A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared to radial access. Ultrasound (US)-guided femoral ...access may reduce major vascular complications and bleeding. We aim to determine whether routinely using US guidance for femoral arterial access for coronary angiography or intervention will reduce Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding or major vascular complications.
The Ultrasound Guidance for Vascular Access for Cardiac Procedures: A Randomized Trial (UNIVERSAL) is a multicentre, prospective, open-label, randomized trial with blinded outcomes assessment. Patients undergoing coronary angiography with or without intervention via a femoral approach with fluoroscopic guidance will be randomized 1:1 to US-guided femoral access, compared to no US. The primary outcome is the composite of major bleeding based on the BARC 2, 3, or 5 criteria or major vascular complications within 30 days. The trial is designed to have 80% power and a 2-sided alpha level of 5% to detect a 50% relative risk reduction for the primary outcome based on a control event rate of 14%.
We completed enrollment on April 29, 2022, with 621 randomized patients. The patients had a mean age of 71 years (25.4% female), with a high rate of comorbidities, as follows: 45% had a prior percutaneous coronary intervention; 57% had previous coronary artery bypass surgery; and 18% had peripheral vascular disease.
The UNIVERSAL trial will be one of the largest randomized trials of US-guided femoral access and has the potential to change guidelines and increase US uptake for coronary procedures worldwide.
Par rapport à l’abord radial, la limitation importante de l’abord artériel fémoral lors des interventions au cœur pose un risque accru de complications vasculaires et de saignements. L’abord fémoral guidé par ultrasons (US) peut contribuer à réduire les complications vasculaires majeures et les saignements. Nous avons pour objectif de déterminer si l’utilisation systématique du guidage par US pour l’abord artériel fémoral lors des angiographies ou des interventions coronariennes contribuera à réduire les saignements de type 2, 3 ou 5 selon le BleedingAcademicResearchConsortium (BARC) ou les complications vasculaires majeures.
L’Ultrasound Guidance forVascular Access forCardiac Procedures:ARandomized Trial (UNIVERSAL) est un essai multicentrique, prospectif, ouvert, à répartition aléatoire, réalisé par une évaluation à l’insu des résultats. Les patients subissant une angiographie coronarienne avec ou sans intervention par voie fémorale sous guidage fluoroscopique seront répartis de façon aléatoire 1:1 à l’abord fémoral guidé par US ou sans US. Le principal critère d’évaluation est le critère composite de saignements majeurs de type 2, 3 ou 5 selon les critères du BARC ou de complications vasculaires majeures dans les 30 jours. L’essai est conçu de façon à avoir une puissance de 80 % et un seuil alpha bilatéral de 5 % pour déterminer la réduction du risque relatif de 50 % du critère d’évaluation principal selon un taux d’événements dans le groupe témoin de 14 %.
Le 29 avril 2022, nous avons terminé le recrutement de 621 patients choisis aléatoirement. Les patients avaient un âge moyen de 71 ans (25,4 % de femmes) et un taux élevé de comorbidités : 45 % avaient déjà subi une intervention coronarienne percutanée, 57 % avaient déjà subi un pontage aorto-coronarien et 18 % avaient une maladie vasculaire périphérique.
L’essai UNIVERSAL qui sera l’un des plus vastes essais à répartition aléatoire sur l’abord fémoral guidé par US a le potentiel de faire changer les lignes directrices et de faire augmenter le recours aux US lors des interventions coronariennes dans le monde entier.
