TY - JOUR
T1 - Real-world management and outcomes of 7 million patients with acute coronary syndrome according to clinical research trial enrolment status
T2 - a propensity matched analysis
AU - Matetic, Andrija
AU - O.Mohamed, Mohamed
AU - Roberts, Derek J.
AU - Rana, Jamal S.
AU - Alraies, M. Chadi
AU - Patel, Brijesh
AU - Sauer, Andrew J.
AU - Diaz-Arocutipa, Carlos
AU - Sattar, Yasar
AU - Van Spall, Harriette G.C.
AU - Mamas, Mamas A.
N1 - Publisher Copyright:
© 2022 The Author(s).
PY - 2022/7/1
Y1 - 2022/7/1
N2 - Aims: We aimed to determine whether clinical outcomes and invasive care of acute coronary syndrome (ACS) patients participating in trials differed from those of non-participants, particularly including those who were trial eligible. Methods and results: We included all hospitalizations with a principal diagnosis of ACS in the US National Inpatient Sample between January 2004 and September 2015, stratified by trial enrolment and eligibility using the International Classification of Diseases, ninth revision. We conducted propensity score matching to investigate the following outcomes: all-cause mortality; major bleeding; stroke; composite of mortality, stroke, and cardiac complications [major adverse cardiovascular and cerebrovascular events (MACCEs)]; coronary angiography (CA); and percutaneous coronary intervention (PCI). A total of 7 091 179 weighted ACS hospitalizations were analysed, including 19 684 (0.3%) trial participants and 7 071 495 non-participants (3 485 514 of whom were trial eligible). Trial participants were more likely to receive CA [Δ% 28.73%, 95% confidence interval (CI) 27.22-30.24, P < 0.001] and PCI (Δ% 27.13%, 95% CI 24.86-29.41, P < 0.001), with decreased mortality (Δ% -3.51%, 95% CI -4.72 to -2.31, P < 0.001), MACCEs (Δ% -3.04%, 95% CI -4.55 to -1.53, P < 0.001), and bleeding (Δ% -0.89%, 95% CI -1.59 to -0.19, P = 0.013) compared with non-participants. After accounting for eligibility, trial participants were more likely to undergo CA (Δ% 22.78%, 95% CI 21.58-23.99, P < 0.001) and PCI (Δ% 23.95%, 95% CI 21.77-26.13, P < 0.001), and had no difference in mortality (Δ% -0.21%, 95% CI -0.65 to 0.24, P = 0.362). Conclusion: Among ACS patients, trial enrolment was associated with significantly greater invasive care and lower mortality than among matched non-participants. Trial participants were more likely to be invasively managed even when compared with eligible non-participants, even though there was no difference in mortality.
AB - Aims: We aimed to determine whether clinical outcomes and invasive care of acute coronary syndrome (ACS) patients participating in trials differed from those of non-participants, particularly including those who were trial eligible. Methods and results: We included all hospitalizations with a principal diagnosis of ACS in the US National Inpatient Sample between January 2004 and September 2015, stratified by trial enrolment and eligibility using the International Classification of Diseases, ninth revision. We conducted propensity score matching to investigate the following outcomes: all-cause mortality; major bleeding; stroke; composite of mortality, stroke, and cardiac complications [major adverse cardiovascular and cerebrovascular events (MACCEs)]; coronary angiography (CA); and percutaneous coronary intervention (PCI). A total of 7 091 179 weighted ACS hospitalizations were analysed, including 19 684 (0.3%) trial participants and 7 071 495 non-participants (3 485 514 of whom were trial eligible). Trial participants were more likely to receive CA [Δ% 28.73%, 95% confidence interval (CI) 27.22-30.24, P < 0.001] and PCI (Δ% 27.13%, 95% CI 24.86-29.41, P < 0.001), with decreased mortality (Δ% -3.51%, 95% CI -4.72 to -2.31, P < 0.001), MACCEs (Δ% -3.04%, 95% CI -4.55 to -1.53, P < 0.001), and bleeding (Δ% -0.89%, 95% CI -1.59 to -0.19, P = 0.013) compared with non-participants. After accounting for eligibility, trial participants were more likely to undergo CA (Δ% 22.78%, 95% CI 21.58-23.99, P < 0.001) and PCI (Δ% 23.95%, 95% CI 21.77-26.13, P < 0.001), and had no difference in mortality (Δ% -0.21%, 95% CI -0.65 to 0.24, P = 0.362). Conclusion: Among ACS patients, trial enrolment was associated with significantly greater invasive care and lower mortality than among matched non-participants. Trial participants were more likely to be invasively managed even when compared with eligible non-participants, even though there was no difference in mortality.
KW - Acute coronary syndrome
KW - Management
KW - Outcomes
KW - Trial enrolment
UR - http://www.scopus.com/inward/record.url?scp=85131701442&partnerID=8YFLogxK
U2 - 10.1093/ehjqcco/qcab098
DO - 10.1093/ehjqcco/qcab098
M3 - Artículo
C2 - 34940843
AN - SCOPUS:85131701442
SN - 2058-5225
VL - 8
SP - 409
EP - 419
JO - European Heart Journal - Quality of Care and Clinical Outcomes
JF - European Heart Journal - Quality of Care and Clinical Outcomes
IS - 4
ER -
