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- Navarese, Eliano P., et al.
(author)
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Comparative Efficacy and Safety of Oral P2Y12 Inhibitors in Acute Coronary Syndrome Network Meta-Analysis of 52 816 Patients From 12 Randomized Trials
- 2020
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In: Circulation. - : Ovid Technologies (Wolters Kluwer Health). - 0009-7322 .- 1524-4539. ; 142:2, s. 150-160
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Journal article (peer-reviewed)abstract
- Background: New randomized, controlled trials have become available on oral P2Y(12)inhibitors in acute coronary syndrome. We aimed to evaluate current evidence comparing the efficacy and safety profile of prasugrel, ticagrelor, and clopidogrel in acute coronary syndrome by a meta-analysis of randomized controlled trials.Methods: We performed a network meta-analysis and direct pairwise comparison analysis of efficacy and safety outcomes from 12 randomized controlled trials including a total of 52 816 patients with acute coronary syndrome.Results: In comparison with clopidogrel, ticagrelor significantly reduced cardiovascular mortality (hazard ratio [HR], 0.82 [95% CI, 0.72-0.92]) and all-cause mortality (HR, 0.83 [95% CI, 0.75-0.92]), whereas there was no statistically significant mortality reduction with prasugrel (HR, 0.90 [95% CI, 0.80-1.01] and HR, 0.92 [95% CI, 0.84-1.02], respectively). In comparison with each other, there were no significant differences in mortality (HR prasugrel versus ticagrelor, 1.10 [95% CI, 0.94-1.29] and 1.12 [95% CI, 0.98-1.28]). In comparison with clopidogrel, prasugrel reduced myocardial infarction (HR, 0.81 [95% CI, 0.67-0.98]), whereas ticagrelor showed no risk reduction (HR, 0.97 [95% CI, 0.78-1.22]). Differences between prasugrel and ticagrelor were not statistically significant. Stent thrombosis risk was significantly reduced by both ticagrelor and prasugrel versus clopidogrel (28%-50% range of reduction). In comparison with clopidogrel, both prasugrel (HR, 1.26 [95% CI, 1.01-1.56]) and ticagrelor (HR, 1.27 [95% CI, 1.04-1.55]) significantly increased major bleeding. There were no significant differences between prasugrel and ticagrelor for all outcomes explored.Conclusions: Prasugrel and ticagrelor reduced ischemic events and increased bleeding in comparison with clopidogrel. A significant mortality reduction was observed with ticagrelor only. There was no efficacy and safety difference between prasugrel and ticagrelor.
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- Figtree, Gemma A, et al.
(author)
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Clinical Outcomes in Patients With ST-Segment Elevation MI and No Standard Modifiable Cardiovascular Risk Factors.
- 2022
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In: JACC. Cardiovascular interventions. - 1876-7605. ; 15:11, s. 1167-1175
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Journal article (peer-reviewed)abstract
- The author recently reported ∼50% excess early mortality in patients with first-presentation ST-segment elevation myocardial infarction (STEMI) without standard modifiable cardiovascular risk factors (SMuRFs); the cause of this is not clear.The aim of this study was to examine differences in infarct characteristics and clinical outcomes in patients with versus without SMuRFs (dyslipidemia, hypertension, diabetes mellitus, and smoking).Individual-level data were pooled from 10 randomized percutaneous intervention (PCI) trials in which infarct size was measured within 1 month by either cardiac magnetic resonance or technetium-99m sestamibi single-photon emission computed tomography imaging. First-presentation STEMI was classified into 2 groups according to the presence or absence of at least 1 SMuRF.Among 2,862 patients, 524 (18.3%) were SMuRF-less. After adjusting for study effect, SMuRF-less patients had more frequent poor pre-PCI flow Thrombolysis In Myocardial Infarction 0/1 compared with patients with at least 1 SMuRF (72.0% vs 64.1%; OR: 1.35; 95% CI: 1.08-1.70). There were no independent associations between the presence or absence of SMuRFs at baseline and infarct size (estimate = -0.35; 95% CI: -1.93 to 1.23), left ventricular ejection fraction (estimate = -0.06; 95% CI: -1.33 to 1.20), or mortality at 30 days (HR: 0.46; 95% CI: 0.19-1.07) and 1 year (HR: 0.74; 95% CI: 0.43-1.29).First-presentation STEMI patients with no identifiable baseline SMuRFs had a higher risk of Thrombolysis In Myocardial Infarction flow grade 0/1 pre-PCI. However, after adjustment, there were no significant associations between SMuRF-less status and infarct size, left ventricle ejection fraction, or mortality.
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- Goodwin, Nathan P., et al.
