Search

Background: Radial artery access for coronary angiography or percutaneous coronary intervention (PCI) reduces the risk of death, bleeding, and vascular complications and is preferred over femoral artery access, leading to a class 1 indication by clinical practice guidelines. However, alternate upper extremity access such as distal radial and ulnar access are not mentioned in the guidelines despite randomized trials. We aimed to evaluate procedural outcomes with femoral, radial, distal radial, and ulnar access sites in patients undergoing coronary angiography or PCI., Methods: PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized clinical trials that compared at least 2 of the 4 access sites in patients undergoing PCI or angiography. Primary outcomes were major bleeding and access site hematoma. Intention-to-treat mixed treatment comparison meta-analysis was performed., Results: From 47 randomized clinical trials that randomized 38 924 patients undergoing coronary angiography or PCI, when compared with femoral access, there was a lower risk of major bleeding with radial access (odds ratio [OR], 0.46 [95% CI, 0.35-0.59]) and lower risk of access site hematoma with radial (OR, 0.34 [95% CI, 0.24-0.48]), distal radial (OR, 0.33 [95% CI, 0.20-0.56]), and ulnar (OR, 0.50 [95% CI, 0.31-0.83]) access. However, when compared with radial access, there was higher risk of hematoma with ulnar access (OR, 1.48 [95% CI, 1.03-2.14])., Conclusions: Data from randomized trials support guideline recommendation of class 1 for the preference of radial access over femoral access in patients undergoing coronary angiography or PCI. Moreover, distal radial and ulnar access can be considered as a default secondary access site before considering femoral access., Registration: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: 42024512365., Competing Interests: Dr Bangalore is on the Advisory Board for Abbott Vascular, Boston Scientific, Biotronik, Amgen, Pfizer, Merck, Reata, Inari, and Truvic. The other authors report no conflicts.

Background: Emerging evidence from randomized clinical trials (RCTs) comparing distal radial access (DRA) with conventional radial access (RA) is available., Objectives: The aim of this study was to provide a quantitative appraisal of the effects of DRA) vs conventional RA for coronary angiography with or without intervention., Methods: The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched for RCT comparing DRA vs conventional RA for coronary angiography and/or intervention. Data were pooled by meta-analysis using a random-effects model. The primary endpoint was radial artery occlusion (RAO) at the longest available follow-up., Results: Fourteen studies enrolling 6,208 participants were included. Compared with conventional RA, DRA was associated with a significant lower risk of RAO, either detected at latest follow-up (risk ratio [RR]: 0.36; 95% CI: 0.23-0.56; P < 0.001; number needed to treat [NNT] = 30) or in-hospital (RR: 0.32; 95% CI: 0.19-0.53; P < 0.001; NNT = 28), as well as EASY (Early Discharge After Transradial Stenting of Coronary Arteries) ≥II hematoma (RR: 0.51; 95% CI: 0.27-0.96; P = 0.04; NNT = 107). By contrast, DRA was associated with a higher risk of access site crossover (RR: 3.08; 95% CI: 1.88-5.06; P < 0.001; NNT = 12), a longer time for radial puncture (standardized mean difference [SMD]: 3.56; 95% CI: 0.96-6.16; P < 0.001), a longer time for sheath insertion (SMD: 0.37; 95% CI: 0.16-0.58; P < 0.001), and a higher number of puncture attempts (SMD: 0.59, 95% CI: 0.48-0.69; P < 0.001)., Conclusions: Compared with conventional RA, DRA is associated with lower risks of RAO and EASY ≥II hematoma but requires longer time for radial artery cannulation and sheath insertion, more puncture attempts, and a higher access site crossover., Competing Interests: Funding Support and Author Disclosures Dr Lefèvre has received honoraria from Abbott, Boston, and Terumo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. All rights reserved.)

[Figure: see text].

Objectives: We sought to evaluate the efficacy and safety of bivalirudin versus heparin in patients with coronary artery disease undergoing transradial artery coronary intervention (TRI)., Background: Bivalirudin and radial artery access are independently associated with improved cardiovascular outcomes. However, data supporting a strategy of combining both to achieve additive improvements in cardiovascular outcomes provide conflicting results., Methods: A systematic search was performed to identify randomized controlled trials (RCTs) of bivalirudin, in which vascular access sites were reported. The primary outcome was net adverse clinical events (NACE) at 30 days. Secondary outcomes were long-term NACE, short-, and long-term major adverse cardiovascular events, all-cause mortality, myocardial infarction, unplanned revascularization, stent thrombosis, and major bleeding., Results: We identified 10 RCTs, including 16,328 patients who underwent TRI (mean age 64.6 ± 15.7 years, 72.5% male). Bivalirudin use was associated with decreased 30-day NACE compared with heparin (6.3 vs. 7.4%; risk ratio [RR] = 0.87; 95% confidence interval [CI] = 0.76-0.99; p = .04; number needed to treat = 91). No significant interactions were observed based on clinical presentation, administration of P2Y 12 inhibitors, or glycoprotein IIb/IIIa-receptor inhibitors (GPI) use. There were no significant differences between groups in any prespecified secondary outcomes. There was, however, a significant reduction of major bleeding in the bivalirudin group compared with heparin when used in combination with routine GPI (RR = 0.41; 95% CI = 0.19-0.90; p = .03)., Conclusions: Among patients undergoing TRI, use of bivalirudin was associated with significantly reduced 30-day NACE compared with heparin. There was no significant difference in long term NACE, ischemic, or bleeding events compared with heparin., (© 2020 Wiley Periodicals, Inc.)

Background: Procedural anticoagulation with bivalirudin (BIV), trans-radial intervention (TRI), and use of a vascular closure device (VCD) are thought to mitigate percutaneous coronary intervention (PCI)-related bleeding. We compared the impact of these bleeding avoidance strategies (BAS) for PCIs stratified by bleeding risk., Methods: We performed a retrospective cohort analysis of PCIs from 18 facilities within one health care system from 2009Q3 to 2017Q4. Bleeding risk was assessed per the National Cardiovascular Data Registry CathPCI bleeding model, with procedures stratified into 6 categories (first, second, third quartiles, 75th-90th, 90th-97.5th, and top 2.5th percentiles). Regression models were used to assess the impact of BAS on bleeding outcome., Results: Of 74 953 PCIs, 9.4% used no BAS, 12.0% used BIV alone, 20.8% used TRI alone, 26.8% used VCD alone, 5.4% used TRI+BIV, and 25.6% used VCD+BIV. The crude bleeding rate was 4.4% overall. Only 2 comparisons showed significant trends across all risk strata: VCD+BIV versus no BAS, odds ratio (95% CI) range: first quartile, 0.36 (0.18-0.72) to top 2.5th percentile, 0.50 (0.32-0.78); TRI versus no BAS, odds ratio (95% CI) range: first quartile, 0.15 (0.06-0.38) to top 2.5th percentile, 0.49 (0.28-0.86). TRI had lower odds of bleeding compared with BIV for all risk strata except the top 2.5th percentile. Addition of BIV to TRI did not change the odds of bleeding for any risk strata. Factors potentially limiting use of TRI (renal failure, shock, cardiac arrest, and mechanical circulatory support) were present in ≤10% of procedures below the 90th percentile., Conclusions: Among individual BAS, only TRI had consistently lower odds of bleeding across all risk strata. Factors potentially limiting TRI were found infrequently in procedures below the 90th percentile of bleeding risk. For transfemoral PCI, VCD+BIV had lower odds of bleeding compared with no BAS across all risk strata.

