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Bleeding is a concern after percutaneous coronary intervention (PCI) and subsequent dual antiplatelet therapy (DAPT). We herein report the incidence and risk factors for major bleeding in the Norwegian Coronary Stent Trial (NORSTENT). NORSTENT was a randomized, double blind, pragmatic trial among patients with acute coronary syndrome or stable coronary disease undergoing PCI during 2008-11. The patients (N = 9,013) were randomized to receive either a drug-eluting stent or a bare-metal stent, and were treated with at least nine months of DAPT. The patients were followed for a median of five years, with Bleeding Academic Research Consortium (BARC) 3-5 major bleeding as one of the safety endpoints. We estimated cumulative incidence of major bleeding by a competing risks model and risk factors through cause-specific Cox models. The 12-month cumulative incidence of major bleeding was 2.3%. Independent risk factors for major bleeding were chronic kidney disease, low bodyweight (< 60 kilograms), diabetes mellitus, and advanced age (> 80 years). A myocardial infarction (MI) or PCI during follow-up increased the risk of major bleeding (HR = 1.67, 95% CI 1-29-2.15). The 12-month cumulative incidence of major bleeding in NORSTENT was higher than reported in previous, explanatory trials. This analysis strengthens the role of chronic kidney disease, advanced age, and low bodyweight as risk factors for major bleeding among patients receiving DAPT after PCI. The presence of diabetes mellitus or recurrent MI among patients is furthermore a signal of increased bleeding risk. Unique identifier NCT00811772; http://www.clinicaltrial.gov.

Observational reports have found that lower homocysteine levels are associated with lower rates of coronary heart disease and stroke. Treatment with folic acid and vitamin B 12 , with or without vitamin B 6 , lowers plasma homocysteine levels. In the NORVIT trial in patients after myocardial infarction, such therapy did not decrease the rate of recurrent infarction, stroke, and sudden death. After myocardial infarction, treatment with folic acid and vitamin B 12 , with or without vitamin B 6 , did not decrease the rate of recurrent infarction, stroke, and sudden death. Case–control as well as prospective studies have demonstrated that the plasma total homocysteine level is a strong, graded, and independent risk factor for coronary heart disease (CHD) and stroke. 1 – 3 Evidence from studies involving so-called mendelian randomization, 4 demonstrating an association between CHD and the 677C→T methylenetetrahydrofolate reductase polymorphism, has provided additional support for a causal relation between homocysteine and CHD. 5 , 6 Plasma total homocysteine can be lowered with the B vitamins folic acid and vitamin B 12 , 7 and persons with high plasma levels or dietary intake of folate and vitamin B 6 have a decreased risk of CHD. 8 – . . .

ObjectivesThis study aimed to investigate determinants of reperfusion within recommended time limits (timely reperfusion) for ST-segment elevation myocardial infarction patients, exploring the impact of geography, patient characteristics and socio-economy.DesignNational register-based cohort study.SettingMultilevel logistic regression models were applied to examine the associations between timely reperfusion and residency in hospital referral areas and municipalities, patient characteristics, and socio-economy.Participants7607 Norwegian ST-segment elevation myocardial infarction patients registered in the Norwegian Registry of Myocardial Infarction during 2015–2018.Main outcome measuresThe odds of timely reperfusion by primary percutaneous coronary intervention (PCI) or fibrinolysis.ResultsAmong 7607 ST-segment elevation myocardial infarction patients in Norway, 56% received timely reperfusion. The Norwegian goal is 85%. While 81% of the patients living in the Oslo hospital referral area received timely reperfusion, only 13% of the patients living in Finnmark did so.Patients aged 75–84 years had lower odds of timely reperfusion than patients below 55 years of age (OR 0.73, 95% CI 0.61 to 0.87). Patients with moderate or high comorbidity had lower odds than patients without (OR 0.81, 95% CI 0.68 to 0.95 and OR 0.61, 95% CI 0.44 to 0.84). More than 2 hours from symptom onset to first medical contact gave lower odds than less than 30 min (OR 0.63, 95% CI 0.54 to 0.72). 1–2 hours of travel time to a PCI centre (OR 0.39, 95% CI 0.31 to 0.49) and more than 2 hours (OR 0.22, 95% CI 0.16 to 0.30) gave substantially lower odds than less than 1 hour of travel time.ConclusionsThe varying proportion of patients receiving timely reperfusion across hospital referral areas implies inequity in fundamental healthcare services, not compatible with established Norwegian health policy. The importance of travel time to PCI centre points at the expanded use of prehospital pharmacoinvasive strategy to obtain the goals of timely reperfusion in Norway.

