (NSTE-ACS). Methods: High-sensitivity cTnI levels were measured at study inclusion and after 48 h in 1615 conservatively managed NSTE-ACS patients from the Global Use of Strategies To Open Occluded Coronary Arteries (GUSTO) IV trial. Results: Patients with moderately increased cTnI levels and without a relevant decrease over time had a significantly raised mortality at 30 days and 1 year. No relevant associations between cTnI changes and recurrent myocardial infarction were seen. Conclusion: The cTnI change is predictive for subsequent mortality in selected conservatively managed NSTE-ACS patients. [ABSTRACT FROM AUTHOR]

The article examines the evidence-based treatment for patients with ST-segment elevation myocardial infarction (STEMI) disorder. The refers to guidelines specified by National Institute for Health and Care Excellence (NICE ) which calls for monitoring of adjunctive therapies for primary percutaneous coronary intervention (PCI). It also states that clinical trials conducted for STEMI care do not correspond to measures of patients' symptoms and quality of life.

Objective: To examine the relationship between sex, country of birth, level of education as an indicator of socioeconomic position, and the likelihood of treatment in a coronary care unit (CCU) for a first-time myocardial infarction. Design: Nationwide register based study. Setting: Sweden. Patients: 199 906 patients (114 387 men and 85,519 women) of all ages who were admitted to hospital for first-time myocardial infarction between 2001 and 2009. Main outcome measures: Admission to a coronary care unit due to myocardial infarction. Results: Despite the observed increasing access to coronary care units over time, the proportion of women treated in a coronary care unit was 13% less than for men. As compared with men, the multivariable adjusted odds ratio among women was 0.80 (95% confidence interval 0.77 to 0.82). This lower proportion of women treated in a CCU varied by age and year of diagnosis and country of birth. Overall, there was no evidence of a difference in likelihood of treatment in a coronary care unit between Sweden-born and foreign-born patients. As compared with patients with high education, the adjusted odds ratio among patients with a low level of education was 0.93 (95% confidence interval 0.89 to 0.96). Conclusions: Foreign-born and Sweden-born first-time myocardial infarction patients had equal opportunity of being treated in a coronary care unit in Sweden; this is in contrast to the situation in many other countries with large immigrant populations. However, the apparent lower rate of coronary care unit admission after first-time myocardial infarction among women and patients with low socioeconomic position warrants further investigation. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to describe the characteristics and outcome of all consecutive patients treated with percutaneous coronary intervention (PCI) in an unselected nationwide cohort over the past 2 decades. Background Over the last 20 years, treatment with PCI has evolved dramatically, but the change in patient characteristics has not been well described. Methods We included all patients undergoing a PCI procedure for the first time between January 1990 and December 2010 from the SCAAR (Swedish Coronary Angiography and Angioplasty Registry). Patients were divided into different cohorts on the basis of the year of the first PCI procedure. Results A total of 144,039 patients was included. The mean age increased from 60.1 ± 9.9 years in 1990 to 1995 to 67.1 ± 11.2 years in 2009 to 2010. The proportion of patients presenting with unstable coronary artery disease and ST-segment elevation myocardial infarction increased from 27.4% and 6.2% to 47.7% and 32.5%, respectively. Diabetes mellitus and multivessel disease were more often present in the later-year cohorts. The 1-year mortality increased from 2.2% in 1990 to 1995 to 5.9% in 2009 to 2010, but after adjustment for age and indication, a modest decrease was shown, mainly in ST-segment elevation myocardial infarction patients. Conclusions Characteristics of PCI patients have changed substantially over time, reflecting the establishment of new evidence. The increasing age and proportion of patients undergoing PCI for acute coronary syndromes greatly influence outcome. Understanding the changing patient characteristics is important for the translation of evidence to real-world clinical practice. [ABSTRACT FROM AUTHOR]

Background--Patients with acute coronary syndromes and history of stroke or transient ischemic attack (TIA) have an increased rate of recurrent cardiac events and intracranial hemorrhages. Methods and Results--We evaluated treatment effects of ticagrelor versus Clopidogrel in patients with acute coronary syndrome with and without a history of prior stroke or TIA in the PLATelet inhibition and patient Outcomes (PLATO) trial. Of the 18 624 randomized patients, 1152 (6.2%) had a history of stroke or TIA. Such patients had higher rates of myocardial infarction (11.5% versus 6.0%), death (10.5% versus 4.9%), stroke (3.4% versus 1.2%), and intracranial bleeding (0.8% versus 0.2%) than patients without prior stroke or TIA. Among patients with a history of stroke or TIA, the reduction of the primary composite outcome and total mortality at 1 year with ticagrelor versus Clopidogrel was consistent with the overall trial results: 19.0% versus 20.8% (hazard ratio, 0.87; 95% confidence interval, 0.66-1.13; interaction P=0.84) and 7.9% versus 13.0% (hazard ratio, 0.62; 95% confidence interval, 0.42-0.91). The overall PLATO-defined bleeding rates were similar: 14.6% versus 14.9% (hazard ratio, 0.99; 95% confidence interval, 0.71-1.37), and intracranial bleeding occurred infrequently (4 versus 4 cases, respectively). Conclusions--Patients with acute coronary syndrome with a prior history of ischemic stroke or TIA had higher rates of clinical outcomes than patients without prior stroke or TIA. However, the efficacy and bleeding results of ticagrelor in these high-risk patients were consistent with the overall trial population, with a favorable clinical net benefit and associated impact on mortality. [ABSTRACT FROM AUTHOR]