Transradial angiography and intervention continues to become increasingly common as an access site for coronary procedures. Since the first "Best Practices" paper in 2013, ongoing trials have shed further light onto the safest and most efficient methods to perform these procedures. Specifically, this document comments on the use of ultrasound to facilitate radial access, the role of ulnar artery access, the utility of non-invasive testing of collateral flow, strategies to prevent radial artery occlusion, radial access for primary PCI and topics that require further study., (© 2019 Wiley Periodicals, Inc.)

Peripheral vascular intervention (PVI) improves quality of life and reduces major adverse limb events in patients with peripheral arterial disease. PVI is commonly performed via the femoral artery, and the most common adverse periprocedural event is a vascular access complication. Transradial access for PVI has the potential to reduce vascular access complications and improve patient outcomes. Further study is needed to elucidate the risks of stroke, acute kidney injury, and radiation exposure in the setting of transradial PVI. As transradial access for PVI progresses, it will be important to build the evidence base along with procedural experience., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Although patients prefer radial over femoral approach, some develop post-procedural arm pain after transradial procedures. This complication has been poorly defined in prior studies. We evaluated the extent of non-ischemic arm pain after transradial arterial access and identify variables that may be associated with this complication., Methods: We performed a retrospective analysis of a 1706 patient database on patients who underwent transradial catheterization at three experienced radial centers. Arm pain was assessed by adult visual analogue scale (score > 4) defined as moderate to severe pain at the accessed forearm not related to hand ischemia and was evaluated at one day after the procedure. Logistic regression was used to identify the predictors of post-procedural arm pain., Results: The overall incidence of post-procedural arm pain one day after a transradial procedure was 4.5%. Covariate associated with post-procedural arm pain were hemostasis compression >4 h (odds ratio (OR) = 29.47, p < 0.001), radial artery occlusion by Doppler evaluation (OR = 3.35, p < 0.001), radial artery diameter < 2.8 mm (OR = 2.66, p = 0.01), and multiple puncture attempts (OR = 2.31, p = 0.03)., Conclusion: Approximately 1 in 20 patients undergoing transradial procedure have post-procedural arm pain one day after the procedure. Predictors of this complication relate to radial hemostasis, radial artery occlusion, radial artery diameter, and number of access attempts., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objectives: To gain insight into current practice of transradial angiography and intervention in the United States and around the world., Background: Transradial access (TRA) has grown worldwide. In a prior survey, there was significant practice variation and there was minimal US participation which limited the generalizability to US operators., Methods: We used an internet-based survey software program to solicit input from practicing interventional cardiologists from the United States and around the world. US operators were compared with outside the United States (OUS) operators and respondent-level comparisons were made with the prior survey to assess for temporal changes in practice., Results: Between August 2016 and January 1, 2017, 125 interventional cardiologists completed the survey representing 91 countries with the United States having 449 (39.9%) respondents. Preprocedure, noninvasive testing for collateral circulation is used more commonly in the United States (54.1%) than around the world (26.6%) but its use has decreased since 2010. In the US, 48.8% of operators never use ultrasound and 92.6% of OUS operators never use it; only 4.4% overall use ultrasound in >50% of cases. Use of bivalirudin has decreased in the US and OUS. Nearly, 30% of operators do not assess for radial artery patency following hemostasis. US respondents used TRA less commonly for primary PCI for STEMI than their global counterparts., Conclusions: There is wide variation in how TRA procedures are performed including relatively low rates of adherence to practices that are known to improve outcomes. Further education aimed at increasing use of best practices will impact patient outcomes., (© 2018 Wiley Periodicals, Inc.)

Background: SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women), a randomized controlled trial comparing radial and femoral access in women undergoing cardiac catheterization or percutaneous coronary intervention (PCI), was terminated early for lower than expected event rates. Whether this was because of patient selection or better access site practice among trial patients is unknown., Methods and Results: SAFE-PCI was conducted within the National Cardiovascular Data Registry CathPCI registry. Using the National Cardiovascular Research Infrastructure Identification, PCI date, and age, patients enrolled in SAFE-PCI were compared with trial-eligible female CathPCI registry patients 1 year before, during, and 1 year after SAFE-PCI enrollment. Patient and procedure characteristics, predicted bleeding and mortality, and post-PCI bleeding were compared between groups. Enrolled SAFE-PCI patients and registry patients from the 3 time periods were linked to Centers for Medicare and Medicaid Services data to compare 30-day death and unplanned revascularization rates. At 54 SAFE-PCI sites, there were 496 SAFE-PCI trial patients with a PCI visit within the CathPCI registry. There were 24 958 registry patients from 1 year before and 1 year after SAFE-PCI enrollment and 15 904 trial-eligible registry patients during trial enrollment. Trial patients were younger, had lower predicted bleeding and mortality, and had lower rates of post-PCI bleeding within 72 hours compared with registry patients. Among 12 212 Centers for Medicare and Medicaid Services-linked patients, there were no significant differences in 30-day death and unplanned revascularization among the 4 groups., Conclusions: Lower predicted risk of bleeding and mortality among SAFE-PCI trial patients compared with registry patients suggests that lower-risk patients were selectively enrolled for the trial. These data demonstrate how registry-based randomized trials may offer methods for enrollment feedback to curb selection bias in recruitment., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01406236.

