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- Harrington, Robert A., et al.
(författare)
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The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA.CER) trial : study design and rationale
- 2009
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Ingår i: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 158:3, s. 327-334
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Tidskriftsartikel (refereegranskat)abstract
- Background The protease-activated receptor 1 (PAR-1), the main platelet receptor for thrombin, represents a novel target for treatment of arterial thrombosis, and SCH 530348 is an orally active, selective, competitive PAR-1 antagonist. We designed TRA.CER to evaluate the efficacy and safety of SCH 530348 compared with placebo in addition to standard of care in patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS) and high-risk features. Trial design TRA.CER is a prospective, randomized, double-blind, multicenter, phase III trial with an original estimated sample size of 10,000 subjects. Our primary objective is to demonstrate that SCH 530348 in addition to standard of care will reduce the incidence of the composite of cardiovascular death, myocardial infarction (MI), stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization compared with standard of care alone. Our key secondary objective is to determine whether SCH 530348 will reduce the composite of cardiovascular death, MI, or stroke compared with standard of care alone. Secondary objectives related to safety are the composite of moderate and severe GUSTO bleeding and clinically significant TIMI bleeding. The trial will continue until a predetermined minimum number of centrally adjudicated primary and key secondary end point events have occurred and all subjects have participated in the study for at least I year. The TRA.CER trial is part of the large phase III SCH 530348 development program that includes a concomitant evaluation in secondary prevention. Conclusion TRA.CER will define efficacy and safety of the novel platelet PAR-1 inhibitor SCH 530348 in the treatment of high-risk patients with NSTE ACS in the setting of current treatment strategies.
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- Olsen, Siv J. S., et al.
(författare)
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Changes in self-reported health and quality of life in octogenarian patients one month after transcatheter aortic valve implantation
- 2017
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Ingår i: European Journal of Cardiovascular Nursing. - : Sage Publications. - 1474-5151 .- 1873-1953. ; 16:1, s. 79-87
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: In addition to favourable results regarding mortality and morbidity it is important to identify the impact transcatheter aortic valve implantation (TAVI) has on patients' quality of life.AIMS: The aims were: (i) to describe clinical characteristics, self-reported health and quality of life in octogenarians before TAVI intervention; (ii) to determine changes in self-reported health and quality of life one month after TAVI; and (iii) to establish the clinical importance of the findings.METHODS: A prospective cohort study was conducted on consecutively enrolled octogenarians with severe aortic stenosis undergoing TAVI (N = 65). Self-reported health and quality of life were recorded at baseline and one month later using two global questions from the World Health Organization Quality of Life Instrument Abbreviated (WHOQOL-BREF), the generic Short Form Health 12 and the disease-specific Minnesota Living with Heart Failure Questionnaire.RESULTS: One month after TAVI, WHOQOL-BREF showed that self-reported health improved moderately (p < 0.001), while quality of life improved slightly, but not statistically significantly (p = 0.06). There were changes in all Short Form Health 12 domains, except social functioning and role emotional. The estimated changes were 3.6 to 5.8 with large confidence intervals. The Physical Component Summary increased statistically significantly from baseline to 30 days (30.6-34.7; p = 0.02), but the Mental Component Summary did not (46.9-50.0; p = 0.13).CONCLUSION: Despite being an advanced treatment performed in a high risk population, TAVI in octogenarians improves short-term self-reported global health and generic physical health and quality of life. These patient-reported outcomes have importance, particularly in this age group.
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- Pettersen, T., et al.