For almost two decades, 12-month dual antiplatelet therapy (DAPT) in acute coronary syndrome (ACS) has been the only class I recommendation on DAPT in American and European guidelines, which has resulted in 12-month durations of DAPT therapy being the most frequently implemented in ACS patients undergoing percutaneous coronary intervention (PCI) across the globe. Twelve-month DAPT was initially grounded in the results of the CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Events) trial, which, by design, studied DAPT versus no DAPT rather than the optimal DAPT duration. The average DAPT duration in this study was 9 months, not 12 months. Subsequent ACS studies, which were not designed to assess DAPT duration, rather its composition (aspirin with prasugrel or ticagrelor compared with clopidogrel) were further interpreted as supportive evidence for 12-month DAPT duration. In these studies, the median DAPT duration was 9 or 15 months for ticagrelor and prasugrel, respectively. Several subsequent studies questioned the 12-month regimen and suggested that DAPT duration should either be fewer than 12 months in patients at high bleeding risk or more than 12 months in patients at high ischemic risk who can safely tolerate the treatment. Bleeding, rather than ischemic risk assessment, has emerged as a treatment modifier for maximizing the net clinical benefit of DAPT, due to excessive bleeding and no clear benefit of prolonged treatment regimens in high bleeding risk patients. Multiple DAPT de-escalation treatment strategies, including switching from prasugrel or ticagrelor to clopidogrel, reducing the dose of prasugrel or ticagrelor, and shortening DAPT duration while maintaining monotherapy with ticagrelor, have been consistently shown to reduce bleeding without increasing fatal or nonfatal cardiovascular or cerebral ischemic risks compared with 12-month DAPT. However, 12-month DAPT remains the only class-I DAPT recommendation for patients with ACS despite the lack of prospectively established evidence, leading to unnecessary and potentially harmful overtreatment in many patients. It is time for clinical practice and guideline recommendations to be updated to reflect the totality of the evidence regarding the optimal DAPT duration in ACS. [ABSTRACT FROM AUTHOR]

The article focuses on a study which investigated the effects of CYP2C19 and ABCB1 single nucleotide polymorphisms on outcomes of treatment with ticagrelor versus clopidogrel for acute coronary syndromes. Study findings revealed that primary outcome occurred less often with ticagrelor versus clopidogrel irrespective of CYP2C19 genotype. It concluded that ticagrelor is a more effective treatment for acute coronary syndromes.

Objectives: The aim of this study was to test the noninferiority of eptifibatide relative to abciximab in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). Background: Glycoprotein IIb/IIIa inhibitors are recommended by international guidelines in patients with acute coronary syndromes undergoing PCI. Abciximab is recommended with a higher level of evidence than eptifibatide in patients with STEMI. No large, prospective, randomized trial comparing abciximab and eptifibatide has been published. Methods: All (n = 11,479) STEMI patients in Sweden who underwent primary PCI and received either eptifibatide or abciximab from 2004 to 2007 were derived from the SCAAR (Swedish Coronary Angiography and Angioplasty Registry). The primary end point was death or myocardial infarction (MI) during 1-year follow-up, with adjustment for baseline differences with a multivariate logistic regression analysis including propensity score. The pre-specified noninferiority margin was set to 1.29. Results: The combined end point occurred in 353 of 2,355 patients (15.0%) treated with eptifibatide and in 1,432 of 9,124 patients (15.7%) treated with abciximab. The unadjusted odds ratio (OR) for eptifibatide versus abciximab was 0.95 (95% confidence interval [CI]: 0.84 to 1.08). Multivariate adjustment (n = 11,317) confirmed noninferiority, with an OR of 0.94 (95% CI: 0.82 to 1.09). The adjusted secondary end points of death and MI separately also showed noninferiority, with ORs of 0.99 (95% CI: 0.82 to 1.19) and 0.88 (95% CI: 0.73 to 1.05), respectively. Conclusions: This large registry study suggests that eptifibatide is noninferior to abciximab in patients with STEMI undergoing primary PCI with respect to death or MI during 1 year, thereby supporting the use of either drug in clinical practice. [ABSTRACT FROM AUTHOR]

The article presents a medical research study that examined the long-term safety and efficacy of drug-eluting coronary stents. 47,967 patients in Sweden who received a coronary stent and who were entered into the Swedish Coronary Angiography and Angioplasty Registry between 2003 and 2006 were evaluated. Patients who received one drug-eluting coronary stent were compared with those who received one bare-metal stent. Researchers found that drug eluting stents are associated with a similar long-term incidence of death or myocardial infarction as compared with bare-metal stents. In addition, a clinically important decrease in the rate of restenosis among high-risk patients was found with drug-eluting stents.

