Safety and tolerability of regadenoson for myocardial perfusion imaging – first Danish experience

Pape, Marianne; Aarøe, Jens; Jensen, Svend Eggert; Petersen, Lars Jelstrup

doi:10.3109/14017431.2016.1163415

Cited by 9 publications

(4 citation statements)

References 29 publications

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“…Across different pharmacological stressors, regadenoson and dobutamine showed an increased likelihood when compared to adenosine. In line with the recent literature, adverse event rates were higher among regadenoson and limited to mild and moderate events, mainly dyspnea [ 24 , 25 ]. This difference could be attributed to the pharmacokinetic properties of regadenoson with a comparably long, tri-phasic half-life time [ 23 ].…”

Section: Adverse Events Risk Factorssupporting

confidence: 87%

Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients

Contributors¹,

Uhlig²,

Luecke

et al. 2019

Eur Radiol

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Objectives To assess the incidence of acute adverse events (AAEs) in gadolinium-enhanced cardiac magnetic resonance (CMR) imaging. Methods Gadolinium-based contrast agent (GBCA)–enhanced CMR data from the multinational, multicenter European Society of Cardiovascular Radiology MRCT Registry was included. AAE severity was classified according to the American College of Radiology Manual on Contrast Media (mild, moderate, severe). Multivariable generalized linear mixed effect models were used to assess the likelihood of AAEs in various GBCA, adjusting for pharmacological stressor, main indications (i.e., suspected or known coronary artery disease or myocarditis), age, sex, and submitting center as a random effect. Results In the study population of 72,839 GBCA-enhanced CMRs, a total of 260 AAEs were reported (0.36%), with a minority of severe AAEs ( n = 24, 0.033%). Allergic-like AAEs were less likely than physiologic AAEs (29% versus 71%). Patients without pharmacological stress imaging had a lower AAE rate (0.22%) compared to stress imaging (0.75%), with the highest AAE rates for regadenoson (2.95%). AAE rates also varied by GBCA subtype (overall p < 0.001). There was significant interaction between GBCA and pharmacological stressor (interaction p = 0.025), with AAE rates ranging between 0 and 10% for certain GBCA/stressor combinations. There was further marginal evidence that higher GBCA volume was associated with higher AAE incidence (OR = 1.02, p = 0.05). Conclusion GBCA-enhanced CMR imaging demonstrates low AAE rates comparable to those of other body regions. AAE likelihood correlates with GBCA subtype, pharmacological stressor, and imaging indication. Intravenous fluid administration in patients with cardiac impairment might contribute to these findings. Key Points • Acute adverse event rates in cardiac magnetic resonance (CMR) imaging with gadolinium-based contrast agents (GBCAs) are low (0.36%), especially for severe adverse events (0.033%). • Mild and moderate adverse events are more frequent during stress CMR imaging. • Physiologic AAEs are more common than allergic AAEs in CMR imaging. Electronic supplementary material The online version of this article (10.1007/s00330-019-06171-2) contains supplementary material, which is available to authorized users.

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Section: Adverse Events Risk Factorssupporting

confidence: 87%

Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients

Contributors¹,

Uhlig²,

Luecke

et al. 2019

Eur Radiol

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show abstract

“…These differences might be attributable to the pharmacologic properties, with a longer half-life and different modes of action of regadenoson and dobutamine compared with adenosine, or owing to so-called nonresponder patients lacking sufficient hemodynamic response to adenosine stress (22,23). The majority of regadenoson-associated AAEs were respiratory events, which is in agreement with the literature (24,25). These results conflict with the European Cardiovascular Magnetic Resonance Registry, which reported lower adverse event rates in stress imaging (although confounders were not accounted for) (9,21).…”

Section: Discussionsupporting

confidence: 88%

Gadolinium-based Contrast Agents for Cardiac MRI: Use of Linear and Macrocyclic Agents with Associated Safety Profile from 154 779 European Patients

