Distal Versus Conventional Radial Access for Coronary Angiography and Intervention The DISCO RADIAL Trial

BACKGROUND Currently, transradial access (TRA) is the recommended access for coronary procedures because of increased safety, with radial artery occlusion (RAO) being its most frequent complication, which will increasingly affect patients undergoing multiple procedures during their lifetimes. Recently, distal radial access (DRA) has emerged as a promising alternative access to minimize RAO risk. A large-scale, international, randomized trial comparing RAO with TRA and DRA is lacking. OBJECTIVES The aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO. METHODS DISCO RADIAL (Distal vs Conventional Radial Access) was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA or TRA with systematic implementation of best practices to reduce RAO. The primary endpoint was the incidence of forearm RAO assessed by vascular ultrasound at discharge. Secondary endpoints include crossover, hemostasis time, and access site-related complications. RESULTS Overall, 657 patients underwent TRA, and 650 patients underwent DRA. Forearm RAO did not differ between groups (0.91% vs 0.31%; P = 0.29). Patent hemostasis was achieved in 94.4% of TRA patients. Crossover rates were higher with DRA (3.5% vs 7.4%; P = 0.002), and median hemostasis time was shorter (180 vs 153 minutes; P < 0.001). Radial artery spasm occurred more with DRA (2.7% vs 5.4%; P = 0.015). Overall bleeding events and vascular complications did not differ between groups. CONCLUSIONS With the implementation of a rigorous hemostasis protocol, DRA and TRA have equally low RAO rates. DRA is associated with a higher crossover rate but a shorter hemostasis time. (C) 2022 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation

Sex differences in plaque characteristics of fractional flow reserve-negative non-culprit lesions after myocardial infarction

Background and aims: Recurrent events after myocardial infarction (MI) are common and often originate from native non-culprit (NC) lesions that are non-flow limiting. These lesions consequently pose as targets to improve long-term outcome. It is, however, largely unknown whether these lesions differ between sexes. The aim of this study was to assess such potential differences. Methods: From the PECTUS-obs study, we assessed sex-related differences in plaque characteristics of fractional flow reserve (FFR)-negative intermediate NC lesions in 420 MI-patients. Results: Among the included patients, 80 (19.1 %) were female and 340 (80.9 %) male. Women were older and more frequently had hypertension and diabetes. In total, 494 NC lesions were analyzed. After adjustment for clinical characteristics and accounting for within-patients clustering, lesion length was longer in female patients (20.8 ± 10.0 vs 18.3 ± 8.5 mm, p = 0.048) and minimum lumen area (2.30 ± 1.42 vs 2.78 ± 1.54 mm2, p &lt; 0.001) and minimum lumen diameter (1.39 ± 0.45 vs 1.54 ± 0.44 mm, p &lt; 0.001) were smaller. The minimum fibrous cap thickness was smaller among females (96 ± 53 vs 112 ± 72 μm, p = 0.025), with more lesions harboring a thin cap fibroatheroma (39.3 % vs 24.9 %, p &lt; 0.001). Major adverse cardiovascular events at two years occurred in 6.3 % of female patients and 11.8 % of male patients (p = 0.15). Conclusions: FFR-negative NC lesions after MI harbored more high-risk plaque features in female patients. Although this did not translate into an excess of recurrent events in female patients in this modestly sized cohort, it remains to be investigated whether this difference affects clinical outcome.</p

Incidence and clinical course of limb dysfunction post cardiac catheterization: a systematic review

