Summary
Radial and brachial access for endovascular treatment of iliac artery stenosis may offer advantages over traditional femoral access, but data on their use in peripheral interventions remain limited. This study from the IRBIS registry evaluated 109 patients and demonstrated 100% technical success, with a low complication rate (3.6%) and a 12-month target lesion revascularization rate of only 3.7%. All access-site complications occurred with brachial access, while left radial access showed the most favorable profile. These findings support the broader adoption of radial and brachial access in clinical practice and highlight the need for randomized trials comparing them with femoral access in peripheral arterial disease interventions.
Introduction
Endovascular treatment of atherosclerotic lesions in peripheral vessels is a rapidly evolving field, driven by advances in scientific research and the continuous development of medical devices such as balloons, stents, catheters, and guidewires [1]. This ongoing evolution also includes significant changes in the approaches used for vascular access during endovascular procedures targeting peripheral vessels. The femoral artery has traditionally been the preferred access site for such interventions. However, a growing body of evidence has supported the safety and efficacy of using percutaneous radial or brachial access as alternatives in recent years. These approaches have been associated with potentially fewer complications and are becoming more widely adopted in clinical practice [2].
The first reported use of the radial artery for coronary angiography, by Lucien Campeau in 1989, marked the beginning of a shift in interventional cardiology [3]. Over the years, the radial approach has become increasingly routine, supported by randomized trials demonstrating its advantages over femoral access, including reduced bleeding complications and improved patient comfort. These positive outcomes in interventional cardiology have spurred interest in applying similar access techniques to vascular surgery, particularly in treating peripheral arterial disease (PAD) [4].
As experience with radial and brachial access has grown, so has the evidence base confirming their utility in peripheral interventions. The potential benefits of these approaches include providing easier post-procedural care, faster patient recovery, and greater overall procedural success. Given these advantages, the shift toward radial and brachial access in peripheral interventions represents a significant advancement in the field of vascular surgery [5].
Aim
The IRBIS registry aimed to investigate the safety and effectiveness of iliac artery stenosis treatment using percutaneous radial or brachial access. By analyzing data from a large patient cohort, the study aimed to provide evidence supporting the use of these access routes and to compare their outcomes with those achieved using traditional femoral access (literature data).
Material and methods
Study population
The IRBIS registry (Safety and Effectiveness of Iliac Artery Stenosis Treated using Percutaneous Radial or BrachIal AccesS) was a retrospective single-center analysis of patients who underwent endovascular treatment for iliac artery stenosis due to symptomatic lower limb ischemia between July 2020 and September 2022. Inclusion in the registry was limited to patients eligible for percutaneous iliac artery revascularization based on prior angioCT imaging or intraoperative angiography performed through radial or brachial access.
Data collection and study endpoints
Demographic information, comorbidities, and key procedural details (including access site, ultrasound use, balloon and stent parameters, contrast volume, and radiation) were examined and documented for all patients. Additionally, procedural outcomes and complications related to the access site were thoroughly reported. The severity of lower extremity claudication was assessed using the Rutherford classification.
The primary measure of this study’s efficacy was the procedure success rate, which was determined by completing the intended procedure without requiring conversion to femoral access. Secondary measures of safety encompassed a combined assessment of access-site complications, including pseudoaneurysms and hematomas, along with the occurrence of postoperative strokes.
We also performed a systematic literature search to obtain data on transfemoral access in peripheral interventions to compare radial/brachial access with femoral access.
Procedure
The choice of vascular access (radial or brachial) was determined by the operator’s preference, considering factors such as the patency of the radial artery. Radial or brachial artery puncture was preceded by a Doppler ultrasound assessment of forearm artery flow, and color Doppler imaging was sometimes used during puncture (Philips Lumify). Dedicated radial artery introducers were used, and 5000 IU of intra-arterial heparin was administered after introducer placement. Patients received dual antiplatelet therapy (75 mg aspirin and 300 mg loading dose of clopidogrel) starting the day before the procedure, continuing for at least 30 days post-procedurally.
