Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With STEMI (DR-STEMI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; ST Elevation Myocardial Infarction; Percutaneous Coronary Intervention; Coronary Catheterization; Distal Transradial Artery; Transradial Artery; Primary PCI
• Intervention / Treatment: Procedure: Coronary angiography +/- percutaneous coronary intervention

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 Type: Interventional
• Enrollment (Estimated): 554
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grigorios Tsigkas, MD, PhD; Phone Number: +306974466662; Email: gregtsig@hotmail.com
• Study Contact Backup: Name: Adel Aminian, MD, PhD; Email: adaminian@hotmail.com

Study Locations

• Belgium
  • Charleroi, Belgium
    • Recruiting
    • Department of Cardiology, Centre Hospitalier Universitaire de Charleroi
    • Contact: Adel Aminian, MD,PhD; Email: adaminian@hotmail.com
• Greece
  • Patras, Greece, 26500
    • Recruiting
    • University Hospital of Patras
    • Contact: Grigorios Tsigkas, MD,PhD; Email: gregtsig@hotmail.com
• Switzerland
  • Geneva, Switzerland
    • Recruiting
    • Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.
    • Contact: Juan F Inglesias, MD; Phone Number: 41793474849; Email: Juanfernando.Iglesias@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
needle-to-wire time	needle-to-wire time	Immediately post-procedurally

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Access site crossover rate	Crossover rate from distal transradial artery access to other access point	Immediately post-procedurally
Sheath insertion time	Duration required from the beginning of puncture until sheath insertion	Immediately post-procedurally
Total procedure time	Total duration of coronary angiography and angioplasty	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	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
Required time for coronary angiography completion, after sheath insertion	Required time for coronary angiography completion, after sheath insertion	Immediately post-procedurally
Required time percutaneous coronary intervention completion	Required time percutaneous coronary intervention completion	Immediately post-procedurally
Total fluoroscopy time	Total fluoroscopy time	Immediately post-procedurally
Total Dose Area Product (DAP)	Total Dose Area Product (DAP)	Immediately post-procedurally
Air Kerma	Air Kerma	Immediately post-procedurally
Hemostasis time	Time required for achieving hemostasis	3 hours
Vascular complications	Vascular complications	24 hours
Hematomas classification (modified EASY classification)	Hematomas classification using modified EASY which is compatible with dTRA	24 hours
30-days Clinical follow-up (on site or via telephone call)	30-days Clinical follow-up (on site or via telephone call)	30 days

Collaborators and Investigators

• Sponsor: University Hospital of Patras
• Investigators: Principal Investigator: Adel Aminian, MD, PhD, Centre Hospitalier Universitaire de Charleroi; Principal Investigator: Juan Inglesias, MD, PhD, Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.; Principal Investigator: Grigorios Tsigkas, MD, PhD, University Hospital of Patras

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 25, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; percutaneous coronary intervention; coronary catheterization; primary PCI; ST Elevation Myocardial Infarction; distal transradial artery; transradial artery
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; ST Elevation Myocardial Infarction
• Other Study ID Numbers: 26150/30.09.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No