Introduction: Over the recent years, there has been increased interest in the use of transradial (TR) access for percutaneous coronary intervention (PCI), including rotational atherectomy (RA). However, a large proportion of operators seem to be reluctant to use TR access for complex PCI including rotational atherectomy for heavily calcified coronary lesions., Methods: We searched MEDLINE, ClinicalTrials.gov and the Cochrane Library for studies comparing radial versus femoral access in patients undergoing RA. Studies were included if they reported at least one of the following outcomes in each group separately: major adverse cardiac events (MACE), major bleeding, stent thrombosis, myocardial infarction (MI), hospital length of stay, radiation exposure, procedure time, procedure success and all-cause mortality. Odds ratio (OR) or mean difference (MD) with 95% confidence interval (CI) were calculated and a p-value of <0.05 was considered as a level of significance., Results: This meta-analysis included 5 retrospective studies with 3315 patients undergoing RA via radial access and 5838 patients via femoral access. Radial access was associated with lower major access site bleeding (OR: 0.45, 95% CI: 0.31-0.67, p < 0.001), and radiation exposure (MD: -16.1, 95%CI: -25.4--6.7 Gy cm 2 , p = 0.0007). There were no significant differences observed in all-cause in-hospital mortality (OR: 0.92, 95% CI: 0.69-1.23, p = 0.58); MACE (OR: 0.80, CI: 0.63, 1.02, p = 0.08), stent thrombosis (OR: 0.28, 95%CI: 0.06-1.33 p = 0.11); and MI (OR: 0.43, 95%CI: 0.15-1.24, p = 0.12). There were no significant differences in hospital stay, procedure time or procedure success between the two groups (p > 0.05)., Conclusion: This meta-analysis of 9153 patients from observational studies demonstrates similar all-cause mortality, MACE, procedural success and procedural time during RA performed using TR access and TF access. However, TR access was associated with decreased access site bleeding and radiation exposure. Given the observational nature of these findings, a randomized controlled trial is warranted for further evidence., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: This study evaluated whether use of different spasmolytic regimens (nitroglycerin or verapamil) administered soon after sheath insertion affects postprocedure radial artery occlusion (RAO) in patients who underwent transradial catheterization., Methods and Results: We performed a post hoc analysis of a randomized trial evaluating the use of 500 μg intra-arterial nitroglycerin just before sheath removal in 1706 patients undergoing transradial catheterization. Patients who received 200 μg or 300 μg nitroglycerin after sheath placement (group A; n = 688) were compared with patients who received 5 mg verapamil after sheath placement (group B; n = 1018). The primary endpoint was RAO diagnosed by Doppler ultrasound examination at 1 calendar day after the procedure. Logistic regression was used to determine predictors of RAO. RAO occurred in 16.0% of group A and 5.4% of group B. After adjustment for potential confounders, neither the use of verapamil nor nitroglycerin was associated with RAO (odds ratio [OR], 1.24; 95% confidence interval [CI], 0.51-3.02; P=.62). Radial artery compression >4 hours was the strongest predictor of RAO (OR, 5.41; 95% CI, 2.31-12.65; P<.001)., Conclusions: In this study, the use of verapamil or nitroglycerin as a spasmolytic regimen was not associated with RAO. Given the strong association between duration of radial compression and RAO, further studies are needed to determine the interaction between vasodilator agents and compression protocols on RAO.

Objectives: We aimed to describe global practice patterns of unfractionated heparin (UFH) use for diagnostic transradial cardiac catheterization., Background: The use of the radial artery approach for cardiac catheterization is increasing globally. Limited contemporary data exist to support the use or optimal dosing of UFH to prevent radial artery occlusion (RAO) and other thromboembolic complications., Methods: We performed a web-based international survey of 450 interventional cardiologists from 34 countries. We collected information regarding the experience and use of UFH for diagnostic transradial cardiac catheterization., Results: The survey was conducted between June and July 2016 and was completed by 227 (50.4%) interventional cardiologists. Overall, 83.3% performed >75% of their coronary angiograms via a radial approach, with the plurality (41.9%) having 10-20 years of clinical experience. Of all respondents, 7.5% did not use UFH for routine diagnostic transradial heart catheterization. Of the 92.5% who did use UFH, it was preferentially administered intra-arterially by 60% and intravenously by 40%. The majority (62.6%) of interventionalists used a fixed UFH dose with 5,000 IU being the most common dose (used in 48%). For those using a weight-based UFH (50 IU/kg) dosing regimen for diagnostic procedures (36.1%), the administered UFH dose ranged from 2,000 up to 10,000 IU., Conclusions: Despite the lack of firm evidence, the majority of interventional cardiologists who participated in the survey use UFH to prevent RAO for diagnostic transradial coronary angiography. However, there exist large practice disparities with regards to dose and route of administration. Given this knowledge gap, a dedicated randomized trial is warranted., (© 2018 Wiley Periodicals, Inc.)

Background: During transradial (TR) access, it remains unclear whether differences in baseline patients characteristics and hemostasis care impact the rate of radial artery occlusion (RAO). We sought to compare the rate of RAO after TR access with the 6 French(Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) or a standard 5 Fr sheath in Japanese and non-Japanese patients., Methods and Results: The Radial Artery Patency and Bleeding, Efficacy, Adverse evenT (RAP and BEAT) trial randomized 1,836 patients undergoing TR coronary angiography and/or interventions to receive the GSS6Fr or the standard 5 Fr Glidesheath (GS5Fr, Terumo, Japan). Out of this study population, 1,087 were Japanese patients and 751 non-Japanese patients. The overall incidence of RAO was significantly higher in Japanese patients (3.6% vs. 1.2%, P = 0.002). Use of GSS6Fr was associated with higher rates of RAO than GS5Fr in Japanese patients (5% vs. 2.2%, P = 0.02) and with similar RAO rates in non-Japanese patients (1.3 vs. 1.1%, P = 1). The mean hemostasis time was significantly longer in Japanese patients (378 ± 253 vs. 159 ± 136 min, P < 0.001) and more Japanese patients had a hemostasis time of more than 6 hr (16.2% vs. 4.9%, P < 0.0001). Longer hemostasis time was an independent predictor of RAO (OR per additional hour 1.070, 95% CI 1.008-1.136, P = 0.03)., Conclusions: Use of GSS6Fr was associated with a higher rate of RAO than a standard 5 Fr sheath in Japanese patients but not in non-Japanese patients. Whether improvement in post-procedural care and reduced hemostasis time could impact the incidence of RAO in Japanese patients should be further assessed., (© 2018 The Authors Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.)

Background: The radial artery (RA) is routinely used for both hemodynamic monitoring and for cardiac catheterization. Although cannulation of the RA is usually undertaken through manual palpation, ultrasound (US)-guided access has been advocated as a mean to increase cannulation success rates and to lower RA complications; however, the published data are mixed. We sought to evaluate the impact of US-guided RA access compared with palpation alone on first-pass success to access RA., Methods and Results: Meta-analysis of 12 randomized controlled trials comparing US-guided with palpation-guided radial access in 2,432 adult participants was done. Hemodynamic monitoring was the most common reason for RA catheterization. Only 2 randomized controlled trials evaluated patients undergoing cardiac catheterization. Ultrasound-guided radial access was associated with increased first-attempt success rate (risk ratio [RR] 1.35, 95% CI 1.16-1.57]) and decreased failure rate (RR 0.52, 95% CI 0.32-0.87). There were no significant differences in the risk of hematoma (RR 0.43, 95% CI 0.27-1.06), the mean time to first successful attempt (mean difference 25.13 seconds, 95% CI -1.06 to 51.34) or to any successful attempt (mean difference -4.74 seconds; 95% CI -22.67 to 13.18) between both groups., Conclusions: Ultrasound-guided technique for RA access has higher first-attempt success and lower failure rate compared with palpation alone, with no significant differences in access site hematoma or time to a successful attempt. These findings support the routine use of US guidance for RA access., (Copyright © 2018 Elsevier Inc. All rights reserved.)

