Ibrahim R, Laffaye TA, Almakadma AH
… +15 more, Hamze M, Pham HN, Mahmoud AK, Awad K, Abdelnabi M, Dreher L, Farina JM, Tamarappoo B, Sorajja D, Lester SJ, Yang E, Lee K, Ayoub C, Mamas MA, Arsanjani R
Cardiovasc Revasc Med
· 2026 May · PMID 42086453
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BACKGROUND: Scarce evidence exists comparing clinical outcomes of novel lipid-lowering monotherapy with standard statin therapy for primary prevention. We compared clinical outcomes among primary prevention patients trea...BACKGROUND: Scarce evidence exists comparing clinical outcomes of novel lipid-lowering monotherapy with standard statin therapy for primary prevention. We compared clinical outcomes among primary prevention patients treated with novel lipid-lowering monotherapy versus statin monotherapy. METHODS: We performed a retrospective matched cohort study using the TriNetX network comprising 107 predominantly U.S. healthcare organizations. Adults with LDL-C > 100 mg/dL, between 2015 and 2024, and no prior ischemic heart disease, heart failure, cerebral infarction, or peripheral vascular disease were included. Exposure was treatment with evolocumab, alirocumab, or inclisiran without concomitant statins within 1 year of the qualifying LDL-C, compared with initiation of statin monotherapy. Propensity score matching was performed 1:1 across 28 covariates. Follow-up began 7 days after treatment initiation and extended to 2 years. Primary outcomes were all-cause mortality and acute myocardial infarction (AMI). Secondary outcomes included hospitalization, acute heart failure, ventricular tachycardia, atrial fibrillation, cerebral infarction, and MACE. RESULTS: After matching, 5844 patients remained in each cohort. Median follow-up was 675 days. All-cause mortality (0.8% vs 1.1%; HR 0.79, 95% CI 0.54-1.15) and AMI (0.3% vs 0.3%; HR 1.31, 95% CI 0.65-2.62) were similar between novel therapy and statin cohorts. Hospitalizations, stroke, atrial fibrillation, ventricular tachycardia, and MACE did not differ significantly. Novel therapies were associated with lower acute heart failure events (0.7% vs 1.2%; HR 0.63, 95% CI 0.42-0.93). CONCLUSIONS: Among patients without prior ASCVD, novel lipid-lowering monotherapy achieved comparable short-term outcomes to statin monotherapy, with fewer acute heart failure events, complementing the VESALIUS trial.
BACKGROUND: In patients with coronary bifurcation lesions (CBLs), main vessel (MV) stenting with provisional side-branch (SB) stenting is a standard technique. T and small protrusion (TAP) stenting is commonly used for b...BACKGROUND: In patients with coronary bifurcation lesions (CBLs), main vessel (MV) stenting with provisional side-branch (SB) stenting is a standard technique. T and small protrusion (TAP) stenting is commonly used for bailout side-branch stenting, but it is a suboptimal technique. The modified TAP (mTAP) stenting technique might overcome the limitations of TAP stenting. OBJECTIVES: We investigated the stenting and procedural outcomes of the mTAP versus TAP techniques by intravascular ultrasound (IVUS) guidance in patients with CBLs. METHODS: A total of 101 patients with non-left main CBLs underwent MV stenting. Of these, 36 patients developed SB dissection, SB ostium stenosis >70%, or reduced flow and underwent SB stenting using mTAP (20 patients) or TAP (16 patients) stenting guided by IVUS. RESULTS: Minimum stent area at the bifurcation segment and at the SB ostium was larger after mTAP versus TAP stenting (6.39 ± 0.30 vs. 5.15 ± 0.20 mm; 3.9 ± 0.46 vs. 3.36 ± 0.30 mm, respectively; P < 0.01). The neocarina length was shorter and the SB ostium stent coverage was higher after mTAP versus TAP stenting (1.5 ± 0.39 vs. 3.6 ± 0.31 mm; 100% vs. 81%, respectively; P < 0.05). The procedure time was shorter, and contrast volume and air Kerma rate were lower in the mTAP versus TAP stenting (77 ± 14 vs. 92 ± 24 minutes; 110 ± 25 vs. 143 ± 40 mL; and 0.88 ± 0.20 vs. 1.2 ± 0.47 Gray, respectively; P < 0.05). CONCLUSIONS: We have provided the first evidence that IVUS-guided mTAP stenting achieves a significantly greater stent area and a shorter neocarina than TAP stenting, while also providing better SB ostium coverage and reduction in procedure time, contrast media usage, and radiation exposure.
