Trial Outcomes & Findings for Comparison of Intravenous Adenosine Infusion With Regadenoson Bolus for Inducing Maximal Coronary Hyperemia (NCT NCT01161121)

Results Overview

FFR (as calculated by the ratio of lowest Pd/Pa at maximal hyperemia) was compared between hyperemia achieved with adenosine and with regadenoson

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

46 participants

Primary outcome timeframe

At maximal, steady-state hyperemia

Results posted on

2017-06-23

Participant Flow

Patients provided written consent for participation in the study prior to cardiac catheterization. Diagnostic coronary angiography was performed utilizing standard techniques. Patients in whom the operator believed needed physiologic coronary assessment with Fractional Flow Reserve (FFR) were then eligible for participation in the study.

Participant milestones

Participant milestones
Measure	Adenosine Then Regadenoson Adenosine infusion will be compared to Regadenoson for efficacy and safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias. All patients to receive Adenosine infusion followed by Regadenoson IV bolus upon return of coronary flow velocity to 15% of pre-dose value. Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia. Regadenoson : Administration of IV regadenoson bolus 0.4 mg/5 mls over 10 seconds followed by a 5 cc NS saline flush
Overall Study STARTED	46
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Intravenous Adenosine Infusion With Regadenoson Bolus for Inducing Maximal Coronary Hyperemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adenosine, Regadenoson n=46 Participants Each patient underwent standard intravenous adenosine infusion (140mcg/kg/min) with invasive pressure recordings for 2 min, or until maximal hyperemia occurred. Five minutes after return to baseline hemodynamics, a single intravenous bolus of 0.4 mg regadenoson was administered, and pressures were recorded for 5 min. FFR values were compared by linear regression and Bland-Altman analysis.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	59 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants

PRIMARY outcome

Timeframe: At maximal, steady-state hyperemia

Population: Per protocol

FFR (as calculated by the ratio of lowest Pd/Pa at maximal hyperemia) was compared between hyperemia achieved with adenosine and with regadenoson

Outcome measures

Outcome measures
Measure	Adenosine n=46 Participants Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias. Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia	Regadenoson n=46 Participants Once the mean coronary flow velocity returns to within 15% pre-dose value following IV infusion of Adenosine, Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml over 10 seconds followed by a 5 cc IV saline flush. regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds.
Difference in FFR Between IV Adenosine and IV Regadenoson	0.84 ratio (Pd/Pa) Standard Deviation 0.11	0.84 ratio (Pd/Pa) Standard Deviation 0.10

SECONDARY outcome

Timeframe: During drug infusion and until restoration of baseline hemodynamics

Maximal heart rate documented following the administration of each agent

Outcome measures

Outcome measures
Measure	Adenosine n=46 Participants Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias. Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia	Regadenoson n=46 Participants Once the mean coronary flow velocity returns to within 15% pre-dose value following IV infusion of Adenosine, Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml over 10 seconds followed by a 5 cc IV saline flush. regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds.
Heart Rate Changes With Drug Baseline Heart Rate	70.8 beats per minute Standard Deviation 11.5	72.4 beats per minute Standard Deviation 12.0
Heart Rate Changes With Drug Maximal Heart Rate	81.7 beats per minute Standard Deviation 13.4	90.4 beats per minute Standard Deviation 13.0

SECONDARY outcome

Timeframe: During drug infusion and until restoration of baseline hemodynamics

Chest pain, chest discomfort, burning, flushing, headache, nausea, or shortness of breath

Outcome measures

Outcome measures
Measure	Adenosine n=46 Participants Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias. Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia	Regadenoson n=46 Participants Once the mean coronary flow velocity returns to within 15% pre-dose value following IV infusion of Adenosine, Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml over 10 seconds followed by a 5 cc IV saline flush. regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds.
Side Effects of Medication Administration Dyspnea	14 participants	13 participants
Side Effects of Medication Administration Chest Pain	16 participants	13 participants
Side Effects of Medication Administration Any Symptom	27 participants	28 participants

Adverse Events

Adenosine

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Regadenoson

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Adenosine n=46 participants at risk Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias. Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia adenosine : Measuring FFR and Coronary Flow Reserve after administration of IV adenosine 140 mcg/kg/min for 2 minutes. regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds.	Regadenoson n=46 participants at risk Once the mean coronary flow velocity returns to within 15% pre-dose value then Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml. Then, a 5 cc saline flush will be administered. regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds.
Respiratory, thoracic and mediastinal disorders Shortness of Breath	30.4% 14/46 • Number of events 14	28.3% 13/46 • Number of events 13
Skin and subcutaneous tissue disorders Flushing	13.0% 6/46 • Number of events 6	19.6% 9/46 • Number of events 9
Gastrointestinal disorders Nausea	4.3% 2/46 • Number of events 2	10.9% 5/46 • Number of events 5
Cardiac disorders Cardiac General -Chest Pain	34.8% 16/46 • Number of events 16	28.3% 13/46 • Number of events 13

Additional Information

Dr. Michael Lim

St. Louis University

Phone: 314-268-7992

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60