Objectives: The aim of this study was to investigate the outcome of bare-metal stents (BMS) versus drug-eluting stents (DES) after on-label as well as off-label use. Background: DES lower restenosis rates while not influencing the risk for death and myocardial infarction when used in Federal Food and Drug Administration (FDA)-approved indications. It is debated whether the clinical results of this so-called on-label use might be extrapolated to off-label situations. Methods: The SCAAR (Swedish Coronary Angiography and Angioplasty Registry) was used to investigate the outcomes in 17,198 patients who underwent stenting with an on-label indication (10,431 BMS and 6,767 DES patients) and 16,355 patients in the context of an off-label indication (9,907 BMS and 6,448 DES patients). The patients were included from 2003 to 2005 with a minimum follow-up of 1 year and a maximum of 4 years. The analysis was adjusted for differences in baseline characteristics. Results: There were not significant differences between on-label DES and BMS (adjusted hazard ratio: 1.02; 95% confidence interval: 0.92 to 1.13) or between off-label DES and BMS (adjusted hazard ratio: 0.95; 95% confidence interval: 0.87 to 1.04) use with regard to the incidence of myocardial infarction and death. Off-label use of DES did not lead to significant differences in the combined risk of death and myocardial infarction compared with BMS throughout the whole spectrum of clinical indications. Conclusions: In contemporary Swedish practice, neither on- nor off-label use of DES is associated with worse outcome than use of BMS. [Copyright &y& Elsevier]

Background Recent reports have indicated that there may be an increased risk of late stent thrombosis with the use of drug-eluting stents, as compared with bare-metal stents. Methods We evaluated 6033 patients treated with drug-eluting stents and 13,738 patients treated with bare-metal stents in 2003 and 2004, using data from the Swedish Coronary Angiography and Angioplasty Registry. The outcome analysis covering a period of up to 3 years was based on 1424 deaths and 2463 myocardial infarctions and was adjusted for differences in baseline characteristics. Results The two study groups did not differ significantly in the composite of death and myocardial infarction during 3 years of follow-up. At 6 months, there was a trend toward a lower unadjusted event rate in patients with drug-eluting stents than in those with bare-metal stents, with 13.4 fewer such events per 1000 patients. However, after 6 months, patients with drug-eluting stents had a significantly higher event rate, with 12.7 more events per 1000 patients per year (adjusted relative risk, 1.20; 95% confidence interval [CI], 1.05 to 1.37). At 3 years, mortality was significantly higher in patients with drug-eluting stents (adjusted relative risk, 1.18; 95% CI, 1.04 to 1.35), and from 6 months to 3 years, the adjusted relative risk for death in this group was 1.32 (95% CI, 1.11 to 1.57). Conclusions Drug-eluting stents were associated with an increased rate of death, as compared with bare-metal stents. This trend appeared after 6 months, when the risk of death was 0.5 percentage point higher and a composite of death or myocardial infarction was 0.5 to 1.0 percentage point higher per year. The long-term safety of drug-eluting stents needs to be ascertained in large, randomized trials [ABSTRACT FROM AUTHOR]

Objective: To compare characteristics and outcome of patients undergoing percutaneous coronary intervention (PCI) in clinics with (WSB) or without (NOSB) on-site cardiac surgery backup. Design: Analysis according to hospital, type of prospectively collected data of all patients who underwent PCI during 2000-3. Setting: The Swedish Coronary Angiography and Angioplasty Registry covers all PCI procedures performed in Sweden. Patients: 34 363 patients underwent PCI between January 2000 and December 2003. 8838 procedures were performed in NOSB (mean age of patients was 64.5 years) hospitals and 25 525 in WSB (mean age of patients was 64.1 years) hospitals (p=0.002). Results: More patients in NOSB hospitals had diabetes (17.8% vs 16.8%; p = 0.03). Other clinical characteristics (previous infarct, previous coronary artery bypass graft (CABG)) also showed a tendency towards worse patients being treated in NOSB hospitals. However, there was a higher percentage of patients with ST-segment elevation myocardial infarction (18% vs 9.7%; p<0.01) in WSB hospitals. After adjusting for differences in baseline risk no significant differences regarding outcome (30-day mortality, 1-year mortality, stroke and emergency CABG) were observable between WSB and NOSB hospitals. This applied to elective and non-elective procedures. Conclusions: On the basis of these data it does not seem warranted to recommend against percutaneous transluminal coronary angioplasty in NOSB hospitals. [ABSTRACT FROM AUTHOR]