BACKGROUND: Mechanical thrombectomy (MT) and catheter-directed thrombolysis (CDT) are treatments for pulmonary embolism (PE), but their recent utilization and relative outcomes are unclear. We evaluated the most recent u...BACKGROUND: Mechanical thrombectomy (MT) and catheter-directed thrombolysis (CDT) are treatments for pulmonary embolism (PE), but their recent utilization and relative outcomes are unclear. We evaluated the most recent utilization trends and compared the in-hospital outcomes of MT and CDT. METHODS: We queried the National Inpatient Sample database to identify adults with a primary diagnosis of PE undergoing either MT or CDT between 2016 and 2022. We excluded those <18 years or undergoing both MT and CDT, surgical thrombectomy, or systemic thrombolysis. Poisson regression models were used to evaluate temporal trends, and multivariate logistic regression models were used to test the association between in-hospital outcomes of MT and CDT. RESULTS: Among 71,175 patients with PE, 32,465 (45.6%) underwent MT, and 38,710 (54.4%) underwent CDT. Utilization of MT increased significantly with an annual percent change (APC) of 68.1% (95% CI, 65.9%-70.5%; p < 0.0001). By contrast, CDT showed a steady decline, with an APC of -0.9% (95% CI, -1.7% to -0.2%; p < 0.0001). MT had higher in-hospital mortality than CDT (5% vs 3% adjusted odds ratio [aOR] 2.12, 95% CI 1.93-2.33; p < 0.0001). MT was also associated with increased risk of mechanical ventilation, ECMO, Impella use, bleeding complications, palliative consult, and DNR status, p for all <0.0001. CONCLUSIONS: This study shows a significant shift in the catheter-directed therapies for PE in the U.S. The use of MT increased between 2016 and 2022 and shows improved clinical outcomes over the years.
BACKGROUND: Hemostatic compression devices (HCDs) are routinely used following transradial catheterization to reduce bleeding risk. However, prolonged compression times can increase the likelihood of radial artery occlus...BACKGROUND: Hemostatic compression devices (HCDs) are routinely used following transradial catheterization to reduce bleeding risk. However, prolonged compression times can increase the likelihood of radial artery occlusion (RAO) and delay patient throughput in the cardiac catheterization laboratory (CCL). METHODS: At a single tertiary care center, we implemented an expedited HCD weaning protocol that halved the time to initial deflation for diagnostic procedures (from 120 to 60 min) and percutaneous coronary intervention (PCI) (from 240 to 120 min). This was a prospective, sequential pre-post implementation study in which patients were enrolled consecutively during each study phase. The protocol utilized expedited serial partial deflations to achieve faster hemostasis while maintaining safety. We recorded timestamps, HCD deflation details, and complications, defined as bleeding, severe hematomas, need for blood transfusion, surgical consultation, or unplanned admission. Rates of complications and times to HCD removal and CCL discharge were compared before and after protocol implementation. RESULTS: A total of 397 patients were included (original protocol n = 200; expedited protocol n = 197). In the entire cohort, mean time to HCD removal decreased from 192 ± 60 to 150 ± 48 min (p < 0.001), and mean time to CCL discharge decreased from 198 ± 54 to 162 ± 60 min (p < 0.001) with the expedited protocol. Rates of serious complications (0.5% vs. 0.0%; p = 0.320) and overall bleeding or hematoma (16.5% vs. 18.3%; p = 0.692) were similar between groups. In the PCI subgroup (n = 58), time to HCD removal (270 ± 30 vs. 210 ± 42 min; p < 0.001) and time to discharge (288 ± 30 vs. 234 ± 60 min; p < 0.001) were also significantly shortened with no serious complications reported. While bleeding events in PCI patients trended higher in the expedited group (8.3% vs. 23.5%; p = 0.171), the difference was not statistically significant. CONCLUSION: An expedited HCD weaning protocol safely reduced CCL length of stay in transradial catheterization without increasing bleeding or serious complications. This approach may improve procedural efficiency and patient throughput.
