Cardiolite® permitted better selection of patients who would benefit from invasive evaluation and revascularization. Its greatest strength was identifying the low risk patient who had a normal or near normal scan who could be spared coronary angiography because of a <1% annual death or infarction rate.

Resting SPECT with this tracer permitted the identification of patients with ischemic cardiomyopathy with predominantly viable myocardiaum who would benefit from revascularization no matter how low the left ventricular ejection fraction-George A. Beller, MDUniversity of Virgina Medical Center, Charlottesville, VA

There is only one Cardiolite

Risk Stratification

An MPI With Cardiolite® Gives You the Information to Help Manage Your Patients.1

Annual rates of cardiac death and MI by scan result2*

*Based on a prospective study of 5,807 consecutive patients, designed to determine the incremental prognostic value of SPECT for the prediction of cardiac death and the implications for risk stratification in patients undergoing dual-isotope SPECT with either exercise or pharmacological stress and followed for 642 ± 226 days, with prognostic data available for 5,183 patients.2

IIStatistically significant (P<0.05) increase in rate of MI versus cardiac death within scan category2

Statistically significant increase as a scan result2

Adapted from Hachamovitch R et al.2

The Signs May Be There in Your Patients With Diabetes and Known or Suspected CAD§

Annual rate of hard events (cardiac death and MI) as a function of scan result in patients with diabetes and known or suspected CAD

§The indications for Cardiolite® are not specific to patients with diabetes. Cardiolite® was shown to be an effective prognostic tool in the evaluation of patients with known or suspected CAD. This was determined in 3 pivotal trials enrolling 1,596 patients, including 311 patients with diabetes, which were used as the basis for approval.4

||Statistically significant (P<0.001) increase in event rates as a function of summed stress score3

Adapted from Kang X et al.3

In patients with diabetes, and with stable CAD and a normal Cardiolite® scan, data indicate a 1–2% risk of cardiac death or MI in the following year3,5¶#

Based on a prospective study of 1,271 consecutively registered patients with diabetes and 5862 patients without diabetes with known or suspected CAD designed to evaluate the incremental value of stress (exercise and pharmacologic) myocardial perfusion SPECT in patients with diabetes.3

#A second prospective study of 929 patients with diabetes and 3,826 patients without diabetes with symptoms of CAD. 4,755 patients were followed for 2.5 (+1.5) years for subsequent occurrence of cardiac death, MI, or revascularization.  A separate survival analysis was performed comparing patients with and without diabetes who had normal stress MPI images. For the first 2 years of the study follow-up, patients with normal stress MPI images had similar survival curves, irrespective of their diabetic status.5

Rely on the Information of an MPI With Cardiolite® for Risk Stratification of Your Patients

SCAN RESULTS (at stress)
Annualized Risk of
Cardiac Events
Potential
Treatment
Implications **
Normal <1% risk of both MI and cardiac death2,6 Risk factor modification in addition to current regimen6
Mildly Abnormal Low risk of cardiac death; intermediate risk of MI2,6
  • Aggressive risk factor modification (RFM)6
  • Medical treatment6
Moderately to Severely Abnormal Intermediate-to-high risk of both MI and cardiac death2,6
  • Aggressive RFM6
  • Medical treatment6
  • Catheterization - dependent on severity of scan6

Scans contributed by Howard Lewin, MD, of Cardiac Imaging Associations

**Results from a gated MPI with Cardiolite® along with other clinical evaluations and test results should all be considered in making patient management decisions.

Is the predicted cardiac mortality in a nuclear stress test with pharmacologic stress the same in women and men?

Predicted cardiac death in women and men as a function
of scan result when pharmacologic stress is used7††, 8†††

††In a study population that consisted of 6,173 consecutive patients with known or suspected CAD who underwent dual isotope MPI with pharmacological stress and followed up for 27 ± 8.8 months ; the final population included 2,677 males and 2,656 females7

Adapted from Berman DS et al.7

†††In a second prospective study of 2,377 consecutive patients (1,226 men and 1,151 women) who underwent exercise or dypyridamole Tc-99m sestamibi SPECT and who were followed up over 15± 8 months where only 2,228 patients were available for follow-up; to evalutate gender differences in the use of Tc-99m sestamibi for subsequent referrals for invasive procedures and its prognostic value in predicitng subsequent cardiac events.8

In women and men, a gated nuclear stress test with Cardiolite®:

