Coronary Disease, Verapamil Toxicity
Conditions
Keywords
Coronary Artery Disease, Coronary Angiography, Percutaneous Coronary Intervention, Transradial, Radial Artery Spasm, Verapamil, Adverse Effects
Brief summary
Background Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. However, verapamil may have side effects and is contraindicated in some clinical settings. Methods: During an investigator-initiated, randomized, double-blind trial, we evaluate the need for preventive verapamil administration. After vascular access is established, patients receive either 5 mg verapamil (n=297) or placebo (n=294). We compare the rate of access site conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural and fluoroscopic times, contrast volume, and subjective pain are investigated as secondary end points.
Interventions
DRUGVerapamil
Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
DRUGPlacebo
Intraarterial administration of 10 mL saline.
Sponsors
State Health Center, Hungary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients undergoing transradial coronary angiography and/or percutaneous coronary intervention * successful cannulation of the radial artery
Exclusion criteria
* reduced left ventricular systolic function (LVEF\<35%) * significant aortic stenosis * bradycardia (\<50/min.) * myocardial infarction complicated by cardiogenic shock and/or high grade AV block
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Access Site Conversions | Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Vasodilator Use | Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention. | — |
| Procedural Time | Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention. | — |
| Rate of Code Breaks | Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention. | Code break: a composite of access site conversion and unplanned use of vasodilators. |
| Contrast Volume | The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention. | — |
| Subjective Pain | Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention. | Analysis of the rates of significant pain defined as pain score ≥4 on a semiquantitative scale ranging from 1 to 6. |
| Fluoroscopic Time | Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention. | — |
Countries
Hungary
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Verapamil Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL. | 297 |
| Placebo Placebo: Intraarterial administration of 10 mL saline. | 294 |
| Total | 591 |
Baseline characteristics
| Characteristic | Verapamil | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 10.5 | 62.5 years STANDARD_DEVIATION 10.8 | 62.1 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment Hungary | 297 participants | 294 participants | 591 participants |
| Sex: Female, Male Female | 111 Participants | 104 Participants | 215 Participants |
| Sex: Female, Male Male | 186 Participants | 190 Participants | 376 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 297 | 0 / 294 |
| serious Total, serious adverse events | 0 / 297 | 0 / 294 |
Outcome results
Primary
Rate of Access Site Conversions
Time frame: Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Verapamil | Rate of Access Site Conversions | 2 participants |
| Placebo | Rate of Access Site Conversions | 5 participants |
p-value: 0.2895% CI: [-0.011, 0.033]Fisher Exact
Secondary
Contrast Volume
Time frame: The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Verapamil | Contrast Volume | 75.0 milliliter |
| Placebo | Contrast Volume | 72.5 milliliter |
p-value: 0.74Wilcoxon (Mann-Whitney)
Secondary
Fluoroscopic Time
Time frame: Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Verapamil | Fluoroscopic Time | 4.8 minutes |
| Placebo | Fluoroscopic Time | 4.4 minutes |
p-value: 0.28Wilcoxon (Mann-Whitney)
Secondary
Procedural Time
Time frame: Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Verapamil | Procedural Time | 17.0 minutes |
| Placebo | Procedural Time | 16.0 minutes |
p-value: 0.37Wilcoxon (Mann-Whitney)
Secondary
Rate of Code Breaks
Code break: a composite of access site conversion and unplanned use of vasodilators.
Time frame: Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Verapamil | Rate of Code Breaks | 4 participants |
| Placebo | Rate of Code Breaks | 10 participants |
p-value: 0.11Fisher Exact
Secondary
Rate of Vasodilator Use
Time frame: Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Verapamil | Rate of Vasodilator Use | 297 participants |
| Placebo | Rate of Vasodilator Use | 6 participants |
p-value: <0.0001Fisher Exact
Secondary
Subjective Pain
Analysis of the rates of significant pain defined as pain score ≥4 on a semiquantitative scale ranging from 1 to 6.
Time frame: Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Verapamil | Subjective Pain | 26 participants |
| Placebo | Subjective Pain | 21 participants |
p-value: 0.45Fisher Exact