After vascular access was established, a pigtail catheter was advanced into the abdominal aorta for angiography, followed by a final eligibility assessment for endovascular treatment. Patients requiring interventions below the inguinal ligament or hybrid treatments were excluded from the IRBIS registry. Only those undergoing percutaneous revascularization of the iliac arteries were retrospectively evaluated.
During the procedure, 6F 90 cm hydrophilic sheaths (Destination, Terumo; Flexor, COOK) and 0.35ʺ Aqwire hydrophilic guidewires (Aqwire, Medtronic) were used. Predilatation was primarily performed using LOVIX (Balton, Warsaw, Poland) and Mustang (Boston Scientific, GA, USA) balloons, and then cobalt-chromium balloon-expandable stents (Neptun C, Balton) were deployed. Quantitative Vascular Analysis (QVA, Siemens Artis Zee Floor) was used to assess the severity of stenosis. Post-procedural care included manual compression for approximately 15 min, followed by mechanical compression (elastic band) after sheath removal.
Follow-up
A 30-day follow-up was conducted to monitor in-hospital outcomes and assess the effectiveness and safety of the procedures. Additionally, at 12 months, we analyzed the stent performance.
Major access-related adverse events were defined as hematomas larger than 5 cm, arterial dissection, pseudoaneurysm, acute arterial thrombosis, or the need for arterial repair. Stroke was defined as neurological symptoms persisting for more than 24 h, confirmed by MR-DWI imaging.
Statistical analysis
Continuous data were presented as mean ± SD or median [range] and categorical variables as proportions, unless otherwise specified. Statistical analyses were performed using R, Version 3.4.1 (R Core Team, Vienna, Austria, 2017; https://www.r-project.org/).
Results
Study population
The study population consisted of 109 individuals aged between 38 and 88 years, with a predominance of men (67%). Most patients presented with intermittent claudication, primarily classified as Rutherford class 3 (85.3%), with smaller proportions in more advanced stages (class 4 – 3.7%, class 5 – 11%). Notably, there was a high prevalence of comorbid conditions, including arterial hypertension (86.2%), hyperlipidemia (68.8%), and coronary artery disease (45.9%), reflecting a population at significant cardiovascular risk.
Lesion characteristics revealed that 65.1% of patients had 60% to 90% stenosis, while nearly a quarter (23.9%) exhibited more severe stenosis between 90% and 99%. Chronic total occlusions were observed in 11% of the study group. Lesions were predominantly located in the external iliac artery (43.1%) and the common iliac artery (39.4%), with a subset of patients (17.4%) having lesions in both locations. The demographic characteristics and comorbidities of the study population are summarized in Table I.
Table I
Baseline demographics and procedural data
Procedural data
Among the 109 patients, 24 (22%) underwent the procedure via radial access, and 85 (78%) via brachial access. Additionally, left-side access was chosen in 84 (77%) cases, while right-side access was used in 25 (23%) cases. Notably, there were no conversions to femoral access during the procedures.
All procedures used a 6 French (F) sheath size, reflecting a standardized approach to vascular access during the interventions. Predilation of the lesion was performed in 28 (26%) patients using the following balloon catheters: Lovix (Balton) in 18 cases, Mustang (Boston) in 6 cases, Pacific (Medtronic) in 2 cases, and Solarice (Medtronic) in 2 cases. There were no balloon catheter-related complications.
The number of stents used per procedure ranged from 1 to 4, with a median of 1 stent. The stents deployed had diameters ranging from 7 to 9 mm and lengths varying between 20 and 80 mm. The average amount of contrast used during the interventions was 184.1 ±60.1 ml. The mean radiation dose administered was 236.7 ±76.5 mGy (Table I).
Safety profile
Overall, adverse and access site-related events were observed in 7.3% and 3.6% of cases, respectively. A summary is provided in Table I.