Objectives: This study was designed to evaluate biomarkers for selection of patients with non–ST-segment elevation acute coronary syndromes (ACS) that derive mortality benefit from revascularization. Background: Biomarkers are essential for identification of patients at increased risk, which may be reduced by revascularization. Methods: During the initial 30 days, 2,340 patients of 7,800 (30%) with non–ST-segment elevation ACS in the GUSTO (Global Utilization of Strategies To open Occluded arteries)-IV trial underwent coronary revascularization. The 1-year mortality was calculated in 30-day survivors stratified by status of revascularization and levels of biomarkers. A propensity score for receiving revascularization was constructed and included in a survival analysis that also included the time point of revascularization as a time-dependent covariate. Results: Elevation of troponin-T or N-terminal pro-B-type natriuretic peptide (NT-proBNP) was associated with a high mortality. In patients with either or both of these markers elevated, a lower mortality following revascularization was observed. In contrast, patients without elevation of these markers had low 1-year mortality without any reduction in mortality following revascularization. In fact, in patients with normal levels of both troponin-T and NT-proBNP, a significant increase in 1-year mortality after revascularization was observed. Elevation of C-reactive protein, interleukin-6, creatinine clearance, and ST-segment depression was also related to a higher mortality. However, independent of these markers, mortality was lower after revascularization. Conclusions: Markers of troponin-T and NT-proBNP not only assist in risk stratification of patients with non–ST-segment elevation ACS but also appear to identify patients who have a reduced mortality associated with early coronary revascularization. [Copyright &y& Elsevier]

The present study evaluated whether biomarkers of ischemia, inflammation, myocardial damage, and dysfunction are equally useful in patients who have diabetes mellitus (DM) for prediction of cardiac events in non–ST-elevation acute coronary syndrome (ACS). DM was present in 1,677 of 7,800 patients (21.5%) who had non–ST-elevation ACS and were included in the Fourth Global Utilization of Strategies To Open Occluded Arteries (GUSTO IV) trial. Creatinine, N-terminal pro–B-type natriuretic peptide (NT–pro-BNP), troponin T, C-reactive protein, and interleukin-6 were analyzed in serum samples that were obtained at a median of 9.5 hours from symptom onset. One-year mortality rates were 13.5% among patients who had DM (n = 227) and 6.9% among those who did not (n = 418, p <0.001). The median level of NT–pro-BNP was 2 times as high in patients who had DM, whereas troponin T levels did not differ by DM status. Mortality increased with ascending quartiles of NT–pro-BNP, with 1-year mortality rates of 3.9% (n = 11) in the bottom quartile and 29% (n = 103) in the top quartile. In multivariable analyses, factors that were predictive of 1-year mortality in patients who did not have DM were also significant for those who did. Presence of ST depression >0.5 mm had the highest odds ratio of 2.3 (95% confidence interval 1.2 to 4.6). NT–pro-BNP levels >669 ng/L (odds ratio 2.0, 95% confidence interval 1.1 to 3.6) and interleukin-6 levels >10 ng/L (odds ratio 1.9, 95% confidence interval 1.2 to 3.0) were significant biomarker predictors. In conclusion, DM confers a high long-term mortality in non–ST-elevation ACS. Despite a larger proportion of ST depression and increased levels of NT–pro-BNP and interleukin-6 at admission, these factors provide independent prognostic information that may improve risk stratification and guidance of treatment. [Copyright &y& Elsevier]

Patients with unstable coronary artery disease (CAD) have an increased risk of subsequent myocardial infarction and death. This study evaluated the safety and efficacy of treatment with glycoprotein IIb/IIIa inhibition in addition to aspirin, low molecular-weight heparin and its influence on coagulation and inflammation. Also, early and differentiated risk assessment utilising markers of inflammation, myocardial damage and dysfunction were evaluated. The Global Utilisation of Strategies To open Occluded arteries-IY (GUSTO-IV) trial randomised 7800 patients with unstable CAD to 24 or 48 hours infusion of unfusion or placebo in addition to routine treatment with aspirin and heparin or dalteparin. Baseline levels of creatinine, C-reactive protein (CRP), troponin T (TnT) and N-terminal pro-brain natriuretic peptide (NT-proBNP) were analysed. At selected sites, all patients received subcutaneous dalteparin (n=974), in stead of heparin infusion (n=6826). In a sub-population of dalteparin treated patients (n=404), serial measurements of markers of coagulation, fibrinolysis and inflammation were also performed. Addition of abciximab to dalteparin as the primary treatment of unstable CAD was not associated with any significant reduction in cardiac events but a doubled risk of bleedings. The combination of abciximab with dalteparin seemed as safe when used with heparin. Despite full dose dalteparin and aspirin there was a simultaneous activation of the inflammation, coagulation and fibrinolysis systems without any influence of the abciximab treatment. Elevated levels of CRR TnT, and NT-proBNP and reduced creatinine clearance were independently related to short and long-term mortality. The best prediction of high and low risk was provided by a combination of NT-proBNP and creatinine clearance. Any detectable elevation of TnT and reduced creatinine clearance, but neither elevation of CRP nor NT-proBNP, were also independently associated to a raised risk of subsequent myocardial infarction. [ABSTRACT FROM AUTHOR]

