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Image Agreement

The number of segments showing reversible defects in the pooled study population is shown below:

Reversable Defects

Using the 17-segment model, the number of segments showing a reversible perfusion defect was calculated for the initial Adenoscan^® (adenosine injection) study and for the second study obtained using Lexiscan or Adenoscan.^1,2

The agreement rate for the image obtained with Lexiscan or Adenoscan relative to the initial Adenoscan image was calculated by determining how frequently the patients assigned to each initial Adenoscan category (0-1, 2-4, or 5-17 reversible segments) were placed in the same category after the randomized scan. The agreement rates for Lexiscan and Adenoscan were calculated as the average of the agreement rates across the 3 categories determined by the initial scan.

ADVANCE studies 1 and 2 each demonstrated that Lexiscan is comparable to Adenoscan in assessing the extent of reversible perfusion abnormalities¹:

All patients underwent initial baseline Adenoscan imaging and then were randomized to a second imaging procedure with either Lexiscan (0.4 mg) or Adenoscan (140 mcg/kg/min). Using the 17-segment model, average agreement rates were determined between the baseline and randomized scans by 3 independent, blinded readers. Data were studied from 2 randomized, double-blind, multicenter studies of 2015 patients with known or suspected coronary artery disease who were indicated for pharmacologic stress MPI. Of those patients, 1871 had images considered valid for the primary efficacy study (Lexiscan: n=1240; Adenoscan: n=631].¹

REFERENCES
1. Lexiscan (regadenoson) injection [package insert]. Deerfield, IL: Astellas Pharma US, Inc.
2. Iskandrian AE, Bateman TM, Belardinelli L, et al. Adenosine versus regadenoson comparative evaluation in myocardial perfusion imaging: results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol. 2007;14:645-658.

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Lexiscan (regadenoson) injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.

IMPORTANT SAFETY INFORMATION

Do not administer Lexiscan to patients with second- or third-degree AV block or sinus node dysfunction unless these patients have a functioning artificial pacemaker.

Fatal cardiac arrest, life-threatening ventricular arrhythmias, and myocardial infarction may result from the ischemia induced by pharmacologic stress agents. Hypersensitivity including anaphylaxis, angioedema, cardiac or respiratory arrest, respiratory distress, decreased oxygen saturation, hypotension, throat tightness, urticaria and rashes have occurred. Resuscitation equipment and trained staff should be immediately available before administering Lexiscan.

Adenosine receptor agonists, including Lexiscan, can depress the SA and AV nodes and may cause first-, second-, or third-degree AV block, or sinus bradycardia requiring intervention. In postmarketing experience, heart block (including third degree), and asystole within minutes of Lexiscan administration have occurred.

Adenosine receptor agonists, including Lexiscan, induce arterial vasodilation and hypotension. The risk of serious hypotension may be higher in patients with autonomic dysfunction, hypovolemia, left main coronary artery stenosis, stenotic valvular heart disease, pericarditis or pericardial effusions, or stenotic carotid artery disease with cerebrovascular insufficiency. In postmarketing experience, transient ischemic attack, seizures and syncope have been observed.

Adenosine receptor agonists, including Lexiscan, may result in clinically significant increases in blood pressure in some patients. In postmarketing experience, cases of potentially clinically significant hypertension have been reported, particularly in patients with underlying hypertension and when low-level exercise was included in the MPI.

Adenosine receptor agonists, including Lexiscan, may cause dyspnea, bronchoconstriction and respiratory compromise. Appropriate bronchodilator therapy and resuscitative measures should be available prior to Lexiscan administration.

The most common adverse reactions (≥5%) to Lexiscan are dyspnea, headache, flushing, chest discomfort, angina pectoris or ST-segment depression, dizziness, chest pain, nausea, abdominal discomfort, dysgeusia, and feeling hot. Most adverse reactions began soon after dosing, and generally resolved within approximately 15 minutes, except for headache, which resolved in most patients within 30 minutes. Aminophylline was used as a reversal agent in 3% of patients.

In postmarketing experience, QTc prolongation, tremor, abdominal pain in association with nausea, vomiting, or myalgias, and diarrhea, fecal incontinence, wheezing and musculoskeletal pain have occurred.

Intravenous Adenoscan is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.

IMPORTANT SAFETY INFORMATION

Adenoscan is contraindicated in patients with second- or third-degree AV block, unless these patients have a functioning artificial pacemaker, sinus node disease, and known or suspected bronchoconstrictive or bronchospastic lung disease.

Fatal cardiac arrest, sustained ventricular tachycardia (requiring resuscitation), and nonfatal myocardial infarction have been reported coincident with Adenoscan infusion. Patients with unstable angina may be at greater risk. Appropriate resuscitative measures should be available.

Adenoscan is a potent peripheral vasodilator and can cause significant hypotension. The risk of hypotension may be higher in patients with cardiac or cerebrovascular insufficiency.

Adenoscan exerts a direct depressant effect on the SA and AV nodes and has the potential to cause first-, second- or third-degree AV block, or sinus bradycardia.

Increases in systolic and diastolic pressure have been observed.

Adenosine receptor agonists, including Adenoscan, may cause bronchoconstriction and respiratory compromise.

Atrial fibrillation has been reported in patients with Adenoscan infusion and may last from a few seconds to hours, however, patients spontaneously converted to normal sinus rhythm.

Most common adverse reactions (≥5%) to Adenoscan are flushing, chest discomfort, dyspnea, headache, discomfort of the throat, neck, or jaw, gastrointestinal discomfort, and lightheadedness/dizziness. Side effects with Adenoscan usually resolve quickly when the infusion is discontinued, although delayed or persistent effects have been observed.

Lexiscan is a registered trademark of Astellas US LLC. Other trademarks listed belong to their respective owners.
Lexiscan was developed in collaboration with Gilead Palo Alto, Inc. (formerly CV Therapeutics, Inc.).