8 research outputs found
High-Sensitivity Cardiac Troponin I and Clinical Risk Scores in Patients With Suspected Acute Coronary Syndrome
Geometrie hochzusammenhaengender Untermannigfaltigkeiten
With 42 refs.SIGLECopy held by FIZ Karlsruhe; available from UB/TIB Hannover / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekDEGerman
Percutaneous coronary intervention versus coronary artery bypass grafting in complex coronary artery disease: Long-term clinical outcomes from a high-volume center
Background: Clinical equipoise between a percutaneous coronary intervention (PCI) and coronary artery bypass grafting surgery (CABG) in the treatment of complex coronary artery disease (CAD), including unprotected left main coronary artery (LMCA) and/or three-vessel disease (3VD), remains debatable.
Methods: A retrospective analysis of an unselected cohort undergoing contemporary PCI versus CABG at a large center in 2015. Patients who received nonemergent treatment of unprotected LMCA and/or 3VD were included. The primary study endpoint was all-cause mortality at 5 years. Secondary endpoints included a composite of all-cause mortality, spontaneous myocardial infarction (MI), or ischemia-driven repeat revascularization at 30 days and 1 year.
Results: Four hundred and thirty patients met the inclusion criteria, 225 had PCI, and 205 had CABG. PCI patients were older with frequent LMCA involvement and higher EuroSCORE yet they had a fourfold shorter in-hospital stay compared to CABG patients. At 5 years, there was no significant difference in the primary endpoint between CABG and PCI (adjusted Hazard ratios 0.68, 95% confidence interval: 0.38–1.22, P = 0.19). Likewise, there was no significant difference in the incidence of the secondary composite endpoint or its components at 30 days or 1 year. A propensity score-matched analysis in 220 patients revealed similar outcomes.
Conclusions: In real-world long-term contemporary data, survival after PCI was comparable to CABG at 5 years in patients with unprotected LMCA and/or 3VD. At 1 year, the incidence of spontaneous MI and ischemia-driven repeat revascularization did not differ between the two cohorts. The mode of revascularization in these complex patients should be guided by the heart team
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Characteristic adverse events and their incidence among patients participating in acute ischemic stroke trials
Adverse events (AE) in trial populations present a major burden to researchers and patients, yet most events are unrelated to investigational treatment. We aimed to develop a coherent list of expected AEs, whose incidence can be predicted by patient characteristics that will inform future trials and perhaps general poststroke care.
We analyzed raw AE data from patients participating in acute ischemic stroke trials. We identified events that occurred with a lower 99% confidence bound greater than nil. Among these, we applied receiver operating characteristic principles to select the fewest types of events that together represented the greatest number of reports. Using ordinal logistic regression, we modeled the incidence of these events as a function of patient age, sex, baseline National Institutes of Health Stroke Scale, and multimorbidity status, defining P<0.05 as statistically significant.
We analyzed 5775 placebo-treated patients, reporting 21 217 AEs. Among 756 types of AEs, 132 accounted for 82.7%, of which 80% began within 10 days after stroke. Right hemisphere (odds ratio [OR], 1.67), increasing baseline National Institutes of Health Stroke Scale (OR, 1.11), multimorbidity status (OR, 1.09 per disease), patient age (OR, 1.01 per year), height (OR, 1.01 per centimeter), diastolic blood pressure (OR, 0.99 per mm Hg), and smoking (OR, 0.82) were independently associated with developing more AEs but together explained only 13% of the variation.
A list of 132 expected AEs after acute ischemic stroke may be used to simplify interpretation and reporting of complications. AEs can be modestly predicted by patient characteristics, facilitating stratification of patients by risk for poststroke complications
Online tool to improve stratification of adverse events in stroke clinical trials
Background and Purpose—Knowing characteristic adverse events (AEs) and their incidence among patients participating in acute stroke trials may assist interpretation of future studies. We aimed to develop an online tool to inform stroke trial safety.
Methods—We identified relevant AEs from patients within the Virtual International Stroke Trials Archive (VISTA), using receiver operating characteristic principles. We modeled their incidence on patient age, baseline National Institutes of Health Stroke Scale, and comorbidities using binary logistic regression. Models with an R2>5% were deemed powerful enough to predict expected AE incidences and were included. The calculator was developed using programs R and Visual Studios.
Results—Forty-eight of the most common AEs were identified and incorporated into the IschAEmic Stroke Calculator. The calculator, publicly available athttp://www.vistacollaboration.org calculates the expected incidence of AEs or groups of AEs in a trial cohort and where possible compares them with the observed incidence.
Conclusions—The IschAEmic Stroke Calculator is an open access resource to support safety interpretation within acute stroke trials. Prediction of AEs with higher likelihood of occurrence may direct preventive clinical measures
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Online Tool to Improve Stratification of Adverse Events in Stroke Clinical Trials
Background and Purpose-
Knowing characteristic adverse events (AEs) and their incidence among patients participating in acute stroke trials may assist interpretation of future studies. We aimed to develop an online tool to inform stroke trial safety.
Methods-
We identified relevant AEs from patients within the Virtual International Stroke Trials Archive (VISTA), using receiver operating characteristic principles. We modeled their incidence on patient age, baseline National Institutes of Health Stroke Scale, and comorbidities using binary logistic regression. Models with an R-2 > 5% were deemed powerful enough to predict expected AE incidences and were included. The calculator was developed using programs R and Visual Studios.
Results-
Forty-eight of the most common AEs were identified and incorporated into the IschAEmic Stroke Calculator. The calculator, publicly available at
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calculates the expected incidence of AEs or groups of AEs in a trial cohort and where possible compares them with the observed incidence.
Conclusions-
The IschAEmic Stroke Calculator is an open access resource to support safety interpretation within acute stroke trials. Prediction of AEs with higher likelihood of occurrence may direct preventive clinical measures
Early experience of intravascular lithotripsy in unprotected calcified left main coronary artery disease
BackgroundTreatment of unprotected severely calcified left main coronary artery (LMCA) disease is a complex interventional procedure. Intravascular lithotripsy (IVL) and rotational atherectomy (RA) are safe and effective methods of treating coronary calcification in the non-LMCA setting. This retrospective analysis assessed the feasibility of IVL versus RA in unprotected LMCA disease.MethodsWe analyzed IVL and RA procedures performed at a large tertiary hospital in the Northeast of England from January 1, 2019 to April 31, 2022. Major safety and efficacy endpoints were procedural and angiographic success, defined by stent delivery with 0.05). In 3 LMCA IVL and 3 LMCA RA cases arrhythmias and cardiac tamponade complicated the procedures respectively. At 1 year, MACE occurred in 10/44 (22.7 %) LMCA IVL, 16/81 (19.8 %) LMCA RA and 25/117 (21.4 %) cases (p > 0.05).ConclusionIn our single center retrospective analysis, IVL is feasible in unprotected calcified LMCA as a second-line and third-line adjuvant calcium modification technique. Its use in unprotected calcified LMCA disease should be formalized with the undertaking of large randomized controlled trials