Circulation. Cardiovascular interventions · 2024
Enhancing Guidewire Efficacy for Transradial Access: The EAGER Randomized Controlled Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Bland Adam C, Meere William, Mikhail Philopatir, Chuah Eunice, Redwood Eleanor, Ferreira David, Howden Nicklas, Perkovic Adam, Saunders Samantha L, Kelty Amy, Kull Tony, Hill Andrew, Spina Roberto, Sarathy Kiran, May Austin, Parkinson Michael, Ishak Mark, Collins Nicholas, Boyle Andrew, William Maged, Jeyaprakash Prajith, Ford Tom J
Аннотация
BACKGROUND: The 1.5 mm Baby J hydrophilic narrow J-tipped wire is a development of the standard 0.035" 3-mm J-tipped peripheral guidewire, designed to improve efficiency of transradial coronary procedures by safely navigating small caliber radial arteries to the aorta. There is currently a lack of evidence comparing the procedural success and safety of different peripheral guidewires used in transradial cardiac procedures. We compared the efficacy and safety of a narrow J-tipped hydrophilic 0.035" wire (intervention, Radifocus Baby J guidewire; TERUMO Co, Tokyo, Japan) versus a standard fixed-core 0.035" J wire (control).
METHODS: Investigator-initiated, blinded, Australian, multicenter randomized trial in patients undergoing clinically indicated coronary angiography or percutaneous coronary intervention. Patients were randomized 1:1 to use either the control guidewire or the intervention guidewire. The primary end point (technical success) was defined as gaining aortic root access with the randomized guidewire.
RESULTS: In all, 330 patients were randomized between October 2022 and June 2023 (median age was 69 years, 36% were female, and body mass index was 29 kg/m2). The primary end point was achieved more frequently in the intervention group (96% versus 84%; absolute risk reduction 12% [95% CI, 5.7-18.3]; P<0.001). Women assigned to the control wire experienced a higher failure rate compared with men (31% versus 8% in men; P<0.001). Fluoroscopy time was significantly lower in the Baby J group (median, 344 versus 491 seconds; P=0.024). The main mechanisms of failure using the control wire were radial artery spasm (15/26; 57%) and subclavian tortuosity (5/26; 19.2%). There were no differences in overall procedure times, major adverse cardiovascular events, or vascular complications between guidewires.
CONCLUSIONS: A narrow 1.5 mm J-tipped hydrophilic guidewire resulted in greater technical success and reduced fluoroscopy time compared with the standard 3-mm J-tipped nonhydrophilic guidewire. The guidewire is safe and demonstrated key incremental benefits for the transradial approach, particularly in women.
REGISTRATION: URL: https://www.anzctr.org.au/; Unique identifier: ACTRN12622001557729.
METHODS: Investigator-initiated, blinded, Australian, multicenter randomized trial in patients undergoing clinically indicated coronary angiography or percutaneous coronary intervention. Patients were randomized 1:1 to use either the control guidewire or the intervention guidewire. The primary end point (technical success) was defined as gaining aortic root access with the randomized guidewire.
RESULTS: In all, 330 patients were randomized between October 2022 and June 2023 (median age was 69 years, 36% were female, and body mass index was 29 kg/m2). The primary end point was achieved more frequently in the intervention group (96% versus 84%; absolute risk reduction 12% [95% CI, 5.7-18.3]; P<0.001). Women assigned to the control wire experienced a higher failure rate compared with men (31% versus 8% in men; P<0.001). Fluoroscopy time was significantly lower in the Baby J group (median, 344 versus 491 seconds; P=0.024). The main mechanisms of failure using the control wire were radial artery spasm (15/26; 57%) and subclavian tortuosity (5/26; 19.2%). There were no differences in overall procedure times, major adverse cardiovascular events, or vascular complications between guidewires.
CONCLUSIONS: A narrow 1.5 mm J-tipped hydrophilic guidewire resulted in greater technical success and reduced fluoroscopy time compared with the standard 3-mm J-tipped nonhydrophilic guidewire. The guidewire is safe and demonstrated key incremental benefits for the transradial approach, particularly in women.
REGISTRATION: URL: https://www.anzctr.org.au/; Unique identifier: ACTRN12622001557729.