| 1. |
- Aasa, Mikael, et al.
(författare)
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Cost and health outcome of primary percutaneous coronary intervention versus thrombolysis in acute ST-segment elevation myocardial infarction-Results of the Swedish Early Decision reperfusion Study (SWEDES) trial.
- 2010
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Ingår i: American heart journal. - : Elsevier BV. - 1097-6744 .- 0002-8703. ; 160:2, s. 322-8
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: In ST-elevation myocardial infarction, primary percutaneous coronary intervention (PCI) has a superior clinical outcome, but it may increase costs in comparison to thrombolysis. The aim of the study was to compare costs, clinical outcome, and quality-adjusted survival between primary PCI and thrombolysis. METHODS: Patients with ST-elevation myocardial infarction were randomized to primary PCI with adjunctive enoxaparin and abciximab (n = 101), or to enoxaparin followed by reteplase (n = 104). Data on the use of health care resources, work loss, and health-related quality of life were collected during a 1-year period. Cost-effectiveness was determined by comparing costs and quality-adjusted survival. The joint distribution of incremental costs and quality-adjusted survival was analyzed using a nonparametric bootstrap approach. RESULTS: Clinical outcome did not differ significantly between the groups. Compared with the group treated with thrombolysis, the cost of interventions was higher in the PCI-treated group ($4,602 vs $3,807; P = .047), as well as the cost of drugs ($1,309 vs $1,202; P = .001), whereas the cost of hospitalization was lower ($7,344 vs $9,278; P = .025). The cost of investigations, outpatient care, and loss of production did not differ significantly between the 2 treatment arms. Total cost and quality-adjusted survival were $25,315 and 0.759 vs $27,819 and 0.728 (both not significant) for the primary PCI and thrombolysis groups, respectively. Based on the 1-year follow-up, bootstrap analysis revealed that in 80%, 88%, and 89% of the replications, the cost per health outcome gained for PCI will be <$0, $50,000, and $100,000 respectively. CONCLUSION: In a 1-year perspective, there was a tendency toward lower costs and better health outcome after primary PCI, resulting in costs for PCI in comparison to thrombolysis that will be below the conventional threshold for cost-effectiveness in 88% of bootstrap replications.
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| 2. |
- Aasa, Mikael, et al.
(författare)
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Risk Reduction for Cardiac Events After Primary Coronary Intervention Compared With Thrombolysis for Acute ST-Elevation Myocardial Infarction (Five-Year Results of the Swedish Early Decision Reperfusion Strategy [SWEDES] Trial).
- 2010
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Ingår i: The American journal of cardiology. - : Elsevier BV. - 1879-1913 .- 0002-9149. ; 106:12, s. 1685-91
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Tidskriftsartikel (refereegranskat)abstract
- Primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction compares favorably to thrombolysis. In previous studies the benefit has been restricted to the early postinfarction period with no additional risk decrease beyond this period. Long-term outcome after use of third-generation thrombolytics and modern adjunctive pharmaceutics in the 2 treatment arms has not been investigated. This study was conducted to compare 5-year outcome after updated regimens of PPCI or thrombolysis. Patients with ST-elevation myocardial infarction were randomized to enoxaparin and abciximab followed by PPCI (n = 101) or enoxaparin followed by reteplase (n = 104), with prehospital initiation of therapy in 42% of patients. Data on survival and major cardiac events were obtained from Swedish national registries after 5.3 years. PPCI resulted in a better outcome with respect to the composite of death or recurrent myocardial infarction (hazard ratio 0.54, confidence interval 0.31 to 0.95) compared to thrombolysis. This was attributed to a significant decrease in cardiac deaths (hazard ratio 0.16, confidence interval 0.04 to 0.74). The difference evolved continuously over the 5-year follow-up. After adjustment for covariates, a significant benefit remained with respect to cardiac death or recurrent infarction but not for the composite of total survival or recurrent myocardial infarction (p = 0.07). The observed differences were not seen in patients in whom therapy was initiated in the prehospital phase. In conclusion, PPCI in combination with enoxaparin and abciximab compares favorably to thrombolysis in combination with enoxaparin with a risk decrease that stretches beyond the early postinfarction period. Prehospital thrombolysis may, however, match PPCI in long-term outcome.
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| 3. |
- Demidova, Marina M., et al.
