Effect of RIVAroxaban in Radial Artery Occlusion Treatment After Cardiac Catheterization (RIVA-RAO)

Effect of RIVAroxaban in Reducing Radial Artery Occlusion Rate After Transradial Coronary Catheterization

The purpose of the RIVA-RAO study is to determine whether the use of Rivaroxaban is an effective treatment of radial artery occlusion (RAO) after cardiac catheterization (both angiography and PCI). This is a prospective, single-center, randomized controlled, open-label study that will randomize patients with RAO into two groups, one receiving Rivaroxaban and the other receiving no anticoagulation. RAO will be detected by radial artery ultrasound up to 24 hours after the procedure.

Study objectives:

Primary objective:

To evaluate the effect of treatment with Rivaroxaban, in patients (both symptomatic and asymptomatic) with RAO after a coronary catheterization procedure (both angiography and percutaneous coronary intervention-PCI), in improving patency rates of the radial artery at 4 weeks after the procedure, compared with no-anticoagulation treatment.

Secondary objectives:

To compare local access site and systemic complications (bleeding events, pseudoaneurysm, arteriovenous fistula) at 4 weeks after the procedure between the two groups.

Study Overview

• Status: Recruiting
• Conditions: Radial Artery Occlusion
• Intervention / Treatment: Drug: Rivaroxaban

Detailed Description

The use of the radial artery as an access site for coronary catheterization procedures, is constantly increasing because of lower rate of access site complications, shorter hospital stay, improved patient comfort and safer hemostasis. Radial artery occlusion remains a concern after transradial procedures, with a varied incidence, ranging from 5 to 38% as reported in the literature and probably reflecting different evaluation methods (pulse palpation versus ultrasound).

Although perceived as usually asymptomatic, RAO may be symptomatic in up to 58.8% of patients, presenting as pain in the forearm, numbness/ paresthesia, paresis or acute ischemia. Moreover RAO excludes the affected vessel from future catheterization procedures, hemodialysis shunts, invasive hemodynamic monitoring, coronary arterial bypass grafting.

Spontaneous recanalization of the vessel after RAO ranges from 5.4 to 47% at 1-month follow up. Today the only randomized studies reagrding RAO treatment have used either low-molecular-weight-heparin (LMWH) or apixaban.

This is a prospective, randomized study that will enroll, after informed written consent, all consecutive patients presenting with RAO, after a coronary catheterization procedure (both angiography and PCI) through the transradial access and having successfully received at least one radial artery sheath of any size at the end of the procedure.

RAO will be diagnosed by radial artery ultrasound (2D, Doppler, colour) performed in all patients after sheath removal and successful local hemostasis and before hospital discharge. Clinical evaluation of radial artery patency with pulse palpation, modified Allen's test and reverse Barbeau test will be also applied in all patients.

Patients diagnosed with RAO will be randomized 1:1 into two groups:

Treatment group, that will receive Rivaroxaban for 4 weeks. Control group, that will not receive any anticoagulation.

All patients with RAO will be re-evaluated by radial artery ultrasound at 1-, 2- 4- weeks to determine radial artery patency and record any bleeding complications according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) Hematoma Classification and the BARC (Bleeding Academic Research Consortium) bleeding definition.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Matthaios Didagelos, MD, MSc, PhD; Phone Number: +30 2310994830; Email: manthosdid@yahoo.gr
• Study Contact Backup: Name: Areti Pagiantza, MD; Phone Number: +30 2313303736; Email: apayantza@gmail.com

Study Locations

• Greece
  • Thessaloniki, Greece, 54636
    • Recruiting
    • Ahepa University Hospital
    • Contact: Areti Pagiantza, MD; Phone Number: +30 2313303736; Email: apayantza@gmail.com
    • Contact: Areti Pagiantza, MD
    • Contact: Matthaios Didagelos, MD, MSc, PhD
    • Contact: Antonios Ziakas, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients (both male and female) undergoing a coronary catheterization procedure (both angiography and PCI) through the transradial access and having successfully received at least one radial artery sheath of any size at the end of the procedure
2. Radial artery occlusion confirmed by ultrasound (2D, Doppler, colour)