Uhlig¹,

Al-Bourini²,

Salgado³

et al. 2020

Radiology: Cardiothoracic Imaging

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C ardiac MRI is a well-established cardiac imaging modality and is considered the reference standard for several diseases (1). According to international registries, intravenous gadolinium-based contrast agents (GBCAs) are used in most cardiac MRI examinations for indications ranging from myocarditis and cardiomyopathy imaging to myocardial viability assessment (2,3). GBCAs can be considered safe for the referred population in general and the cardiac MRI population in particular, with reported acute adverse event (AAE) rates between 0.04% and 2.2% (4-11).Because of the toxicity of free gadolinium 3+ ions, ligands are used to create gadolinium chelates for safe use of GBCAs in humans. Based on the type of ligand, GB-CAs can be generally classified as linear or macrocyclic (12). There have been growing concerns about cerebral gadolinium depositions after repeated GBCA administration, with some studies suggesting that the molecular GBCA structure affected these depositions, with higher likelihood for deposit with linear compounds compared with macrocyclic GBCAs (13,14). As a preventive measure, in late 2017, the European Medicines Agency (EMA) suspended the marketing authorization of linear GBCA types (except for hepatic imaging), and this suspension was ratified by the European Commission (15). To our knowledge, there are currently no data on the effects of these regulatory changes on case numbers or on the cardiac MRI safety profile.This study assesses the contemporary effect of the EMA regulatory decision on use of GBCAs in cardiac MRI and the associated safety profile of GBCAs with regard to AAEs using a multinational registry.

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“…Three patients (1.3%) required administration of pharmaceuticals or hemodynamic support to relieve their symptoms. If hemodynamic responses are considered, a significant (p<0.0001) drop in SBP and DBP was observed as well as an increase in the heart rate ( 11 ). Complications of regadenoson in our study were observed more rarely compared to those studies; dyspnea was present in 7% of patients, followed by overall weakness (4.6%), and no cases of headache and chest discomfort were reported.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Regadenoson and Dipyridamole Safety Profiles During Stress Myocardial Perfusion Imaging

Roczniak¹,

Bączalska²,

Kanclerz³

et al. 2023

Mirt

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Objectives: The pharmacological stress test with vasodilator agents is an alternative cardiological diagnostic tool for patients with contraindications to the classical stress test provided by physical activity during single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI). The study compared the frequency of the side effects of regadenoson and dipyridamole during a SPECT MPI. Methods: This retrospective study included data of 283 consecutive patients who underwent pharmacological stress tests in years 2015-2020. The study group consisted of 240 patients who had received dipyridamole and 43 patients who had received regadenoson. The collected data included the patients’ characteristics, the occurrence of side effects (divided into mild: headache, vertigo, nausea, vomiting, dyspnea, chest discomfort, hot flushes, general weakness and severe: bradycardia, hypotension, loss of consciousness), and blood pressure values/measurements. Results: Overall, complications occurred relatively often (regadenoson: 23.2%, dipirydamol: 26.7%, p=0.639). Procedure discontinuation was necessary in 0.7% of examinations, whereas pharmacological support was necessary in 4.7%. There was no difference in the prevalence of mild (regadenoson: 16.2%, dipirydamol: 18.3%, p=0.747) and severe complications (regadenoson: 11.6%, dipyridamole: 15.0%, p=0.563). However, regadenoson has been found to cause a significantly smaller mean decrease of systolic blood pressure (SBP) (regadenoson: -2.6±10.0 mmHg, dipyridamole: -8.7±9.6 mmHg, p=0.002), diastolic blood pressure (DBP) (regadenoson: -0.9±5.4 mmHg, dipyridamole: -3.6±6.2 mmHg, p=0.032), as well as mean arterial pressure (MAP) (regadenoson: -1.5±5.6 mmHg, dipyridamole: -5.4±6.5 mmHg, p=0.001). Conclusion: Regadenoson and dipyridamole presented a similar safety profile during SPECT MPI. However, regadenoson has been found to cause significantly smaller decreases in SBP, DBP, and MAP.

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Safety and tolerability of regadenoson for myocardial perfusion imaging – first Danish experience

Abstract: Regadenoson for MPI is easy to use with a high frequency of AEs, which are generally mild in severity, transient, and resolve spontaneously.

Cited by 9 publications

References 29 publications

Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients

Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients

Gadolinium-based Contrast Agents for Cardiac MRI: Use of Linear and Macrocyclic Agents with Associated Safety Profile from 154 779 European Patients

Comparison of Regadenoson and Dipyridamole Safety Profiles During Stress Myocardial Perfusion Imaging

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