(författare)
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Prognostic value of early sustained ventricular arrhythmias in ST-segment elevation myocardial infarction treated by primary percutaneous coronary intervention : A substudy of VALIDATE-SWEDEHEART trial
- 2023
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Ingår i: Heart rhythm O2. - : Elsevier. - 2666-5018. ; 4:3, s. 200-206
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Prognostic assessment of ventricular tachycardia (VT) or ventricular fibrillation (VF) in ST-segment elevation myocardial infarction (STEMI) is based mainly on distinguishing between early (<48 hours) and late arrhythmias, and does not take into account its time distribution with regard to reperfusion, or type of arrhythmia.OBJECTIVE: We analyzed the prognostic value of early ventricular arrhythmias (VAs) in STEMI with regard to their type and timing.METHODS: The prespecified analysis of the multicenter prospective Bivalirudin versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarctionin 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 included 2886 STEMI patients undergoing primary percutaneous coronary intervention (PCI). VA episodes were characterized regarding their type and timing. Survival status at 180 days was assessed through the population registry.RESULTS: Nonmonomorphic VT or VF was observed in 97 (3.4%) and monomorphic VT in 16 (0.5%) patients. Only 3 (2.7%) early VA episodes occurred after 24 hours from symptom onset. VA was associated with higher risk of death (hazard ratio 3.59; 95% confidence interval [CI] 2.01-6.42) after adjustment for age, sex, and STEMI localization. VA after PCI was associated with an increased mortality compared with VA before PCI (hazard ratio 6.68; 95% CI 2.90-15.41). Early VA was associated with in-hospital mortality (odds ratio 7.39; 95% CI 3.68-14.83) but not with long-term prognosis in patients discharged alive. The type of VA was not associated with mortality.CONCLUSION: VA after PCI was associated with an increased mortality compared with VA before PCI. Long-term prognosis did not differ between patients with monomorphic VT and nonmonomorphic VT or VF, but events were few. VA incidence during 24 to 48 hours of STEMI is negligibly low, thus precluding assessment of its prognostic importance.
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| 4. |
- Erlinge, D., et al.
(författare)
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Bivalirudin versus Heparin Monotherapy in Myocardial Infarction
- 2017
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Ingår i: New England Journal of Medicine. - : Massachusetts Medical Society. - 0028-4793 .- 1533-4406. ; 377:12, s. 1132-1142
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Tidskriftsartikel (refereegranskat)abstract
- Background The comparative efficacy of various anticoagulation strategies has not been clearly established in patients with acute myocardial infarction who are undergoing percutaneous coronary intervention (PCI) according to current practice, which includes the use of radial-artery access for PCI and administration of potent P2Y12 inhibitors without the planned use of glycoprotein IIb/IIIa inhibitors. Methods In this multicenter, randomized, registry-based, open-label clinical trial, we enrolled patients with either ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) who were undergoing PCI and receiving treatment with a potent P2Y12 inhibitor (ticagrelor, prasugrel, or cangrelor) without the planned use of glycoprotein IIb/IIIa inhibitors. The patients were randomly assigned to receive bivalirudin or heparin during PCI, which was performed predominantly with the use of radial-artery access. The primary end point was a composite of death from any cause, myocardial infarction, or major bleeding during 180 days of follow-up. Results A total of 6006 patients (3005 with STEMI and 3001 with NSTEMI) were enrolled in the trial. At 180 days, a primary end-point event had occurred in 12.3% of the patients (369 of 3004) in the bivalirudin group and in 12.8% (383 of 3002) in the heparin group (hazard ratio, 0.96; 95% confidence interval [CI], 0.83 to 1.10; P=0.54). The results were consistent between patients with STEMI and those with NSTEMI and across other major subgroups. Myocardial infarction occurred in 2.0% of the patients in the bivalirudin group and in 2.4% in the heparin group (hazard ratio, 0.84; 95% CI, 0.60 to 1.19; P=0.33), major bleeding in 8.6% and 8.6%, respectively (hazard ratio, 1.00; 95% CI, 0.84 to 1.19; P=0.98), definite stent thrombosis in 0.4% and 0.7%, respectively (hazard ratio, 0.54; 95% CI, 0.27 to 1.10; P=0.09), and death in 2.9% and 2.8%, respectively (hazard ratio, 1.05; 95% CI, 0.78 to 1.41; P=0.76). Conclusions Among patients undergoing PCI for myocardial infarction, the rate of the composite of death from any cause, myocardial infarction, or major bleeding was not lower among those who received bivalirudin than among those who received heparin monotherapy. (Funded by the Swedish Heart-Lung Foundation and others; VALIDATE-SWEDEHEART ClinicalTrialsRegister.eu number, 2012-005260-10 ; ClinicalTrials.gov number, NCT02311231 .).