Background It is unclear if holding angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) prior to coronary angiography reduces contrast-induced acute kidney injury ...(AKI). We undertook a randomized trial to investigate the effect of holding ACEI/ARB therapy prior to coronary angiography on the incidence of AKI. Methods We randomly assigned 208 patients with moderate renal insufficiency (creatinine ≥ 1.7 mg/dL within 3 months and/or documented creatinine ≥ 1.5 mg/dL within 1 week before cardiac catheterization) to hold ACEI/ARB ≥24 hours preprocedure or continue ACEI/ARB. The primary outcome was the incidence of AKI defined as an absolute rise in serum creatinine of ≥0.5 mg/dL from baseline and/or a relative rise in serum creatinine of ≥25% compared with baseline measured at 48 to 96 hours postcardiac catheterization. Results All patients were taking an ACEI (72.1%) or ARB (27.9%) prior to randomization. At 48 to 96 hours, the primary outcome occurred in 18.4% of patients who continued ACEI/ARB compared with 10.9% of the patients who held ACEI/ARB (hazard ratio 0.59, 95% CI 0.30-1.19, P = .16). In a prespecified secondary outcome, there was a lower rise in mean serum creatinine after the procedure in patients who held ACEI/ARB (0.3 ± 0.5 vs 0.1 ± 0.3 mg/dL, P = .03). The clinical composite of death, myocardial infarction, ischemic stroke, congestive heart failure, rehospitalization for cardiovascular cause, or need for dialysis preprocedure occurred in 3.9% who continued ACEI/ARB compared with 0% who held the ACEI/ARB (hazard ratio 0.11, 95% CI 0.01-2.96, P = .06). Conclusion In this pilot study of patients with moderate renal insufficiency undergoing cardiac catheterization, with-holding ACEI/ARB resulted in a non-significant reduction in contrast-induced AKI and a significant reduction in post-procedural rise of creatinine. This low cost intervention could be considered when referring a patient for cardiac catheterization.
Objectives The study sought to evaluate the relationship between procedural volume and outcomes with radial and femoral approach. Background RIVAL (RadIal Vs. femorAL) was a randomized trial of ...radial versus femoral access for coronary angiography/intervention (N = 7,021), which overall did not show a difference in primary outcome of death, myocardial infarction, stroke, or non–coronary artery bypass graft major bleeding. Methods In pre-specified subgroup analyses, the hazard ratios for the primary outcome were compared among centers divided by tertiles and among individual operators. A multivariable Cox proportional hazards model was used to determine the independent effect of center and operator volumes after adjusting for other variables. Results In high-volume radial centers, the primary outcome was reduced with radial versus femoral access (hazard ratio HR: 0.49; 95% confidence interval CI: 0.28 to 0.87) but not in intermediate- (HR: 1.23; 95% CI: 0.88 to 1.72) or low-volume centers (HR: 0.83; 95% CI: 0.52 to 1.31; interaction p = 0.021). High-volume centers enrolled a higher proportion of ST-segment elevation myocardial infarction (STEMI). After adjustment for STEMI, the benefit of radial access persisted at high-volume radial centers. There was no difference in the primary outcome between radial and femoral access by operator volume: high-volume operators (HR: 0.79; 95% CI: 0.48 to 1.28), intermediate (HR: 0.87; 95% CI: 0.60 to 1.27), and low (HR: 1.10; 95% CI: 0.74 to 1.65; interaction p = 0.536). However, in a multivariable model, overall center volume and radial center volume were independently associated with the primary outcome but not femoral center volume (overall percutaneous coronary intervention volume HR: 0.92, 95% CI: 0.88 to 0.96; radial volume HR: 0.88, 95% CI: 0.80 to 0.97; and femoral volume HR: 1.00, 95% CI: 0.94 to 1.07; p = 0.98). Conclusions Procedural volume and expertise are important, particularly for radial percutaneous coronary intervention. (A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention PCI Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy RIVAL; NCT01014273 )
Objectives The purpose of this study was to determine the consistency of the effects of radial artery access in patients with ST-segment elevation myocardial infarction (STEMI) and in those with ...non–ST-segment elevation acute coronary syndrome (NSTEACS). Background The safety associated with radial access may translate into mortality benefit in higher-risk patients, such as those with STEMI. Methods We compared efficacy and bleeding outcomes in patients randomized to radial versus femoral access in RIVAL (RadIal Vs femorAL access for coronary intervention trial) (N = 7,021) separately in those with STEMI (n = 1,958) and NSTEACS (n = 5,063). Interaction tests between access site and acute coronary syndrome type were performed. Results Baseline characteristics were well matched between radial and femoral groups. There were significant interactions for the primary