Elbenawi H, Abdelgalil MS, Zaaya M
… +11 more, Doma M, Cangut B, Almaadawy O, Abdelkarim I, Ibrahim R, Sadek YA, Al-Azizi KM, Goldsweig AM, Elbadawi A, Stone GW, Elgendy IY
BACKGROUND: Surgical ventricular reconstruction (SVR) is not always feasible in patients with ischaemic cardiomyopathy and left ventricular (LV) aneurysm, due to high surgical risk. The Revivent-TC Transcatheter Ventricu...BACKGROUND: Surgical ventricular reconstruction (SVR) is not always feasible in patients with ischaemic cardiomyopathy and left ventricular (LV) aneurysm, due to high surgical risk. The Revivent-TC Transcatheter Ventricular Enhancement System is a less invasive alternative option. METHODS: We conducted a systematic literature search using PubMed, Ovid Medline and Google Scholar between January 2013 up to May 2025 to assess the effectiveness and safety of Revivent-TC System. Inclusion criteria included symptomatic patients with ischaemic left ventricular (LV) systolic impairment and anterior or anteroseptal scar, with appropriate anatomy confirmed by cardiac magnetic resonance (CMR), who were treated with the device. Outcomes included echocardiographic parameters, procedural data, adverse events and survival. RESULTS: Eight studies (276 patients) were included: seven observational and the prospective non-randomised dual-arm ALIVE trial. Mean age was 61.8 years; 73% were male with LV ejection fraction (EF) ranging from 22.8% to 35.6%. Procedural success ranged from 96 to 100%, with procedure-related mortality of 2.5%. Conversion to full median sternotomy was required in 1.4% due to complications such as right ventricular (RV) perforation, acute mitral regurgitation and right ventricular (RV) failure. Surgical re-intervention was required in 4.3% of patients. Overall mortality during follow-up was 6.5%. Statistically significant improvement in LVEF and LV volumes was observed across observational studies, persisting up to 5 years post-operatively. Improvements in exercise tolerance, NYHA functional class and quality of life were also observed. However, the ALIVE trial did not demonstrate a significant clinical benefit over guideline-directed medical therapy (win ratio 1.13; p = 0.32), with cardiovascular mortality and HF hospitalisation numerically favouring the control group. CONCLUSIONS: The Revivent-TC system is associated with LV volume reduction and functional improvements in selected patients, offering a less invasive alternative to surgical ventricular reconstruction. However, the evidence base consists predominantly of small observational studies, and the only controlled trial did not demonstrate significant benefit on hard clinical endpoints. Longer-term randomised data, including a guideline-directed medical therapy comparator arm, are needed before definitive conclusions about efficacy can be drawn.
Cardiovasc Revasc Med
· 2026 Mar · PMID 42000295
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BACKGROUND: Obesity is increasingly recognized as a critical modifier of outcomes following transcatheter aortic valve replacement (TAVR), predisposing patients to subclinical leaflet thrombosis (SLT), hypo-attenuated le...BACKGROUND: Obesity is increasingly recognized as a critical modifier of outcomes following transcatheter aortic valve replacement (TAVR), predisposing patients to subclinical leaflet thrombosis (SLT), hypo-attenuated leaflet thickening (HALT), and paravalvular leak (PVL). Metabolic inflammation, endothelial dysfunction, and pro-thrombotic states associated with obesity contribute to impaired bioprosthetic valve healing. Tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, has demonstrated robust metabolic, anti-inflammatory, and vascular protective effects. However, its impact on post-TAVR valve performance has not been previously evaluated. OBJECTIVES: To determine whether tirzepatide therapy initiated before TAVR and continued post-procedure reduces the incidence of HALT and PVL in obese patients undergoing TAVR. METHODS: TAVR-MET was a prospective, randomized, open-label, multicenter trial enrolling obese patients (BMI ≥ 30 kg/m) undergoing transfemoral TAVR. Patients were randomized to tirzepatide therapy or standard care. The primary endpoint was HALT incidence at 6 months assessed by 4D-CT or transesophageal echocardiography (TEE). Secondary endpoints included PVL severity, major adverse valve events (MAVE), inflammatory biomarker changes, weight reduction, and bleeding outcomes. RESULTS: Among 260 randomized patients, tirzepatide therapy significantly reduced HALT incidence (8.4% vs 21.6%, p = 0.002) and ≥ mild PVL (10.7% vs 25.3%, p = 0.006) at 6 months. Tirzepatide was