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| 5. |
- Fröbert, Ole, et al.
(författare)
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Thrombus Aspiration during ST-Segment Elevation Myocardial Infarction
- 2013
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Ingår i: New England Journal of Medicine. - : Massachusetts Medical Society. - 0028-4793 .- 1533-4406. ; 369:17, s. 1587-1597
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundThe clinical effect of routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) is uncertain. We aimed to evaluate whether thrombus aspiration reduces mortality. MethodsWe conducted a multicenter, prospective, randomized, controlled, open-label clinical trial, with enrollment of patients from the national comprehensive Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and end points evaluated through national registries. A total of 7244 patients with STEMI undergoing PCI were randomly assigned to manual thrombus aspiration followed by PCI or to PCI only. The primary end point was all-cause mortality at 30 days. ResultsNo patients were lost to follow-up. Death from any cause occurred in 2.8% of the patients in the thrombus-aspiration group (103 of 3621), as compared with 3.0% in the PCI-only group (110 of 3623) (hazard ratio, 0.94; 95% confidence interval [CI], 0.72 to 1.22; P=0.63). The rates of hospitalization for recurrent myocardial infarction at 30 days were 0.5% and 0.9% in the two groups, respectively (hazard ratio, 0.61; 95% CI, 0.34 to 1.07; P=0.09), and the rates of stent thrombosis were 0.2% and 0.5%, respectively (hazard ratio, 0.47; 95% CI, 0.20 to 1.02; P=0.06). There were no significant differences between the groups with respect to the rate of stroke or neurologic complications at the time of discharge (P=0.87). The results were consistent across all major prespecified subgroups, including subgroups defined according to thrombus burden and coronary flow before PCI. ConclusionsRoutine thrombus aspiration before PCI as compared with PCI alone did not reduce 30-day mortality among patients with STEMI. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT01093404.)
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| 6. |
- Aasa, Mikael
(författare)
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Reperfusion therapy in acute ST-elevation myocardial infarction : a comparison between primary percutaneous intervention and thrombolysis in a short- and long-term perspective
- 2010
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Approximately 35,000 people suffer from a heart attack in Sweden annually. Among them, approximately 8000 are diagnosed with a ST-elevation myocardial infarction (STEMI) where timely reperfusion has been shown to save lives. Previous studies that have compared the existing reperfusion strategies, thrombolysis (TL) and primary PCI (PPCI), made use of treatment regimens that since have been improved with the use of mechanical and medical adjunctives. The objective of this thesis was to compare both of these strategies employing updated regimens in accordance to current guidelines with respect to; 1) efficacy in restoring blood flow and myocardial perfusion, 2) clinical outcome and 3) cost-effectiveness. Methods and results: Between November 2001 and May 2003, 205 patients with STEMI were randomized to PPCI with adjunctive abciximab or TL. The low molecular weight heparin enoxaparin was used as anticoagulant in both groups. In 42% treatment was initiated in the pre-hospital phase. The primary end points were the rate of STsegment resolution (STRES) ≥ 50% 120 minutes after inclusion and the rate of normalized (TIMI 3) flow in the infarct related vessel 5-7 days after treatment, serving as surrogates for a beneficial outcome. Secondary end points were the ability to restore myocardial perfusion evaluated angiographically by TIMI Myocardial Perfusion Grade (TMPG) 5-7 days after inclusion in the study, clinical events at 30 days and one year cost-effectiveness. The patients were followed prospectively for one year and, in addition, information on survival status and major clinical events was collected from national registries for an extended follow up period of a median of 5.3 years. STRES≥ 50% was achieved in 68% following PPCI and 64% after TL (n.s.). However, the TIMI 3 rate was higher after PPCI compared to TL (71% vs. 54%, p=0.04). TMPG tended to be better in the PPCI group than in the TL group. An analysis of the evolution of TMPG in the PPCI cohort revealed that there was a significant improvement of myocardial perfusion in the week following PPCI. Thirty day mortality rates were low and similar in the groups. At one year PPCI was tended to be less costly ($-2,505) than TL ($-2,505; n.s.), mainly due to higher costs for re-hospitalizations in the TL group. Primary PCI also lead to an insignificant gain in quality-adjusted survival (0.031 QALYs). A bootstrap analysis indicated that PPCI has a high probability of being cost-effective when a threshold value of $50,000 is employed. A survival analysis at 5.3 years showed a significant benefit from PPCI in terms of the combination of all-cause death and recurrent infarction (p=0.03) as well as for cardiac mortality alone (p=0.02). Conclusion: Primary PCI is more efficient than thrombolysis in re-establishing antegrade flow in the infarct- related artery and offers a better long term clinical outcome with respect to major cardiac events without an increase in societal costs. Thus, based on the conditions under which this study was performed, primary PCI is a more efficient alternative than thrombolysis for the treatment of ST-elevation myocardial infarction.