outcome of death/myocardial infarction/stroke/non–coronary artery bypass graft–related major bleeding (p = 0.025), the secondary outcome of death/myocardial infarction/stroke (p = 0.011) and mortality (p = 0.001). In STEMI patients, radial access reduced the primary outcome compared with femoral access (3.1% vs. 5.2%; hazard ratio HR: 0.60; p = 0.026). For NSTEACS, the rates were 3.8% and 3.5%, respectively (p = 0.49). In STEMI patients, death/myocardial infarction/stroke were also reduced with radial access (2.7% vs. 4.6%; HR 0.59; p = 0.031), as was all-cause mortality (1.3% vs. 3.2%; HR: 0.39; p = 0.006), with no difference in NSTEACS patients. Operator radial experience was greater in STEMI versus NSTEACS patients (400 vs. 326 cases/year, p < 0.0001). In primary PCI, mortality was reduced with radial access (1.4% vs. 3.1%; HR: 0.46; p = 0.041). Conclusions In patients with STEMI, radial artery access reduced the primary outcome and mortality. No such benefit was observed in patients with NSTEACS. The radial approach may be preferred in STEMI patients when the operator has considerable radial experience. (A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention (PCI) Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy RIVAL; NCT01014273 )
Abstract Background Dual antiplatelet therapy (DAPT) is necessary to prevent thrombosis yet increases bleeding after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). ...Antiplatelet monotherapy with a potent P2Y12 receptor antagonist may reduce bleeding while maintaining anti thrombotic efficacy compared with conventional DAPT. Methods TWILIGHT is a randomized, double blind placebo-controlled trial evaluating the comparative efficacy and safety of antiplatelet monotherapy versus DAPT in up to 9000 high-risk patients undergoing PCI with DES. Upon enrollment after successful PCI, all patients will be treated with open label low-dose aspirin (81–100 mg daily) plus ticagrelor (90 mg twice daily) for 3 months. Event-free patients will then be randomized in a double-blind fashion to low-dose aspirin versus matching placebo with continuation of open-label ticagrelor for an additional 12 months. The primary hypothesis is that a strategy of ticagrelor monotherapy will be superior with respect to the primary endpoint of bleeding academic research consortium (BARC) type 2, 3 or 5, while maintaining non-inferiority for ischemic events compared with ticagrelor plus ASA. Conclusions TWILIGHT is the largest study to date that is specifically designed and powered to demonstrate reductions in bleeding with ticagrelor monotherapy versus ticagrelor plus ASA beyond 3 months post-procedure in a high-risk PCI population treated with DES. The trial will provide novel insights with respect to the potential role of ticagrelor monotherapy as an alternative for long-term platelet inhibition in a broad population of patients undergoing PCI with DES.
Abstract Background Since the introduction of newer, more potent P2Y12 receptor inhibitors (P2Y12 ris), practice patterns and associated clinical outcomes in patients with myocardial infarction (MI) ...undergoing percutaneous coronary intervention (PCI) and also requiring oral anticoagulation (OAC) have not been fully characterized. Methods The Canadian Observational Antiplatelet Study was a prospective, multicenter, longitudinal, observational study (26 hospitals, Dec/11-May/13) describing P2Y12 ri treatment patterns and outcomes in patients with ST-elevation and non-ST-elevation MI undergoing PCI. We describe the clinical characteristics, treatment patterns, bleeding and ischemic outcomes over the 15-month follow-up within and between the subgroups of patients discharged on either dual antiplatelet therapy (DAPT; ASA + P2Y12 ri) or triple therapy (ASA + P2Y12 ri + OAC). Results Of the 2034 patients at discharge, 86% (n = 1757) were on DAPT, while 14% (n = 277) were on triple therapy (50% warfarin, 50% non-vitamin K oral anticoagulant NOAC). The frequency of newer P2Y12 ri use (prasugrel or ticagrelor) was similar in the DAPT and triple therapy groups (28% vs 26%, respectively). In the triple therapy group, NOAC use was higher in those receiving a new P2Y12 ri compared to those receiving clopidogrel (75% vs 41%, respectively, P < .0001). The unadjusted and adjusted events of MACE and bleeding were higher in the triple therapy group. For patients on triple therapy, the bleeding or MACE events were not significantly different between those on clopidogrel versus those on ticagrelor or prasugrel. Conclusion In this observational study of MI patients requiring PCI, 1 in 8 were discharged on triple antithrombotic therapy, of whom 26% were on newer P2Y12 ris. Patients on triple therapy had higher risk at baseline, with higher unadjusted and adjusted MACE and bleeding events compared to those on DAPT alone. Amongst triple therapy-treated patients, there was no difference in the MACE and bleeding events regardless of the P2Y12 ri used.
