Radial Artery Spasm
Conditions
Keywords
radial artery spasm, verapamil, transradial access
Brief summary
Coronary angiography (CAG) is an invasive imaging method performed to determine the degree of coronary artery disease. Radial artery spasm (RAS) is one of the most common complications during coronary angiography performed via the transradial approach, causing patient discomfort or sometimes interrupting the procedure. There are many studies on RAS, and various pharmacoagents administered intravenously (intraarterial) to prevent RAS have been described. However, there is limited data in the literature regarding oral pharmacoagents that will prevent this complication. In our study, the preventive effect of Verapamil, given orally 2 hours before coronary angiography, on radial artery spasm will be investigated.
Detailed description
Transradial access (TRA) has emerged as the preferred modality for vascular access in coronary interventions worldwide, prompting growing interest in its potential applications across other interventional specialties, especially in neurovascular procedures. Radial artery spasm (RAS) remains the most common complication of TRA, often causing procedural difficulties, patient discomfort, and an increased risk of access site crossover. The incidence of radial artery spasm reported in the literature varies widely, with estimates ranging from 4% to over 51.3%, influenced by factors such as definitions, patient selection, and the operator's experience. After puncturing the radial artery (Puncture-induced RAS) and inserting the sheath-but before administering intra-arterial spasmolytics-local discomfort and pain may trigger a sympathetic vasoconstrictive response, potentially leading to the onset of RAS. A previous study has stated that preventing RAS is more effective than treating it after it has been established. In this context, we will conduct a randomized controlled trial to evaluate the efficacy of 120 mg of oral verapamil administered two hours before radial artery puncture in reducing the incidence of radial artery spasm (RAS)
Interventions
DRUGVerapamil
Prevent
Sponsors
Mersin Medicalpark Hastanesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who undergo daily coronary angiography * Whose Allen test is normal. * Must be able to swallow tablets
Exclusion criteria
* Allen test results are distorted, * No pulse in the radial artery, * Patients who have previously undergone radial angiography and whose hemodynamics are compromised will be excluded from the study. * Patients with known contraindications to verapamil (significant aortic stenosis, heart rate \<50/min, high-grade atrioventricular block, myocardial infarction) complicated with cardiogenic shock, or left ventricular ejection fraction \<35%).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Radial Artery Spasm (RAS) | During the coronary angiography procedure (up to 2 hours from sheath insertion) | Clinical RAS defined as presence of at least 2 of the following: (1) forearm pain ≥ 4/10, (2) pain during catheter manipulation, (3) catheter movement restriction, (4) pain during sheath removal, (5) difficulty in sheath removal. |
| Number of Participants With Ultrasonographically Confirmed Radial Artery Spasm (Ultrasonographic RAS) | During the procedure, immediately after catheterization (within 2 hours) | Radial artery spasm (RAS) was defined as luminal narrowing of ≥50% as measured by ultrasonography at the access site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedural Success | During the procedure (from sheath insertion to procedure completion) | Procedure success was defined as completing coronary angiography or PCI using the initial radial artery approach without requiring a switch to an alternative access site. |
| Mean Volume of Contrast Media Used (mL) (mL) | During the procedure (from sheath insertion to procedure completion) | The volume of contrast media (in ml) used was recorded |
| Mean of the Dose Area Product (DAP) | During the procedure (from sheath insertion to procedure completion) | The parameters collected for radiation exposure included the DAP |
| Mean of the Fluoroscopy Time | During the procedure (from sheath insertion to procedure completion) | The parameters collected for radiation exposure included the fluoroscopy time (in minutes) |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
All consecutive patients undergoing transradial coronary angiography between June-November 2024 at Medicalpark Hospital (Mersin, Turkey) were included. Exclusion criteria were abnormal Allen test, absent radial pulse, prior radial access, hemodynamic instability, or contraindications to verapamil (e.g., severe AS, HR \<50, high-grade AV block, cardiogenic shock, EF \<35%).