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| 7. |
- Aasa, M., et al.
(författare)
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Temporal changes in TIMI myocardial perfusion grade in relation to epicardial flow, ST-resolution and left ventricular function after primary percutaneous coronary intervention
- 2007
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Ingår i: Coron Artery Dis. - 0954-6928. ; 18:7, s. 513-518
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Myocardial perfusion at the end of reperfusion therapy assessed angiographically with thrombolysis in myocardial infarction (TIMI) myocardial perfusion grade (TMPG) has been associated with recovery of left ventricular (LV) function and survival. The aim of this analysis was to study the evolution of TMPG within the first week following primary percutaneous coronary intervention (PCI) and its association with ECG-derived ST-segment resolution (STRES) and recovery of LV function. METHODS: A total of 76 patients with acute myocardial infarction were pretreated with enoxaparine and abciximab and subjected to primary PCI within a prospective study and evaluated with TMPG assessed on coronary angiography at the end of the procedure and after 5-7 days. STRES was evaluated at 120 min post inclusion and global LV function was assessed by echocardiography after 30 days. RESULTS: Reperfusion (TIMI flow 2-3) was reached in all patients. Forty one percent had 'open myocardium' (i.e. TMPG 2 or 3) after PCI, a number that increased to 61% after 5-7 days (P=0.003). STRES >50% was reached in 73% of the patients and there was a good correlation between TMPG and STRES. Furthermore, those who improved from 'closed' to 'open myocardium' had higher STRES (and similar to those with 'open myocardium' already post-PCI) than those who had 'closed myocardium' at both occasions (80 vs. 52%, P=0.012). CONCLUSION: A significant increase was found in the number of patients with 'open myocardium' within the first week post-primary PCI and STRES seems to predict this improvement.
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| 8. |
- Elcadi, Guilherme H, 1966-, et al.
(författare)
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No differences in oxygenation in the forearm and shoulder of patients with work-related muscle pain and healthy subjects during a low-load sustained contraction
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- A frequently ascribed symptom associated to work-related muscle pain (WRMP) is muscle fatigue. Studies investigating oxygenation and hemodynamics in association to fatigue development in the muscles of patients with WRMP are sparse. Inadequate oxygen consumption and/or inadequate blood supply can influence the ability of the muscles to withstand fatigue. In this study we applied near-infrared spectroscopy (NIRS) and electromyography (EMG) to investigate oxygenation, hemodynamics and muscle activity in the extensor carpi radialis (ECR) and trapezius (TD) muscles of patients with WRMP and healthy controls. Eighteen patients with diffuse neck-shoulder-arm pain and 17 controls (matched in age and sex) were equipped with NIRS and EMG probes. After determination of maximal voluntary contraction (MVC) a sustained contraction of 15% MVC was performed with a cutoff for the maximum time of 12 min. Variables generated were StO2% and HbT from NIRS and RMS%max and MPF from EMG during the contraction. T tests and Mann-Whitney tests were used for analyzes of differences in MVC and endurance times. Full factorial repeated measures analyses of variance (ANOVA) were used to assess differences between patients and controls in NIRS and EMG parameters over time. Results showed no differences in MVC between patients and controls. We found, however, a shorter endurance time for patients compared to controls. There were no significant differences in StO2%, HbT, RMS and MPF responses during contraction between groups for the ECR. For the TD there was a group effect for StO2% with patients showing a lower level at rest and throughout the contraction. For the ECR and TD oxygenation, hemodynamics, RMS and MPF there were no straightforward differences between patients and controls that could explain the differences in endurance time. Therefore, we conclude that the shorter endurance time seen in the present study was not measurable by physiological indicators investigated in this group of patients.