(författare)
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Sex differences in incidence of self-reported adverse drug reactions after percutaneous coronary intervention
- 2023
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Ingår i: European Heart Journal. - : Oxford University Press. - 0195-668X .- 1522-9645. ; 44:Supplement_2
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundDespite experiencing adverse drug reactions (ADRs) more often than men, the proportion of women participating in clinical drug trials is low. Thus, evidence for sex differences in the incidence of ADRs is limited.AimTo determine sex differences in incidence of self-reported ADRs after percutaneous coronary intervention (PCI). Further, to determine whether receiving information about ADRs is associated with sex.MethodsCONCARDPCI is a prospective multicentre cohort study (N=3417) conducted at seven referral PCI centres in two Nordic countries. Clinical data were collected from patients’ medical records. Socio-demographic characteristics were obtained by self-report after PCI. Two questions from the Heart Continuity of Care Questionnaire (HCCQ) were used to determine if information about potential ADRs was received before hospital discharge. De novo created questions were used to determine if patients reported ADRs from prescribed therapy. Questionnaires were distributed two- (T1), six- (T2), and twelve months (T3) after hospital discharge to assess the incidence of self-reported ADRs in a longitudinal perspective. Logistic regression was utilised to scrutinize the aims, reported as odds ratios (ORs) with 95% confidence intervals (CIs).ResultsPatients were predominantly male (78%), with a mean age of 65 years (SD 11). Female patients were older (68, SD 10). Acute coronary syndrome was the most frequent cause of admission for PCI (62%). At T1, 2656 of the included patients responded to the questions from the HCCQ. Of these, 1019 patients (39%) reported being informed of potential ADRs from prescribed therapy, 1075 patients (42%) reported not having been informed, 511 patients (20%) reported ‘Hard to decide’, and 51 (2%) reported ‘Not applicable’. Patients reporting ‘Hard to decide’ or ‘Not applicable’ were excluded from further analysis. Women were less likely to receive information than men (OR 0.58, CI 0.45 – 0.75, p<0.001). For the total study population, 42%, 49% and 40% reported ADRs at T1-T3 respectively. After adjusting for sociodemographic and clinical variables, the incidence of self-reported ADRs were significantly higher in women compared to men at T1 (OR 1.71, CI 1.36 – 2.15, p<0.001), T2 (OR 1.89, CI 1.49 – 2.38, p<0.001), and T3 (OR 1.79, CI 1.40 – 2.28, p<0.001).ConclusionWomen report significantly more ADRs from prescribed therapy than men after PCI. However, they are less likely to receive information about potential ADRs compared to men. Efforts to improve communication on ADRs and gender equity should be a priority.
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- Eide, Leslie S. P., et al.
(författare)
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Delirium as a predictor of physical and cognitive function in individuals aged 80 and older after transcatheter aortic valve implantation or surgical aortic valve replacement
- 2016
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Ingår i: Journal of The American Geriatrics Society. - : Wiley. - 0002-8614 .- 1532-5415. ; 64:6, s. 1178-1186
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: To determine how development of delirium after surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) could predict activity of daily living (ADL) and instrumental ADLs (IADL) disability, cognitive function, and self-reported health in individuals aged 80 and older.Design: Prospective cohort study. Setting: Tertiary university hospital.Participants: Individuals aged 80 and older undergoing elective SAVR or TAVI (N = 136).Measurements: Delirium was assessed for 5 days using the Confusion Assessment Method. The Barthel Index, Nottingham Extended ADL Scale, and SF-12 were used to determine ADL and IADL ability and self-reported health at baseline and 1- and 6-month follow-up. Cognition was assessed using the Mini-Mental State Examination at baseline and 6-month follow-up.Results: Participants had lower IADL scores 1 month after SAVR than at baseline (baseline 58, 1 month: delirium 42, no delirium 50, P ≤.02), but scores had returned to baseline levels at 6 months. The Medical Outcomes Study 12-item Short-Form Health Survey (SF-12) Physical Component Summary (PCS) score was higher at 6-month follow-up (48) than at baseline (39), especially in participants who did not develop delirium (P <.001). No differences in other outcomes were found. Regression models suggest that delirium may help predict IADL disability 1 month after baseline (P ≤.07) but does not predict large differences in ADL disability, cognitive function, or SF-12-scores. Individuals who underwent TAVI and developed delirium had lower ADL (baseline 19, 1-month 16, P <.001) and IADL (baseline 49, 1-month 40, P =.003) scores at 1-month follow-up. SF-12 PCS score (baseline 30) increased from baseline to 1- (35, P =.04) and 6- (35, P =.02) month follow-up in individuals who underwent TAVI and did not develop delirium. Delirium after TAVI predicted greater ADL and IADL disability at 1-month but not at 6-month follow-up.Conclusion: Individuals who develop delirium after SAVR and TAVI have poorer short-term IADL function but do not seem to have long-term reductions in physical, mental, or self-reported health.