This article summarizes the current research on the benefits of using the transradial approach for percutaneous procedures and the radial artery as a conduit for coronary artery bypass surgery. Based on the available evidence, the authors provide recommendations for the use of the radial artery in patients undergoing percutaneous or surgical coronary procedures., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study was conducted to determine the association between radial access, guided femoral access, and non-guided femoral access on postprocedural bleeding and vascular complications after percutaneous coronary intervention (PCI)., Background: Bleeding events and major vascular complications after PCI are associated with increased morbidity, mortality, and cost. While the radial approach has been shown to be superior to the femoral approach in reducing bleeding and vascular complications, whether the use of micropuncture, fluoroscopy, or ultrasound mitigates these differences is unknown., Methods: We conducted a post hoc analysis of women in the SAFE-PCI for Women trial who underwent PCI and had the access method identified (n = 643). The primary endpoint of postprocedure bleeding or vascular complications occurring within 72 hours or at discharge was adjudicated by an independent clinical events committee and was compared based on three categories of access technique: radial, guided femoral (fluoroscopy, micropuncture, ultrasound), or non-guided femoral (none of the aforementioned). Differences between the groups were determined using multivariate logistic regression using radial access as the reference., Results: Of the PCI population, 330 underwent radial access, 228 underwent guided femoral access, and 85 underwent non-guided femoral access. There was a statistically significant lower incidence of the primary endpoint with radial access vs non-guided femoral access; however, there was no significant difference between radial approach and femoral access guided by fluoroscopy, micropuncture, or ultrasound., Conclusions: This post hoc analysis demonstrates that while radial access is safer than non-guided femoral access, guided femoral access appears to be associated with similar bleeding events or vascular complications as radial access.

Objectives: The study sought to define patient, operator, and institutional factors associated with transradial access (TRA) in ST-segment elevation myocardial infarction (STEMI) percutaneous coronary intervention (PCI), the variation in use across operators and institutions, and the relationship with mortality and bleeding., Background: TRA for PCI in STEMI is underutilized. Factors associated with TRA are not well described, nor is there variation across operators and institutions or their relationship with outcomes., Methods: The authors used hierarchical logistic regression to identify patient, operator, and institutional characteristics associated with TRA use as well as determine the variation in TRA for STEMI PCI from 2009 to 2015. They also described the relationship between operator- and institution-level use and risk-adjusted bleeding and mortality., Results: Among 692,433 patients undergoing STEMI PCI, 12% (n = 82,618) utilized TRA. TRA increased from 2% to 23% from 2009 to 2015, but with significant geographic variation. Age, sex, cardiogenic shock, cardiac arrest, operators entering practice before 2012, and nonacademically affiliated institutions were associated with lower rates of TRA. There was significant operator and institutional variation, wherein identical patients would have >8-fold difference in odds of TRA for STEMI PCI by changing operators (median odds ratio: 8.7), and >5-fold difference by changing institutions (median odds ratio: 5.1). Greater TRA use across operators was associated with reduced bleeding (rho = -0.053), whereas TRA use across institutions was associated with reduced mortality (rho = -0.077)., Conclusions: Transradial access for STEMI PCI is increasing, but remains underutilized with significant geographic, operator, and institutional variation. These findings suggest an ongoing opportunity to standardize STEMI care., (Published by Elsevier Inc.)

Aims: The 6 Fr Glidesheath Slender (GSS6Fr) is a recently developed thin-walled radial sheath with an outer diameter (OD) that is smaller than the OD of standard 6 Fr sheaths. The purpose of this trial was to clarify whether the use of this new slender sheath would result in similar rates of RAO to a standard 5 Fr sheath in unselected patients undergoing transradial (TR) coronary angiography and/or intervention, and to assess the relative importance of sheath size and haemostasis protocol on the rate of RAO., Methods and Results: We conducted a randomised, multicentre, non-inferiority trial comparing the GSS6Fr against the standard GS5Fr in patients undergoing TR coronary angiography and/or intervention. Patients in each group were subsequently randomised to undergo patent haemostasis or the institutional haemostasis protocol. The primary endpoint was the occurrence of RAO at discharge. A total of 1,926 patients were randomised in 12 centres. The incidence of RAO was 3.47% with GSS6Fr compared with 1.74% with GS5Fr (risk difference 1.73%, 95% CI: 0.51-2.95%; pnon-inferiority=0.150). Patients randomised to patent haemostasis had a similar rate of RAO compared with institutional haemostasis (2.61% vs. 2.61%, p=1). There was no difference with regard to all secondary endpoints, including vascular access-site complications, local bleeding and spasm., Conclusions: In this large multicentre randomised trial, the GSS6Fr was associated with a low event rate for the primary endpoint (RAO), although non-inferiority to the GS5Fr was not met, due to a lower than expected rate of RAO in the GS5Fr group. As compared to institutional haemostasis, the use of patent haemostasis was not associated with a reduced rate of RAO.

Objectives: The aim of this study was to compare bivalirudin with heparin as anticoagulant agents in patients with ST-segment elevation myocardial infarction treated with radial primary percutaneous coronary intervention (PCI)., Background: Recent studies in which PCI was performed predominantly via radial access did not show bivalirudin to be superior to heparin., Methods: Outcomes were compared in patients with STEMI included in the National Cardiovascular Data Registry CathPCI database from 2009 to 2015 who underwent primary PCI via radial access and who were anticoagulated with bivalirudin or heparin., Results: The sample included 67,368 patients, of whom 29,660 received bivalirudin and 37,708 received heparin. The 2 groups of patients did not differ significantly in their mean age or percentage of men. The unadjusted comparison showed no significant difference in the rate of the composite endpoint of death, myocardial infarction, or stroke (4.6% vs. 4.7%; p = 0.47) and a significantly higher rate of acute stent thrombosis (1.00% vs. 0.60%; p < 0.001) with bivalirudin compared with heparin. After adjusting for multiple variables, including a propensity score reflecting the probability of receiving bivalirudin, the odds ratio of the composite endpoint of death, myocardial infarction, or stroke for bivalirudin versus heparin was 0.95 (95% confidence interval: 0.87 to 1.05; p = 0.152), and the odds ratio for acute stent thrombosis was 2.11 (95% confidence interval: 1.73 to 2.57) for bivalirudin versus heparin. Major bleeding rates were not significantly different., Conclusions: In patients undergoing primary PCI via transradial access anticoagulated with bivalirudin or heparin, there was no difference in the composite endpoint of death, myocardial infarction, or stroke., (Published by Elsevier Inc.)

