Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)

Efficacy of Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve Measurements

The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.

This is a prospective open label, single center pilot trial that will evaluate regadenoson compared to Adenoscan® to be given IV in the assessment of Fractional Flow Reserve. Forty eight subjects will be enrolled and get Adenoscan® administered via IV followed by Regadenoson IV.

Inclusion Criteria:

• Patients undergoing elective left heart catheterization
• Age ≥ 18 years (female not of child bearing potential)
• Able to provide written informed consent

Exclusion Criteria:

• Contraindications to administration of either Adenoscan® or Regadenoson
• High degree AV block, sick sinus syndrome without a functioning pacemaker
• Symptomatic bradycardia
• Recent STEMI (< 5 days)
• Recent NSTEMI (<5 days) if the peak CK is > 1000 IU
• Dipyridamole use within 24 hours
• Adenoscan® is contraindicated (hypersensitivity to Adenoscan®, Regadenoson, or aminophylline
• Known severe bronchoconstrictive lung disease