Exclusion Criteria:

1. Age < 18 years
2. Unable to provide informed written consent
3. Any contraindication to receive Rivaroxaban

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: Intervention; Patients with RAO that will receive Rivaroxaban	Drug: Rivaroxaban; Patients with RAO that will receive p.o. tabs Rivaroxaban 20 mg q.d.
No Intervention: Control; Patients with RAO that will not receive any anticoagulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial artery patency	Radial artery patency at 4 weeks after the procedure, evaluated with radial artery ultrasound.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding events	To compare bleeding events (based on the BARC bleeding definition) at 4 weeks after the procedure.	4 weeks

Collaborators and Investigators

• Sponsor: AHEPA University Hospital
• Investigators: Study Chair: Antonios Ziakas, Professor, AHEPA University Hospital, Thessaloniki, Greece

Publications and helpful links

General Publications

• Didagelos M, Pagiantza A, Zegkos T, Zarra K, Angelopoulos V, Kouparanis A, Peteinidou E, Kassimis G, Karvounis H, Ziakas A. Low Molecular Weight Heparin in Improving RAO After Transradial Coronary Catheterization: The LOW-RAO Randomized Study. JACC Cardiovasc Interv. 2022 Aug 22;15(16):1686-1688. doi: 10.1016/j.jcin.2022.05.047. Epub 2022 Jul 27. No abstract available.
• Bernat I, Aminian A, Pancholy S, Mamas M, Gaudino M, Nolan J, Gilchrist IC, Saito S, Hahalis GN, Ziakas A, Louvard Y, Montalescot G, Sgueglia GA, van Leeuwen MAH, Babunashvili AM, Valgimigli M, Rao SV, Bertrand OF; RAO International Group. Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper. JACC Cardiovasc Interv. 2019 Nov 25;12(22):2235-2246. doi: 10.1016/j.jcin.2019.07.043.
• Amirpour A, Zavar R, Seifipour A, Sadeghi M, Shirvani E, Kermani-Alghoraishi M, Sanei H, Hashemi Jazi SM, Pourmoghaddas A, Khosravi Farsani A, Zarepour E, Safaei A, Hassannejad R. Apixaban, a Novel Oral Anticoagulant, Use to Resolute Arterial Patency in Radial Artery Occlusion Due to Cardiac Catheterization; A Pilot Randomized Clinical Trial. ARYA Atheroscler. 2023 Nov-Dec;19(6):18-26. doi: 10.48305/arya.2023.41915.2909.
• Tsigkas G, Papanikolaou A, Apostolos A, Kramvis A, Timpilis F, Latta A, Papafaklis MI, Aminian A, Davlouros P. Preventing and Managing Radial Artery Occlusion following Transradial Procedures: Strategies and Considerations. J Cardiovasc Dev Dis. 2023 Jun 30;10(7):283. doi: 10.3390/jcdd10070283.
• Didagelos M, Pagiantza A, Zegkos T, Papanastasiou C, Zarra K, Angelopoulos V, Kouparanis A, Peteinidou E, Sianos G, Karvounis H, Ziakas A. Low-molecular-weight heparin in radial artery occlusion treatment: the LOW-RAO randomized study. Future Cardiol. 2022 Feb;18(2):91-100. doi: 10.2217/fca-2021-0067. Epub 2021 Aug 16.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: February 2, 2025
• First Submitted That Met QC Criteria: February 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 9, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: treatment; complications; transradial; radial artery occlusion; coronary catheterization
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Anticoagulants; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Rivaroxaban
• Other Study ID Numbers: 107/2025

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
• product manufactured in and exported from the U.S.: No