Background: Patients with chronic kidney disease (CKD) are at increased risk for bleeding, transfusion, and dialysis after cardiac catheterization. Whether rates of these complications are increased in this high-risk population undergoing transradial access compared with transfemoral access is unknown., Methods and Results: From the Veterans Affairs (VA) Clinical Assessment Reporting and Tracking program, we identified 229 108 patients undergoing cardiac catheterization between 2007 and 2014, of which 48 155 (21.0%) had baseline glomerular filtration rate (GFR) between 15 and 59 mL/min. We used multivariable Cox modeling to determine the independent association between transradial access and postprocedure transfusion as well as progression to new dialysis by degree of renal dysfunction. Overall, 35 979 (15.7%) of patients underwent Transradial access. Transradial patients tended to be slightly younger, but, overall, had similar rates of CKD compared to transfemoral patients (24.3% vs 27.1%). Transradial patients had longer fluoroscopy times (7.2 vs 6.0 minutes; P <0.001), but lower contrast use (85.0 vs 100.0 mL; P <0.001). The estimated rate of blood transfusion within 48 hours was lower among transradial patients (0.85% vs 1.01%) as were rates of new dialysis at 1 year (0.58% vs 0.71%). After multivariable adjustment, transradial access was associated with lower rates of progression to dialysis at 1 year overall (hazard ratio [HR], 0.83; 95% CI, 0.70-0.98), with no trend of increased risk for dialysis by degree of CKD compared with transfemoral access. Transradial access was associated with greater reduction in transfusion rates with increasing degree of CKD ( P value for trend=0.04: non-CKD: HR, 0.99; 95% CI, 0.73-1.34; GFR 45-59 mL/min: HR, 0.93; 95% CI, 0.70-1.23; GFR 30-44 mL/min: HR, 0.73; 95% CI, 0.51-1.03; GFR 15-29 mL/min: HR, 0.43; 95% CI, 0.20-0.90)., Conclusions: Among patients undergoing cardiac catheterization in the VA health system, transradial access was associated with lower risk for postprocedure transfusion within 48 hours among patients with more-severe CKD, and with lower risk of progression to end-stage renal disease at 1 year compared with transfemoral access. These data provide additional evidence that transradial access may provide significant benefit in this high-risk population., (© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Objectives: The aim of this study was to examine the independent impact of various care pathways, including those involving transradial intervention (TRI) and same-day discharge (SDD) after elective percutaneous coronary intervention (PCI), on hospital costs., Background: PCI is associated with costs of $10 billion annually. Alternative payment models for PCI are being implemented, but few data exist on strategies to reduce costs. Various PCI care pathways, including TRI and SDD, exist, but their association with costs and outcomes is unknown., Methods: In total, 279,987 PCI patients eligible for SDD in the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims files were analyzed. Hospital costs in 2014 U.S. dollars were estimated using cost-to-charge ratios. Propensity scores for TRI and SDD, with propensity adjustment via inverse probability weighting, was performed., Results: Of the 279,987 PCI procedures, TRI was used in 9.0% (13.5% of which were SDD), and SDD was used in 5.3% of cases (23.1% of which were TRI). TRI (vs. transfemoral intervention) was associated with lower adjusted costs of $916 (95% confidence interval [CI]: $778 to $1,035), as was SDD ($3,502; 95% CI: $3,486 to $3,902). The adjusted cost associated with TRI and SDD was $13,389 (95% CI: $13,161 to $13,607), while the cost associated with transfemoral intervention and non-same-day discharge was $17,076 (95% CI: $16,999 to $17,147), a difference of $3,689 (95% CI: $3,486 to $3,902; p < 0.0001). Shifting current practice from transfemoral intervention non-same-day discharge to TRI SDD by 30% could potentially save a hospital performing 1,000 PCIs each year $1 million and the country $300 million annually., Conclusions: Among Medicare beneficiaries, TRI with SDD was independently associated with fewer complications and lower in-hospital costs. These findings have important implications for changing the current PCI care pathways to improve outcomes and reduce costs., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Studies showing an advantage of transradial approach (TR) for coronary angiography and intervention (PCI) compared to the transfemoral approach (TF) predominantly included a younger population. Therefore, we conducted a meta-analysis of published studies to determine the efficacy of TR in the elderly population., Methods and Results: A comprehensive search identified 16 studies [3 randomized controlled studies, 13 observational] comprising 777,841 elderly patients undergoing PCI. TR was used in 99,201 patients and TF in 678,640 patients. The results from observational studies showed that TR was associated with a lower rate of vascular complications (0.4% vs. 0.8%, OR 0.36, 95% CI 0.30-0.44), stroke (0.3% vs. 0.4%, OR 0.81, 95% CI 0.66-1.0) and death (2.0% vs. 2.2%, OR 0.51, 95% CI 0.41-0.63). RCTs confirmed findings from observational studies for both significant reduction in vascular complications (2.7% vs. 7%, OR 0.37, 95% CI 0.23-0.60) and stroke (0.4% vs. 1.4%, OR 0.31, 95% CI 0.10-0.97) but showed no effect on mortality (3.3% vs. 2.8%, OR 1.20, 95% CI 0.69-2.09). However, among patients with ST elevation myocardial infarction (STEMI), TR was associated with a mortality benefit (5% vs. 7%, OR 0.48, 95% CI 0.25-0.90, p=0.02). Access site crossover rate was higher for TR compared to the TF approach (11% vs. 3%, p=0.0003) but there was no difference in contrast media use, procedure duration, fluoroscopy time and door to balloon time for STEMI., Conclusion: TR for PCI in the elderly is associated with a reduced risk of stroke, lower rate of vascular complications overall and a mortality benefit for patients presenting with STEMI. The access site cross rate for TR is higher compared to TF but remains acceptably low. TR should be the preferred strategy for PCI in the elderly to optimize clinical benefit in this high-risk group., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: We examined whether the radial artery diameter is correlated with body mass index (BMI) in patients undergoing transradial catheterization., Methods: 1706 patients undergoing trans-radial catheterization at three experienced, high-volume, radial centers were analyzed. Radial and ulnar artery diameters were determined by ultrasound in the distal third of the forearm one day post procedure. Pearson correlation test was used to measure the relationship between continuous variables., Results: Radial diameter was larger than the ulnar artery [median 2.8mm (interquartile range (IQR): 2.4-3.1mm) vs. median 2.4mm (IQR: 2.1-2.6mm), p<0.001]. Women had smaller radial and ulnar arteries compared to men [median 2.6mm (IQR: 2.3-2.9mm) vs. median 2.8 (IQR: 2.4-3.2mm), p<0.001 and median 2.2mm (IQR: 2.0-2.5mm) vs. median 2.5mm (IQR: 2.2-2.7mm), p<0.001, respectively]. There was no correlation between radial diameter and BMI (Pearson correlation=0.003, p=0.88 (2-sided)), but a strong linear correlation between the radial and ulnar artery diameter existed (Pearson correlation=0.48, p<0.001 (2-sided)). After adjustment for clinical variables including diabetes, gender, and age, female gender was associated with smaller radial diameter (<2.8mm) (odds ratio 1.72; 95% CI 1.40-2.12, p<0.001)., Conclusions: No correlation was observed between radial artery diameter and BMI, although female gender was associated with smaller radial diameter. This suggests catheterization can be performed without anthropometric consideration, although it should be recognized women may have smaller radial arteries. As the diameter of the radial is larger than the ulnar artery, the radial should remain the default catheterization access-site., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Objectives: Periprocedural bleedings, often related to vascular access site, represent an important drawback of percutaneous coronary procedures and are associated with worse outcomes. Radial access (RA) and, potentially, femoral access (FA) with vascular closure device (VCD) are useful strategies in order to mitigate periprocedural bleedings; nevertheless, their relative efficacy is largely undetermined. We aimed to perform a systematic review and meta-analysis of available studies comparing the efficacy of RA and FA with hemostasis by VCD (FA + VCD) on the reduction of access-site complications and/or periprocedural bleedings., Methods: Published studies reporting outcomes on access-site complications and periprocedural bleedings were included in the analysis. Data were extracted by two independent reviewers; odds ratio (OR) and 95% confidence interval (CI) were calculated by random-effects model and were used as summary statistics., Results: We included in the analysis 13 studies, of which 5 were randomized. Access-site complications were reported by 11 studies, amounting to 157,031 patients (77,713 in the RA group and 79,318 in the FA + VCD group), whereas periprocedural bleedings were reported by 12 studies, amounting to 600,196 patients (137,277 in the RA group and 462,919 in the FA + VCD group). RA was associated with a significant reduction in access-site complications (OR, 0.25; 95% CI ,0.21-0.31; P<.001) and periprocedural bleedings (OR, 0.40; 95% CI, 0.34-0.48; P<.001) as compared with FA + VCD; the results were consistent among randomized and observational studies., Conclusions: This meta-analysis shows that RA is superior to FA + VCD in the reduction of access-site complications and periprocedural bleedings.

