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. 2024 Mar 18;20(6):e363–e375. doi: 10.4244/EIJ-D-23-00779

Table 3. In-hospital outcomes and complications.

Variable ACURATE (n=251) EVOLUT (n=584) p-value ACURATE (n=234) EVOLUT (n=234) p-value
Mean gradient post-intervention, mmHg 13.0 [9.0; 19.0]; 249 13.0 [9.0; 18.0]; 561 0.376 13.0 [9.0; 19.0] 12.0 [9.0; 16.0] 0.193
EOA post-intervention, cm2 1.5 [1.3; 1.7]; 187 1.5 [1.3; 1.9]; 250 0.021 1.5 [1.3; 1.7] 1.5 [1.4; 2.0] 0.022
Severe PPM 30/181 (16.6) 35/249 (14.1) 0.472 28 (16.6) 10 (9.8) 0.149
AR ≥moderate 6/249 (2.4) 17/574 (3.0) 0.659 6 (2.6) 4 (1.7) 0.532
Technical success (VARC-3) 229 (91.2) 521 (89.2) 0.375 217 (92.7) 208 (88.9) 0.200
Device success (VARC-3) 171 (68.1) 402 (68.8) 0.840 163 (69.7) 173 (73.9) 0.355
Coronary occlusion requiring PCI 13 (5.2) 24 (4.1) 0.491 9 (3.8) 11 (4.7) 0.820
Myocardial infarction 1 (0.4) 4 (0.7) 0.623 0 2 (0.9) 0.499
Annular rupture 0 1 (0.2) 0.512 0 1 (0.4) >0.99
Conversion to sternotomy 1 (0.4) 2 (0.3) 0.901 1 (0.4) 0 >0.99
Multiple valve implantation 4 (1.6) 8 (1.4) 0.803 4 (1.7) 4 (1.7) >0.99
Malpositioning 6 (3.1) 18 (3.1) 0.936 7 (3.0) 5 (2.1) 0.771
Major vascular complication 14 (5.6) 36 (6.2) 0.743 12 (5.1) 11 (4.7) >0.99
Type 3-4 bleeding 10 (4.2) 30 (5.1) 0.474 8 (3.4) 13 (5.6) 0.372
Any stroke 4 (1.6) 11 (1.9) 0.770 4 (1.7) 6 (2.6) 0.751
Acute kidney injury stage 3-4 5 (2.0) 23 (4.0) 0.152 4 (1.7) 6 (2.6) 0.751
Pacemaker implantation 2 (0.8) 17 (2.9) 0.060 2 (0.9) 6 (2.6) 0.285
Values denote n (%), n/N (%), or median [IQR]. ACURATE: ACURATE neo/neo2 group; AR: aortic regurgitation; EOA: effective orifice area; EVOLUT: Evolut R/PRO/PRO+ group; IQR: interquartile range; PCI: percutaneous coronary intervention; PPM: prosthesis-patient mismatch; VARC: Valvular Academic Research Consortium