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¶#

Based on a prospective study of 1,271 consecutively registered patients with diabetes and 5,862 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.
  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.

 

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)

 

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