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https://orcid.org/0000-0003-4395-6742
Department of Advanced Biomedical Sciences, University Federico II of Naples, Italy (G.G., G.E.).
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https://orcid.org/0000-0001-9008-3011
Cardiology Department, Alto Vicentino Hospital, Santorso, Italy (DG).
Cardiovascular Research Institute, Mater Private Hospital, Royal College of Surgeons in Ireland, Dublin (D.G.).
ISA Research Center, German Heart Center Munich, Technical University of Munich, Germany (DG).
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https://orcid.org/0000-0003-2329-2504
Population Health Research Institute, McMaster University and Hamilton Health Sciences, Canada (S.S.J., S.R.M.).
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https://orcid.org/0000-0001-8875-8841
University of British Columbia, Vancouver, Canada (J.C.).
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https://orcid.org/0000-0002-4643-1709
Department of Medicine, University of Ottawa Heart Institute, Canada (M.L.M., G.A.W.).
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https://orcid.org/0000-0003-3142-7667
University Hospital and Faculty of Medicine Pilsen, Charles University, Czech Republic (I.B.).
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https://orcid.org/0000-0003-1611-7708
Agostino Gemelli University Hospital Foundation, IRCCS, Rome, Italy (ER).
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https://orcid.org/0000-0003-2914-0894
The Duke Clinical Research Institute, Durham, NC (S.V.R.).
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https://orcid.org/0000-0002-9609-3728
Department of Cardiology, Isala Heart Center, Zwolle, The Netherlands (M.A.H.v.L., T.A.M.).
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https://orcid.org/0000-0003-3258-949X
Population Health Research Institute, McMaster University and Hamilton Health Sciences, Canada (S.S.J., S.R.M.).
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Quebec Heart and Lung Institute, Quebec City, Canada (O.F.B.).
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Department of Medicine, University of Ottawa Heart Institute, Canada (M.L.M., G.A.W.).
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https://orcid.org/0000-0002-4298-1607
Department of Cardiology, Isala Heart Center, Zwolle, The Netherlands (M.A.H.v.L., T.A.M.).
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https://orcid.org/0000-0003-2128-9205
Department of Cardiology, University Hospital of Bern, Switzerland (G.C.M.S., S.W., M.V.).
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https://orcid.org/0000-0003-0565-7127
Department of Advanced Biomedical Sciences, University Federico II of Naples, Italy (G.G., G.E.).
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https://orcid.org/0000-0003-2653-6762
Department of Cardiology, University Hospital of Bern, Switzerland (G.C.M.S., S.W., M.V.).
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https://orcid.org/0000-0002-5985-0670
Applied Health Research Center, Li Ka Shing Knowledge Institute, St Michael’s Hospital, and Department of Medicine, University of Toronto, Canada (P.J.).
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Correspondence to: Marco Valgimigli, MD, PhD, Division of Cardiology, Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Via Tesserete, 48, CH-6900, University of Italian Switzerland (USI), Lugano, Switzerland.E-mail
Department of Cardiology, University Hospital of Bern, Switzerland (G.C.M.S., S.W., M.V.).
Division of Cardiology, Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale (EOC), Lugano, Switzerland (MV).
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In some randomized clinical trials, transradial access (TRA) compared with transfemoral access (TFA) was associated with lower mortality in patients with coronary artery disease undergoing invasive management. We analyzed the effects of TRA versus TFA across multicenter randomized clinical trials and whether these associations are modified by patient or procedural characteristics.
We performed an individual patient data meta-analysis of multicenter randomized clinical trials comparing TRA with TFA among patients undergoing coronary angiography with or without percutaneous coronary intervention. The primary outcome was all-cause mortality and the co–primary outcome was major bleeding at 30 days. The primary analysis was conducted by 1-stage mixed-effects models on the basis of the intention-to-treat cohort. The effect of access site on mortality and major bleeding was assessed further by multivariable analysis. The relationship among access site, bleeding, and mortality was investigated by natural effect model mediation analysis with multivariable adjustment.
A total of 21 600 patients (10 775 TRA, 10 825 TFA) from 7 randomized clinical trials were included. The median age was 63.9 years, 31.9% were women, 95% presented with acute coronary syndrome, and 75.2% underwent percutaneous coronary intervention. All-cause mortality (1.6% versus 2.1%; hazard ratio, 0.77 [95% CI, 0.63–0.95]; P=0.012) and major bleeding (1.5% versus 2.7%; odds ratio, 0.55 [95% CI, 0.45–0.67]; P<0.001) were lower with TRA. Subgroup analyses for mortality showed consistent results, except for baseline hemoglobin level (Pinteraction=0.003), indicating that the benefit of TRA was substantial in patients with moderate or severe anemia, whereas it was not significant in patients with milder or no baseline anemia. After adjustment, TRA remained associated with 24% and 51% relative risk reduction of all-cause mortality and major bleeding, respectively. A mediation analysis showed that the benefit of TRA on mortality was only partially driven by major bleeding prevention and ancillary mechanisms are required to fully explain the causal association.
TRA is associated with lower all-cause mortality and major bleeding at 30 days compared with TFA. The effect on mortality was driven by patients with anemia. The reduction in major bleeding only partially explains the mortality benefit.
URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42018109664.
*G. Gargiulo and D. Giacoppo contributed equally.
Circulation is available at www.ahajournals.org/journal/circ
This work was presented as an abstract at the ESC Congress, August 26-29, 2022, in Barcelona, Spain.
Supplemental Material is available at https://www.ahajournals.org/doi/suppl/10.1161/CIRCULATIONAHA.122.061527.
For Sources of Funding and Disclosures, see page 1342.
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