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Your search keyword '"Margriet I. Klees"' showing total 4 results
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4 results on '"Margriet I. Klees"'

1. Efficacy and safety of the endothelin-1 receptor antagonist macitentan in epicardial and microvascular vasospasm; a proof-of-concept study

Author

Rutger G.T. Feenstra, Tijn P.J. Jansen, S. Matthijs Boekholdt, Janet E. Brouwer, Margriet I. Klees, Yolande Appelman, Marianne E. Wittekoek, Tim P. van de Hoef, Robbert J. de Winter, Jan J. Piek, Peter Damman, and Marcel A.M. Beijk

Subjects
Vasospastic angina, Microvascular angina, Coronary artery spasm, Macitentan, Proof of concept, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: Treatment of patients diagnosed with angina due to epicardial or microvascular coronary artery spasm (CAS) is challenging because patients often remain symptomatic despite conventional pharmacological therapy. In this prospective, randomized, double-blind, placebo-controlled, sequential cross-over proof-of-concept study, we compared the efficacy and safety of macitentan, a potent inhibitor of the endothelin-1 receptor, to placebo in symptomatic patients with CAS despite background pharmacological treatment. Methods: Patients with CAS diagnosed by invasive spasm provocation testing with >3 anginal attacks per week despite pharmacological treatment were considered for participation. Participants received either 10 mg of macitentan or placebo daily for 28 days as add-on treatment. After a wash-out period patients were crossed over to the alternate treatment arm. The primary endpoint was the difference in anginal burden calculated as [1] the duration (in minutes) * severity (on a Visual Analogue Scale (VAS) pain scale 1–10); and [2] the frequency of angina attacks * severity during medication use compared to the run-in phase. Results: 28 patients of whom 22 females (79%) and a mean age of 55.3 ± 7.6 completed the entire study protocol (epicardial CAS n = 19 (68), microvascular CAS n = 9 (32)). Change in both indices of anginal burden were not different during treatment with add-on macitentan as compared to add-on placebo (duration*severity: −9 [−134 78] vs −45 [−353 11], p = 0.136 and frequency*severity: −1.7 [−5.8 1.2] vs −1.8 [−6.2 0.3], p = 0.767). The occurrence and nature of self-reported adverse events were closely similar between the treatment phase with macitentan and placebo. Conclusion: In patients with angina due to epicardial or microvascular CAS despite background pharmacological treatment, 28 days of add-on treatment with the ET-1 receptor antagonist, macitentan 10 mg daily, did not reduce anginal burden compared to add-on treatment with placebo.Trial Registration https://trialsearch.who.int/, Identifier: EUCTR2018-002623-42-NL. Registration date: 20 February 2019.

Published
2023
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2. ST-segment deviation on the admission electrocardiogram, treatment strategy, and outcome in non–ST-elevation acute coronary syndromes

Author

Jan G.P. Tijssen, Alexander Hirsch, Robbert J. de Winter, Jan H. Cornel, Margriet I. Klees, Fons Windhausen, and Freek W.A. Verheugt

Subjects
Acute coronary syndrome, medicine.medical_specialty, medicine.diagnostic_test, business.industry, ST elevation, medicine.disease, Confidence interval, Angina, Internal medicine, Angiography, medicine, Cardiology, ST segment, Myocardial infarction, Myocardial infarction diagnosis, Cardiology and Cardiovascular Medicine, business
Abstract

Background We assessed the prognostic significance of the presence of cumulative ( ∑ ) ST-segment deviation on the admission electrocardiogram (ECG) in patients with non–ST-elevation acute coronary syndrome and an elevated troponin T randomized to a selective invasive (SI) or an early invasive treatment strategy. Methods A 12-lead ECG obtained at admission was available for analysis from 1163 patients. The presence and magnitude of ST-segment deviation was measured in each lead, and absolute ST-segment deviation was summed. The effect of treatment strategy was assessed for patients with or without ∑ ST-segment deviation of at least 1 mm. Results The incidence of death or myocardial infarction (MI) by 1 year in patients with ∑ ST-segment deviation of at least 1 mm was 18.0% compared with 11.1% in patients with ∑ ST-segment deviation of less than 1 mm ( P = .001). Among patients with ∑ ST-segment deviation of at least 1 mm, the incidence of death or MI was 21.9% in the early invasive group compared with 14.2% in SI group ( P ∑ ST-segment deviation of at least 1 mm randomized to SI who did not undergo angiography compared with patients who underwent angiography before discharge (10.9% vs 2.4%, P = .003). In a forward logistic regression analysis, the presence of ST-segment deviation was an independent predictor for failure of medical therapy (coronary angiography within 30 days after randomization in the SI group) (odds ratio, 1.56; 95% confidence interval, 1.12-2.18; P = .009). Conclusion Patients with non–ST-elevation acute coronary syndrome and an elevated troponin T and ∑ ST-segment deviation of at least 1 mm are at increased risk of death or MI, more often fail on medical therapy, and more often experience a spontaneous MI after discharge when angiography was not performed during initial hospitalization.