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| 9. |
- Eide, Leslie S. P., et al.
(författare)
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Readmissions and mortality in delirious versus non-delirious octogenarian patients after aortic valve therapy : A prospective cohort study
- 2016
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Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 6:10
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: To determine whether postoperative delirium predicts first-time readmissions and mortality in octogenarian patients within 180 days after aortic valve therapy with surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI), and to determine the most common diagnoses at readmission.Design: Prospective cohort study of patients undergoing elective SAVR or TAVI.Setting: Tertiary university hospital that performs all SAVRs and TAVIs in Western Norway.Participants: Patients 80+ years scheduled for SAVR or TAVI and willing to participate in the study were eligible. Those unable to speak Norwegian were excluded. Overall, 143 patients were included, and data from 136 are presented. Primary and secondary outcome measures: The primary outcome was a composite variable of time from discharge to first all-cause readmission or death. Secondary outcomes were all-cause first readmission alone and mortality within 180 days after discharge, and the primary diagnosis at discharge from first-time readmission. Delirium was assessed with the confusion assessment method. First-time readmissions, diagnoses and mortality were identified in hospital information registries.Results: Delirium was identified in 56% of patients. The effect of delirium on readmissions and mortality was greatest during the first 2 months after discharge (adjusted HR 2.9 (95% CI 1.5 to 5.7)). Of 30 first-time readmissions occurring within 30 days, 24 (80%) were patients who experienced delirium. 1 patient (nondelirium group) died within 30 days after therapy. Delirious patients comprised 35 (64%) of 55 first-time readmissions occurring within 180 days. Circulatory system diseases and injuries were common causes of first-time readmissions within 180 days in delirious patients. 8 patients died 180 days after the procedure; 6 (75%) of them experienced delirium. Conclusions: Delirium in octogenarians after aortic valve therapy might be a serious risk factor for postoperative morbidity and mortality. Cardiovascular disorders and injuries were associated with first-time readmissions in these patients.
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- Leonardi, Sergio, et al.
(författare)
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Effect of vorapaxar on myocardial infarction in the thrombin receptor antagonist for clinical event reduction in acute coronary syndrome (TRA·CER) trial
- 2013
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Ingår i: European Heart Journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 34:23, s. 1723-1731
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Tidskriftsartikel (refereegranskat)abstract
- AimsThe TRA·CER trial compared vorapaxar, a novel platelet protease-activated receptor (PAR)-1 antagonist, with placebo in 12 944 patients with high-risk non–ST-segment elevation acute coronary syndromes (NSTE ACS). In this analysis, we explored the effect of vorapaxar on myocardial infarction (MI).Methods and resultsA blinded, independent central endpoint adjudication committee prospectively defined and classified MI according to the universal MI definition, including peak cardiac marker value (creatine kinase-MB [CK-MB] and/or troponin). Because the trial failed to meet its primary endpoint, these analyses are considered exploratory. During a median follow-up of 502 days, 1580 MIs occurred in 1319 patients. The majority (n = 1025, 64.9%) were type 1 (spontaneous) MI, followed by type 4a [percutaneous coronary intervention (PCI)-related] MI (n = 352; 22.3%). Compared with placebo, vorapaxar reduced the hazard of a first MI of any type by 12% [hazard ratio (HR), 0.88; 95% confidence interval (CI), 0.79–0.98; P = 0.021] and the hazard of total number of MIs (first and subsequent) by 14% (HR, 0.86; 95% CI, 0.77–0.97; P = 0.014), an effect that was sustained over time. Vorapaxar reduced type 1 MI by 17% (HR, 0.83; 95% CI, 0.73–0.95; P = 0.007). Type 4a MIs were not significantly reduced by vorapaxar (HR, 0.90; 95% CI, 0.73–1.12; P = 0.35). Vorapaxar effect was consistent across MI sizes defined by peak cardiac marker elevations and across key clinical subgroups; however, in patients not treated with thienopyridine at baseline (HR, 0.65; 95% CI, 0.46–0.92) compared with patients who received thienopyridine (HR, 0.91; 95% CI, 0.81–1.02), there was a trend towards a higher effect (Pint = 0.077).ConclusionThe PAR-1 antagonist vorapaxar was associated with a reduction of MI, including total number of infarctions. This reduction was sustained over time and was mostly evident in type 1 MI, the most common type of MI observed.
