Efficacy of a seal-wing paclitaxel-eluting balloon catheters in the treatment of bare metal stent restenosis

Pleva, Leos; Kukla, Pavel; Zapletalova, Jana; Hlinomaz, Ota

doi:10.1186/s12872-017-0602-6

BMC Cardiovascular Disorders

Table 1 Baseline parameters

From: Efficacy of a seal-wing paclitaxel-eluting balloon catheters in the treatment of bare metal stent restenosis

	Seal-wing PEB	Iopromide-coated PEB	EES	p
	Seal-wing PEB	Iopromide-coated PEB	EES	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%)/	0.288^c	0.762^c
Male/female	15 (23.44%)	25 (36.74%)	22 (32.35%)	0.288^c	0.762^c
Age, years	65.25 ± 11.01^a	65.6 ± 10.9^a	65.5 ± 10.6^a	1.000^d	1.000^d
Body mass index, kg/m²	28.38 ± 4.93^a/21.19^b	28.7 ± 4.0^a/19.23^b	29.3 ± 4.2^a/18.61^b	1.000^f	0.255^f
Ejection fraction, %	52.31 ± 10.01^a/55.00^b	49.74 ± 11.95^a/50.0^b	49.57 ± 11.44^a/50.0^b	0.732^f	0.729^f
Diabetes mellitus	18 (28.12%)	17 (25.00%)	18 (26.47%)	1.000^c	1.000^c
Renal insufficiency	2 (3.12%)	2 (2.94%)	7 (10.29%)	1.000^e	0.495^e
CABG	6 (9.38%)	3 (4.41%)	6 (8.82%)	1.000^e	1.000^e
Ever smoked	31 (48.44%)	31 (45.59%)	29 (42.65%)	1.000^e	1.000^c
Previous MI	31 (48.44%)	43 (63.24%)	41 (60.29%)	0.117^c	0.258^c
2VD/3VD	43 (67.19%)	38 (55.88%)	41 (60.29%)	1.000^c	1.000^c
Multi ISR	5 (7.81%)	4 (5.88%)	5 (7.35%)	1.000^e	1.000^c
Baseline PCI
ACSy (STEMI/NSTEMI)	37 (57.81%)	45 (66.18%)	50 (73.53%)	0.966^c	0.171^c
stable AP	27 (42.19%)	23 (33.82%)	18 (26.47%)	0.966^c	0.171^c
Type of lesion
B2/C	47 (68.12%)	51 (68.92%)	47 (63.51%)	1.000^c	1.000^c
Lesion localization
LAD/RD	34 (49.28%)	35 (47.30%)	40 (54.05%)	1.000^e	1.000^e
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 ± 0.48^a/3.00^b	3.18 ± 0.43^a/3.0^b	3.20 ± 0.41^a/3.0^b	0.390^f	0.225^f
Length of the previous stent, mm	25.67 ± 15.48^a/20.00^b	22.65 ± 11.70^a/19.0^b	19.39 ± 9.27^a/16.0^b	0.720^f	0.012^f
In-stent restenosis
ACSy, STEMI/NSTEMI	19 (29.69%)	24 (35.29%)	25 (36.76%)	1.000^e	0.333^c
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 ± 11.06^a/7.00^b	12.10 ± 8.47^a/9.0^b	16.51 ± 9.49^a/24.0^b	1.000^f	0.042^f
Type of ISR
I (focal; all)	25 (36.23%)	30 (40.54%)	21 (28.38%)	1.000^e	1.000^e
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%)	0.933^c	0.002^c
ISR; PEB/EES diameter, mm	3.27 ± 0.47^a/3.17^b	3.32 ± 0.39^a/3.5^b	3.31 ± 0.43^a/3.5^b	1.000^f	1.000^f
ISR; PEB/EES length, mm	23.19 ± 12.98^a/20.00^b	22.53 ± 8.13^a/20.0^b	28.47 ± 12.76^a/24.0^b	1.000^f	0.0003^f
Postdilatation, atm	13.48 ± 2.34^a/12.00^b	14.84 ± 2.77^a/16.0^b	14.11 ± 2.45^a/12.0^b	0.009^f	0.411^f
Second stent implantation	8 (11.59%)	11 (14.86%)	11 (14.86%)	1.000^c	1.000^c
Crossover to DES	2 (2.9%)	2 (2.7%)	-	1.000^c	-

Qualitative data are given as n (%); quantitative data as ^amean (± standard deviation) and ^bmedian
^cchi-square test; ^dStudent T-test; ^eFisher’s exact test; ^fMann–Whitney U test

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