Published
2007
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3. Randomized trial comparing same-day discharge with overnight hospital stay after percutaneous coronary intervention: results of the Elective PCI in Outpatient Study (EPOS)

Author

Marcel G. W. Dijkgraaf, Lea M. Dijksman, Margriet I. Klees, Jan G.P. Tijssen, Robbert J. de Winter, Karel T. Koch, Jan J. Piek, Gerlind S. Heyde, ACS - Amsterdam Cardiovascular Sciences, Cardiology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, APH - Amsterdam Public Health, and Epidemiology and Data Science

Subjects
medicine.medical_specialty, Night Care, Randomization, medicine.medical_treatment, Cost-Benefit Analysis, Coronary Disease, law.invention, Randomized controlled trial, law, Physiology (medical), Angioplasty, medicine, Ambulatory Care, Humans, Myocardial infarction, Angioplasty, Balloon, Coronary, Early discharge, business.industry, Patient Selection, Percutaneous coronary intervention, Health Care Costs, medicine.disease, Patient Discharge, Surgery, Hospitalization, Treatment Outcome, Patient Satisfaction, Ambulatory, Conventional PCI, Cardiology and Cardiovascular Medicine, business, Follow-Up Studies
Abstract

Background— Percutaneous coronary intervention (PCI) in a day-case setting might reduce logistic constraints on hospital resources, but data on safety are limited. We evaluated the safety and feasibility of same-day discharge after PCI. Methods and Results— Eight hundred consecutive patients scheduled for elective PCI by femoral approach were randomized to same-day discharge or overnight hospital stay. Four hours after PCI, patients were triaged as suitable for early discharge or not. Suitable patients were discharged immediately or kept overnight, according to randomization. Patients with an indication for extended hospital stay were not discharged regardless of randomization. Primary end points were death, myocardial infarction, coronary artery bypass graft surgery, repeat PCI, or puncture-related complications occurring within 24 hours after PCI. A total of 403 patients were assigned to same-day discharge, of whom 77 (19%) were identified for extended observation; 397 patients were assigned to overnight stay, of whom 85 (21%) were identified for extended observation. Among all patients, the composite primary end point occurred in 9 (2.2%) same-day discharge patients and in 17 (4.2%) overnight stay patients (risk difference, −0.020; 95% CI, −0.045 to −0.004; P for noninferiority P for noninferiority Conclusions— Same-day discharge after elective PCI is feasible and safe in the majority (80%) of patients selected for day-case PCI. Same-day discharge does not lead to additional complications compared with overnight stay.

Published
2007

4. ST-segment deviation on the admission electrocardiogram, treatment strategy, and outcome in non-ST-elevation acute coronary syndromes A substudy of the Invasive versus Conservative Treatment in Unstable coronary Syndromes (ICTUS) Trial

Author

Fons, Windhausen, Alexander, Hirsch, Jan G P, Tijssen, Jan Hein, Cornel, Freek W A, Verheugt, Margriet I, Klees, and Robbert J, de Winter

Subjects
Male, Cardiotonic Agents, Troponin I, Myocardial Infarction, Reproducibility of Results, Syndrome, Middle Aged, Prognosis, Risk Assessment, Sensitivity and Specificity, Survival Analysis, Survival Rate, Electrocardiography, Treatment Outcome, Risk Factors, Acute Disease, Outcome Assessment, Health Care, Prevalence, Humans, Female, Angina, Unstable, Angioplasty, Balloon, Coronary, Netherlands
Abstract

We assessed the prognostic significance of the presence of cumulative (Sigma) ST-segment deviation on the admission electrocardiogram (ECG) in patients with non-ST-elevation acute coronary syndrome and an elevated troponin T randomized to a selective invasive (SI) or an early invasive treatment strategy.A 12-lead ECG obtained at admission was available for analysis from 1163 patients. The presence and magnitude of ST-segment deviation was measured in each lead, and absolute ST-segment deviation was summed. The effect of treatment strategy was assessed for patients with or without SigmaST-segment deviation of at least 1 mm.The incidence of death or myocardial infarction (MI) by 1 year in patients with SigmaST-segment deviation of at least 1 mm was 18.0% compared with 11.1% in patients with SigmaST-segment deviation of less than 1 mm (P = .001). Among patients with SigmaST-segment deviation of at least 1 mm, the incidence of death or MI was 21.9% in the early invasive group compared with 14.2% in SI group (P.01). However, we observed a significantly higher rate of MI after hospital discharge among patients with SigmaST-segment deviation of at least 1 mm randomized to SI who did not undergo angiography compared with patients who underwent angiography before discharge (10.9% vs 2.4%, P = .003). In a forward logistic regression analysis, the presence of ST-segment deviation was an independent predictor for failure of medical therapy (coronary angiography within 30 days after randomization in the SI group) (odds ratio, 1.56; 95% confidence interval, 1.12-2.18; P = .009).Patients with non-ST-elevation acute coronary syndrome and an elevated troponin T and SigmaST-segment deviation of at least 1 mm are at increased risk of death or MI, more often fail on medical therapy, and more often experience a spontaneous MI after discharge when angiography was not performed during initial hospitalization.

Published
2007

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