Background: Risk stratification is important in patients with unstable coronary artery disease (CAD), i.e. unstable angina or non-ST-elevation myocardial infarction. This article focuses on the emerging role of N-terminal pro brain natriuretic peptide (NT-proBNP) and the results from the FAST, GUSTO IV and FRISC II trials. Methods: In the FAST study, NT-proBNP was measured on admission in 755 patients admitted because of symptoms suggestive of unstable CAD. Follow up was performed after 40 months. The GUSTO IV and the FRISC II-trials included patients with unstable CAD and NT-proBNP was analyzed in 6806 and 2019 patients, with follow up after 1 and 2 years, respectively. Results: In the FAST study, patients in the 2nd, 3rd, and 4th NT-proBNP quartile had a relative risk of subsequent death of 4.2 (1.6–11.1), 10.7 (4.2–26.8) and 26.6 (10.8–65.5), respectively. In the GUSTO IV trial, increasing quartiles of NT-proBNP were related to short and long term mortality which at 1 year was; 1.8%, 3.9%, 7.7% and 19.2% (P<0.001), respectively. In multivariable analyses including well-known predictors of outcome, NT-proBNP level was independently associated to mortality in all three studies. In the FRISC II trial, the NT-proBNP level, especially if combined with a marker of inflammation, identified those with the greatest benefit from an early invasive strategy. Conclusion: NT-proBNP is strongly associated with mortality in patients with suspected or confirmed unstable CAD and, combined with a marker of inflammation, seems helpful in identifying those with greatest benefit from an early invasive strategy. [Copyright &y& Elsevier]

Background: Troponin is a specific marker of myocardial damage. For early prediction of coronary events in patients with suspicion of acute coronary syndromes the assay also needs to be highly sensitive. Methods and results: A rapid troponin I assay was performed prior to inclusion in 4447 acute coronary syndrome patients in the GUSTO-IV trial. A quantitative troponin T analysis was later performed on blood samples obtained at randomization by a central laboratory. There was an agreement between the rapid troponin I assay and troponin T (≤/>0.1 μg/l) in 3596 (80.9%) patients. A positive rapid troponin I was identifying any elevation of troponin T (>0.01 μg/l) in 1990 patients (90.4%) whereas a negative rapid troponin I was corresponding to negative troponin T (≤0.01 μg/l) in only 1217 patients (54.2%). Patients with a positive versus negative rapid troponin I had an increased risk of death or myocardial infarction at 30 days (9.3 vs. 5.9%; odds ratio, O.R. 1.64; 95% confidence interval, 1.31–2.06). Troponin T elevation (>0.1 μg/l) provided a better (10.5 v. 4.9%, O.R. 2.26; C.I. 1.79–2.85) risk stratification. Regardless of a positive or a negative rapid troponin I, the troponin T result (>0.1 vs. ≤0.1 μg/l) stratified the patients into high and low risk of events at 30 days, (10.3 vs. 5.7%, P=0.002) and (11.5 vs. 4.8%, P<0.001), respectively. Conclusion: In a population with non-ST elevation acute coronary syndrome a positive rapid troponin I assay is a specific indicator of troponin elevation and a predictor of early outcome. However, a negative rapid troponin I is not a reliable indicator of the absence of myocardial damage and does not indicate a low risk of subsequent cardiac events.A rapid troponin I assay was performed prior to inclusion in 4447 acute coronary syndrome patients in the GUSTO-IV trial and related to a centrally analyzed quantitative troponin T test. A positive rapid troponin I was well corresponding to any elevation of troponin T (>0.01 μg/l) and predicted an unfavorable outcome at 30 days. However, a negative rapid troponin I was corresponding to troponin T ≤0.01 μg/l in only half of the patients. Troponin T >0.1 μg/l vs. ≤0.1 μg/l provided a better risk stratification than the rapid troponin I result. For patients with troponin T elevation (>0.1 μg/l) the 30 day event rate was high regardless of the rapid troponin I result. [Copyright &y& Elsevier]

: BackgroundA third-generation troponin T assay with improved precision and a lower detection limit has been developed. However, the appropriate cutoff for identifying patients with the acute coronary syndrome who are at low risk of subsequent mortality has not been established.: MethodsA retrospective evaluation of data from the Fragmin and fast Revascularization during InStability in Coronary artery disease II (FRISC-II) trial suggested that a cutoff below 0.1 μg/L for troponin T levels might be more useful in risk stratification. A prospective validation of two cutoff levels (0.03 μg/L and 0.01 μg/L) was performed in 7115 patients with non–ST-elevation acute coronary syndrome from the Global Utilization of Strategies To open Occluded arteries IV (GUSTO-IV) trial.: ResultsPatients with troponin T levels >0.1 μg/L had greater 30-day mortality (5.5% [201/3679]) than did those with levels ≤0.1 μg/L (2.2% [75/3436], P <0.001). A cutoff value of 0.03 μg/L provided better discrimination between high and low risk: 5.1% (234/4552) versus 1.6% (42/2563). However, a cutoff value at the lower limit of detection, 0.01 μg/L, provided the best discrimination: 5.0% (254/5123) versus 1.1% (22/1992) (P<0.001). This cutoff level had the highest negative predictive value; it also discriminated best for the combined endpoint of death and myocardial infarction.: ConclusionUsing a cutoff of ≤0.01 μg/L for the third-generation troponin T assay, the detection level of the assay, is useful for identifying patients with the acute coronary syndrome who are at low risk of subsequent mortality. [Copyright &y& Elsevier]