Background Patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease who undergo primary percutaneous coronary intervention (PCI) are most commonly ...treated with PCI to the culprit lesion only. Whether a strategy of complete revascularization in these patients is superior is unknown. We performed a meta-analysis comparing the benefits and risks of routine culprit-only PCI vs multivessel PCI in STEMI. Methods MEDLINE, EMBASE, ISI Web of Science, and The Cochrane Register of Controlled Trials were searched from 1996 to January 2011. Relevant conference abstracts were searched from January 2002 to January 2011. Studies included STEMI with multivessel disease receiving primary PCI. The primary end point was long-term mortality. Data were combined using a fixed-effects model. Results Of 507 citations, 26 studies (3 randomized, 23 nonrandomized; 46,324 patients, 7886 multivessel PCI and 38,438 culprit-only PCI) were included. There was no significant difference in hospital mortality with multivessel PCI vs culprit-only PCI (odds ratio OR 1.11, 95% CI 0.98-1.25, P = .10 randomized OR 0.24, 95% CI 0.06-0.91, P = .04; nonrandomized OR 1.12, 95% CI 1.00-1.27, P = .06). However, if multivessel PCI during index catheterization was performed, hospital mortality was increased (OR 1.35, 95% CI 1.19-1.54, P < .001). When multivessel PCI was performed as a staged procedure, hospital mortality was lower (OR 0.35, 95% CI 0.21-0.59; P < .001; P interaction < .001). Reduced long-term mortality (OR 0.74, 95% CI 0.65-0.85, P < .001randomized OR 0.61, 95% CI 0.28-1.33, P = .22; nonrandomized OR 0.75, 95% CI 0.65-0.86, P < .001) and repeat PCI (OR 0.65; 95% 0.46-0.90, P = .01randomized OR 0.31, 95% CI 0.17-0.57, P < .001; nonrandomized OR 0.88, 95% CI 0.59-1.31, P = .54) were observed with multivessel PCI. Conclusion Overall, staged multivessel PCI improved short- and long-term survival and reduced repeat PCI. Still, large randomized trials are required to confirm the benefits of staged multivessel PCI in STEMI.
Background Radial access for percutaneous coronary intervention is associated with lower rates of access site complications and bleeding. However, elderly patients have more complex vascular anatomy ...and radial access may be more challenging in this population. There remains uncertainty regarding the role of radial access in elderly patients undergoing cardiac catheterization. Methods and Results The RIVAL trial randomized patients with acute coronary syndromes undergoing cardiac catheterization to radial versus femoral access. In this analysis, the rates of access site complications and access site cross-over were compared across different age groups. Among the 7,021 patients, 1035 (15%) were ≥75 years of age. Across all age categories, radial access was consistently associated with higher rates of access site cross over and lower rates of major access site complications, with no significant interaction between age and access site. Radial access was associated with lower rates of major vascular access site complications in patients ≥75 years of age (3.6% vs 6.6%; P = .03) and in patients <75 years of age (1.0% vs 3.2%; P < .001; P value for interaction = .2). The rates of access site crossover were higher with radial access among patients ≥75 (12.5% vs 2.6%; P < .001) and <75 (6.7% vs 1.9%; P < .001; P value for interaction = .9). There were no significant differences in the primary composite outcome (death, myocardial infarction, stroke or non coronary artery bypass graft major bleeding) or its individual components in either age group. In patients ≥75 years of age undergoing primary percutaneous coronary intervention, there was no significant difference in procedure time (120 vs 115 minutes; P = .3). Conclusions Consistent with the overall RIVAL trial population, elderly patients undergoing cardiac catheterization have lower rates of major bleeding or access site complications and higher rates of access site crossover with radial access compared to femoral access.