BackgroundWe sought to systematically review the available literature on limb dysfunction after transradial or transfemoral cardiac catheterization.Methods & ResultsMEDLINE and EMBASE were searched for studies evaluating any transradial or transfemoral procedures and limb function outcomes. Data was extracted, results were narratively synthesized with similar treatment arms. 15 studies with 3616 participants were included in transradial access (TRA) group. 3 studies reported nerve damage with a combined incidence of 0.16%, 4 studies reported sensory loss, tingling and numbness with a pooled incidence of 1.61%. Pain after TRA was the most common form of limb dysfunction (7.77%) reported in 3 studies. The incidence of hand dysfunction defined as disability, grip strength change, power loss or neuropathy was low at 0.49%. Although RAO was not a primary end point for this review, it was observed in 3.57% of the participants in a total of 8 studies included.4 studies with 15,903,894 participants were included in the transfemoral access (TFA) group. Rate of peripheral neuropathy was observed at 0.004%, sensory neuropathy due to local groin injury and retroperitoneal haematomas was 0.04% and 0.17% respectively, whereas motor deficit due to femoral and obturator nerve damage was 0.13%.ConclusionsLimb dysfunction post cardiac catheterization is rare, patients may have nonspecific sensory and motor complaints that resolve over a period of time

SUGAR-DIP trial: Oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial

Introduction In women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM. Methods The SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle. Ethics and dissemination The study protocol was approved by the Ethics Committee of the Utrecht University Medical Centre. Approval by the boards of management for all participating hospitals will be obtained. Trial results will be submitted for publication in peer-reviewed journals

Chronic radial artery occlusion does not cause exercise induced hand ischemia

Objectives: The aim of the study was to evaluate the occurrence of hand ischemia in patients with radial artery occlusion (RAO), using the contralateral hand as control. Background: Radial artery occlusion is a common complication (6%) after transradial access (TRA) but rarely leads to major ischemic events due to the collateral perfusion of the hand. However, it has been reported that RAO can become symptomatic, possibly as a consequence of hand ischemia. To evaluate the existence of exercise induced hand ischemia in patients with RAO, we initiated the present study. Methods: After a transradial coronary procedure, patients with suspicion of RAO were asked for study participation. After informed consent, radial ultrasound was performed. In patients with confirmed RAO, rest perfusion of the digits was analyzed by laser Doppler digital imaging. Occurrence of ischemia during exercise was assessed with transcutaneous oxygen pressure (TcPO2) and thumb capillary lactate. All analyses were performed in both the RAO side as well as the contralateral side as control. Results: RAO occlusion was confirmed in 18 patients. After 5 min of exercise there were no significant differences in TcPO2 (51.4 mmHg [±17.2] vs 43.9 mmHg [±15.5], P = 0.18) or lactate (2.0 mmol/L [±0.7] vs 2.1 mmol/L [±0.7], P = 0.80) between RAO side and control side. Differences in mean TcPO2 were found to be stable during exercise and not different from baseline differences. Conclusions: Chronic radial artery occlusion does not lead to exercise induced hand ischemia

Extremity Dysfunction After Large-Bore Radial and Femoral Arterial Access

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Hand Sensibility after Transradial Arterial Access: An Observational Study in Patients with and without Radial Artery Occlusion

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The Effect of Transradial Coronary Catheterization on Upper Limb Function

AbstractObjectivesThe aim of this study was to analyze the change of upper limb function when percutaneous coronary procedures were performed through the radial artery.BackgroundIt is currently unknown if upper limb function is affected by transradial (TR) catheterization.MethodsBetween January 2013 and February 2014, upper limb function was assessed in a total of 338 patients undergoing coronary catheterization in an ambulatory setting (85% radial approach, 15% femoral approach). Upper limb function was assessed with the self-reported shortened version of the Disabilities of Arm, Shoulder, and Hand questionnaire. The presence and severity of upper extremity cold intolerance was assessed with the self-reported Cold Intolerance Symptom Severity questionnaire. Both questionnaires were completed before the catheterization and at 30-day follow-up. Higher scores represent worse upper limb functionality or symptoms. The nonparametric Wilcoxon signed-rank test was used to assess the change of upper limb function and symptoms over time.ResultsUpper limb function did not change significantly over time when catheterization was performed through the radial artery (p = 0.06). The number of procedure-related extremity complaints that persisted during 30-day follow-up were not different between both access groups (TR access 10.5%, transfemoral access 11.5%; p = 0.82). The upper extremity was not affected by cold intolerance after TR access at 30-day follow-up (p = 0.91).ConclusionsUpper limb function was not affected when coronary catheterizations and interventions were performed through the radial artery