: ObjectivesWe sought to evaluate C-reactive protein (CRP) and troponin T (TnT) as predictors of risk of the individual end points of mortality and myocardial infarction (MI) in a large cohort of patients with acute coronary syndrome (ACS).: BackgroundBoth CRP and TnT predict risk of future coronary events in patients with ACS. However, the relationships between the levels of the markers and the individual end points are still unclear.: MethodsBaseline levels of CRP and TnT were determined in 7,108 patients with ACS not undergoing early revascularization in the Global Use of Strategies To Open occluded arteries trial IV (GUSTO-IV) trial and related to outcome at 30 days.: ResultsQuartiles of TnT related to 30-day mortality, which was 1.1%, 3.7%, 3.7%, and 7.4% (p < 0.001) and to the rate of MI: 2.5%, 6.7%, 7.2%, and 5.6% (p < 0.001). Quartiles of CRP also related to 30-day mortality, which was 2.0%, 3.3%, 3.9%, and 6.3% (p < 0.001), whereas there was no relationship to the 30-day rate of MI: 5.6%, 4.7%, 5.2%, and 5.9% (p = 0.48). On multivariable analysis, both TnT and CRP were independent predictors of mortality, but only TnT was a predictor of MI. The combination of CRP and TnT provides an even better risk stratification of mortality, with 0.3% and 9.1% death rates, respectively, when both markers are in the bottom versus top quartiles.: ConclusionsIn ACS, baseline levels of TnT and CRP are independently related to 30-day mortality. Any detectable elevation of TnT, but not of CRP, is also associated with an increased risk of subsequent MI. Regarding mortality, the combination of both markers provides a better risk stratification than either one alone. [Copyright &y& Elsevier]

Abstract: Objectives: We sought to evaluate C-reactive protein (CRP) and troponin T (TnT) as predictors of risk of the individual end points of mortality and myocardial infarction (MI) in a large cohort of patients with acute coronary syndrome (ACS). Background: Both CRP and TnT predict risk of future coronary events in patients with ACS. However, the relationships between the levels of the markers and the individual end points are still unclear. Methods: Baseline levels of CRP and TnT were determined in 7,108 patients with ACS not undergoing early revascularization in the Global Use of Strategies To Open occluded arteries trial IV (GUSTO-IV) trial and related to outcome at 30 days. Results: Quartiles of TnT related to 30-day mortality, which was 1.1%, 3.7%, 3.7%, and 7.4% (p < 0.001) and to the rate of MI: 2.5%, 6.7%, 7.2%, and 5.6% (p < 0.001). Quartiles of CRP also related to 30-day mortality, which was 2.0%, 3.3%, 3.9%, and 6.3% (p < 0.001), whereas there was no relationship to the 30-day rate of MI: 5.6%, 4.7%, 5.2%, and 5.9% (p = 0.48). On multivariable analysis, both TnT and CRP were independent predictors of mortality, but only TnT was a predictor of MI. The combination of CRP and TnT provides an even better risk stratification of mortality, with 0.3% and 9.1% death rates, respectively, when both markers are in the bottom versus top quartiles. Conclusions: In ACS, baseline levels of TnT and CRP are independently related to 30-day mortality. Any detectable elevation of TnT, but not of CRP, is also associated with an increased risk of subsequent MI. Regarding mortality, the combination of both markers provides a better risk stratification than either one alone. [Copyright &y& Elsevier]

The author reflects on the cardiovascular medicine and the interventional cardiology and the attention gained by them. The need of clinical registry in case of prospective randomized trial leading into the revolutioning of these trials is discussed. The importance of scientific clinical evidence and the role of European Society of Cardiology in prescribing guidelines related to prospective randomized study are also discussed. INSETS: Box 1 Pros and cons of randomised clinical trials;Box 2 Pros and cons of observational studies from registries;Box 3 Pros and cons of randomised clinical registry trials.

The article offers information on topics related to FIREHAWK stent, a surgical stent used for symptomatic coronary artery disease. Topics mentioned include the importance of the development of drug-eluting stents in the improvement of acute coronary syndromes and coronary artery disease treatment, the promotion of medical care quality to patients with coronary artery disease, and the randomised clinical trial for the FIREHAWK stent in Europe.