Objectives: We evaluated outcomes associated with transradial vs. transfemoral approaches and vorapaxar in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) in the TRACER trial., Background: Vorapaxar reduces ischemic events but increases the risk of major bleeding., Methods: We compared 30-day and 2-year major adverse cardiac events (MACE: cardiovascular death, myocardial infarction, stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization) and noncoronary artery bypass graft (CABG)-related bleedings in 2,192 transradial and 4,880 transfemoral patients undergoing PCI after adjusting for confounding variables, including propensity for transradial access., Results: Overall, 30-day GUSTO moderate/severe and non-CABG TIMI major/minor bleeding occurred less frequently in transradial (0.9% vs. 2.0%, P = 0.001) vs. transfemoral (1.1% vs. 2.5%, P = 0.005) patients. A similar reduction was seen at 2 years (3.3% vs. 4.7%, P = 0.008; 3.3% vs. 4.9%, P < 0.001, respectively). Transradial was associated with an increased risk of ischemic events at 30 days (OR 1.38, 95% CI 1.11-1.72; P = 0.004), driven primarily by increased periprocedural myocardial infarctions. At 2 years, rates of MACE were comparable (HR 1.14, 95% CI 0.98-1.33; P = 0.096). Although bleeding rates were higher with vorapaxar in transfemoral vs. transradial patients, there was no significant treatment interaction. Also, the access site did not modulate the association between vorapaxar and MACE., Conclusions: Transradial access was associated with lower bleeding rates and similar long-term ischemic outcomes, suggesting transradial access is safer than transfemoral access among ACS patients receiving potent antiplatelet therapies. Because of the nonrandomized allocation of arterial access, these results should be considered exploratory. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)

Objectives: The aim of this study was to provide a quantitative appraisal of the effects on clinical outcomes of radial access for coronary interventions in patients with coronary artery disease (CAD)., Background: Randomized trials investigating radial versus femoral access for percutaneous coronary interventions have provided conflicting evidence. No comprehensive quantitative appraisal of the risks and benefits of each approach is available across the whole spectrum of patients with stable or unstable CAD., Methods: The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched for randomized trials comparing radial versus femoral access for coronary interventions. Data were pooled by meta-analysis using a fixed-effects or a random-effects model, as appropriate. Pre-specified subgroup analyses according to clinical presentation, in terms of stable CAD, non-ST-segment elevation acute coronary syndromes, or ST-segment elevation myocardial infarction were performed., Results: Twenty-four studies enrolling 22,843 participants were included. Compared with femoral access, radial access was associated with a significantly lower risk for all-cause mortality (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.59 to 0.87; p = 0.001, number needed to treat to benefit [NNTB] = 160), major adverse cardiovascular events (OR: 0.84; 95% CI: 0.75 to 0.94; p = 0.002; NNTB = 99), major bleeding (OR: 0.53; 95% CI: 0.42 to 0.65; p < 0.001; NNTB = 103), and major vascular complications (OR: 0.23; 95% CI: 0.16 to 0.35; p < 0.001; NNTB = 117). The rates of myocardial infarction or stroke were similar in the 2 groups. Effects of radial access were consistent across the whole spectrum of patients with CAD for all appraised endpoints., Conclusions: Compared with femoral access, radial access reduces mortality and MACE and improves safety, with reductions in major bleeding and vascular complications across the whole spectrum of patients with CAD., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: We analyzed the effect of nitroglycerin on radial artery occlusion (RAO) in women undergoing transradial catheterization., Methods: A total of 1706 patients undergoing transradial catheterization were randomized to receive either 500μg intra-arterial nitroglycerin or placebo at the end of the radial procedure. We explored the gender-based analysis between women (n=539) and men (n=1167). The primary outcome was the incidence of RAO as confirmed by absence of antegrade flow at one day after the transradial procedure evaluated by duplex ultrasound of the radial artery., Results: The use of nitroglycerin, as compared with placebo, did not significantly reduce the risk of RAO in women patients [odds ratio, 0.69; 95% confidence interval (CI), 0.38 to 1.26; P=0.147]. The risk of RAO was higher in women age <60years as compared with women age ≥60years [5.6% vs. 3.5%; odds ratio, 2.16; 95% CI, 1.18 to 3.94; P=0.008]. In women age <60years (n=237), both counter puncture technique and a duration of hemostasis ≥4h were associated with a similar enhanced risk of developing RAO (odds ratio, 3.51; 95% CI, 1.59 to 7.72; P<0.001)., Conclusions: The administration of nitroglycerin at the end of a transradial catheterization in women did not reduce the risk of RAO as determined by ultrasound one day after the radial procedure. Age <60years was associated with a higher risk of RAO compared with age ≥60years in women. Further strategies to reduce RAO in women are needed., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Transradial access for cardiac catheterisation results in lower bleeding and vascular complications than the traditional transfemoral access route. However, the increased radiation exposure potentially associated with transradial access is a possible drawback of this method. Whether transradial access is associated with a clinically significant increase in radiation exposure that outweighs its benefits is unclear. Our aim was therefore to compare radiation exposure between transradial access and transfemoral access for diagnostic coronary angiograms and percutaneous coronary interventions (PCI)., Methods: We did a systematic review and meta-analysis of the scientific literature by searching the PubMed, Embase, and Cochrane Library databases with relevant terms, and cross-referencing relevant articles for randomised controlled trials (RCTs) that compared radiation parameters in relation to access site, published from Jan 1, 1989, to June 3, 2014. Three investigators independently sorted the potentially relevant studies, and two others extracted data. We focused on the primary radiation outcomes of fluoroscopy time and kerma-area product, and used meta-regression to assess the changes over time. Secondary outcomes were operator radiation exposure and procedural time. We used both fixed-effects and random-effects models with inverse variance weighting for the main analyses, and we did confirmatory analyses for observational studies., Findings: Of 1252 records identified, we obtained data from 24 published RCTs for 19 328 patients. Our primary analyses showed that transradial access was associated with a small but significant increase in fluoroscopy time for diagnostic coronary angiograms (weighted mean difference [WMD], fixed effect: 1·04 min, 95% CI 0·84-1·24; p<0·0001) and PCI (1·15 min, 95% CI 0·96-1·33; p<0·0001), compared with transfemoral access. Transradial access was also associated with higher kerma-area product for diagnostic coronary angiograms (WMD, fixed effect: 1·72 Gy·cm(2), 95% CI -0·10 to 3·55; p=0·06), and significantly higher kerma-area product for PCI (0·55 Gy·cm(2), 95% CI 0·08-1·02; p=0·02). Mean operator radiation doses for PCI with basic protection were 107 μSv (SD 110) with transradial access and 74 μSv (68) with transfemoral access; with supplementary protection, the doses decreased to 21 μSv (17) with transradial access and 46 μSv (9) with transfemoral. Meta-regression analysis showed that the overall difference in fluoroscopy time between the two procedures has decreased significantly by 75% over the past 20 years from 2 min in 1996 to about 30 s in 2014 (p<0·0001). In observational studies, differences and effect sizes remained consistent with RCTs., Interpretation: Transradial access was associated with a small but significant increase in radiation exposure in both diagnostic and interventional procedures compared with transfemoral access. Since differences in radiation exposure narrow over time, the clinical significance of this small increase is uncertain and is unlikely to outweigh the clinical benefits of transradial access., Funding: None., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Over the past several years, the transradial approach (TRA) for cardiac catheterization has become increasingly adopted in the United States. The increased utilization of the TRA is grounded on 2 decades of research, showing reduced bleeding and vascular complications to complement improved patient quality of life. However, the concern over cost, radiation exposure, and acknowledged "learning curve" has kept the transfemoral approach (TFA) the mainstay of most US catheterization laboratories. More recent larger multi-centered randomized studies have aimed to address outcomes and these concerns between the TR and TF approaches. This article will review the changing trends in TRA in the US, discuss clinical (bleeding and mortality) and non-clinical (quality of life and cost) outcomes from recent randomized studies, and finally discuss certain aspects when it comes to adopting TRA., (Copyright © 2015 Elsevier Inc. All rights reserved.)

