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Results from the UNIVERSAL Trial Presented at TCT and Simultaneously Published in JAMA Cardiology

BOSTON – September 18, 2022 – Results from one of the largest multicenter randomized trials comparing ultrasound with fluoroscopic guidance (US) versus fluoroscopic guidance alone during vascular femoral access for patients undergoing cardiac procedures did not reduce vascular complications or bleeding but it did lower the number of attempts and venipuncture. However, in patients receiving vascular closure devices, US did reduce vascular complications and bleeding.

Findings were reported today at TCT 2022, the 34^th annual scientific symposium of the Cardiovascular Research Foundation (CRF). TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

Although transradial access for cardiac procedures reduces bleeding at the access site by more than 60%, femoral access is still needed for large bore procedures and patients with small or occluded radial arteries. The rate of femoral vascular complications remains high in this subgroup of patients and previous randomized trials of ultrasound (US) guidance have shown mixed results.

Between June 26, 2018, and April 26, 2022, 621 patients were randomized 1:1 at two centers in Canada. Patients with ST-elevation myocardial infarction were not eligible to participate. The trial population had a high rate of comorbidities including 51% of which had a prior myocardial infarction, 42% had diabetes, 45% had prior percutaneous coronary intervention (PCI), 57% had previous coronary bypass surgery, 19% had atrial fibrillation, and 18% had peripheral vascular disease. For the index procedure, 80% were 6 French, 42% underwent PCI, 14% underwent chronic total occlusion (CTO) PCI and closure devices were used in 52.1% of patients.

The primary outcome, defined as the composite of major vascular complications or major bleeding based on Bleeding Academic Research Consortium (BARC) 2, 3, or 5 criteria within 30 days, occurred in 40 of 311 patients (12.9%) in the ultrasonography group versus 50 of 310 patients (16.1%) without ultrasonography (odds ratio, 0.77 [95% CI, 0.49-1.20]; p=.25). The key secondary outcome of the rates of BARC 2, 3, or 5 bleeding were 10.0% (31 of 311) versus 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).

The study also found that 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.

In the pre-specified subgroup analysis, patients who had a closure device had a significant benefit for US (OR 0.44 95% CI 0.23-0.82, interaction p=0.004). This makes sense as US avoids multiple punctures and allows the operator to choose a site free of disease or calcium.

An updated meta-analysis of all the available trials including UNIVERSAL with more than 4,000 patients shows that US reduces major bleeding and vascular complications (RR 0.58; 95% CI 0.43-0.76).

“Although ultrasonography guidance for femoral access did not reduce the primary events of bleeding or vascular complications, some benefits were identified,” said Sanjit S. Jolly, MD, MSc, Interventional Cardiologist with Hamilton Health Sciences and Professor of Medicine at McMaster University. “Ultrasonography did improve first-pass success and reduced the number of attempts as well as the risk of venipuncture. Therefore, larger trials may be able to identify additional benefits for this technique.”

“We need to put this into perspective because ultrasonography has no risks and is low cost, and so we need to focus on training. Finally, transradial access remains the best way to prevent femoral access bleeding”.

The study was funded by Hamilton Health Sciences Foundation and McMaster Cardiology program.

Dr. Jolly reported the following disclosures: grant/research support from Boston Scientific and consulting fees/honoraria from Medtronic and Penumbra.

About CRF and TCT

The Cardiovascular Research Foundation (CRF) is one of the world’s leading nonprofit organizations specializing in interventional cardiology innovation, research, and education. CRF is dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 30 years, CRF has helped accelerate medical breakthroughs and educated doctors on the latest treatments for heart disease. CRF’s centers of excellence include the CRF Skirball Center for Innovation, CRF Clinical Trials Center, CRF Center for Education, CRF Digital, TCTMD, and Structural Heart: The Journal of the Heart Team.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the premier educational meeting specializing in interventional cardiovascular medicine. Now in its 34^th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.

For more information, visit www.crf.org and www.tctconference.com.

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