The article discusses a study conducting a trials of patients with Atrial Fibrillation (AF) have revealed that anticoagulation with non-vitamin K antagonists or so-called novel oral anticoagulants (NOACs) are found to be effective as oral vitamin K antagonism by warfarin in decreasing the risk of cardioembolic stroke and systemic embolism. It also discusses the need for further research on the optimal antithrombotic strategies in patients with AF who have had a recent myocardial infarction.

Aims Underestimation of cardiovascular risk may interfere with prevention of cardiovascular diseases (CVDs). We investigate whether general health and family history of myocardial infarction (MI) are associated with underestimation of perceived cardiovascular risk, and if the participants' calculated risk modifies that association. Methods and results The analysis sample consisted of 526 individuals, 50--64 years old, from a population-based cohort study. Information on general health (poor/fairly good, good, and very good/excellent), family history of MI, and self-perceived risk relative to others of similar age and sex were collected though a web-based survey. Participants were categorized into underestimation (n = 162, 31%), accurate estimation (n = 222, 42%), and overestimation (n = 142, 27%) of cardiovascular risk by comparing calculated Systematic Coronary Risk Estimation (SCORE) with self-perceived risk. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for underestimation vs. accurate estimation of cardiovascular risk were computed using logistic regression (n = 384). Very good general health (OR 2.60, 95% CI 1.10-6.16) and lack of family history (OR 2.27, 95% CI 1.24--4.18) were associated with underestimation of cardiovascular risk. The associations were modified by the participants' calculated risk level; the association was stronger for high-risk individuals; without family history OR 22.57 (95% CI 6.17--82.54); with very good/excellent health OR 15.78 (95% CI 3.73-66.87). Conclusion A good general health and the lack of family CVD history can obscure the presence of other risk factors and lead to underestimation of cardiovascular risk, especially for high-risk individuals. It is, therefore, crucial to address the fact that the development of CV disease may be silent and multifactorial. [ABSTRACT FROM AUTHOR]

The article discusses research which investigated the outcomes after thrombus aspiration for ST elevation myocardial infarction (STEMI). It references a study by Sanjit Jolly et al published in the October 13, 2015 online issue of the journal. Topics cited include the increased risk of stroke in thrombectomy, the lesson in clinical medicine of the widespread use of routine thrombectomy, based on a small amount of evidence and the reason on the failure of thrombectomy to improve outcome.

Early and late readmissions after Transcatheter Aortic Valve Replacement (TAVR) are common and associated with worse outcome. A risk prediction model (TAVR-30) was recently developed using readily available clinical variables to identify patients at risk for hospital readmission within 30 days after TAVR. We performed an independent external validation of the TAVR-30 model. The Swedish TAVR-registry, linked together with other mandatory national registries was used to identify all TAVR procedures, variables from the original model, hospitalizations and deaths between the years 2008 to 2021. A total of 8459 patients underwent TAVR, 7693 patients had complete data and were included in the analysis. Out of these, 928 patients experienced a readmission within 30 days. Using the estimates from the original model, a concordance (c)-index of 0.51, a calibration slope of 0.07 and intercept of −0.62 were obtained respectively, overall implying poor model performance. This independent external validation indicates poor performance of the TAVR-30 model in a Swedish setting. Further research is needed to develop more reliable tools for predicting the risk of early hospital readmission after TAVR, as well as, for providing a deeper understanding of how to develop risk models that performs well in patients with multiple underlying comorbidities. • This external validation indicates poor performance of the TAVR-30 model. • Inadequate performance of a risk score can lead to unbeneficial medical practices. • Validation studies are important to increase the confidence about risk scores. • The use of this model in its current state is not advisable. [ABSTRACT FROM AUTHOR]

BACKGROUND: The benefit:risk profile of bivalirudin versus heparin anticoagulation in patients with non--ST-segment--elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) is uncertain. Study-level meta-analyses lack granularity to provide conclusive answers. We sought to compare the outcomes of bivalirudin and heparin in patients with non--ST-segment--elevation myocardial infarction undergoing PCI. METHODS: We performed an individual patient data meta-analysis of patients with non--ST-segment--elevation myocardial infarction in all 5 trials that randomized ≥1000 patients with any myocardial infarction undergoing PCI to bivalirudin versus heparin (MATRIX [Minimizing Adverse Hemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox], VALIDATE-SWEDEHEART [Bivalirudin Versus Heparin in ST-Segment and Non--ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence- Based Care in Heart Disease Evaluated According to Recommended Therapies Registry Trial], ISAR-REACT 4 [Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 4], ACUITY [Acute Catheterization and Urgent Intervention Triage Strategy], and BRIGHT [Bivalirudin in Acute Myocardial Infarction vs Heparin and GPI Plus Heparin Trial]). The primary effectiveness and safety end points were 30-day all-cause mortality and serious bleeding. RESULTS: A total of 12 155 patients were randomized: 6040 to bivalirudin (52.3% with a post-PCI bivalirudin infusion), and 6115 to heparin (53.2% with planned glycoprotein IIb/IIIa inhibitor use). Thirty-day mortality was not significantly different between bivalirudin and heparin (1.2% versus 1.1%; adjusted odds ratio, 1.24 [95% CI, 0.86--1.79]; P=0.25). Cardiac mortality, reinfarction, and stent thrombosis rates were also not significantly different. Bivalirudin reduced serious bleeding (both access site--related and non--access site--related) compared with heparin (3.3% versus 5.5%; adjusted odds ratio, 0.59; 95% CI, 0.48--0.72; P<0.0001). Outcomes were consistent regardless of use of a post-PCI bivalirudin infusion or routine lycoprotein IIb/IIIa inhibitor use with heparin and during 1-year follow-up. CONCLUSIONS: In patients with non--ST-segment--elevation myocardial infarction undergoing PCI, procedural anticoagulation with bivalirudin and heparin did not result in significantly different rates of mortality or ischemic events, including stent thrombosis and reinfarction. Bivalirudin reduced serious bleeding compared with heparin arising both from the access site and nonaccess sites. [ABSTRACT FROM AUTHOR]