During the in-hospital period and the 30-day follow-up, no deaths, amputations, or reinterventions were recorded. Two patients experienced angina requiring transfer to the cardiology department, where they underwent invasive diagnostics and coronary angioplasty. One patient suffered a minor ischemic stroke (confirmed by MRI-DWI), with symptoms resolving after 4 days of conservative treatment. In 1 case, during the recanalization of the common iliac artery occlusion, thrombus migration to the distal limb occurred, resulting in superficial femoral artery embolism, which was successfully treated with emergency embolectomy.
All access-site-related complications were associated with brachial access. Arterial thrombosis at the brachial puncture site was observed in 2 patients, necessitating emergency surgical treatment – brachial artery thrombectomy. Two additional patients developed hematomas at the brachial puncture site, with one requiring surgical intervention.
At 12 months, the target lesion revascularization rate was 3.7% (n = 4). No stent thrombosis was recorded.
Discussion
In the presented registry, the use of radial or brachial access was associated with acceptable complication rates. Major access site-related complications requiring surgical intervention occurred in 3.6% of cases, and these complications were manageable with local anesthesia, involving relatively minor procedures such as thrombectomy and artery suturing. Moreover, the choice of access site did not affect the number of successful procedures, which was 100%.
The findings of this study align with the growing body of evidence indicating the potential of brachial or radial access use in peripheral vascular interventions. Brachial and radial access routes offer several distinct advantages, including reduced risk of access site complications, shorter recovery times, increased patient comfort, and decreased costs. These benefits are particularly relevant in patients with significant comorbidities, such as those observed in our study population, where the prevalence of conditions such as arterial hypertension, coronary artery disease, and diabetes increases the likelihood of complications from femoral access. One of the key advantages of brachial or radial access is the lower incidence of bleeding complications. Femoral punctures can result in significant bleeding, hematoma formation, and even retroperitoneal hemorrhage, which can be life-threatening. In contrast, brachial and radial access sites are more superficial and compressible, making post-procedure hemostasis easier to achieve and reducing the risk of major bleeding events. This is particularly beneficial in patients receiving antiplatelet or anticoagulant therapy, who are at higher risk for bleeding complications [6, 7]. In our study, there were no bleeding complications that required blood transfusion.
This study builds upon previous findings, indicating that percutaneous radial artery access is a safe and effective alternative to common femoral artery (CFA) access for PAD treatment. A recent prospective analysis involving 120 patients undergoing radial access for peripheral vascular intervention (PVI) achieved successful access in 99% of cases. Notably, our study’s success rate was 100% [8]. Lorenzoni et al. evaluated 110 patients undergoing above-the-knee interventions, primarily using left radial access, with an overall success rate of 91%, which aligns with our findings [9]. A meta-analysis of four comparative studies, encompassing 114 radial and 208 CFA accesses for PVI, revealed no significant differences in technical success, though radial access was associated with fewer complications [10]. This was also confirmed in another recent meta-analysis [11]. Sayfo et al. reported a successful access rate of 98.1% of cases. Femoral access was required in only 3 (1.9%) cases due to arterial spasm, arm pain, and non-crossable lesions. Additionally, 2 (1.3%) cases required simultaneous pedal access to treat below-the-knee lesions [12].
Furthermore, brachial and radial access has been associated with fewer vascular complications, such as pseudoaneurysms and arteriovenous fistulas. The brachial and radial arteries’ smaller diameter than the femoral artery necessitates using smaller sheath sizes, further reducing the risk of arterial injury and associated complications. Literature reports indicate that the incidence of complications at the femoral access site is in the range of 5–23% for hematomas, 0.5–9% for pseudoaneurysms, and 0.8–20% for access artery occlusions. Furthermore, the RIVAL trial demonstrated a higher incidence of major complications associated with femoral access compared to radial access, including large hematomas, deaths, myocardial infarctions, strokes, and pseudoaneurysms [13].
