TY - JOUR
T1 - Transradial Access for High-Risk Percutaneous Coronary Intervention
T2 - Implications of the Risk-Treatment Paradox
AU - Amin, Amit P.
AU - Rao, Sunil V.
AU - Seto, Arnold H.
AU - Thangam, Manoj
AU - Bach, Richard G.
AU - Pancholy, Samir
AU - Gilchrist, Ian C.
AU - Kaul, Prashant
AU - Shah, Binita
AU - Cohen, Mauricio G.
AU - Gluckman, Ty J.
AU - Bortnick, Anna
AU - Devries, James T.
AU - Kulkarni, Hemant
AU - Masoudi, Frederick A.
N1 - Funding Information:
Funding for this study was provided by an unrestricted grant by Terumo Corporation, Value-driven PCI. However, no sponsor participated in the concept, design and conduct of the study, collection, analysis, or interpretation of the data, nor in the preparation, review, nor approval of the article.
Funding Information:
Dr Amin has been funded via a comparative effectiveness research KM1 career development award from the Clinical and Translational Science Award program of the National Center for Advancing Translational Sciences of the National Institutes of Health (NIH), Grant Numbers UL1TR000448, KL2TR000450, TL1TR000449 and the National Cancer Institute of the NIH, Grant Number 1KM1CA156708-01; an AHRQ R18 grant award (Grant Number R18HS0224181-01A1), and is a consultant to Terumo. Drs Amin and Kulkarni had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Dr Shah receives grant funding from the VA Office of Research and Development (iK2CX001074) and NIH National Heart Lung Blood Institute (1R01HL146206); serves on the advisory board for Philips Volcano and Radux Technology; and serves as a consultant for Terumo Medical. Dr Cohen is a consultant for Abiomed, Zoll, AstraZeneca, Merit Medical, Terumo Medical. Ownership shares in Accumed Radial Systems. Dr Seto is a consultant for Terumo. Dr Masoudi has an institutional contract with the American College of Cardiology for his role as Chief Scientific Advisor, National Cardiovascular Data Registry. The other authors report no conflicts.
Publisher Copyright:
© 2021 Lippincott Williams and Wilkins. All rights reserved.
PY - 2021/7/1
Y1 - 2021/7/1
N2 - Background: Transradial percutaneous coronary intervention (PCI; TRI) reduces adverse outcomes when compared with transfemoral PCI (TFI). However, TRI is also used less in high-risk patients. It remains unknown how baseline patient risk influences access-site choice among PCI operators and whether the absolute benefit of TRI is greater among patients at high risk for bleeding, acute kidney injury (AKI), and death. Methods: We analyzed 28 005 PCIs performed in a 7-hospital system between July, 01, 2009 and April 30, 2018, to assess the choice of access-site (TRI versus TFI) as a function of baseline risk for bleeding, AKI, and death, and examined whether the association between TRI use (versus TFI) and in-hospital outcomes is influenced by baseline risk. Results: Among 28 005 PCIs, over a 9-year period, TRI increased over time, however, a risk-Treatment paradox for TRI use was observed not only for bleeding risk, but also AKI, and mortality risks, where TRI use was lower in those at highest risk. Operator variability with TRI was large. The incidences of bleeding, AKI, and death were higher with TFI versus TRI. The absolute risk difference between TRI and TFI increased with increasing baseline risk. The number needed to treat to prevent one adverse event with TRI (versus TFI) in low-, moderate-And high-risk groups, respectively, was 259, 82, and 32 for bleeding; 194, 53, and 40 for AKI; and 957, 78, and 18 for death. Conclusions: This analysis of a large multicenter cohort of patients with PCI demonstrates a risk-Treatment paradox for TRI use, not only for bleeding, but also for AKI and death. Despite this, a greater absolute risk difference favoring TRI was observed among patients with the highest baseline risk. Addressing the risk-Treatment paradox by preferentially selecting TRI across the spectrum of risk, but especially high-risk cases, may be an important potential strategy for improving outcomes with PCI.
AB - Background: Transradial percutaneous coronary intervention (PCI; TRI) reduces adverse outcomes when compared with transfemoral PCI (TFI). However, TRI is also used less in high-risk patients. It remains unknown how baseline patient risk influences access-site choice among PCI operators and whether the absolute benefit of TRI is greater among patients at high risk for bleeding, acute kidney injury (AKI), and death. Methods: We analyzed 28 005 PCIs performed in a 7-hospital system between July, 01, 2009 and April 30, 2018, to assess the choice of access-site (TRI versus TFI) as a function of baseline risk for bleeding, AKI, and death, and examined whether the association between TRI use (versus TFI) and in-hospital outcomes is influenced by baseline risk. Results: Among 28 005 PCIs, over a 9-year period, TRI increased over time, however, a risk-Treatment paradox for TRI use was observed not only for bleeding risk, but also AKI, and mortality risks, where TRI use was lower in those at highest risk. Operator variability with TRI was large. The incidences of bleeding, AKI, and death were higher with TFI versus TRI. The absolute risk difference between TRI and TFI increased with increasing baseline risk. The number needed to treat to prevent one adverse event with TRI (versus TFI) in low-, moderate-And high-risk groups, respectively, was 259, 82, and 32 for bleeding; 194, 53, and 40 for AKI; and 957, 78, and 18 for death. Conclusions: This analysis of a large multicenter cohort of patients with PCI demonstrates a risk-Treatment paradox for TRI use, not only for bleeding, but also for AKI and death. Despite this, a greater absolute risk difference favoring TRI was observed among patients with the highest baseline risk. Addressing the risk-Treatment paradox by preferentially selecting TRI across the spectrum of risk, but especially high-risk cases, may be an important potential strategy for improving outcomes with PCI.
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U2 - 10.1161/CIRCINTERVENTIONS.120.009328
DO - 10.1161/CIRCINTERVENTIONS.120.009328
M3 - Article
C2 - 34253050
AN - SCOPUS:85111077901
SN - 1941-7640
VL - 14
SP - E009328
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
IS - 7
ER -