Abstract Background Several biomarkers have been shown to improve risk stratification in patients with non-ST-segment elevation acute coronary syndrome (NSTEACS); however, they have not been ...integrated into risk prediction tools. Methods C-reactive-protein, N-terminal-pro–brain natriuretic peptide (NT-proBNP), and haemoglobin A1C were measured in 6447 patients with NSTEACS who were enrolled in the Clopidogrel in Unstable Angina to Prevent Recurrent Events trial. A risk score to predict cardiovascular (CV) death, myocardial infarction (MI), or stroke at 1 year was developed by incorporating biomarkers that were independently predictive of events with traditional variables, electrocardiogram, and troponin-T. Model discrimination was evaluated using c-statistic, integrated discrimination improvement, and net reclassification index, and validated using bootstrap methods. Results During 1 year of follow-up, 686 patients experienced a CV event. Each biomarker predicted CV death, MI, or stroke; however, only NT-proBNP and haemoglobin A1C improved model discrimination, increasing the c-statistic (0.66-0.71), integrated discrimination improvement to 3.4%, and net reclassification index to 17.5% ( P < 0.0001 for all measures). A risk score ranging from 0 to 20 points including variables for age, prior MI/stroke, sex, ST-segment deviation, troponin-T, NT-proBNP, and haemoglobin A1C classified individuals into low-, intermediate-, and high-risk groups with rates of CV death, MI, stroke of 3.7%, 9.1%, 17.8%, respectively. The absolute benefit of dual antiplatelet therapy versus aspirin alone was 1.0%, 4.7%, and 3.0% in low-, intermediate-, and high-risk groups, respectively. Conclusions The addition of NT-proBNP and haemoglobin A1C to 5 standard variables creates a 7-variable risk score that improves prediction of CV events at 1 year and aids in risk-based selection of patients with NSTEACS for dual antiplatelet therapy.
Background Small randomized trials have demonstrated that radial access reduces access site complications compared to a femoral approach. The objective of this meta-analysis was to determine if ...radial access reduces major bleeding and as a result can reduce death and ischemic events compared to femoral access. Methods MEDLINE, EMBASE, and CENTRAL were searched from 1980 to April 2008. Relevant conference abstracts from 2005 to April 2008 were searched. Randomized trials comparing radial versus femoral access coronary angiography or intervention that reported major bleeding, death, myocardial infarction, and procedural or fluoroscopy time were included. A fixed-effects model was used with a random effects for sensitivity analysis. Results Radial access reduced major bleeding by 73% compared to femoral access (0.05% vs 2.3%, OR 0.27 95% CI 0.16, 0.45, P < .001). There was a trend for reductions in the composite of death, myocardial infarction, or stroke (2.5% vs 3.8%, OR 0.71 95% CI 0.49-1.01, P = .058) as well as death (1.2% vs 1.8% OR 0.74 95% CI 0.42-1.30, P = .29). There was a trend for higher rate of inability to the cross lesion with wire, balloon, or stent during percutaneous coronary intervention with radial access (4.7% vs 3.4% OR 1.29 95% CI 0.87, 1.94, P = .21). Radial access reduced hospital stay by 0.4 days (95% CI 0.2-0.5, P = .0001). Conclusions Radial access reduced major bleeding and there was a corresponding trend for reduction in ischemic events compared to femoral access. Large randomized trials are needed to confirm the benefit of radial access on death and ischemic events.
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