A well-established body of evidence demonstrating the advantages of a transradial approach for coronary angiography and intervention has led to worldwide adoption of this technique. In some countries, radial access has replaced femoral access as the dominant access site for percutaneous coronary intervention (PCI). More recently, numerous randomized controlled trials have compared transradial and transfemoral access in patients with ST elevation myocardial infarction (STEMI) and have shown that transradial access is associated with lower mortality and less major bleeding. This review examines the advantages of transradial primary PCI for STEMI patients, addresses concerns in adopting this approach for primary PCI, and reviews recommendations on how to start a transradial primary PCI program., (Published by Elsevier Inc.)

Objectives: This study sought to perform a randomized noninferiority trial of radiation exposure during cardiac catheterization comparing femoral access (FA) with left radial access (LRA) and right radial access (RRA)., Background: Increased radiation exposure with radial approach compared with femoral approach remains a controversial issue., Methods: This study randomized 1,493 patients undergoing cardiac catheterization at a tertiary care center to FA, LRA, and RRA in a 1:1:1 fashion. The primary endpoint was air kerma. The secondary endpoints included dose-area product, fluoroscopy time and operator dose per procedure, number of cineangiograms, and number of catheters., Results: Baseline and procedural characteristics were similar among groups. No significant differences were observed in air kerma (medians: FA: 421 mGy [interquartile range (IQR): 337 to 574 mGy], LRA: 454 mGy [IQR: 331 to 643 mGy], and RRA: 483 mGy [IQR: 382 to 592 mGy], p = 0.146), dose-area product (medians: FA: 25.5 Gy cm(2) [IQR: 19.6 to 34.5 Gy cm(2)], LRA: 26.6 Gy cm(2) [IQR: 19.5 to 37.5 Gy cm(2)], and RRA: 27.7 Gy cm(2) [IQR: 21.9 to 34.4 Gy cm(2)], p = 0.40), or fluoroscopy time (medians: FA: 1.3 min [IQR: 1.0 to 1.7 min], LRA: 1.3 min [IQR: 1.0 to 1.7 min], and RRA: 1.32 min [IQR: 1.0 to 1.7 min], p = 0.19) among the 3 access sites. Median operator exposure was higher in the LRA group (3 mrem [IQR: 2 to 5 mrem], p = 0.001 vs. FA, and p = 0.0001 vs. RRA) compared with the FA (2 mrem [IQR: 2 to 4 mrem] and RRA groups (3 mrem [IQR: 2 to 5 mrem])., Conclusions: Radiation exposure to patients was similar during diagnostic coronary angiography with FA, RRA, and LRA. However, LRA was associated with significantly higher operator radiation exposure than were FA and RRA procedures. (Randomized Evaluation of Vascular Entry Site and Radiation Exposure [REVERE]; NCT01677481)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The prevention of major bleeding during percutaneous coronary intervention is one of the most widely discussed and often controversial topics within interventional cardiology. The choice of arterial access should be considered a mechanism for bleeding avoidance, and various strategies have been proposed to prevent or lower major bleeding and vascular complications with varying levels of strength. Herein, we review the current literature on arterial access as a bleeding avoidance strategy during percutaneous coronary intervention and its impact on outcome and provide a consensus opinion based on the strength of the evidence supporting various techniques., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management., Methods: We did a randomised, multicentre, superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention. Patients were randomly allocated (1:1) to radial or femoral access with a web-based system. The randomisation sequence was computer generated, blocked, and stratified by use of ticagrelor or prasugrel, type of acute coronary syndrome (ST-segment elevation myocardial infarction, troponin positive or negative, non-ST-segment elevation acute coronary syndrome), and anticipated use of immediate percutaneous coronary intervention. Outcome assessors were masked to treatment allocation. The 30-day coprimary outcomes were major adverse cardiovascular events, defined as death, myocardial infarction, or stroke, and net adverse clinical events, defined as major adverse cardiovascular events or Bleeding Academic Research Consortium (BARC) major bleeding unrelated to coronary artery bypass graft surgery. The analysis was by intention to treat. The two-sided α was prespecified at 0·025. The trial is registered at ClinicalTrials.gov, number NCT01433627., Findings: We randomly assigned 8404 patients with acute coronary syndrome, with or without ST-segment elevation, to radial (4197) or femoral (4207) access for coronary angiography and percutaneous coronary intervention. 369 (8·8%) patients with radial access had major adverse cardiovascular events, compared with 429 (10·3%) patients with femoral access (rate ratio [RR] 0·85, 95% CI 0·74-0·99; p=0·0307), non-significant at α of 0·025. 410 (9·8%) patients with radial access had net adverse clinical events compared with 486 (11·7%) patients with femoral access (0·83, 95% CI 0·73-0·96; p=0·0092). The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery (1·6% vs 2·3%, RR 0·67, 95% CI 0·49-0·92; p=0·013) and all-cause mortality (1·6% vs 2·2%, RR 0·72, 95% CI 0·53-0·99; p=0·045)., Interpretation: In patients with acute coronary syndrome undergoing invasive management, radial as compared with femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality., Funding: The Medicines Company and Terumo., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Objectives: The purpose of this study was to determine the efficacy and safety of radial versus femoral access in women undergoing coronary angiography/intervention., Background: The risk of bleeding and vascular access site complications are higher in women than in men., Methods: In a pre-specified RIVAL (RadIal Vs femorAL access for coronary intervention) subgroup analysis, we compared outcomes in women (n=1,861) and men (n=5,160) randomized to radial versus femoral access., Results: Overall, women were at higher risk of major vascular complications compared with men (4.7% vs. 