associated with marked reductions in CRP and body weight without an increase in major bleeding. Multivariable analysis identified tirzepatide use, CRP reduction >30%, and BMI <32 kg/m at follow-up as independent predictors of HALT absence. CONCLUSIONS: Metabolic modulation with tirzepatide significantly improves post-TAVR valve healing and hemodynamics in obese patients. These findings introduce a novel cardio-metabolic strategy to reduce structural valve complications following TAVR. TRIAL SUMMARY: TAVR-MET STUDY: The TAVR-MET trial was a prospective, randomized, multicenter study designed to evaluate whether metabolic modulation with tirzepatide, a dual GIP/GLP-1 receptor agonist, could improve bioprosthetic valve outcomes following transcatheter aortic valve replacement (TAVR) in obese patients. Obesity is increasingly recognized as a key determinant of post-TAVR complications, particularly subclinical leaflet thrombosis (HALT) and paravalvular leak (PVL), driven by chronic inflammation, endothelial dysfunction, and a prothrombotic state. Tirzepatide has demonstrated potent weight-reducing, anti-inflammatory, and vascular protective effects, but its role in structural valve outcomes had not previously been explored. The trial enrolled 260 obese patients (BMI ≥ 30 kg/m) undergoing transfemoral TAVR across eight high-volume centers. Participants were randomized to receive tirzepatide initiated four weeks before TAVR and continued for 12 months, or standard care alone. All patients received guideline-directed antithrombotic therapy. The primary endpoint was the incidence of HALT at six months assessed by advanced imaging. Secondary endpoints included PVL severity, major adverse valve events, inflammatory biomarker changes, weight reduction, and bleeding outcomes. At six months, tirzepatide therapy was associated with a significant reduction in HALT compared with standard care, as well as a marked decrease in ≥ mild paravalvular leak. These structural valve improvements were accompanied by substantial weight loss and significant reductions in systemic inflammatory markers, without an increase in major bleeding or adverse safety signals. Multivariable analysis confirmed tirzepatide use and inflammation reduction as independent predictors of improved valve outcomes. In conclusion, the TAVR-MET trial provides the first clinical evidence that targeted metabolic therapy can favorably influence bioprosthetic valve healing after TAVR. These findings support a novel cardio-metabolic strategy for improving post-TAVR outcomes in obese patients and highlight the importance of addressing metabolic inflammation alongside procedural excellence in contemporary structural heart interventions.
BACKGROUND: Radial artery occlusion (RAO) after transradial PCI is the most common vascular complication. While prior studies highlight sheath size, sheath-to-artery ratio and hemostasis technique, radial tortuosity and...BACKGROUND: Radial artery occlusion (RAO) after transradial PCI is the most common vascular complication. While prior studies highlight sheath size, sheath-to-artery ratio and hemostasis technique, radial tortuosity and a dominant ulnar artery have been less explored. OBJECTIVES: Evaluate post-procedural vascular ultrasound-defined anatomical features linked to established, symptomatic RAO and describe reperfusion outcomes. METHODS: In a single-center observational cohort, 103 post-PCI patients underwent vascular ultrasound (51 RAO, 52 controls). Measured variables included radial/ulnar diameters, tortuosity and high brachial bifurcation. Multivariable logistic regression with Firth correction identified independent associated factors. Follow-up vascular ultrasound was available in a subset. RESULTS: Dominant ulnar artery (≥0.24 cm and larger than the radial) was independently associated with RAO (OR 8.0, p = 0.02), as was radial tortuosity (OR 4.0, p = 0.03). Prior ipsilateral radial access carried a strong association (OR = 15) but was insignificant (p = 0.06). The final model showed excellent discrimination (AUC 0.93). At follow-up (n = 26), most RAO cases remained occluded despite anticoagulation; only two patients demonstrated late reperfusion at 5-6 months. CONCLUSIONS: Post-procedural vascular ultrasound demonstrated that dominant ulnar perfusion and radial tortuosity were strongly associated with symptomatic RAO. While causality cannot be inferred, these findings generate hypotheses that selected anatomical patterns may be associated with increased susceptibility and warrant prospective validation. A "vascular ultrasound-first" strategy warrants evaluation prospectively to preserve radial patency.
