RAPISCAN (régadénoson monohydraté) - Imagerie de perfusion myocardique

Key points

Approval of reimbursement of RAPISCAN (regadenoson) as pharmacological stress agent for myocardial perfusion imaging in adult patients unable to undergo adequate exercise stress.

The Committee points out the need for procedures associated with RAPISCAN (regadenoson) (myocardial perfusion positron emission tomography [PET] and perfusion coronary computed tomography [CT]) to be assessed with a view to funding.

Therapeutic improvement?

No therapeutic improvement in the diagnostic management of myocardial ischemia by pharmacological stress perfusion imaging in patients unable to undergo adequate exercise stress.

Role in therapeutic strategy?

The diagnostic management and assessment of chronic coronary syndrome, which requires exploring the adaptability of coronary circulation during stress, is the subject of a care pathway guide prepared by HAS and published in 2021, and European Society of Cardiology (ESC) guidelines published in 2019 are also available.

The first stage of the care pathway is based on the clinical examination, which the clinician uses as a basis to calculate the pre-test probability (PTP) using validated scores. It involves estimating the probability of having obstructive coronary disease which will then determine the nature of the investigations to be carried out where applicable.

Best practice guidelines recommend the use of non-invasive imaging tests as first-line tests for intermediate- and high-PTP patients. The objective is to reserve coronary angiography, which is an invasive test, for patients who absolutely need it (with a view to possible coronary revascularisation). It is recommended to select the initial non-invasive diagnostic test according to the clinical probability of obstructive coronary disease and other patient characteristics influencing test performance, patient preferences, local expertise, and test availability.

For patients for whom coronary disease cannot be ruled out by clinical assessment alone, non-invasive diagnostic tests (coronary CT or non-invasive functional imaging tests) are recommended as a first-line approach, while exercise stress tends to be recommended as a second-line approach where other non-invasive or invasive imaging methods are not available:

• coronary CT, due to its ability to rule out disease, is the preferred test in cases of low or intermediate PTP of ischemic heart disease (< 15%) in patients allowing good image acquisition (no calcification, obesity, arrhythmia, etc.) and with no history of ischemic heart disease;
• functional tests coupled with non-invasive imaging have a benefit in the detection and quantification of ischemic heart disease, and in the assessment of myocardial viability with a view to revascularisation; therefore, they should be preferred for patients with an intermediate (PTP between 5 and 15%) or high (PTP > 15%) probability of ischemic heart disease to guide myocardial revascularisation;
• the role of exercise stress in the diagnostic strategy in respect of chronic coronary syndrome is different according to the guidelines:
  • the ESC does not recommend it as a first-line approach, but as an alternative test to confirm or rule out coronary disease where other non-invasive or invasive imaging methods are not available;
  • the French Society of Cardiology (SFC) recommends it as a first-line approach, specifying that its interpretation and benefit must not be confined to studying repolarisation alone.

For functional imaging stress tests (echocardiography, cardiac MRI, SPECT, PET), myocardial ischemia may be induced:

• by a stress test recommended as a first-line approach where the patient is capable of sufficient or optimal exercise (this physiological test enables better assessment of how the heart adapts to exercise);
• or by a pharmacological stimulation test if the stress test is not feasible: using a positive inotropic agent (dobutamine) or vasodilators (dipyridamole, adenosine, regadenoson).

It should be noted that besides echocardiography, dobutamine-induced pharmacological stress is very rarely used in routine practice, and national learned societies (French Society of Radiology [

[SFR], French Society of Cardiovascular Imaging [SFICV] and French Society of Cardiology [SFC]) recommend preferential use of vasodilator agents for other myocardial perfusion imaging procedures.

Role of the medicinal product

RAPISCAN (regadenoson) is a diagnostic option in the same way as proprietary medicinal products based on adenosine and dipyridamole (although they are off-label apart from myocardial scintigraphy) for use as a pharmacological stress agent for myocardial perfusion imaging in adult patients unable to undergo adequate exercise stress.