Yanming Fan1, Qingmin Wei1, Junna Cai1, Yanbo Wang2, Xianghua Fu3. 1. Xingtai People's hospital. 2. The Second Hospital of Hebei Medical University. 3. The Second Hospital of Hebei Medical University. fuxh999@163.com.
Abstract
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.
RCT Entities:
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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