Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With STEMI

Coronary Artery Disease Clinical Trial

— DR-STEMI  

Official title:

Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With ST-elevation Myocardial Infraction (STEMI): The DR-STEMI Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05605288
• Other study ID #: 26150/30.09.22
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: University Hospital of Patras
• Contact: Grigorios Tsigkas, MD, PhD
• Phone: +306974466662
• Email: gregtsig[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 554
• Est. completion date: December 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Catheterization
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Percutaneous Coronary Intervention
• Primary PCI
• ST Elevation Myocardial Infarction

Intervention

Procedure:
• Coronary angiography +/- percutaneous coronary intervention
Coronary angiography +/- percutaneous coronary intervention

Locations

Country	Name	City	State
Belgium	Department of Cardiology, Centre Hospitalier Universitaire de Charleroi	Charleroi
Greece	University Hospital of Patras	Patras
Switzerland	Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Patras

Countries where clinical trial is conducted

Belgium,  Greece,  Switzerland, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	needle-to-wire time	needle-to-wire time	Immediately post-procedurally
Secondary	Radial artery occlusion using Doppler examination prior to hospital discharge	Radial artery patency evaluation with Doppler ultrasound prior to hospital discharge for detecting possible occlusion after cannulation	The evaluation will be performed during hospitalization for STEMI and prior discharge, typically the 4th day after PCI
Secondary	Access site crossover rate	Crossover rate from distal transradial artery access to other access point	Immediately post-procedurally
Secondary	Sheath insertion time	Duration required from the beginning of puncture until sheath insertion	Immediately post-procedurally
Secondary	Total procedure time	Total duration of coronary angiography and angioplasty	Immediately post-procedurally
Secondary	The time interval between the initiation of radial artery puncture and the completion of coronary angiography, until the beginning of the possible PCI	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
Secondary	Required time for coronary angiography completion, after sheath insertion	Required time for coronary angiography completion, after sheath insertion	Immediately post-procedurally
Secondary	Required time percutaneous coronary intervention completion	Required time percutaneous coronary intervention completion	Immediately post-procedurally
Secondary	Total fluoroscopy time	Total fluoroscopy time	Immediately post-procedurally
Secondary	Total Dose Area Product (DAP)	Total Dose Area Product (DAP)	Immediately post-procedurally
Secondary	Air Kerma	Air Kerma	Immediately post-procedurally
Secondary	Hemostasis time	Time required for achieving hemostasis	3 hours
Secondary	Vascular complications	Vascular complications	24 hours
Secondary	Hematomas classification (modified EASY classification)	Hematomas classification using modified EASY which is compatible with dTRA	24 hours
Secondary	30-days Clinical follow-up (on site or via telephone call)	30-days Clinical follow-up (on site or via telephone call)	30 days