DR-STEMI: Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With STEMI
Study Details
Study Description
Brief Summary
Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed for undertaking percutaneous coronary angiography and interventions. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Gaining vascular access is the first, mandatory step for undertaking percutaneous coronary angiography and interventions. The recent guidelines, published by European Society of Cardiology (ESC), American College of Cardiology (ACC), American Heart Association (AHA) and Society for Cardiovascular Angiography and Interventions (SCAI), propose TRA as the gold standard for acute coronary syndromes (ACS), chronic coronary syndrome (CCS) percutaneous coronary interventions (PCI). Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Mutual point of all the previous RCTs is that excluded patients suffering from ST-elevation Myocardial Infraction (STEMI). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Distal transradial artery access Vascular access after cannulation of distal transradial artery through anatomical snuffbox for coronary angiography and interventions |
Procedure: Coronary angiography +/- percutaneous coronary intervention
Coronary angiography +/- percutaneous coronary intervention
|
| Active Comparator: Conventional transradial artery access Vascular access after puncturing on the conventional transradial artery for performing coronary angiography and interventions |
Procedure: Coronary angiography +/- percutaneous coronary intervention
Coronary angiography +/- percutaneous coronary intervention
|
Outcome Measures
Primary Outcome Measures
- Needle-to-balloon time [Immediately post-procedurally]
Needle-to-balloon time
Secondary Outcome Measures
- Radial artery occlusion using Doppler examination prior to hospital discharge [The evaluation will be performed during hospitalization for STEMI and prior discharge, typically the 4th day after PCI]
Radial artery patency evaluation with Doppler ultrasound prior to hospital discharge for detecting possible occlusion after cannulation
- Access site crossover rate [Immediately post-procedurally]
Crossover rate from distal transradial artery access to other access point
- Sheath insertion time [Immediately post-procedurally]
Duration required from the beginning of puncture until sheath insertion
- Total procedure time [Immediately post-procedurally]
Total duration of coronary angiography and angioplasty
- The time interval between the initiation of radial artery puncture and the completion of coronary angiography, until the beginning of the possible PCI [Immediately post-procedurally]
The time interval between the initiation of radial artery puncture and the completion of coronary angiography, until the beginning of the possible PCI
- Required time for coronary angiography completion, after sheath insertion [Immediately post-procedurally]
Required time for coronary angiography completion, after sheath insertion
- Required time percutaneous coronary intervention completion [Immediately post-procedurally]
Required time percutaneous coronary intervention completion
- Total fluoroscopy time [Immediately post-procedurally]
Total fluoroscopy time
- Total Dose Area Product (DAP) [Immediately post-procedurally]
Total Dose Area Product (DAP)
- Air Kerma [Immediately post-procedurally]
Air Kerma
- Hemostasis time [3 hours]
Time required for achieving hemostasis
- Vascular complications [24 hours]
Vascular complications
- Hematomas classification (modified EASY classification) [24 hours]
Hematomas classification using modified EASY which is compatible with dTRA
- 30-days Clinical follow-up (on site or via telephone call) [30 days]
30-days Clinical follow-up (on site or via telephone call)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age > 18 years old
-
Indication: ST-Elevation Myocardial Infraction
Exclusion Criteria:
-
Non-palpable radial artery
-
Previous CABG
-
Anatomical restrictions for forearm approach
-
Hemodynamic instability
-
Previous radial artery catheterization from the same arm during the last 30-days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Cardiology, Centre Hospitalier Universitaire de Charleroi | Charleroi | Belgium | ||
| 2 | University Hospital of Patras | Patras | Greece | 26500 |
Sponsors and Collaborators
- University Hospital of Patras
Investigators
- Principal Investigator: Grigorios Tsigkas, MD, PhD, University Hospital of Patras
- Principal Investigator: Adel Aminian, MD, PhD, Centre Hospitalier Universitaire de Charleroi
Study Documents (Full-Text)
None provided.More Information
Publications
- Aminian A, Sgueglia GA, Wiemer M, Kefer J, Gasparini GL, Ruzsa Z, van Leeuwen MAH, Ungureanu C, Leibundgut G, Vandeloo B, Kedev S, Bernat I, Ratib K, Iglesias JF, Al Hage E, Posteraro GA, Pascut D, Maes F, Regazzoli D, Kakonyi K, Meijers TA, Colletti G, Krivoshei L, Lochy S, Zafirovska B, Horak D, Nolan J, Degrauwe S, Tobita K, Saito S. Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1191-1201. doi: 10.1016/j.jcin.2022.04.032. Epub 2022 May 17.
- Didagelos M, McEntegart M, Kouparanis A, Tsigkas G, Koutouzis M, Tsiafoutis I, Kassimis G, Oldroyd KG, Ziakas A. Distal Transradial (Snuffbox) Access for Coronary Catheterization: A Systematic Review. Cardiol Rev. 2021 Jul-Aug 01;29(4):210-216. doi: 10.1097/CRD.0000000000000339.
- Eid-Lidt G, Rivera Rodriguez A, Jimenez Castellanos J, Farjat Pasos JI, Estrada Lopez KE, Gaspar J. Distal Radial Artery Approach to Prevent Radial Artery Occlusion Trial. JACC Cardiovasc Interv. 2021 Feb 22;14(4):378-385. doi: 10.1016/j.jcin.2020.10.013.
- Sgueglia GA, Hassan A, Harb S, Ford TJ, Koliastasis L, Milkas A, Zappi DM, Navarro Lecaro A, Ionescu E, Rankin S, Said CF, Kuiper B, Kiemeneij F. International Hand Function Study Following Distal Radial Access: The RATATOUILLE Study. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1205-1215. doi: 10.1016/j.jcin.2022.04.023. Epub 2022 May 17.
- Tsigkas G, Apostolos A, Davlouros P. Less Is More, But Not Always: Distal Transradial Access for Radial Artery Occlusion Prevention. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1202-1204. doi: 10.1016/j.jcin.2022.05.001. Epub 2022 May 17. No abstract available.
- Tsigkas G, Moulias A, Papageorgiou A, Ntouvas I, Grapsas N, Despotopoulos S, Apostolos A, Papanikolaou A, Smaili K, Vasilagkos G, Davlouros P, Hahalis G. Transradial access through the anatomical snuffbox: Results of a feasibility study. Hellenic J Cardiol. 2021 May-Jun;62(3):201-205. doi: 10.1016/j.hjc.2020.02.002. Epub 2020 Mar 2.
- Tsigkas G, Papageorgiou A, Moulias A, Apostolos A, Kalogeropoulos AP, Davlouros P. Reply: Distal Transradial Access for Primary PCI in ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Interv. 2022 Apr 11;15(7):795-796. doi: 10.1016/j.jcin.2022.02.039. No abstract available.
- Tsigkas G, Papageorgiou A, Moulias A, Kalogeropoulos AP, Papageorgopoulou C, Apostolos A, Papanikolaou A, Vasilagkos G, Davlouros P. Distal or Traditional Transradial Access Site for Coronary Procedures: A Single-Center, Randomized Study. JACC Cardiovasc Interv. 2022 Jan 10;15(1):22-32. doi: 10.1016/j.jcin.2021.09.037. Epub 2021 Dec 15.
- 26150/30.09.22