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Objectives. The aim of this study was to compare health-related quality of life (HRQoL) scores obtained from the instrument Short Form (SF)-36 through the so-called SF-6D utilities, and those obtained from 15D, in patients with ST-elevation myocardial infarction (STEMI), and to evaluate the consequences in estimation of quality adjusted life years (QALYs). Design. This was a sub-study of the Norwegian District Treatment of STEMI, in which patients with STEMI treated with tenecteplase, were randomized to early angioplasty or standard management ( n = 266). HRQoL data were collected at all visits (0, 1, 3, 7 and 12 months). All patients with complete data were included ( n = 248). Results. The score range was 0.33-1.0 for SF-6D and 0.49-1.0 for 15D. Mean utility scores from 15D were higher and had different distribution compared to scores from SF-6D. Mean QALY for the whole group was higher using 15D than SF-6D (0.89 vs. 0.77). The incremental number of QALYs with early angioplasty compared to standard treatment was 0.005 (95% CI: − 0.018 to 0.028) using SF-6D, and 0.004 (95% CI: − 0.010 to 0.018) using the 15D instrument. Conclusions. Choice of instrument may influence HRQoL scores, but not necessarily the gain in QALYs. [ABSTRACT FROM AUTHOR]

Objectives: The goal of this study was to compare a strategy of immediate transfer for percutaneous coronary intervention (PCI) with an ischemia-guided approach after thrombolysis in patients with very long transfer distances to PCI. Background: Thrombolysis remains the treatment of choice in ST-segment elevation myocardial infarction (STEMI) when primary PCI cannot be performed within 90 to 120 min. The optimal treatment after thrombolysis is still unclear. Methods: A total of 266 patients with acute STEMI living in rural areas with more than 90-min transfer delays to PCI were treated with tenecteplase, aspirin, enoxaparin, and clopidogrel and randomized to immediate transfer for PCI or to standard management in the local hospitals with early transfer, only if indicated for rescue or clinical deterioration. The primary outcome was a composite of death, reinfarction, stroke, or new ischemia at 12 months, and analysis was by intention to treat. Results: The primary end point was reached in 28 patients (21%) in the early invasive group compared with 36 (27%) in the conservative group (hazard ratio: 0.72, 95% confidence interval: 0.44 to 1.18, p = 0.19). The composite of death, reinfarction, or stroke at 12 months was significantly reduced in the early invasive compared with the conservative group (6% vs. 16%, hazard ratio: 0.36, 95% confidence interval: 0.16 to 0.81, p = 0.01). No significant differences in bleeding or infarct size were observed. Conclusions: Immediate transfer for PCI did not improve the primary outcome significantly, but reduced the rate of death, reinfarction, or stroke at 12 months in patients with STEMI, treated with thrombolysis and clopidogrel in areas with long transfer distances. (Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction; NCT00161005). [Copyright &y& Elsevier]

Objectives. Thrombolysis is the treatment of choice for patients with ST-elevation myocardial infarction (STEMI) living in rural areas with long transfer delays to percutaneous coronary intervention (PCI). This trial compares two different strategies following thrombolysis: to transfer all patients for immediate coronary angiography and intervention, or to manage the patients more conservatively. Design. The NORwegian study on DIstrict treatment of STEMI (NORDISTEMI) is an open, prospective, randomized controlled trial in patients with STEMI of less than 6 hours of duration and more than 90 minutes expected time delay to PCI. A total of 266 patients will receive full-dose thrombolysis, preferably prehospitally, and then be randomized to either strategy. Our primary endpoint is the one year combined incidence of death, reinfarction, stroke or new myocardial ischaemia. The study is registered with ClinicalTrials.gov, number NCT00161005. Results. By April 2006, 109 patients have been randomized. Thrombolysis has been given prehospitally to 52% of patients. The median transport distance from first medical contact to catheterization laboratory was 155 km (range 90–396 km). Results of the study are expected in 2008. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: Both pharmacological and invasive treatment might influence the inflammatory and pro-thrombotic responses observed in acute ST-elevation myocardial infarction (STEMI). We aimed to study whether circulating levels of inflammatory and pro-thrombotic markers differ in STEMI patients treated with early angioplasty compared to standard therapy following thrombolysis. Furthermore, we wanted to study if levels of markers were related to infarct size. Materials and Methods: This was a substudy of the NORwegian study on DIstrict treatment of ST-Elevation Myocardial Infarction (NORDISTEMI), in which STEMI patients treated with thrombolysis were randomized to early invasive or standard therapy. Fasting blood samples were collected in the morning 3days and 3months after onset of STEMI. Commercially available ELISA methods were used for determination of inflammatory and pro-thrombotic markers. Infarct size was assessed by SPECT after 3months. Results: 246 patients were included in this substudy. At 3days, levels of prothrombin fragment 1+2 and D-dimer were higher in the early invasive compared to the standard treatment group, whereas levels of soluble CD40 ligand were lower (p<0.01 for all). No other differences between groups were found in any of the measured markers. Significant, although weak correlations were found between Day 3 levels of C-reactive protein, interleukin-6, prothrombin fragment 1+2 and D-dimer, and infarct size assessed by SPECT after 3months. Conclusions: An early invasive strategy following thrombolysis for STEMI was associated with higher subacute levels of D-dimer and prothrombin fragment 1+2, and lower levels of soluble CD40 ligand than standard treatment. Further studies are needed to establish the relation between these changes and clinical outcome. The NORDISTEMI was registered at www.clinicaltrials.gov, NCT00161005. [Copyright &y& Elsevier]