Radial vs. Femoral Access for Cardiac Catheterization Complications

(REBIRTH Trial)

Recruiting at 5 trial locations

Overseen By Olga Mastrodemos

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Minneapolis Heart Institute Foundation

Must not be taking: Vitamin K antagonists

Disqualifiers: STEMI, Valvular disease, Hemodialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

Duration: During procedure

3266 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods for cardiac catheterization, a procedure to assess heart health. It compares the radial approach, which uses the wrist, with the femoral approach, which uses the groin. The femoral approach further divides into using either an 18-gauge needle or a 21-gauge needle. The trial aims to determine which method results in fewer complications for individuals without a specific type of heart attack. Participants should experience heart-related symptoms and require a heart procedure but must not have had a recent severe heart attack. As an unphased trial, this study allows participants to contribute to important research that could enhance cardiac care techniques.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking oral factor Xa or IIa inhibitors, you should not have taken them within 24 hours before the procedure.

What is the safety track record for these treatments?

Research shows that using the wrist (radial access) for heart procedures is generally safe. The most common issue is a 5% chance of artery blockage in the wrist, which is usually not serious. Serious problems, such as a tear in the artery or a painful condition from pressure buildup, are rare. The wrist method also results in less bleeding compared to the groin (femoral access).

For the groin method, even with the latest techniques, sources do not highlight specific safety concerns. However, advanced tools like ultrasound and special devices can enhance safety.

Overall, both wrist and groin methods have been successfully used in many patients. Each has its own risks, but they are generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two different techniques for cardiac catheterization—radial access and femoral access. Radial access stands out due to its use of ultrasound guidance and a micropuncture needle or a catheter-over-needle system, which can potentially lead to fewer complications and quicker recovery times compared to traditional femoral access. On the other hand, the femoral access technique is being evaluated with state-of-the-art enhancements like ultrasound and fluoroscopic guidance, immediate angiography after arterial access, and the use of a vascular closure device, all of which aim to improve safety and outcomes. By comparing these advanced techniques, the study seeks to determine which approach minimizes complications and enhances patient recovery.

What evidence suggests that this trial's access methods could be effective for cardiac catheterization?

Research has shown that using the wrist (radial access) for cardiac catheterization is highly effective, achieving a success rate of over 90% for diagnostic procedures. In this trial, participants will undergo either radial access or femoral access for their procedure. Studies have found that radial access significantly reduces bleeding compared to groin (femoral) access. Regarding safety, the risk of death within 30 days is similar for both methods. Both approaches are effective and offer distinct benefits, but wrist access might slightly lower the risk of certain complications. ^{3 4 6 7 8}

Who Is on the Research Team?

Emmanouil Brilakis, MD, PhD

Principal Investigator

Minneapolis Heart Institute Foundation

Are You a Good Fit for This Trial?

Adults over 18 eligible for cardiac catheterization via both radial and femoral access, who consent to participate. Suitable for those needing diagnostic angiography or urgent/elective PCI, but not for patients with recent oral anticoagulant use, peripheral arterial disease affecting access sites, limited life expectancy, certain heart conditions or procedures within the next month.

Inclusion Criteria

Has provided informed consent and agrees to participate

I am scheduled for a heart artery exam due to chest pain, possibly with treatment.

I can have a heart catheterization through my wrist or groin.

Exclusion Criteria

I took blood thinners less than 24 hours before the procedure.

I have a dialysis access point in my arm that can be used for a heart procedure.

Coexisting conditions that limit life expectancy to less than 30 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiac catheterization using either radial or state-of-the-art femoral access

During procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including evaluations of myocardial infarction and procedural success

4 weeks

Evaluations up to 30 days

What Are the Treatments Tested in This Trial?

Interventions

• Radial Access
• State-of-the-art femoral access with 18 gauge needle
• State-of-the-art femoral access with 21 gauge needle

Trial Overview

This phase IV trial compares two methods of accessing the heart during catheterization: through the wrist (radial access) and upper thigh (femoral access). Participants are randomly assigned to one method; those in the femoral group are further randomized to receive either a smaller (21 gauge) or larger (18 gauge) needle.

How Is the Trial Designed?

Group I: State-of-the-art femoral access Active Control 2 Interventions

Femoral access for cardiac catheterization. Femoral access will be obtained using state-of-the-art techniques (ultrasound and fluoroscopic guidance for arterial puncture, immediate femoral angiography after obtaining access and use of a vascular closure device whenever possible).

Group II: Radial access Active Control 1 Intervention

Radial access for cardiac catheterization. Radial access will be performed using ultrasound guidance and a micropuncture needle or catheter-over-needle system, as per the local standard of care.

Who Is Running the Clinical Trial?

Minneapolis Heart Institute Foundation

Lead Sponsor

Trials

32

Recruited

15,700+

Published Research Related to This Trial

In a study of 56 patients on uninterrupted warfarin therapy, radial access for cardiac catheterization was found to be as effective as femoral access, with procedural success achieved in all femoral patients and only one crossover in the radial group.

Radial access significantly reduced access-site complications during percutaneous coronary intervention (PCI), with 37.5% of femoral patients experiencing complications compared to none in the radial group, highlighting its safety advantage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radial versus femoral access for orally anticoagulated patients. Ziakas, AG., Koskinas, KC., Gavrilidis, S., et al.[2014]

In a study of 499 patients undergoing transradial coronary procedures, the rate of radial artery occlusion at 90 days was low at 5%, with no significant difference between the new RY Stop device and the standard TR Band.