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- Solvang, SH, et al.
(författare)
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Kynurenines, Neuropsychiatric Symptoms, and Cognitive Prognosis in Patients with Mild Dementia
- 2019
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Ingår i: International journal of tryptophan research : IJTR. - : SAGE Publications. - 1178-6469. ; 12, s. 1178646919877883-
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Tidskriftsartikel (refereegranskat)abstract
- Circulating tryptophan (Trp) and its downstream metabolites, the kynurenines, are potentially neuroactive. Consequently, they could be associated with neuropsychiatric symptoms and cognitive prognosis in patients with dementia. Objective: The objective of this study was to assess associations between circulating kynurenines, cognitive prognosis, and neuropsychiatric symptoms. Methods: We measured baseline serum Trp, neopterin, pyridoxal 5′-phosphate (PLP), and 9 kynurenines in 155 patients with mild dementia (90 with Alzheimer’s disease, 65 with Lewy body dementia). The ratios between kynurenine and Trp and kynurenic acid (KA) to kynurenine (KKR) were calculated. The Mini-Mental State Examination (MMSE) and the Neuropsychiatric Inventory (NPI) were administered at baseline and annually over 5 years. Associations between baseline metabolite concentrations with MMSE and the NPI total score were assessed using a generalized structural equation model (mixed-effects multiprocess model), adjusted for age, sex, current smoking, glomerular filtration rate, and PLP. Post hoc associations between KKRs and individual NPI items were assessed using logistic mixed-effects models. False discovery rate (0.05)–adjusted P values ( Q values) are reported. Results: Kynurenine had a nonlinear quadratic relationship with the intercept of the MMSE scores over 5 years ( Q < 0.05), but not with the slope of MMSE decline. Kynurenine was associated with a higher NPI total score over time ( Q < 0.001). Post hoc, both KKR and KA were associated with more hallucinations ( Q < 0.05). Conclusions: Kynurenine has a complex relationship with cognition, where both low and high levels were associated with poor cognitive performance. A higher KKR indicated risk for neuropsychiatric symptoms, especially hallucinations.
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- Valaker, I., et al.
(författare)
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Relational continuity with healthcare providers after percutaneous coronary interventions : the patient perspective
- 2017
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Ingår i: European Journal of Cardiovascular Nursing. - : Sage Publications. - 1474-5151 .- 1873-1953. ; 16:Suppl. 1, s. S89-S89
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Tidskriftsartikel (refereegranskat)abstract
- Background: Relational continuity plays an important role when organizing the health care services for patients after early discharge. However, little is known about how patients experience relational continuity after percutaneous coronary interventions (PCI). Relational continuity has been defined as an ongoing therapeutic relationship between a patient and one or more healthcare providers.Purpose: To explore how patients undergoing PCI experience relational continuity after early discharge.Methods: Patients undergoing PCI hospitalized 6-8 weeks earlier, ⩾ 18 years and living at home at the time of inclusion were eligible for the study. Patients were purposively recruited from the Norwegian Registry for Invasive Cardiology. The study used an explorative design, and semistructured interviews were conducted with nine women and 13 men. The majority were older than 67 years, suffered an ST-elevation infarction and did not participate in cardiac rehabilitation. Interviews were analyzed using qualitative content analysis according to Graneheim and Lundman.Results: Important dimensions inherent in relational continuity found in this study were: (1) genuine interest in the patient as a person, (2) fostering a trusting relationship,(3) knowledge about the patient’s current health status (4) the importance of a motivated and supportive healthcare provider, and (5) being in competent and safe hands.Conclusions: Establishing trusting relationships with multiple healthcare providers and especially with the GP provide patients with a sense of security and predictability. At present, GPs are joined by numerous of other healthcare providers offering supplemental services. Developing clinical pathways, interdisciplinary teams, and adding more nursing personnel on advanced level in primary careseems to be important. Furthermore, collaboration with user organizations could be an arena for better communication between healthcare providers and patients undergoing PCI. There is a need for new knowledge about relational continuity through research and education within this field.
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