Background US and European guidelines diverge on whether to vaccinate adults who are not at high risk for cardiovascular events against influenza. Here, we investigated the associations between influenza vaccination and risk for acute myocardial infarction, stroke and pulmonary embolism during the 2009 pandemic in Norway, when vaccination was recommended to all adults. Methods Using national registers, we studied all vaccinated Norwegian individuals who suffered AMI, stroke, or pulmonary embolism from May 1, 2009 through September 30, 2010. We defined higher-risk individuals as those using anti-diabetic, anti-obesity, anti-thrombotic, pulmonary or cardiovascular medications (i.e. individuals to whom vaccination was routinely recommended); all other individuals were regarded as having lower-risk. We estimated incidence rate ratios with 95% CI using conditional Poisson regression in the pre-defined risk periods up to 180 days following vaccination compared to an unexposed time-period, with adjustment for season or daily temperature. Results Overall, we observed lower risk for cardiovascular events following influenza vaccination. When stratified by baseline risk, we observed lower risk across all three outcomes in association with vaccination among higher-risk individuals. In this subgroup, relative risks were 0.72 (0.59–0.88) for AMI, 0.77 (0.59–0.99) for stroke, and 0.73 (0.45–1.19) for pulmonary embolism in the period 1–14 days following vaccination when compared to the background period. These associations remained essentially the same up to 180 days after vaccination. In contrast, the corresponding relative risks among subjects not using medications were 4.19 (2.69–6.52), 1.73 (0.91–3.31) and 2.35 (0.78–7.06). Conclusion In this nationwide study, influenza vaccination was associated with overall cardiovascular benefit. This benefit was concentrated among those at higher cardiovascular risk as defined by medication use. In contrast, our results demonstrate no comparable inverse association with thrombosis-related cardiovascular events following vaccination among those free of cardiovascular medications at baseline. These results may inform the risk–benefit balance for universal influenza vaccination.

Background Seasonal changes in cardiovascular disease (CVD) risk factors may be due to exposure to seasonal environmental variables like temperature and acute infections or seasonal behavioural patterns in physical activity and diet. Investigating the seasonal pattern of risk factors should help determine the causes of the seasonal pattern in CVD. Few studies have investigated the seasonal variation in risk factors using repeated measurements from the same individual, which is important as individual and population seasonal patterns may differ. Methods The authors investigated the seasonal pattern in systolic and diastolic blood pressure, heart rate, body weight, total cholesterol, triglycerides, high-density lipoprotein cholesterol, C reactive protein and fibrinogen. Measurements came from 38 037 participants in the population-based cohort, the Tromsø Study, examined up to eight times from 1979 to 2008. Individual and population seasonal patterns were estimated using a cosinor in a mixed model. Results All risk factors had a highly statistically significant seasonal pattern with a peak time in winter, except for triglycerides (peak in autumn), C reactive protein and fibrinogen (peak in spring). The sizes of the seasonal variations were clinically modest. Conclusions Although the authors found highly statistically significant individual seasonal patterns for all risk factors, the sizes of the changes were modest, probably because this subarctic population is well adapted to a harsh climate. Better protection against seasonal risk factors like cold weather could help reduce the winter excess in CVD observed in milder climates.