  • Adds incremental value in the prediction of cardiac death7
  • Provides information that may assist you in making patient management decisions1
Click here to view footnotes
  1. Cardiolite® [package insert]. N. Billerica, MA: Lantheus Medical Imaging; 2009.
  2. Hachamovitch R, Berman DS, Shaw LJ, et al. Incremental prognostic value of myocardial perfusion single photon emission computed tomography for the prediction of cardiac death: differential stratification for risk of cardiac death and myocardial infarction. Circulation. 1998;97:535–543.
  3. Kang X, Berman DS, Lewin HC, et al. Incremental prognostic value of myocardial perfusion single photon emission computed tomography in patients with diabetes mellitus. Am Heart J. 1999;138:1025–1032.
  4. Data on file. Lantheus Medical Imaging, Inc.
  5. Giri S, Shaw LJ, Murthy DR, et al. Impact of diabetes on the risk stratification using stress single-photon emission computed tomography myocardial perfusion imaging in patients with symptoms suggestive of coronary artery disease. Circulation. 2002;105:32–40.
  6. Hachamovitch R. Risk assessment of patients with known or suspected CAD using stress myocardial perfusion SPECT: Part II: determining cost-effective test strategies. Rev Cardiovasc Med. 2001;2:41–47.
  7. Berman DS, Kang X, Hayes SW, et al. Adenosine myocardial perfusion single-photon emission computed tomography in women compared with men: impact of diabetes mellitus on incremental prognostic value and effect on patient management. J Am Coll Cardiol. 2003;41:1125–1133.
  8. Travin MI, Duca MD, Kline GM, et al. Relation of gender to physician use of test results and to the prognostic value of stress technetium 99m sestamibi myocardial single-photon emission computed tomography. Am Heart J. 1997;134:73-82.

 

Lantheus Medical Imaging

Indications and Usage for Cardiolite®:
Myocardial Imaging:  CARDIOLITE® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions.  CARDIOLITE® evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g. exercise or pharmacologic stress in accordance with the pharmacologic stress agent’s labeling).

CONTRAINDICATIONS:
None known.

IMPORTANT SAFETY INFORMATION: 

CARDIOLITE® has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria.  In some patients the allergic symptoms developed on the second injection during CARDIOLITE® imaging.  The most frequently reported adverse events include headache, chest pain/angina, ST segment changes on ECG, nausea, and abnormal taste and smell.

Infrequently, death has occurred 4 to 24 hours after Tc99m Sestamibi use and is usually associated with exercise stress testing (See Section 5.2). Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events.

WARNINGS AND PRECAUTIONS:
In studying patients in whom cardiac disease is known or suspected, care should
be taken to assure continuous monitoring and treatment in accordance with safe,
accepted clinical procedure.

Caution should be exercised and emergency equipment should be available when administering CARDIOLITE®.

Before administering CARDIOLITE® patients should be asked about the possibility of allergic reactions to either CARDIOLITE® or MIRALUMA®.
MIRALUMA® is an identical compound used in breast imaging.

The contents of the vial are intended only for use in the preparation of Technetium Tc99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure.

Please see full Prescribing Information: Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection)

Indications and Usage for Thallous Chloride Tl 201 Injection:
Thallous Chloride TI 201 Injection may be useful in myocardial perfusion imaging using either planar or SPECT (Single Photon Computed Tomography) techniques for the diagnosis and localization of myocardial infarction.  It may also have prognostic value regarding survival, when used in the clinically stable patient following the onset of symptoms of an acute myocardial infarction, to assess the site and size of the perfusion defect.

Thallous Chloride TI 201 Injection may also be useful in conjunction with exercise stress testing as an adjunct in the diagnosis of ischemic heart disease (atherosclerotic coronary artery disease).

It is usually not possible to differentiate recent from old myocardial infarction, or to differentiate between recent myocardial infarction and ischemia.

Thallous Chloride TI 201 is indicated also for the localization of sites of parathyroid hyperactivity in patients with elevated serum calcium and parathyroid hormone levels.  It may also be useful in pre-operative screening to localize extrathyroidal and mediastinal sites of parathyroid hyperactivity and for postsurgical reexamination.  Thallous Chloride Tl 201 Injection has not been adequately demonstrated to be effective for the localization of normal parathyroid glands.

CONTRAINDICATIONS: None known.

Important Safety Information:
 Following the administration of Thallous Chloride Tl 201  Injection, adverse anaphylactoid reactions have been reported (characterized by cardiovascular, respiratory, and cutaneous symptoms), some severe enough to require treatment.  Hypotension, pruritus, flushing and diffuse rash which responds to antihistamines have been reported.  Other reported events include itching, nausea/vomiting, mild diarrhea, tremor, shortness of breath, chills, fever, conjunctivitis, sweating and blurred vision.

WARNINGS:
In studying patients in whom myocardial infarction or ischemia is known or suspected, care should be taken to assure continuous clinical monitoring and treatment in accordance with safe, accepted procedure.  Exercise stress testing should be performed only under the supervision of a qualified physician and in a laboratory equipped with appropriate resuscitation equipment.
The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex.

PRECAUTIONS:
Data are not available concerning the effect of marked alterations in blood glucose, insulin, or pH (such as is found in diabetes mellitus) on the quality of Thallous ­Chloride TI 201 Injection scans.  Attention is directed to the fact that thallium is a potassium analog, and since the transport of potassium is affected by these factors, the possibility exists that the thallium may likewise be affected.

General

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Thallous Chloride TI 201 Injection, as all radioactive materials, must be handled with care and used with appropriate safety measures to minimize external radiation exposure to patients and to clinical personnel. 

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides.

Please see full Prescribing Information: Thallous Chloride Tl 201 Injection