TY - JOUR
T1 - Prevalence of the Academic Research Consortium high bleeding risk criteria in patients undergoing endovascular therapy for peripheral artery disease in lower extremities
AU - Hashimoto, Ryota
AU - Numasawa, Yohei
AU - Yokokura, Souichi
AU - Daigo, Kyohei
AU - Sakata, Shingo
AU - Imaeda, Shohei
AU - Hitomi, Yasuhiro
AU - Sato, Kazuki
AU - Taruoka, Akira
AU - Haginiwa, Sho
AU - Kojima, Hidenori
AU - Tanaka, Makoto
AU - Kuno, Toshiki
AU - Kodaira, Masaki
N1 - Funding Information:
We thank Hanne Gadeberg, PhD, and Emily Woodhouse, PhD, from Edanz Group (https://en-author-services.edanzgroup.com/ac) for editing a draft of this manuscript.
Publisher Copyright:
© 2021, Springer Japan KK, part of Springer Nature.
PY - 2021/9
Y1 - 2021/9
N2 - The Academic Research Consortium (ARC) recently published a definition of patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention. However, the prevalence of the ARC-HBR criteria in patients undergoing endovascular therapy (EVT) for peripheral artery disease in lower extremities has not been thoroughly investigated. This study sought to investigate the prevalence and impact of the ARC-HBR criteria in patients undergoing EVT. We analyzed 277 consecutive patients who underwent their first EVT from July 2011 to September 2019. We applied the full ARC-HBR criteria to the study population. The primary end point was a composite outcome of all-cause mortality, Bleeding Academic Research Consortium 3 or 5 bleeding, and lower limb amputation within 12 months of EVT. Among the 277 patients, 193 (69.7%) met the ARC-HBR criteria. HBR patients had worse clinical outcomes compared with non-HBR patients at 12 months after EVT, including a higher incidence of the composite primary outcome (19.2% vs. 3.6%, p < 0.001) and all-cause death (7.8% vs. 0%, p = 0.007). In a multivariate Cox proportional hazards regression analysis, presence of the ARC-HBR criteria [hazard ratio (HR) 4.15, 95% confidence interval (CI) 1.25–13.80, p = 0.020], body mass index (HR 1.13, 95% CI 1.01–1.27, p = 0.042), diabetes mellitus (HR 2.70, 95% CI 1.28–5.69, p = 0.009), hyperlipidemia (HR 0.41, 95% CI 0.21–0.80, p = 0.009), and infrapopliteal lesions (HR 3.51, 95% CI 1.63–7.56, p = 0.001) were independent predictors of the primary composite outcome. Approximately 70% of Japanese patients undergoing EVT met the ARC-HBR criteria, and its presence was strongly associated with adverse outcomes within 12 months of EVT.
AB - The Academic Research Consortium (ARC) recently published a definition of patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention. However, the prevalence of the ARC-HBR criteria in patients undergoing endovascular therapy (EVT) for peripheral artery disease in lower extremities has not been thoroughly investigated. This study sought to investigate the prevalence and impact of the ARC-HBR criteria in patients undergoing EVT. We analyzed 277 consecutive patients who underwent their first EVT from July 2011 to September 2019. We applied the full ARC-HBR criteria to the study population. The primary end point was a composite outcome of all-cause mortality, Bleeding Academic Research Consortium 3 or 5 bleeding, and lower limb amputation within 12 months of EVT. Among the 277 patients, 193 (69.7%) met the ARC-HBR criteria. HBR patients had worse clinical outcomes compared with non-HBR patients at 12 months after EVT, including a higher incidence of the composite primary outcome (19.2% vs. 3.6%, p < 0.001) and all-cause death (7.8% vs. 0%, p = 0.007). In a multivariate Cox proportional hazards regression analysis, presence of the ARC-HBR criteria [hazard ratio (HR) 4.15, 95% confidence interval (CI) 1.25–13.80, p = 0.020], body mass index (HR 1.13, 95% CI 1.01–1.27, p = 0.042), diabetes mellitus (HR 2.70, 95% CI 1.28–5.69, p = 0.009), hyperlipidemia (HR 0.41, 95% CI 0.21–0.80, p = 0.009), and infrapopliteal lesions (HR 3.51, 95% CI 1.63–7.56, p = 0.001) were independent predictors of the primary composite outcome. Approximately 70% of Japanese patients undergoing EVT met the ARC-HBR criteria, and its presence was strongly associated with adverse outcomes within 12 months of EVT.
KW - Endovascular therapy
KW - High bleeding risk
KW - Percutaneous coronary intervention
KW - Peripheral artery disease
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U2 - 10.1007/s00380-021-01813-2
DO - 10.1007/s00380-021-01813-2
M3 - Article
C2 - 33651134
AN - SCOPUS:85102083721
SN - 0910-8327
VL - 36
SP - 1350
EP - 1358
JO - Heart and vessels
JF - Heart and vessels
IS - 9
ER -