SYNERGY-Everolimus-Eluting Stent With a Bioabsorbable Polymer in ST-Elevation Myocardial Infarction: CLEAR SYNERGY OASIS-9 Registry.

Our objective was to evaluate the clinical effectiveness of the SYNERGY stent (Boston Scientific Corporation, Marlborough, Massachusetts) in patients with ST-elevation myocardial infarction (STEMI). The only drug-eluting stent approved for treatment of STEMI by the Food and Drug Administration is the Taxus stent (Boston Scientific) which is no longer commercially available, so further data are needed. The CLEAR SYNERGY stent registry was embedded into a larger randomized trial of patients with STEMI (n = 7,000), comparing colchicine versus placebo and spironolactone versus placebo. The primary outcome for the SYNERGY stent registry is major adverse cardiac events (MACE) as defined by cardiovascular death, recurrent MI, or unplanned ischemia-driven target vessel revascularization within 12 months. We estimated a MACE rate of 6.3% at 12 months after primary percutaneous coronary intervention for STEMI based on the Thrombectomy vs percutaneous coronary intervention alone in STEMI (TOTAL) trial. Success was defined as upper bound of confidence interval (CI) to be less than the performance goal of 9.45%. Overall, 733 patients were enrolled from 8 countries with a mean age 60.2 years, 19% diabetes mellitus, 41.3% anterior MI, and median door-to-balloon time of 72 minutes. The MACE rate was 4.8% (95% CI 3.2 to 6.3%) at 12 months which met the success criteria against performance goal of 9.45%. The rates of cardiovascular death, recurrent MI, or target vessel revascularization were 2.7%, 1.9%, 1.0%, respectively. The rates of acute definite stent thrombosis were 0.3%, subacute 0.4%, late 0.4%, and cumulative stent thrombosis of 1.1% at 12 months. In conclusion, the SYNERGY stent in STEMI performed well and was successful compared with the performance goal based on previous trials.

Ultrasound guidance for transfemoral access in coronary procedures: an individual participant-level data metaanalysis from the femoral ultrasound trialist collaboration.

BACKGROUND: Randomised controlled trials of ultrasound (US)-guided transfemoral access (TFA) for coronary procedures have shown mixed results. AIMS: We aimed to compare US-guided versus non-US-guided TFA from randomised data in an individual participant-level data (IPD) meta-analysis. METHODS: We completed a systematic review and an IPD meta-analysis of all randomised controlled trials comparing US-guided versus non-US-guided TFA for coronary procedures. We performed a one-stage mixed-model meta-analysis using the intention-to-treat population from included trials. The primary outcome was a composite of major vascular complications or major bleeding within 30 days. RESULTS: A total of 2,441 participants (1,208 US-guided, 1,233 non-US-guided) from 4 randomised clinical trials were included. The mean age was 65.5 years, 27.0% were female, and 34.5% underwent a percutaneous coronary intervention. The incidence of major vascular complications or major bleeding (34/1,208 [2.8%] vs 55/1,233 [4.5%]; odds ratio [OR] 0.61, 95% confidence interval [CI]: 0.39-0.94; p=0.026) was lower in the US-guided TFA group. In the prespecified subgroup of participants who received a vascular closure device, those randomised to US-guided TFA experienced a reduction in the primary outcome (2.1% vs 5.6%; OR 0.36, 95% CI: 0.19-0.69), while no benefit for US guidance was observed in the subgroup without vascular closure devices (4.1% vs 3.3%; OR 1.21, 95% CI: 0.65-2.26; interaction p=0.009). CONCLUSIONS: In participants undergoing coronary procedures by TFA, US guidance decreased the composite outcome of major vascular complications or bleeding and may be especially helpful when using vascular closure devices.

Ultrasound-guided femoral access in patients with vascular closure devices: a prespecified analysis of the randomised UNIVERSAL trial.