BACKGROUND: Invasive physiologic assessment with fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) guides coronary revascularization and supports deferral of nonischemic lesions; however, sex-specific...BACKGROUND: Invasive physiologic assessment with fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) guides coronary revascularization and supports deferral of nonischemic lesions; however, sex-specific outcomes after physiology-guided deferral remain incompletely characterized. METHODS: We performed a retrospective cohort study using the TriNetX Global Collaborative Network to identify adults undergoing invasive physiologic assessment with FFR or iFR in whom revascularization was deferred. The primary endpoint was a composite of percutaneous coronary intervention (PCI), myocardial infarction (MI), or all-cause mortality. Secondary outcomes included individual components of the composite and acute heart failure. Women and men were matched 1:1 using propensity scores. Odds ratios (OR) and hazard ratios (HR) with 95% confidence intervals (CI) were calculated. RESULTS: Among 140,262 eligible patients, 47,413 matched pairs were identified after propensity score matching. Over 2 years of follow-up, women had lower odds of the composite endpoint compared with men (4192 vs 4569 events; OR 0.85, 95% CI 0.81-0.89; P < 0.001). Repeat PCI was less frequent in women (OR 0.82, 95% CI 0.78-0.86; P < 0.001), and all-cause mortality was modestly lower (OR 0.93, 95% CI 0.88-0.98; P = 0.032). MI rates were comparable (OR 1.03, 95% CI 0.97-1.09; P = 0.338). Acute heart failure occurred more frequently in women (OR 1.05, 95% CI 1.01-1.09; P = 0.046). Female sex was independently associated with lower revascularization risk (HR 0.83, 95% CI 0.79-0.87; P = 0.001). CONCLUSIONS: Women had lower rates of repeat revascularization and mortality over 2 years after physiology-guided deferral, with similar MI rates but a slightly higher rate of acute heart failure compared with men.
Muthusamy TS, Kolanthaivelu J, Choo GH
… +10 more, Wan Rahimi Shah WF, Thuraisingham S, Omar AF, Chew DSP, Goh KY, Tan K, Chan LHW, Melaku GD, Garcia-Garcia HM, Mohd Ali R
Cardiovasc Revasc Med
· 2026 Mar · PMID 41982016
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BACKGROUND: Hertz Contact Intravascular Lithotripsy (HC-IVL) is the first mechanical IVL platform designed to fragment coronary calcium, while minimizing injury to adjacent non-calcified vessel tissue and eliminating the...BACKGROUND: Hertz Contact Intravascular Lithotripsy (HC-IVL) is the first mechanical IVL platform designed to fragment coronary calcium, while minimizing injury to adjacent non-calcified vessel tissue and eliminating the need for external energy source or capital equipment. The PINNACLE-I clinical trial has demonstrated the safety and effectiveness of HC-IVL in treating moderate to severe calcific coronary lesions. In the MY-IVL Study, we aim to evaluate the safety and performance of HC-IVL in a real-world population including patients with multivessel disease, left main disease, chronic total occlusions, and in-stent restenosis. METHODS: This study includes consecutive patients undergoing HC-IVL between April and September 2025 at a single center with an estimated sample size of 100 subjects. All subjects undergo angiographic and intravascular imaging (OCT / IVUS) at baseline, post-HC-IVL, and post-PCI. Primary safety endpoint was 30-day freedom from MACE (cardiovascular death, MI, target vessel revascularization). Co-primary effectiveness endpoints were residual stenosis <30% without intraprocedural MACE and minimum stent area ≥ 4.9 mm by intravascular imaging. All imaging analyses are performed by an independent core laboratory. RESULTS: A total of 102 patients with 130 calcified lesions were treated with HC-IVL, with successful device delivery in all cases and a median of one IVL catheter used per procedure. The primary safety endpoint was achieved in 96.1%, with 96.3% of stented lesions demonstrating residual stenosis <30% without intraprocedural MACE. The 30-day MACE rate was 3.9%, with no myocardial infarction, no target vessel revascularization, and no device-related complications. By intravascular imaging, the mean minimum stent area was 6.89 mm and the lower bound of the 95% confidence interval was 6.50 mm, which exceeded the PG of 4.9 mm (p < 0.0001). Mean stent expansion was 113.7% across a wide spectrum of calcium morphologies including concentric, eccentric, and circumferential arcs up to 360°. Acute angiographic gain averaged 1.75 ± 0.58 mm with a final in-lesion diameter stenosis of 10.7%. CONCLUSIONS: MY-IVL study demonstrates that the LithiX HC-IVL system provides safe, effective, and efficient calcium modification across diverse calcified lesion morphologies in a high-risk, real-world Asian PCI population, facilitating optimal coronary stent implantation with favorable early clinical outcomes.