While both devices showed similar levels of discomfort and low rates of vascular complications, the RY Stop device was associated with a higher incidence of bleeding (12% vs. 3% for TR Band), indicating a potential safety concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is radial artery occlusion and local vascular complications following transradial coronary procedures affected by the type of haemostasis device used? A non-inferiority Randomized Controlled Trial (RadCom trial). Due-Tønnessen, N., Egeland, CH., Meyerdierks, OJ., et al.[2022]

In a study of 58,862 PCI procedures, radial access resulted in significantly fewer major bleeding events (0.9%) compared to femoral access (2.2%), indicating a potential safety advantage for radial access.

However, radial access was associated with higher radiation exposure and longer fluoroscopy times, suggesting that while it may reduce bleeding risks, femoral access with bivalirudin could be the safest option overall for PCI procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of safety outcomes for radial versus femoral access for percutaneous coronary intervention from a large clinical registry. Dobies, DR., Barber, KR., Cohoon, AL.[2021]

In a study of 8,159 cardiac catheterizations, 3,369 (41.3%) were performed using the radial artery approach, which resulted in a low incidence of severe vascular complications (0.06%).

All 21 cases of severe complications, including hematomas and perforations, were managed conservatively without the need for blood transfusions, highlighting the effectiveness of non-invasive treatment strategies for these complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vascular complications associated with radial artery access for cardiac catheterization]. Sanmartín, M., Cuevas, D., Goicolea, J., et al.[2012]

Using ultrasound guidance during femoral artery catheterization significantly reduces the risk of vascular-access related complications, with a complication rate of 1.9% compared to 4.3% without ultrasound, based on a systematic review of 5 randomized-controlled trials involving 1553 patients.

The reduction in complications is mainly due to fewer local hematomas; however, when excluding hematomas, the significance of the results diminishes, indicating that further research is needed to fully understand the impact of ultrasound on major bleeding and other vascular complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound Guidance in Femoral Artery Catheterization: A Systematic Review and a Meta-Analysis of Randomized Controlled Trials. Rashid, MK., Sahami, N., Singh, K., et al.[2020]

Radial artery access for coronary catheterization is generally safer than femoral access, but there is a risk of complications such as pseudoaneurysms, as demonstrated in two reported cases.

Both patients who developed pseudoaneurysms after radial artery access underwent successful surgical exploration, highlighting the importance of monitoring for this rare but serious complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radial artery pseudoaneurysm following coronary angiography in two octogenarians. Hamid, T., Harper, L., McDonald, J.[2021]

Using radial access for catheterization leads to lower rates of bleeding and mortality compared to the traditional femoral approach, making it a safer option for patients.

Although radial access may have a higher rate of access site failure, this technique is still preferred as it reduces serious complications associated with femoral access, suggesting that improvements in radial techniques will enhance patient outcomes further.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sirens song or a bugle call to charge. Gilchrist, IC.[2019]

The percutaneous transradial approach for coronary angiography and intervention is becoming more popular in the U.S. due to its better vascular safety compared to the traditional femoral approach.

Despite its advantages, there are still potential complications, such as pseudoaneurysm and radial artery occlusion, that can occur after transradial cardiac catheterization, highlighting the need for awareness and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular Complications of Percutaneous Transradial Cardiac Catheterization. Patwardhan, M., Mehra, S., Movahed, A., et al.[2022]

In a study of 8404 patients with acute coronary syndrome, using radial access for coronary procedures resulted in fewer net adverse clinical events compared to femoral access, particularly reducing major bleeding and all-cause mortality.

Radial access was associated with a lower rate of major adverse cardiovascular events (8.8% vs. 10.3% for femoral access), although this difference was not statistically significant at the stricter alpha level of 0.025.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. Valgimigli, M., Gagnor, A., Calabró, P., et al.[2023]

Citations

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pmc.ncbi.nlm.nih.gov

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Effectiveness and safety of transradial artery access for ...

The success rate for diagnostic angiography through the radial artery is well over 90%, and it is rare to need to switch to a femoral approach. To date, there ...

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Procedural Outcomes With Femoral, Radial, Distal ...

Radial access significantly reduced bleeding complications when compared with femoral access and thus supports the guideline recommendation of a ...

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karger.com

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Efficacy and Safety of Distal Radial Artery Access versus ...

Eight studies reported a success rate of the procedure having 4,352 patients (2,170 DRA vs. 2,182 PRA). The analysis showed comparable results (RR 0.98, 95% CI: ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0167527321015084

Outcomes of distal versus conventional transradial access ...

The access success rate was 94.3%, which is comparable with the proximal radial approach. •. The distal approach significantly reduced the rate ...

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jamanetwork.com

jamanetwork.com/journals/jamacardiology/fullarticle/2758278

Safety and Efficacy of Femoral Access vs Radial Access in ...

The primary outcome, 30-day all-cause mortality, occurred in 17 patients (1.5%) assigned to radial access and in 15 patients (1.3%) assigned to ...

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ncbi.nlm.nih.gov

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Cardiac Catheterization Risks and Complications - NCBI - NIH

The most frequent complication after transradial access is about a 5% risk of radial artery occlusion. This is a clinically insignificant complication if the ...

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ahajournals.org

ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.119.007386

Transradial Artery Access Complications | Circulation

Major intra- and postprocedural complications such as radial artery perforation and compartment syndrome are rare following TRA. Their ...

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citoday.com

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Managing Complications of Transradial Catheterization

These complications include arterial injury, spasm, occlusion, perforation, hematoma, and pseudoaneurysm.