Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
2002-07-22
2004-06-29
Henley, III, Raymond J. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
active
06756408
ABSTRACT:
FIELD OF THE INVENTION
The subject invention relates, generally, to methods and materials for protecting a subject against myocardial cell damage and, more particularly, for protecting a subject against myocardial cell damage resulting from coronary intervention.
BACKGROUND OF THE INVENTION
Percutaneous coronary intervention (“PCI”) is an important treatment for coronary artery disease and other forms of atherosclerosis obstruction of the coronary arteries. However, myocardial necrosis (infarction) during PCI may occur in almost half of otherwise successful PCI (Klein et al., “Incidence and Clinical Significance of Transient Creatine Kinase Elevations and the Diagnosis of Non-Q Wave Myocardial Infarction Associated with Coronary Angioplasty,”
J. Am. Coll. Cardiol.,
17:621-626 (1991) (“Klein”); Oh et al., “Creatine Kinase Release after Successful Percutaneous Transluminal Coronary Angioplasty,”
Am. Heart J.,
109:1225-1231 (1985) (“Oh”); and Pauletto et al., “Changes in Myoglobin, Creatine Kinase, and Creatine Kinase-MB after Percutaneous Transluminal Coronary Angioplasty for Stable Angina Pectoris,”
Am. J. Cardiol.,
59: 999-1000 (1987)) and is associated with an increased incidence of late adverse outcomes, particularly death, even with minor elevations in biochemical markers (Simoons et al., “Minimal myocardial damage during coronary intervention is associated with impaired outcome,” Eur. Heart J., 20:1112-1119 (1999) (“Simoons”); Kong et al., “Prognostic implication of creatine kinase elevation following elective coronary artery interventions,”
JAMA,
277:461-466 (1997); Abdelmeguid et al., “Significance of Mild Transient Release of Creatine Kinase-MB Fraction after Percutaneous Coronary Interventions,”
Circulation,
94:1528-1536 (1996); and Akkerhuis et al., “Minor Myocardial Damage and Prognosis: Are Spontaneous and Percutaneous Coronary Intervention—Related Events Different?”
Circulation,
105:554-556 (2002)). These biochemical markers include the enzyme creatine kinase (“CK”), the myocardial specific enzyme CKMB, and the myocardial cell protein troponin I and troponin T, and an increase in these markers after PCI is associated with a worsened prognosis.
The causes of myocardial enzyme elevation after otherwise successful PCI are multiple and are believed to include the development of mechanical complications such as slow flow, side branch occlusion, transient major vessel closure, or prolonged coronary spasm (Klein and Oh). In the majority of cases, however, enzyme release occurs without any apparent mechanical complication. In this setting, the most likely cause is microembolization (Topol et al., “Recognition of Importance of Embolization in Atherosclerotic Vascular Disease,”
Circulation,
101:570-580 (2000)).
In an effort to reduce post-PCI complications, various compounds can be administered to the subject. These include glycoprotein IIb/IIIa receptor antagonists, aspirin, and heparin. However, these compounds have not proven to be wholly effective in reducing post-PCI myocardial necrosis and other forms of post-PCI cell myocardial cell damage.
Accordingly, there exists a need for methods of protecting against the incidence of myocardial necrosis and other forms of myocardial cell damage during or subsequent to PCI. The present invention is directed, in part, to meeting this need.
SUMMARY OF THE INVENTION
The present invention relates to a method for reducing myocardial cell damage during and/or after percutaneous coronary intervention in a subject's coronary artery. The method includes instilling a beta blocker directly into the subject's coronary artery prior to percutaneous coronary intervention.
The present invention also relates to a kit for carrying out percutaneous coronary intervention. The kit comprises a catheter and a beta blocker.
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Board of Regents , The University of Texas System
Henley III Raymond J.
Rogalskyj & Weyand LLP
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