23 Generalizability of HFrEF trials Table 1 (continued). Characteristics of HFrEF patients by RCT and registry groups Registry population RCT vs RCT-eligible RCT population N= 16 922 RCT- eligible N= 26 104 (56%) RCT-noneligible N=20 810 (44%) Difference in mean or proportion (99% CI) p-value b NYHA Functional Class – no (%) I 3 (0.02%) 0 (0%) 4459 (21%) - *** II 10 394 (61%) 14 478 (55%) 7231 (35%) III 6422 (38%) 10 623 (41%) 7673 (37%) IV 113 (1%) 1003 (4%) 1447 (7%) Medical history – no (%) Hypertension 11 517(68%) 14 654 (56%) 11 505 (55%) 11.9% (10.7%, 13.2%) *** Diabetes mellitus 5711 (34%) 7083 (27%) 5649 (27%) 6.6% (5.4%, 7.8%) *** Coronary artery disease 14 541 (86%) 11 916 (52%) a 9497 (55%) a 33.8% (32.7%, 34.9%) *** History of MI 5721 (34%) 8120 (31%) 6776 (33%) 2.7% (1.5%, 3.9%) *** Atrial fibrillation 449 (38%) c 12563 (48%) 10014 (48%) -10.4% (-14.1% -6.7%) *** Valvular disease 2009 (12%) 5616 (22%) 5280 (25%) -10.7% (-11.7%, -9.8%) *** Stroke/ TIA 1564 (9%) 3220 (14%) a 3067 (18%) a -4.8% (-5.7%, -4.0%) *** Anaemia 588 (3%) 6611 (25%) 9064 (44%) -21.8% (-22.6%, -21.1%) *** COPD 1482 (9%) 5084 (19%) 4417 (21%) -10.7% (-11.6%, -9.9%) *** Depression 451 (3%) 1117 (5%) a 894 (5%) a -2.2% (-2.7%, -1.7%) *** Cancer 462 (3%) 0 (0%) 6710 (32%) 2.7% (2.4%, 3.1%) *** Coronary revascularisation PCI 1538 (9%) 1994 (8%) 1528 (7%) - *** CABG 1029 (6%) 3038 (12%) 2609 (13%) PCI + CABG 236 (1%) 2913 (11%) 2020 (10%) 2.1
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