BACKGROUND: Whether ultrasound (US)-guided femoral access compared to femoral access without US guidance decreases access site complications in patients receiving a vascular closure device (VCD) is unclear. AIMS: We aimed to compare the safety of VCD in patients undergoing US-guided versus non-US-guided femoral arterial access for coronary procedures. METHODS: We performed a prespecified subgroup analysis of the UNIVERSAL trial, a multicentre randomised controlled trial of 1:1 US-guided femoral access versus non-US-guided femoral access, stratified for planned VCD use, for coronary procedures on a background of fluoroscopic landmarking. The primary endpoint was a composite of major Bleeding Academic Research Consortium 2, 3 or 5 bleeding and vascular complications at 30 days. RESULTS: Of 621 patients, 328 (52.8%) received a VCD (86% ANGIO-SEAL, 14% ProGlide). In patients who received a VCD, those randomised to US-guided femoral access compared to non-US-guided femoral access experienced a reduction in major bleeding or vascular complications (20/170 [11.8%] vs 37/158 [23.4%], odds ratio [OR] 0.44, 95% confidence interval [CI]: 0.23-0.82). In patients who did not receive a VCD, there was no difference between the US- and non-US-guided femoral access groups, respectively (20/141 [14.2%] vs 13/152 [8.6%], OR 1.76, 95% CI: 0.80-4.03; interaction p=0.004). CONCLUSIONS: In patients receiving a VCD after coronary procedures, US-guided femoral access was associated with fewer bleeding and vascular complications compared to femoral access without US guidance. US guidance for femoral access may be particularly beneficial when VCD are used.

Design and Rationale of Routine UltrasouNd GuIdance for Vascular AccEss foR Cardiac Procedures: A Randomized TriaL (UNIVERSAL).

Background: 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. Methods: 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%. Results: 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. Conclusions: 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.

Introduction: 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 B leeding A cademic R esearch C onsortium (BARC) ou les complications vasculaires majeures. Méthodes: L' U ltrasou n d Gu i dance for V ascular Acc e ss fo r Cardiac Procedure s : A Randomized Tria l (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 %. Résultats: 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. Conclusions: 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.

Routine Ultrasonography Guidance for Femoral Vascular Access for Cardiac Procedures: The UNIVERSAL Randomized Clinical Trial.

Importance: A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared with radial access. Strategies to make femoral access safer are needed. Objective: To determine whether routinely using ultrasonography guidance for femoral arterial access for coronary angiography/intervention reduces bleeding or vascular complications. Design, Setting, and Participants: The Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures (UNIVERSAL) randomized clinical trial is a multicenter, prospective, open-label trial of ultrasonography-guided femoral access vs no ultrasonography for coronary angiography or intervention with planned femoral access. Patients were randomized from June 26, 2018, to April 26, 2022. Patients with ST-elevation myocardial infarction were not eligible. Interventions: Ultrasonography guidance vs no ultrasonography guidance for femoral arterial access on a background of fluoroscopic landmarking. Main Outcomes and Measures: The primary composite outcome is the composite of major bleeding based on the Bleeding Academic Research Consortium 2, 3, or 5 criteria or major vascular complications within 30 days. Results: A total of 621 patients were randomized at 2 centers in Canada (mean [SD] age, 71 [10.24] years; 158 [25.4%] female). The primary outcome occurred in 40 of 311 patients (12.9%) in the ultrasonography group vs 50 of 310 patients (16.1%) without ultrasonography (odds ratio, 0.77 [95% CI, 0.49-1.20]; P = .25). The rates of Bleeding Academic Research Consortium 2, 3, or 5 bleeding were 10.0% (31 of 311) vs 10.7% (33 of 310) (odds ratio, 0.93 [95% CI, 0.55-1.56]; P = .78). The rates of major vascular complications were 6.4% (20 of 311) vs 9.4% (29 of 310) (odds ratio, 0.67 [95% CI, 0.37-1.20]; P = .18). Ultrasonography improved first-pass success (277 of 311 [86.6%] vs 222 of 310 [70.0%]; odds ratio, 2.76 [95% CI, 1.85-4.12]; P < .001) and reduced the number of arterial puncture attempts (mean [SD], 1.2 [0.5] vs 1.4 [0.8]; mean difference, -0.26 [95% CI, -0.37 to -0.16]; P < .001) and venipuncture (10 of 311 [3.1%] vs 37 of 310 [11.7%]; odds ratio, 0.24 [95% CI, 0.12-0.50]; P < .001) with similar times to access (mean [SD], 114 [185] vs 129 [206] seconds; mean difference, -15.1 [95% CI, -45.9 to 15.8]; P = .34). All prerandomization prespecified subgroups were consistent with the overall finding. Conclusions and Relevance: In this randomized clinical trial, use of ultrasonography for femoral access did not reduce bleeding or vascular complications. However, ultrasonography did reduce the risk of venipuncture and number of attempts. Larger trials may be required to demonstrate additional potential benefits of ultrasonography-guided access. Trial Registration: ClinicalTrials.gov Identifier: NCT03537118.