Background Many post-myocardial infarction (MI) patients struggle with physical activity behavior change (BC) for life-long secondary prevention. There is limited knowledge about factors influencing long-term physical activity BC among post-MI patients. This qualitative study aimed to explore the beliefs and experiences related to post-MI patients’ physical activity BC process following a year’s participation in a supervised and self-monitored exercise program: the Norwegian Trial of Physical Exercise After MI (NorEx). Methods We conducted a qualitative study, performing in-depth semi-structured interviews with a randomly selected sample of NorEx participants when they were scheduled for cardiopulmonary exercise testing after one year of participation. Interviews were transcribed verbatim and the data was analyzed by applying reflexive thematic analysis. Results Seventeen participants ( n  = 4 female [24%]; median age, 61 years; median time since index MI, 4 years) were recruited and interviewed once. Analysis resulted in four main themes (nine sub-themes): (1) Personal responsibility to exercise (Exercise is safe, Health benefits, Habitual exercise); (2) Peer social support for a sense of safety and belonging (Social exercise, Supervision is preferred); (3) Research participation transformed exercise beliefs (High-intensity exercise is superior, Personal Activity Intelligence (PAI) promotes exercise adherence); and (4) Mind the intention-behavior gap (Initial anxiety, Lack of continued follow-up). Conclusions Several participants reported that they were able to maintain exercise BC during a year’s participation in NorEx. Nevertheless, a perceived lack of continued and individualized follow-up made some participants struggle with motivation and self-regulation, leading to an intention-behavior gap. Therefore, our findings suggest there is a need for individualized and continued social support and supervision from health and exercise professionals to maintain long-term exercise BC for secondary prevention among post-MI patients. Trial registration The NorEx study has been registered at ClinicalTrials.gov (NCT04617639, registration date 2020-10-21).

Purpose: To assess whether acute myocardial infarction (MI) diagnoses in national health registers are sufficiently correct and complete to replace manual collection of endpoint data for a population-based, epidemiological study. Patients and Methods: Using the Tromso Study Cardiovascular Disease Register for 2013-2014 as gold standard, we calculated correctness (defined as positive predictive value (PPV)) and completeness (defined as sensitivity) of MI cases in the Norwegian Myocardial Infarction Register and the Norwegian Patient Register separately and in combination. We calculated the sensitivity and PPV with 95% confidence intervals using the Clopper-Pearson Exact test. Results: We identified 153 MI cases in the gold standard. In the Norwegian Myocardial Infarction Register, we found a PPV of 97.1% (95% confidence interval (CI) 92.8-99.2) and a sensitivity of 88.2% (95% CI 82.0-92.9). In the Norwegian Patient Register, the PPV was 96.3% (95% CI 91.6-98.8) and the sensitivity was 85.6% (95% CI 79.0-90.8). The combined dataset of the Norwegian Myocardial Infarction Register and the Norwegian Patient Register had a PPV of 96.6% (95% CI 92.1-98.9) and a sensitivity of 91.5% (95% CI 85.995.4). Conclusion: MI diagnoses in both the Norwegian Myocardial Infarction Register and the Norwegian Patient Register were highly correct and complete, and each of the registers could be considered as endpoint sources for the Tromso Study. A combination of the two national registers seemed, however, to represent the most comprehensive data source overall. The benefits of using data from national registers as endpoints in epidemiological studies include faster, less resource-intensive access to nationwide data and considerably lower loss to follow-up, compared to manual data collection in a limited geographical area. Keywords: cardiovascular diseases, data quality, registers, data collection, quality control

ObjectivesElevated blood cholesterol is a modifiable risk factor for cardiovascular disease. Cholesterol level surveillance is necessary to study population disease burden, consider priorities for prevention and intervention and understand the effect of diet, lifestyle and treatment. Previous studies show a cholesterol decline in recent decades but lack data to follow individuals born in different decades throughout life.MethodsWe investigated changes in age-specific and birth cohort-specific total cholesterol (TC) levels in 43 710 women and men born in 1905–1977 (aged 20–95 years at screening) in the population-based Tromsø Study. Fifty-nine per cent of the participants had more than one and up to six repeated TC measurements during 1979–2016. Linear mixed models were used to test for time trends.ResultsMean TC decreased during 1979–2016 in both women and men and in all age groups. The decrease in TC in age group 40–49 years was 1.2 mmol/L in women and 1.0 mmol/L in men. Both the 80th and the 20th percentile of the population TC distribution decreased in both sexes and all age groups. Longitudinal analysis showed that TC increased with age to a peak around middle age followed by a decrease. At any given age, TC significantly decreased with increase in year born. Lipid-lowering drug use was rare in 1994, increased thereafter, but was low (<3% in women and <5% in men) among those younger than 50 years in all surveys. Between 1994 and 2016, lipid-lowering drug treatment in individuals 50 years and older explained 21% and 28% of the decrease in TC levels in women and men, respectively.ConclusionsWe found a substantial decrease in mean TC levels in the general population between 1979 and 2016 in all age groups. In birth cohorts, TC increased with age to a peak around middle age followed by a decrease.