(author)
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Morbidity and Mortality Associated With Heart Failure in Acute Coronary Syndrome : A Pooled Analysis of 4 Clinical Trials
- 2023
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In: Journal of Cardiac Failure. - : Elsevier. - 1071-9164 .- 1532-8414. ; 29:12, s. 1603-1614
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Journal article (peer-reviewed)abstract
- Background: Heart failure (HF) may complicate acute coronary syndrome (ACS) and is associ-ated with a high burden of short-and long-term morbidity and mortality. Only limited data regarding future ischemic events and rehospitalization are available for patients who suffer HF before or during ACS.Methods: A secondary analysis of 4 large ACS trials (PLATO, APPRAISE-2, TRACER, and TRIL-OGY ACS) using Cox proportional hazards models was performed to investigate the associa-tion of HF status (no HF, chronic HF, de novo HF) at presentation for ACS with all-cause and cardiovascular death, major adverse cardiovascular event (MACE ), myocardial infarction, stroke, and hospitalization for heart failure (HHF) by 1 year. Cumulative incidence plots are presented at 30 days and 1 year.Results: A total of 11.1% of the 47,474 patients presenting with ACS presented with evidence of acute HF, 55.0% of whom presented with de novo HF. Patients with chronic HF presented with evidence of acute HF at a higher rate than those with no previous HF (40.3% vs 6.9%). Compared to those without HF, those with chronic and de novo HF had higher rates of all-cause mortality (adjusted hazard ratio [aHR] 2.01, 95% confidence interval [CI] 1.72-2.34 and aHR 1.47, 95% CI1.15-1.88, respectively), MACE (aHR 1.47, 95% CI1.31-1-.66 and aHR 1.38, 95% CI1.12-1.69), and HHF (aHR 2.29, 95% CI2.02-2.61 and aHR 1.48, 95% CI 1.20-1.82) at 1 year.Conclusion: In this large cohort of patients with ACS, both prior and de novo HF complicating ACS were associated with significantly higher risk-adjusted rates of death, ischemic events and HHF at 30 days and 1 year. Further studies examining the association between HF and out-comes in this high-risk population are warranted, especially given the advent of more contem-porary HF therapies.
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- Iverson, G. L., et al.
(author)
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Reliability of serum S100B measurement following mild traumatic brain injury: a comparison of assay measurements from two laboratories
- 2020
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In: Brain Injury. - : Informa UK Limited. - 0269-9052 .- 1362-301X. ; 34:9, s. 1237-1244
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Journal article (peer-reviewed)abstract
- Objective There is enormous research and clinical interest in blood-based biomarkers of mild traumatic brain injury (MTBI) sustained in sports, daily life, or military service. We examined the reliability of a commercially available assay for S100B used on the same samples by two different laboratories separated by 2 years in time. Methods and Procedures A cohort of 163 adult patients (head CT-scanned, n = 110) with mild head injury were enrolled from the emergency department (ED). All had Glasgow Coma Scale scores of 14 or 15 in the ED (94.4% = 15). The mean time between injury and venous blood sampling was 2.9 h (SD = 1.4; Range = 0.5-6.0 h). Serum S100B was measured at two independent centers using the same high throughput clinical assay (Elecsys S100B (R); Roche Diagnostics). Results The Spearman correlation between the two assays in the total sample (N = 163) was r = 0.93. A Wilcoxson Signed Ranks test indicated that the median scores for the values differed (Z = 2,082,p< .001, Cohen's d = 0.151, small effect size). The values obtained from the two laboratories were very similar for identifying traumatic intracranial abnormalities (sensitivity = 80.1% versus 85.7%). Conclusions The serum S100B results measured using the same assay in different laboratories yielded highly correlated and clinically similar, but clearly not identical, results.
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- Madhavan, Mahesh V, et al.
(author)
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Antiplatelet strategies in acute coronary syndromes: design and methodology of an international collaborative network meta-analysis of randomized controlled trials.
- 2021
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In: Minerva cardioangiologica. - 1827-1618. ; 69:4, s. 398-407
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Journal article (peer-reviewed)abstract
- The optimal choice of oral P2Y12 receptor inhibitors has the potential to significantly influence outcomes. We seek to compare the safety and efficacy of the three most commonly used oral P2Y12 receptor inhibitors (clopidogrel, prasugrel, and ticagrelor) in acute coronary syndromes (ACS) via a comprehensive systematic review and network meta-analysis.We will perform a comprehensive search for randomized clinical trials which compared cardiovascular and hemorrhagic outcomes after use of at least two of the distinct oral P2Y12 receptor inhibitors (i.e. clopidogrel, prasugrel, and ticagrelor). In addition, key inclusion criteria will be trial size of at least 100 patients and at least 1 month of follow-up time. Several pre-specified subgroups will be explored, including Asian patients, patients presenting with ST-elevation myocardial infarction, patients of advanced age, and others.Exploratory frequentist pairwise meta-analyses will be based primarily on a random-effects method, relying on relative risks (RR) for short-term endpoints and incidence rate ratios (IRR) for long-term endpoints. Inferential frequentist network meta-analysis will be based primarily on a random-effects method, relying on RR and IRR as specified above. Results will be reported as point summary of effect, 95% CI, and p-values for effect, and graphically represented using forest plots.An international collaborative network meta-analysis has begun to comprehensively analyze the safety and efficacy of prasugrel, ticagrelor and clopidogrel, each on a background of aspirin, for management of patients with ACS. It is our hope that the rigor and breadth of the undertaking described herein will provide novel insights that will inform optimal patient care for patients with ACS treated conservatively, or undergoing revascularization.
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