Clinical trial NCT05605288: Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With STEMI
Official title: Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With ST-elevation Myocardial Infraction (STEMI): The DR-STEMI Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Coronary Artery Disease
Distal Transradial Artery
Transradial Artery
Coronary Catheterization
Percutaneous Coronary Intervention
Primary PCI
Keywords: ST Elevation Myocardial Infarction
Coronary Artery Disease
distal transradial artery
transradial artery
coronary catheterization
percutaneous coronary intervention
primary PCI
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: needle-to-wire time
timeFrame: Immediately post-procedurally
Secondary outcomes:
measure: Radial artery occlusion using Doppler examination prior to hospital discharge
timeFrame: The evaluation will be performed during hospitalization for STEMI and prior discharge, typically the 4th day after PCI
measure: Access site crossover rate
timeFrame: Immediately post-procedurally
measure: Sheath insertion time
timeFrame: Immediately post-procedurally
measure: Total procedure time
timeFrame: Immediately post-procedurally
measure: The time interval between the initiation of radial artery puncture and the completion of coronary angiography, until the beginning of the possible PCI
timeFrame: Immediately post-procedurally
measure: Required time for coronary angiography completion, after sheath insertion
timeFrame: Immediately post-procedurally
measure: Required time percutaneous coronary intervention completion
timeFrame: Immediately post-procedurally
measure: Total fluoroscopy time
timeFrame: Immediately post-procedurally
measure: Total Dose Area Product (DAP)
timeFrame: Immediately post-procedurally
measure: Air Kerma
timeFrame: Immediately post-procedurally
measure: Hemostasis time
timeFrame: 3 hours
measure: Vascular complications
timeFrame: 24 hours
measure: Hematomas classification (modified EASY classification)
timeFrame: 24 hours
measure: 30-days Clinical follow-up (on site or via telephone call)
timeFrame: 30 days
Other outcomes:
Locations:
city: Charleroi
country: Belgium
facility: Department of Cardiology, Centre Hospitalier Universitaire de Charleroi
city: Patras
country: Greece
facility: University Hospital of Patras
city: Geneva
country: Switzerland
facility: Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.
Study officials:
affiliation: University Hospital of Patras
name: Grigorios Tsigkas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Charleroi
name: Adel Aminian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.
name: Juan Inglesias, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
citation: 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.
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.