Disease-specific registers may be used for measuring and improving healthcare and patient outcomes, and for disease surveillance and research, provided they contain valid and reliable data. The aim of this study was to assess the interrater reliability of all variables in a national myocardial infarction register. We randomly selected 280 patients who had been enrolled from 14 hospitals to the Norwegian Myocardial Infarction Register during the year 2013. Experienced audit nurses, who were blinded to the data about the 280 patients already in the register, completed the Norwegian Myocardial Infarction paper forms for 240 patients by review of medical records. We then extracted all registered data on the same patients from the Norwegian Myocardial Infarction Register. To compare the interrater reliability between the register and the audit nurses, we calculated intraclass correlations coefficient for continuous variables, Cohen's kappa and Gwet's first agreement coefficient (AC1) for nominal variables, and quadratic weighted Cohen's kappa and Gwet's second AC for ordinal variables. We found excellent (AC1 >0.80) or good (AC1 0.61-0.80) agreement for most variables, including date and time variables, medical history, investigations and treatments during hospitalization, medication at discharge, and ST-segment elevation or non-ST-segment elevation acute myocardial infarction. However, only moderate agreement (AC1 0.41-0.60) was found for family history of coronary heart disease, diagnostic electrocardiography, and complications during hospitalization, whereas fair agreement (AC1 0.21-0.40) was found for acute myocardial infarction location. A high percentage of missing data was found for symptom onset, family history, body mass index, infarction location, and new Q-wave. Most variables in Norwegian Myocardial Infarction Register had excellent or good reliability. However, some important variables had lower reliability than expected or had missing data. Precise definitions of data elements and proper training of data abstractors are necessary to ensure that clinical registries contain valid and reliable data.

Aims: Health registers are used for administrative purposes, disease surveillance, quality assessment, and research. The value of the registers is entirely dependent on the quality of their data. The aim of this study was to investigate and compare the completeness and correctness of the acute myocardial infarction (AMI) diagnosis in the Norwegian Myocardial Infarction Register and in the Norwegian Patient Register. Methods: All Norwegian patients admitted directly to St Olavs hospital, Trondheim University Hospital, Trondheim University Hospital from 1 July to 31 December 2012 and who had plasma levels of cardiac troponin T measured during their hospitalization (n=4835 unique individuals, n=5882 hospitalizations) were identified in the hospital biochemical database. A gold standard for AMI was established by evaluation of maximum troponin T levels and by review of the information in the medical records. Cases of AMI in the registers were classified as true positive, false positive, true negative, and false negative according to the gold standard. We calculated sensitivity, positive predictive value (PPV), specificity, and negative predictive value (NPV). Results: The Norwegian Myocardial Infarction Register had a sensitivity of 86.0% (95% confidence interval (CI) 82.8–89.3%), PPV of 97.9% (96.4–99.3%), and specificity of 99.9% and NPV of 98.9% (98.6-99.2%) (99.8–100%). The corresponding figures for the Norwegian Patient Register were 85.8% (95% CI 82.5–89.1%), 95.1% (92.9–97.2%), and 99.7% (99.5–99.8%) and 98.9% (98.6-99.2%), respectively. Both registers had a sensitivity higher than 95% when compared to hospital discharge diagnoses. The results were similar for men and women and for cases below and above 80 years of age. Conclusions: The Norwegian Myocardial Infarction Register and the Norwegian Patient Register are adequately complete and correct for administrative purposes, disease surveillance, quality assessment, and research.