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| 9. |
- Elcadi, Guilherme H, et al.
(författare)
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No differences in oxygenation in the forearm and shoulder of patients with work-related muscle pain and healthy subjects during a low-load sustained contraction
- 2013
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- A frequently ascribed symptom associated to work-related muscle pain (WRMP) is muscle fatigue. Studies investigating oxygenation and hemodynamics in association to fatigue development in the muscles of patients with WRMP are sparse. Inadequate oxygen consumption and/or inadequate blood supply can influence the ability of the muscles to withstand fatigue. In this study we applied near-infrared spectroscopy (NIRS) and electromyography (EMG) to investigate oxygenation, hemodynamics and muscle activity in the extensor carpi radialis (ECR) and trapezius (TD) muscles of patients with WRMP and healthy controls. Eighteen patients with diffuse neck-shoulder-arm pain and 17 controls (matched in age and sex) were equipped with NIRS and EMG probes. After determination of maximal voluntary contraction (MVC) a sustained contraction of 15% MVC was performed with a cutoff for the maximum time of 12 min. Variables generated were StO2% and HbT from NIRS and RMS%max and MPF from EMG during the contraction. T tests and Mann-Whitney tests were used for analyzes of differences in MVC and endurance times. Full factorial repeated measures analyses of variance (ANOVA) were used to assess differences between patients and controls in NIRS and EMG parameters over time. Results showed no differences in MVC between patients and controls. We found, however, a shorter endurance time for patients compared to controls. There were no significant differences in StO2%, HbT, RMS and MPF responses during contraction between groups for the ECR. For the TD there was a group effect for StO2% with patients showing a lower level at rest and throughout the contraction. For the ECR and TD oxygenation, hemodynamics, RMS and MPF there were no straightforward differences between patients and controls that could explain the differences in endurance time. Therefore, we conclude that the shorter endurance time seen in the present study was not measurable by physiological indicators investigated in this group of patients.
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| 10. |
- Elcadi, Guilherme H., 1966-, et al.
(författare)
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Oxygenation and Hemodynamics Do Not Underlie Early Muscle Fatigue for Patients with Work-Related Muscle Pain
- 2014
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Ingår i: PLOS ONE. - : PLOS (Public library of science). - 1932-6203. ; 9:4
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Tidskriftsartikel (refereegranskat)abstract
- Patients suffering from work-related muscle pain (WRMP) fatigue earlier during exercise than healthy controls. Inadequate oxygen consumption and/ or inadequate blood supply can influence the ability of the muscles to withstand fatigue. However, it remains unknown if oxygenation and hemodynamics are associated with early fatigue in muscles of WRMP patients. In the present study we applied near-infrared spectroscopy (NIRS) on the extensor carpi radialis (ECR) and trapezius (TD) muscles of patients with WRMP (n = 18) and healthy controls (n = 17). Our objective was to determine if there were group differences in endurance times for a low-level contraction of 15% maximal voluntary contraction (MVC) -sustained for 12-13 min, and to see if these differences were associated with differences in muscle oxygenation and hemodynamics. At baseline, oxygen saturation (StO(2)%) was similar between groups for the ECR, but StO2% was significantly lower for TD for the WRMP patients (76%) compared to controls (85%) (P < 0.01). Also, baseline ECR blood flow was similar in the two groups. For both muscles there were a larger number of patients, compared to controls, that did not maintain the 15% MVC for the allotted time. Consequently, the endurance times were significantly shorter for the WRMP patients than controls (medians, ECR: 347 s vs. 582 s; TD: 430 s vs. 723 s respectively). Responses in StO(2)% during the contractions were not significantly different between groups for either muscle, i.e. no apparent difference in oxygen consumption. Overall, we interpret our findings to indicate that the early fatigue for our WRMP patients was not associated with muscle oxygenation and hemodynamics.
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