Seal-wing PEB | Iopromide-coated PEB | EES | p | ||
---|---|---|---|---|---|
Seal-wing vs. iopromide- PEB | Seal-wing PEB vs. EES | ||||
Demographic parameters | |||||
Patients/ ISR lesions, n | 64/69 | 68/74 | 68/74 | ||
Male/female | 49 (76.56%)/ | 43 (63.24%)/ | 46 (67.65%)/ | 0.288c | 0.762c |
15 (23.44%) | 25 (36.74%) | 22 (32.35%) | |||
Age, years | 65.25 ± 11.01a | 65.6 ± 10.9a | 65.5 ± 10.6a | 1.000d | 1.000d |
Body mass index, kg/m2 | 28.38 ± 4.93a/21.19b | 28.7 ± 4.0a/19.23b | 29.3 ± 4.2a/18.61b | 1.000f | 0.255f |
Ejection fraction, % | 52.31 ± 10.01a/55.00b | 49.74 ± 11.95a/50.0b | 49.57 ± 11.44a/50.0b | 0.732f | 0.729f |
Diabetes mellitus | 18 (28.12%) | 17 (25.00%) | 18 (26.47%) | 1.000c | 1.000c |
Renal insufficiency | 2 (3.12%) | 2 (2.94%) | 7 (10.29%) | 1.000e | 0.495e |
CABG | 6 (9.38%) | 3 (4.41%) | 6 (8.82%) | 1.000e | 1.000e |
Ever smoked | 31 (48.44%) | 31 (45.59%) | 29 (42.65%) | 1.000e | 1.000c |
Previous MI | 31 (48.44%) | 43 (63.24%) | 41 (60.29%) | 0.117c | 0.258c |
2VD/3VD | 43 (67.19%) | 38 (55.88%) | 41 (60.29%) | 1.000c | 1.000c |
Multi ISR | 5 (7.81%) | 4 (5.88%) | 5 (7.35%) | 1.000e | 1.000c |
Baseline PCI | |||||
ACSy (STEMI/NSTEMI) | 37 (57.81%) | 45 (66.18%) | 50 (73.53%) | 0.966c | 0.171c |
stable AP | 27 (42.19%) | 23 (33.82%) | 18 (26.47%) | ||
Type of lesion | |||||
B2/C | 47 (68.12%) | 51 (68.92%) | 47 (63.51%) | 1.000c | 1.000c |
Lesion localization | |||||
LAD/RD | 34 (49.28%) | 35 (47.30%) | 40 (54.05%) | 1.000e | 1.000e |
RCx/OM | 15 (21.74%) | 16 (21.62%) | 10 (13.51%) | ||
RCA | 18 (26.09%) | 22 (29.73%) | 22 (29.73%) | ||
SVG | 2 (2.9%) | 1 (1.35%) | 2 (2.70%) | ||
Diameter of the previous stent, mm | 3.09 ± 0.48a/3.00b | 3.18 ± 0.43a/3.0b | 3.20 ± 0.41a/3.0b | 0.390f | 0.225f |
Length of the previous stent, mm | 25.67 ± 15.48a/20.00b | 22.65 ± 11.70a/19.0b | 19.39 ± 9.27a/16.0b | 0.720f | 0.012f |
In-stent restenosis | |||||
ACSy, STEMI/NSTEMI | 19 (29.69%) | 24 (35.29%) | 25 (36.76%) | 1.000e | 0.333c |
Stable AP | 42 (65.62%) | 41 (60.29%) | 33 (48.53%) | ||
Other, silent ischemia | 4 (6.25%) | 3 (4.41%) | 10 (14.71%) | ||
Time to ISR, months | 12.49 ± 11.06a/7.00b | 12.10 ± 8.47a/9.0b | 16.51 ± 9.49a/24.0b | 1.000f | 0.042f |
Type of ISR | |||||
I (focal; all) | 25 (36.23%) | 30 (40.54%) | 21 (28.38%) | 1.000e | 1.000e |
II (diffuse) | 33 (47.83%) | 34 (45.95%) | 35 (47.30%) | ||
III (proliferative) | 6 (8.7%) | 5 (6.76%) | 8 (10.81%) | ||
IV (occlusion) | 5 (7.25%) | 5 (6.76%) | 10 (13.51%) | ||
Periprocedural parameters | |||||
Cutting predilatation | 20 (28.99%) | 16 (21.62%) | 5 (6.76%) | 0.933c | 0.002c |
ISR; PEB/EES diameter, mm | 3.27 ± 0.47a/3.17b | 3.32 ± 0.39a/3.5b | 3.31 ± 0.43a/3.5b | 1.000f | 1.000f |
ISR; PEB/EES length, mm | 23.19 ± 12.98a/20.00b | 22.53 ± 8.13a/20.0b | 28.47 ± 12.76a/24.0b | 1.000f | 0.0003f |
Postdilatation, atm | 13.48 ± 2.34a/12.00b | 14.84 ± 2.77a/16.0b | 14.11 ± 2.45a/12.0b | 0.009f | 0.411f |
Second stent implantation | 8 (11.59%) | 11 (14.86%) | 11 (14.86%) | 1.000c | 1.000c |
Crossover to DES | 2 (2.9%) | 2 (2.7%) | - | 1.000c | - |