In a registry study, Levin et al. analyzed 520 patients who underwent radial access for PVI, identifying access-site hematomas in 4.8% of cases, with 0.8% requiring surgical management [14]. In a retrospective comparison, Staniloae et al. examined 27 radial and 41 CFA access cases for aortoiliac interventions, observing no need for transfusions in either group. However, 7.3% of CFA patients experienced bleeding at the access site [15]. Cortese et al. similarly reported no major in-hospital bleeding and a minor vascular bleeding rate of 0.7% following radial access for PVI [16]. Conversely, Kimmelstiel et al. studied 23,934 patients undergoing PVI via CFA access and found an 8.7% rate of periprocedural bleeding or transfusion events [17]. Given the known association between procedural transfusions and increased mortality, these findings highlight the importance of minimizing bleeding risks when choosing between radial and CFA access, particularly in patients with diseased or calcified vessels [18]. Additionally, radial or brachial access hematomas are easier to detect and control due to the superficial position of the artery. In Table II, we summarized femoral access complications in papers that we identified during a systematic literature search, confirming the observations that the success rate from transradial/transbrachial access is not significantly lower than from femoral access, and the femoral access is associated with higher rates of complications.
Table II
Femoral access site technical success and complications – systematic literature search results
| Study | No. of participants | Procedure success and complications |
|---|---|---|
| Staniloae et al. 2010 [25] | TRA – 27 TFA – 41 | Success TRA vs. TFA: 87.9% vs. 97.8% Major access site complications: 0 vs. 0 Minor access site complications: 0 vs. 7.3% |
| Cortese et al. 2018 [26] | TRA – 433 TFA/TBA – 473 | Success TRA vs. TFA/TBA: 90% vs. 92% Contrast volume: 253.1 ±131.6 vs. 226.6 ±108.6 ml BARC bleeding ≥ 3: 6.7% vs. 19.7% In-hospital transfusion: 0.2% vs. 5.1% In-hospital death: 3.5% vs. 4.0% |
| Roy et al. 2016 [21] | TRA – 65 TFA - 123 | Success TRA vs. TFA: 83.1% vs. 92.7% Contrast volume: 132.1 ±98.2 vs. 99.9 ±59.5 ml Stroke: 0 vs. 0 Major vascular bleeding: 0 vs. 0.7% Access site occlusion: 3.7% vs. 0 Pseudoaneurysm: 0 vs. 4.5% AV fistula: 0 vs. 0.7% Hematoma > 5 cm: 0 vs. 0.7% |
| Ruzsa et al. 2022 [27] | 180 | Success TRA vs. TFA: 96.7% vs. 100% Major access site complications: 0 vs. 3.3% Minor access site complications: 3.3% vs. 13.3% |
| Maximus et al. 2023 [28] | 270 TRA 1210 TBA 59,723 TFA | TRA vs. TBA vs. TFA Contrast volume: 99 ±67 vs. 83 ±56 vs. 88 ±59 ml Minor access site complications: Hematoma: 1.5% vs. 5.3% vs. 1.5% Pseudoaneurysm: 0.4% vs. 0.6% vs. 0.08% AV fistula: 0 vs. 0 vs. 0.01% Significant access site complications: Hematoma: 0.4% vs. 1.3% vs. 0.2% Pseudoaneurysm: 0% vs. 0.2% vs. 0.2% AV fistula: 0 vs. 0 vs. 0.01% |
Additionally, using left radial or brachial access, in particular, reduced the risk of procedure-related stroke, as it avoids manipulation near the aortic arch, a common source of embolic material during catheterization. In this study, a minor stroke was observed in 1 (0.9%) patient, with symptoms resolved after 4 days of pharmacological treatment. The literature data estimate the incidence of cerebrovascular events related to radial access at 0.1–0.5%, although some authors report rates as high as 4% [19]. To minimize the risk of cerebral and peripheral embolization associated with guidewire passage and catheter manipulation in the aortic arch, particular care is required during these stages of the procedure, and the use of left radial or brachial access, hydrophilic guidewires, and catheters is recommended [18]. One case of a minor stroke in the presented registry occurred in a patient treated via the right brachial access. It should also be noted that using systems larger than 6F may increase the risk of cerebral incidents, and monitoring and maintaining the activated clotting time (ACT) around 250 s during the procedure is suggested for prevention [20]. Operators should also consider avoiding radial access in patients at high risk for stroke, particularly those with significant aortic arch atheroma. Importantly, the risk of cerebral embolism during brachial or radial access is significantly influenced by the presence of aortic arch atheroma (‘shaggy aorta’). Therefore, preprocedural angioCT to assess for aortic plaques might be recommended prior to choosing upper-limb access, especially in elderly or high-risk patients. This step may help mitigate the risk of stroke by enabling more appropriate access planning.
