Key result
A 7-Fr sheath does not increase 1-year radial artery occlusion versus a 6-Fr sheath.
Why the study?
The study was designed to explore the impact of 6-Fr versus 7-Fr sheaths on the incidence of long-term radial artery occlusion following trans-radial coronary intervention.
Does a 7-French sheath increase the incidence of radial artery occlusion at 1 year compared to a 6-French sheath in patients undergoing trans-radial coronary intervention?
RCT (n=214)
Single-blind (outcome assessor blinded)
Computer-generated random numbers in a 1:1 ratio
No
Does a 7-French sheath increase the incidence of radial artery occlusion at 1 year compared to a 6-French sheath in patients undergoing trans-radial coronary intervention?
Absolute Event Rate: 12.84% vs 8.57%
p-value: p=0.313
The use of a 7-French sheath for trans-radial coronary intervention does not significantly increase the long-term risk of radial artery occlusion compared to a 6-French sheath.
Supports 7-Fr sheath use in transradial PCI without added 1-year radial occlusion risk; extends randomized safety data on sheath size.
BACKGROUND: The aim of this study was to explore the impact of 6-Fr and 7-Fr sheaths on the incidence of long-term radial artery occlusion (RAO) after trans-radial coronary intervention (TRI). METHODS: From September 2013 to January 2016, patients with ischemic heart disease including acute myocardial infarction and true bifurcation lesions were randomly assigned to 6-Fr group and 7-Fr group immediately after coronary angiography in a 1:1 ratio. The radial artery diameters were observed by ultrasound examination one day prior to TRI as well as at 30 days and 1 year after TRI. The primary endpoint was the incidence of RAO at 1-year after TRI. The secondary endpoints were the incidence of local vascular complications during hospitalization and changes of radial artery diameters within 1-year after TRI between the two groups. Additionally, multivariate logistic regression analysis was used to explore potential factors related to the incidence of long-term RAO after TRI. RESULTS: A total of 214 patients were enrolled and randomly assigned to 6-Fr group (n = 105) or 7-Fr group (n = 109). There was no significant difference in the incidence of RAO at 1-year after TRI (8.57% vs. 12.84%, p = 0.313). Moreover, no significant difference was observed in the incidence of local vascular complications during hospitalization (20% vs. 24.77%, p = 0.403). After 1-year follow-up, no significant difference was found in radial artery diameters (2.63 ± 0.31 mm vs. 2.64 ± 0.27 mm, p = 0.802). Multivariate logistic analysis revealed that repeated TRI was an independent risk factor of long-term RAO 1 year after TRI (OR = 10.316, 95% CI 2.928-36.351, p = 0.001). CONCLUSIONS: Compared to 6-Fr sheath, 7-Fr sheath did not increase short-term or long-term incidence of RAO after TRI.
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Fan et al. (2019) conducted an RCT in Ischemic heart disease with true bifurcation lesions (n=214). 7-Fr sheath vs. 6-Fr sheath was evaluated on Incidence of radial artery occlusion (RAO) at 1-year after trans-radial coronary intervention (p=0.313). The use of a 7-Fr sheath did not significantly increase the incidence of radial artery occlusion at 1 year compared to a 6-Fr sheath (12.84% vs. 8.57%, p=0.313) in patients undergoing trans-radial coronary intervention.
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