Coronary Artery Disease, Vascular Access Complication
Conditions
Keywords
Radial artery, coronary angiography, percutaneous coronary intervention, safety, efficacy, radial approach, anatomical snuff box
Brief summary
The aim of this non-inferiority trial is to determine if the distal radial access (DRA) during percutaneous coronary intervention (PCI) has an acceptable efficacy compared to the reference access through the conventional radial artery (TRA) with a lower rate of radial artery occlusion (RAO) in real life practice.
Detailed description
The conventional radial approach is the recommended vascular access for percutaneous coronary interventions. It is effective, feasible, but associated with a risk of occlusion of the radial artery. The distal radial approach is proposed as a new approach to reduce complications and preserve the radial artery. However, few clinical trials in real life were conducted in North African patients. This trial aims to evaluate the efficacy and safety of the distal radial approach versus the conventional radial approach. This trial is a non-inferiority, randomized controlled trial with two parallel arms: distal radial approach and conventional radial approach. Two hundred and fifty patients scheduled for percutaneous coronary intervention will be included. The two main endpoints are the puncture success rate with a non-inferiority margin of 10% and the rate of 30-day occlusion of the punctured radial artery. Secondary endpoints: catheterization success, crossover rate, procedure time, radial artery spasm, bleeding complications, QuickDASH score, pain score and operator satisfaction A single blind analysis will be led according to the per-protocol and intention-to-treat methods. Avoiding occlusion of the puncture site allows to preserve the radial artery for subsequent coronary or cerebral percutaneous interventions as well as for coronary bypasses and hemodialysis fistulas. The results will provide the parameters related to the efficacy and safety of the distal radial approach, so improving clinical practice.
Interventions
PROCEDUREdistal radial artery approach
Procedure: Use of radial artery for access for a coronary angiography or intervention After preparation and local anesthesia, the operator will puncture the distal radial artery in the dorsum of the hand or the anatomical snuff-box. Then a sheath will be placed. A cocktail combining Risordan®, Loxen® and unfractionated heparin will be injected through the sheath. a wire will be introduced. At the end of the procedure, the sheath will be removed immediately and hemostasis by compression will be carried out with an elastic band for 12 hours. The choice of limb side, sheath, catheters will be chosen according to the operator's discretion.
PROCEDUREconventional radial artery approach
Procedure: conventional radial access for a percutaneous coronary intervention After preparation and local anesthesia, the operator will puncture the proximal radial artery at the conventional site in distal forearm. Then a sheath will be placed. A cocktail combining Risordan®, Loxen® and unfractionated heparin will be injected through the sheath. a wire will be introduced. At the end of the procedure, the sheath will be removed immediately and hemostasis by compression will be carried out with an elastic band for 12 hours. The choice of limb side, sheath, catheters will be chosen according to the operator's discretion.
Sponsors
General Administration of Military Health, Tunisia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
single blind during the analyze
Intervention model description
Prospective, single-center, single-blind, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 18 years old. * Hospitalized in the cardiology department of the military hospital of Tunis. * elective Percutaneous coronary intervention performed by experienced operators or fellows trained in the proximal and distal radial approach Non-inclusion criteria: * not provided written informed consent * both radial arteries were used for prior catheterization * Under oral anticoagulation * Having coronary bypass surgery * Hemodynamic instability * contra-indication to the radial approach: * Orthopedic surgery: amputation * Severe burns of both upper limbs. * Radial artery pulse not palpable, negative modified Allen test or Barbeau classification type D * Identified radial vascular anomaly: stenosis, fistula, tortuosity not allowing passage of the catheter
Exclusion criteria
* death within a short period of time after admission * PCI by the same puncture site will be performed within 30 days after the first puncture * lost to follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Puncture success rate | During the procedure | Comparison of Puncture success rate between two groups: Distal Radial Access (DRA) and conventional Trans Radial Access (TRA) |
| Radial artery occlusion rate | 30 days | Use of ALLEN and Barbeau tests, if abnormal, color Doppler ultrasound to assess the patency of the radial artery will be realized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radial artery spasm | During the procedure | The incidence of vasospasm that necessitates additional medication or forces access site cross over is registered |
| Number of patients presenting hematoma | 24 hours | Hematoma according to Early Discharge After Transradial Stenting of Coronary Arteries Study (EASY) score, The score ranges from 1 (≤5 cm diameter) to 5 ( ischemic threat of the hand). |
| Crossover rate | During the procedure | Comparison of the access site crossover rate in each group to complete the staged procedure |
| QuickDASH questionnaire | 30 days | The Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH) score is used to assess hand function. The score ranges from 0 (no disability) to 100 (most severe disability) |
| Operator satisfaction | at the end of the inclusion | through 0-10 rating scale; 0 being very dissatisfied; 0 being very satisfied |
| Pain scale | 24 hours | through 0-10 numeric pain rating scale, 0 being no pain and 10 being the worst pain imaginable |
| Duration of the puncture | During the procedure | Exact measurement of puncture duration in seconds |
Countries
Tunisia
Contacts
Primary ContactAymen Noamen, MD
Backup ContactAhmed Ben Amara, fellow
Outcome results
None listed