1.7%; p<0.0001). Major vascular complications were significantly reduced with radial access in women (3.1% vs. 6.1%; hazard ratio [HR]: 0.5; 95% confidence interval [CI]: 0.32 to 0.78; p=0.002) and in men (0.7% vs. 2.8%; HR: 0.27; 95% CI: 0.17 to 0.45; p<0.0001; interaction p=0.092). Crossover rates were higher with radial compared with femoral access in women (11.1% vs. 1.9%; HR: 5.88; p<0.0001) and men (6.3% vs. 1.9%; HR: 3.32; p<0.0001; interaction p=0.054). Percutaneous coronary intervention (PCI) success rates were similar irrespective of access site (women: HR: 1.05; p=0.471; men: HR: 1.00; p=0.888; interaction p=0.674), with no differences in PCI complications. In multivariable analyses, female sex was an independent predictor of major vascular complications (HR: 2.39; 95% CI: 1.76 to 3.25; p<0.0001). There were consistent findings for women and men, with no difference for the primary composite endpoint of death, myocardial infarction, stroke, and non-coronary artery bypass grafting bleeding (women: 3.9% vs. 5.0%; HR: 0.77; 95% CI: 0.50 to 1.19; men: 3.54% vs. 3.5%; HR: 1.00; 95% CI: 0.75 to -1.34; interaction p=0.325)., Conclusions: Women undergoing coronary angiography and PCI have a higher risk of vascular access site complications compared with men, and radial access is an effective method to reduce these complications., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Radial artery occlusion (RAO) is the most common complication of the transradial approach (TRA) to cardiac catheterization, with a reported incidence between 0.8 % and 30 %. RAO is likely the result of acute thrombus formation and complicated by neointimal hyperplasia. Most RAO are asymptomatic with rare cases of acute hand or digit ischemia reported in the literature. The role of testing for dual circulation to the hand in determining the safety of TRA as it relates to symptomatic RAO is controversial; however, modifiable risk factors like low sheath-to-artery ratio, adequate anticoagulation, and non-occlusive ("patent") hemostasis are likely to prevent RAO. This review examines the incidence of RAO, potential mechanisms leading to RAO, and strategies to prevent and treat RAO.

Background/purpose: Compared with trans-femoral percutaneous coronary intervention (TFI), trans-radial PCI (TRI) has a lower risk of bleeding, access site complications and hospital costs, and is preferred by patients. However, TRI accounts for a minority of PCIs in the US, and there is currently little research that explores why., Methods/material: We conducted a national survey in February 2013 to assess perceptions of TRI vs. TFI, and barriers to TRI adoption and implementation among interventional cardiologists employed by the US Veterans Health Administration (VHA), and linked these data to site-level TRI annual rates for 2013., Results: We received 78 completed surveys (32% response rate). Respondents at sites that perform few or no TRIs identified increased radiation exposure as the greatest barrier while at sites that perform a high percentage of TRIs respondents identified the steep learning curve as the greatest barrier. Majorities of survey respondents at all sites rated TRI as superior on 5 of 7 criteria, including patient comfort and bleeding complications, but rated TFI as superior on procedure time and procedure success., Conclusions: Even interventional cardiologists at sites that perform few or any TRIs recognized the superiority of TRI for patient comfort and safety, but rated it inferior to TFI on procedure time and technical results. Interventional cardiologists at high-TRI labs rated TRI as equivalent on procedure time and technical results. Efforts to increase TRI adoption and implementation may be more successful if they emphasize that procedure times and technical results depend on achieving proficiency., (Published by Elsevier Inc.)

Objectives: This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial., Background: Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear., Methods: Women undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population., Results: The trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access., Conclusions: In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Adoption of transradial percutaneous coronary intervention (TRI) in the United States is low and may be related to challenges learning the technique. We examined the relationships between operator TRI volume and procedural metrics and outcomes., Methods and Results: We used CathPCI Registry data from July 2009 to December 2012 to identify new radial operators, defined by an exclusively femoral percutaneous coronary intervention approach for 6 months after their first percutaneous coronary intervention in the database and ≥15 total TRIs thereafter. Primary outcomes of fluoroscopy time, contrast volume, and procedure success were chosen as markers of technical proficiency. Secondary outcomes included in-hospital mortality, bleeding, and vascular complications. Adjusted outcomes were analyzed by using operator TRI experience as a continuous variable with generalized linear mixed models. Among 54 561 TRI procedures performed at 704 sites, 942 operators performed 1 to 10 procedures, 942 operators performed 11 to 50 procedures, 375 operators performed 51 to 100 procedures, and 148 operators performed 101 to 200 procedures. As radial caseload increased, more TRIs were performed in women, in patients presenting with ST-segment elevation myocardial infarction, and for emergency indications. Decreased fluoroscopy time and contrast use were nonlinearly associated with greater operator TRI experience, with faster reductions observed for newer (<30-50 cases) compared with more experienced (>30-50 cases) operators. Procedure success was high, whereas mortality, bleeding, and vascular complications remained low across TRI volumes., Conclusions: As operator TRI volume increases, higher-risk patients are chosen for TRI. Despite this, operator proficiency improves with greater TRI experience, and safety is maintained. The threshold to overcome the learning curve appears to be approximately 30 to 50 cases., (© 2014 American Heart Association, Inc.)