TY - JOUR
T1 - Influence of Bleeding Risk on Outcomes of Radial and Femoral Access for Percutaneous Coronary Intervention: An Analysis From the GLOBAL LEADERS Trial
AU - Gao, Chao
AU - Buszman, Piotr
AU - Buszman, Paweł
AU - Chichareon, Ply
AU - Modolo, Rodrigo
AU - Garg, Scot
AU - Takahashi, Kuniaki
AU - Kawashima, Hideyuki
AU - Wang, Rutao
AU - Chang, Chun Chin
AU - Kogame, Norihiro
AU - Tomaniak, Mariusz
AU - Ono, Masafumi
AU - Hara, Hironori
AU - Slagboom, Ton
AU - Aminian, Adel
AU - Naber, Christoph Kurt
AU - Carrie, Didier
AU - Hamm, Christian
AU - Steg, Philippe Gabriel
AU - Onuma, Yoshinobu
AU - Geuns, Robert-Jan van
AU - Serruys, Patrick W.
AU - Zurakowski, Aleksander
N1 - Funding Information: P.C. reports a research grant from Biosensors , outside of the submitted work. R.M. received research grants from Biosensors and SMT. C.H. received advisory Board fees from AstraZeneca. P.G.S. received grants and personal fees from Bayer/Janssen, Merck, Sanofi, and Amarin, personal fees from Amgen, Bristol Myers Squibb, Boehringer Ingelheim , Pfizer, Novartis , Regeneron, Lilly, and AstraZeneca , and grants, personal fees, and nonfinancial support from Servier, outside the submitted work. Y.O. reports being a member of advisory board of Abbott Vascular. R.-J.v.G. received speakers fees from Abbott Vascular and Boston Scientific . P.W.S. reports personal fees from Biosensors, Cardialysis, Medtronic, Micel Technologies, Sinomedical Sciences Technology, Philips/Volcano, Xeltis, and HeartFlow, outside of the submitted work. The other authors have no conflicts of interest to disclose. Funding Information: This study was sponsored by the European Cardiovascular Research Institute (Rotterdam, The Netherlands), which received funding from 1 device ( Biosensors International ) and 2 drug (Astra Zeneca and The Medicines Company) manufacturers. The study funders had no role in trial design, data collection, analysis, interpretation of the data, preparation, approval, or decision to submit the manuscript for publication. Funding Information: This study was sponsored by the European Cardiovascular Research Institute (Rotterdam, The Netherlands), which received funding from 1 device (Biosensors International) and 2 drug (Astra Zeneca and The Medicines Company) manufacturers. The study funders had no role in trial design, data collection, analysis, interpretation of the data, preparation, approval, or decision to submit the manuscript for publication.P.C. reports a research grant from Biosensors, outside of the submitted work. R.M. received research grants from Biosensors and SMT. C.H. received advisory Board fees from AstraZeneca. P.G.S. received grants and personal fees from Bayer/Janssen, Merck, Sanofi, and Amarin, personal fees from Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Pfizer, Novartis, Regeneron, Lilly, and AstraZeneca, and grants, personal fees, and nonfinancial support from Servier, outside the submitted work. Y.O. reports being a member of advisory board of Abbott Vascular. R.-J.v.G. received speakers fees from Abbott Vascular and Boston Scientific. P.W.S. reports personal fees from Biosensors, Cardialysis, Medtronic, Micel Technologies, Sinomedical Sciences Technology, Philips/Volcano, Xeltis, and HeartFlow, outside of the submitted work. The other authors have no conflicts of interest to disclose. Publisher Copyright: © 2020 Canadian Cardiovascular Society Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/1
Y1 - 2021/1
N2 - Background: Radial artery access has been shown to reduce mortality and bleeding events, especially in patients with acute coronary syndromes. Despite this, interventional cardiologists experienced in femoral artery access still prefer that route for percutaneous coronary intervention. Little is known regarding the merits of each vascular access in patients stratified by their risk of bleeding. Methods: Patients from the Global Leaders trial were dichotomized into low or high risk of bleeding by the median of the PRECISE-DAPT score. Clinical outcomes were compared at 30 days. Results: In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.42-1.15). Radial access was associated with a significantly lower rate of the secondary safety end point, Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding (HR 0.55, 95% CI 0.36-0.84). Compared by bleeding risk strata, in the high bleeding score population, the primary (HR 0.47, 95% CI 0.26-0.85; P = 0.012; Pinteraction = 0.019) and secondary safety (HR 0.57, 95% CI 0.35-0.95; P = 0.030; Pinteraction = 0.631) end points favoured radial access. In the low bleeding score population, however, the differences in the primary and secondary safety end points between radial and femoral artery access were no longer statistically significant. Conclusions: Our findings suggest that the outcomes of mortality or new Q-wave MI and BARC 3 or 5 bleeding favour radial access in patients with a high, but not those with a low, risk of bleeding. Because this was not a primary analysis, it should be considered hypothesis generating.
AB - Background: Radial artery access has been shown to reduce mortality and bleeding events, especially in patients with acute coronary syndromes. Despite this, interventional cardiologists experienced in femoral artery access still prefer that route for percutaneous coronary intervention. Little is known regarding the merits of each vascular access in patients stratified by their risk of bleeding. Methods: Patients from the Global Leaders trial were dichotomized into low or high risk of bleeding by the median of the PRECISE-DAPT score. Clinical outcomes were compared at 30 days. Results: In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.42-1.15). Radial access was associated with a significantly lower rate of the secondary safety end point, Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding (HR 0.55, 95% CI 0.36-0.84). Compared by bleeding risk strata, in the high bleeding score population, the primary (HR 0.47, 95% CI 0.26-0.85; P = 0.012; Pinteraction = 0.019) and secondary safety (HR 0.57, 95% CI 0.35-0.95; P = 0.030; Pinteraction = 0.631) end points favoured radial access. In the low bleeding score population, however, the differences in the primary and secondary safety end points between radial and femoral artery access were no longer statistically significant. Conclusions: Our findings suggest that the outcomes of mortality or new Q-wave MI and BARC 3 or 5 bleeding favour radial access in patients with a high, but not those with a low, risk of bleeding. Because this was not a primary analysis, it should be considered hypothesis generating.
UR - http://www.scopus.com/inward/record.url?scp=85089366536&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.cjca.2020.01.029
DO - https://doi.org/10.1016/j.cjca.2020.01.029
M3 - Article
C2 - 32450057
SN - 0828-282X
VL - 37
SP - 122
EP - 130
JO - Canadian Journal of Cardiology
JF - Canadian Journal of Cardiology
IS - 1
ER -