Background: Hypertension is the leading risk factor for death worldwide, and high levels of physical activity are associated with a lower incidence of hypertension. The associations of excessive levels of exercise and incidence of hypertension are less well known. We aim to compare the incidence of hypertension among 206 889 participants in a long-distance cross-country skiing event and 505 542 people randomly sampled from the general population (matched to the skiers on age, sex, and place of residence).Methods: Skiers' best performance (in percent of winning time) and number of completed races during the study period were associated with incidence of hypertension after participation in Vasaloppet. Hypertension was defined as prescription of blood pressure-lowering drugs as obtained from the national drug registry. Models were adjusted for sex, age, education, and income (total effect).Results: During a median time of risk of 8.3 years, skiers had a lower incidence of hypertension compared with nonskiers (hazard ratio [HR], 0.59 [95% CI, 0.58-0.60]). Among the skiers, better performance (in percent of winning time) in Vasaloppet was strongly associated with a lower incidence of hypertension (fastest fifth: HR, 0.41 [95% CI, 0.39-0.42]; slowest fifth: HR, 0.78 [95% CI, 0.75-0.81]). The association was nearly linear and did not differ between sexes. Among the skiers, a weaker association was seen between the number of completed races during the study period and the incidence of hypertension (1 race: HR, 0.63 [95% CI, 0.62-0.65]; >5 races: HR, 0.51 [95% CI, 0.50-0.53]). A subanalysis of 10 804 participants including adjustment for lifestyle factors showed similar results.Conclusions: Participation in a long-distance skiing event was associated with a 41% lower incidence of hypertension over the next 8 years compared with nonparticipation. A near linear association between performance and incidence of hypertension was observed. This adds to the list of beneficial effects of intensive training, because hypertension is the leading risk factor of premature death globally. [ABSTRACT FROM AUTHOR]

A response from the authors of the article "Thrombus Aspiration During ST-Segment Elevation Myocardial Infarction," published in the October 24, 2013 issue is presented.

Background: Patients with type 2 diabetes have an increased risk of death and cardiovascular events and people with diabetes or prediabetes have been found to have increased atherosclerotic burden in the coronary and carotid arteries. This study will estimate the cross-sectional prevalence of atherosclerosis in the coronary and carotid arteries in individuals with prediabetes and diabetes, compared with normoglycaemic individuals in a large population-based cohort. Methods: The 30,154 study participants, 50–64 years, were categorized according to their fasting glycaemic status or self-reported data as normoglycaemic, prediabetes, and previously undetected or known diabetes. Prevalence of affected coronary artery segments, severity of stenosis and coronary artery calcium score (CACS) were determined by coronary computed tomography angiography. Total atherosclerotic burden was assessed in the 11 clinically most relevant segments using the Segment Involvement Score and as the presence of any coronary atherosclerosis. The presence of atherosclerotic plaque in the carotid arteries was determined by ultrasound examination. Results: Study participants with prediabetes (n = 4804, 16.0%) or diabetes (n = 2282, 7.6%) had greater coronary artery plaque burden, more coronary stenosis and higher CACS than normoglycaemic participants (all, p < 0.01). Among male participants with diabetes 35.3% had CACS ≥ 100 compared to 16.1% among normoglycaemic participants. For women, the corresponding figures were 8.9% vs 6.1%. The prevalence of atherosclerosis in the coronary arteries was higher in participants with previously undetected diabetes than prediabetes, but lower than in patients with known diabetes. The prevalence of any plaque in the carotid arteries was higher in participants with prediabetes or diabetes than in normoglycaemic participants. Conclusions: In this large population-based cohort of currently asymptomatic people, the atherosclerotic burden in the coronary and carotid arteries increased with increasing degree of dysglycaemia. The finding that the atherosclerotic burden in the coronary arteries in the undetected diabetes category was midway between the prediabetes category and patients with known diabetes may have implications for screening strategies and tailored prevention interventions for people with dysglycaemia in the future. [ABSTRACT FROM AUTHOR]