Pre-assignment details
No pre-assignment washout or run-in period was required. All eligible participants were randomized immediately after enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants did not receive any prophylactic medication to prevent radial artery spasm and underwent standard transradial coronary angiography. | 75 |
| Verapamil Participants received a single oral dose of verapamil (120 mg) approximately 2 hours before transradial coronary angiography as prophylaxis against radial artery spasm. | 75 |
| Total | 150 |
Baseline characteristics
| Characteristic | Verapamil | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 11.1 | 58.8 years STANDARD_DEVIATION 11.6 | 58.1 years STANDARD_DEVIATION 12.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Turkey | 75 Participants | 150 Participants | 75 Participants |
| Sex: Female, Male Female | 26 Participants | 49 Participants | 23 Participants |
| Sex: Female, Male Male | 49 Participants | 101 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 75 |
| other Total, other adverse events | 0 / 75 | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 | 0 / 75 |
Outcome results
Primary
Number of Participants With Clinical Radial Artery Spasm (RAS)
Clinical RAS defined as presence of at least 2 of the following: (1) forearm pain ≥ 4/10, (2) pain during catheter manipulation, (3) catheter movement restriction, (4) pain during sheath removal, (5) difficulty in sheath removal.
Time frame: During the coronary angiography procedure (up to 2 hours from sheath insertion)
Population: All randomized participants were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Clinical Radial Artery Spasm (RAS) | 23 participants |
| Verapamil | Number of Participants With Clinical Radial Artery Spasm (RAS) | 3 participants |
Primary
Number of Participants With Ultrasonographically Confirmed Radial Artery Spasm (Ultrasonographic RAS)
Radial artery spasm (RAS) was defined as luminal narrowing of ≥50% as measured by ultrasonography at the access site.
Time frame: During the procedure, immediately after catheterization (within 2 hours)
Population: All randomized participants were included in the analysis (75 in the placebo group and 75 in the oral verapamil group)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Ultrasonographically Confirmed Radial Artery Spasm (Ultrasonographic RAS) | 36 participants |
| Verapamil | Number of Participants With Ultrasonographically Confirmed Radial Artery Spasm (Ultrasonographic RAS) | 8 participants |
Secondary
Mean of the Dose Area Product (DAP)
The parameters collected for radiation exposure included the DAP
Time frame: During the procedure (from sheath insertion to procedure completion)
Population: All randomized participants were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean of the Dose Area Product (DAP) | 873.9 Gy·cm2 | Standard Deviation 732.3 |
| Verapamil | Mean of the Dose Area Product (DAP) | 878.8 Gy·cm2 | Standard Deviation 736.7 |
Secondary
Mean of the Fluoroscopy Time
The parameters collected for radiation exposure included the fluoroscopy time (in minutes)
Time frame: During the procedure (from sheath insertion to procedure completion)
Population: All randomized participants were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean of the Fluoroscopy Time | 7.9 minute | Standard Deviation 7.3 |
| Verapamil | Mean of the Fluoroscopy Time | 6.9 minute | Standard Deviation 5.8 |
Secondary
Mean Volume of Contrast Media Used (mL) (mL)
The volume of contrast media (in ml) used was recorded
Time frame: During the procedure (from sheath insertion to procedure completion)
Population: All randomized participants were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Volume of Contrast Media Used (mL) (mL) | 133.8 Milliliters (mL) | Standard Deviation 71.9 |
| Verapamil | Mean Volume of Contrast Media Used (mL) (mL) | 136.4 Milliliters (mL) | Standard Deviation 78.3 |
Secondary
Number of Participants With Procedural Success
Procedure success was defined as completing coronary angiography or PCI using the initial radial artery approach without requiring a switch to an alternative access site.
Time frame: During the procedure (from sheath insertion to procedure completion)
Population: All randomized participants were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Procedural Success | 75 participants |
| Verapamil | Number of Participants With Procedural Success | 75 participants |