One limitation of radial access is the technical properties of the equipment used, particularly the diameter and length of the systems, with length being particularly significant for taller patients. Additionally, the nature of chronic total occlusions (CTO) can complicate the procedure due to limited support for the guidewire, which is related to the distance of the treated site from the vascular access point. Using long reinforced vascular sheaths (120–130 cm) enhances the technical feasibility of the procedure, while using smaller-diameter stents and balloons may reduce the number of complications [9]. Also, as shown in the literature, radial access was associated with slightly higher contrast volumes than the femoral access (Table II).
Moreover, an advantage of radial or brachial access is the ability to treat bilateral iliac artery lesions without additional punctures. In the evaluated group, bilateral treatment of iliac artery lesions was performed in 8 patients (7.2%). Roy et al. also noted that this access method reduces the dissection risk in the aorto-iliac segment compared to femoral access and crossover procedures, especially with unfavorable aortic bifurcation angles [21]. An additional technical advantage of upper-limb access might be the enhanced pushability of wires and devices, which becomes particularly important in more complex procedures such as fully percutaneous covered endovascular reconstruction of aortic bifurcation (CERAB). The upper approach provides a more favorable alignment for navigating challenging anatomy, especially in cases with steep aortic bifurcations or heavily calcified lesions. Although our study focused on standard iliac PTA, this benefit highlights the potential for wider applicability of upper-limb access in advanced endovascular reconstructions.
Finally, brachial and radial access can facilitate quicker patient turnover and potentially lower hospital costs by reducing the need for prolonged monitoring and extended hospital stays associated with femoral access complications [8]. These factors, combined with the safety profile of brachial and radial access, make them an interesting option in managing iliac artery disease [22, 23]. However, large-scale randomized trials are still needed to confirm its impact on mortality and other outcomes [24].
This study has several limitations that should be acknowledged. First, the sample size of 109 patients, while informative, may limit the generalizability of the findings to broader populations. Additionally, the study’s retrospective nature could introduce selection bias (no randomization) and limit the ability to establish causality between the access site and clinical outcomes. A further limitation is the heterogeneity of access sites – radial and brachial – which were combined in the analysis. While both are upper-extremity accesses, they differ in anatomical properties, complication profiles, and technical feasibility. This introduces potential bias and limits the interpretability of our findings when comparing them to studies evaluating each access separately. Future studies should aim to analyze these approaches separately, preferably in randomized or propensity-matched designs, to generate more definitive evidence [25–28].
Conclusions
Endovascular procedures are continuously evolving, aiming to improve their effectiveness, reduce procedural risk, and enhance patient post-operative comfort. One promising development in this regard is the more frequent use of radial or brachial access, whose safety and technical feasibility are well documented in the literature. The presented data further support these findings. According to the authors, the left radial artery is the preferred access site, as it is associated with a lower complication rate than brachial access. Designing randomized trials comparing radial and femoral access may provide insights that could lead to a broader shift in endovascular treatment strategies.