BACKGROUND: Non-obstructive coronary artery disease (NOCA) is characterized by coronary ischemia/angina without significant epicardial coronary stenosis. This study explored sex-related differences in clinical characteri...BACKGROUND: Non-obstructive coronary artery disease (NOCA) is characterized by coronary ischemia/angina without significant epicardial coronary stenosis. This study explored sex-related differences in clinical characteristics, endotypes, and angina outcomes in NOCA patients. METHODS: We conducted a retrospective, multicenter, observational study including all consecutive atients diagnosed with a NOCA syndrome between January 2020 and March 2025 at three different tertiary hospitals. NOCA patients were classified into microvascular angina, vasospastic angina or mixed angina, according to standardized criteria. The Seattle Angina Questionnaire 7 (SAQ-7) was evaluated at baseline and at 6-month follow-up. RESULTS: A total of 287 patients (65.1% women) were included. Men had higher rate of positive ischemia tests (49.2% vs. 67.0%; p = 0.004) and lower prevalence of anxiety/depression (37.93% vs. 19.0%; p < 0.001); as compared with women. No significant differences were observed between groups regarding NOCA endotype and treatment. SAQ-7 scores were significantly lower in women than in men either at baseline or 6-month follow-up (56.00 [47.00-66.00] vs. 63.00 [51.75-73.00]; p = 0.002 and 67.00 [56.00-80.00] vs. 80.00 [65.00-92.25]; p < 0.001, respectively). There was a significant improvement in both groups (women: + 9.00 [2.00-22.00]; p < 0.001; men: + 17.00 [2.00-27.75]; p < 0.001) between baseline and follow-up, without any statistically significant difference between men and women (p = 0.062). CONCLUSIONS: Women with NOCA syndrome exhibit a higher prevalence of psychological comorbidities and lower positive ischemia test. They had worse angina symptoms compared with men. These findings may highlight the need for sex-specific therapeutic strategies in NOCA syndrome.
BACKGROUND: In patients with radial artery occlusion (RAO), contralateral transradial access (TRA) may be infeasible or strategically undesirable. Transulnar access (TUA) ipsilateral to RAO is anatomically plausible; how...BACKGROUND: In patients with radial artery occlusion (RAO), contralateral transradial access (TRA) may be infeasible or strategically undesirable. Transulnar access (TUA) ipsilateral to RAO is anatomically plausible; however, contemporary evidence on vascular safety and hand function is limited and methodologically heterogeneous. ULNART is a prospective, multicenter cohort designed to evaluate the short- and long-term safety and functional outcomes of TUA ipsilateral to RAO using standardized imaging, quantitative testing, and patient-reported outcome measures (PROMs). METHODS: Adults with documented RAO undergoing elective invasive coronary angiography or percutaneous coronary intervention (PCI) are enrolled when contralateral TRA is not feasible or when preservation of the contralateral radial artery is clinically desirable. Baseline assessment includes color duplex ultrasonography (CDUS) to confirm RAO and evaluate ulnar artery suitability. A focused bilateral neurologic examination in the ulnar nerve distribution is performed to identify pre-existing motor or sensory deficits. Bilateral quantitative assessment of hand function and sensation includes handgrip strength, key pinch strength, and tactile thresholds, measured using validated instruments (JAMAR dynamometer, pinch gauge, and WEST monofilaments). Patient-reported outcomes are collected using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) and Cold Intolerance Symptom Severity (CISS) questionnaires. Procedures are performed via TUA ipsilateral to RAO with per-protocol anticoagulation and hemostasis is achieved with a compression device adapted at the access-site point. Patent hemostasis is initially confirmed by CDUS and then monitored by plethysmography on the fifth digit. Follow-up assessments, including CDUS, neurologic examination, and bilateral functional testing, are conducted within 24 h after hemostatic band removal and at 30 and 180 days. The primary endpoint is a composite of serious access-related vascular and clinical neuromuscular complications at 30 days. Secondary endpoints include access-site crossover rate, early (≤24 h) and delayed (6-month) access-related complications, and longitudinal changes in handgrip strength, key pinch strength, tactile sensibility, and PROMs. The study targets 127 participants, providing a two-sided 95% confidence interval with a ± 4% half-width around an expected 5% primary event rate. CONCLUSIONS: ULNART will provide prospective evidence on the safety of TUA ipsilateral to RAO and its effect on hand function. The findings are intended to guide access selection when TRA is unavailable, inform patient counseling, and support follow-up strategies in this population.