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coverage
between
durable-polymer
441
442
25
everolimus-eluting
stents
and
443
Figure Legends
444
445
Fig. 1: Comparison of device description
446
447
Fig. 2: Representative frequency-domain optical coherence tomography images
448
(A) smooth protrusion; (B) disrupted fibrous tissue protrusion; (C) abnormal intra-stent tissue; (D)
449
evaluation of the unevenness of the intra-stent tissue; (E) major evagination
450
451
Fig. 3: Trial profile
452
453
454
455
456
457
458
459
460
26
461
Tables
462
Table 1: Non-inferiority test for the percentages of covered struts (primary endpoint) and uncovered
463
struts at 2 weeks
Percentage of covered struts*
Average
Standard error
BP-EES, %
51
71.4 (95% CI: 67.3–75.4)
2.04
DP-EES, %
57
72.3 (95% CI: 68.5–76.2)
1.94
Δ(BP-EES−DP-EES), %
−0.94 (90% CI: −5.62–3.74); p = 0.0765
Percentage of uncovered struts*
Average
Standard error
BP-EES, %
51
25.6 (95% CI: 22.0–29.1)
1.79
DP-EES, %
57
24.5 (95% CI: 21.2–27.9)
1.70
Δ(BP-EES−DP-EES), %
1.03 (90% CI: −3.07–5.13); p = 0.0557
464
Values expressed as average (95% confidence interval). BP-EES: biodegradable polymer-coated
465
everolimus-eluting stents, CI: confidence interval, DP-EES: durable polymer-coated everolimus-eluting
466
stent.
467
*: assessed by multilevel analysis.
468
27
Table 2: OCT results post-PCI and at follow-up
Post-PCI
2-week follow-up
BP-EES
DP-EES
BP-EES
DP-EES
n = 53
n = 58
n = 51
n = 57
Stent length, mm
29.8 (22.8–38.3)
28.4 (22.2–35.0)
0.23
29.6 (22.4–39.0)
28.0 (22.7–35.1)
Minimum stent area, mm2
5.28 (4.55–7.08)
5.42 (4.46–7.33)
0.82
5.74 (4.59–8.26)
Minimum lumen area, mm2
5.02 (4.28–6.20)
5.13 (3.81–6.38)
0.81
Maximum malapposed area, mm2 0.54 (0.25–0.83)
0.85 (0.46–1.34)
Malapposed volume, mm3
4.06 (2.4–5.97)
Intra-stent tissue volume, mm3
18.6 (12.7–29.2)
Lesion level
P value
12-month follow-up
BP-EES
DP-EES
n = 36
n = 47
0.33
27.8 (21.6–34.6)
27.2 (22.6–34.7)
0.69
5.51 (4.54–7.33)
0.61
5.74 (4.95–8.73)
5.45 (4.48–7.41)
0.23
5.45 (4.43–7.55)
5.08 (4.03–6.87)
0.52
4.64 (3.26–6.39)
4.72 (3.65–6.01)
0.62
0.002
0.58 (0.3–1.3)
0.89 (0.6–1.27)
0.08
0.30 (0.15–0.51)
0.42 (0.24–0.85)
0.05
6.28 (3.79–10.5)
0.01
5.18 (3.08–11.2)
7.16 (4.34–11.5)
0.10
0.71 (0.00–2.09)
2.07 (0.29–4.35)
0.002
13.6 (8.96–21.7)
0.01
12.9 (8.68–21.4)
11.6 (7.45–16.7)
0.21
29.6 (0.00–55.0)
19.1 (5.59–29.1)
0.26
28
P value
p value
Qualitative
intra-stent
tissue
assessment
Smooth protrusion, n (%)
Disrupted
fibrous
14 (26.4)
21 (36.2)
0.27
14 (27.5)
15 (26.3)
0.89
NA
NA
12 (22.6)
18 (31.0)
0.32
13 (25.5)
13 (22.8)
0.75
NA
NA
53 (100)
58 (100)
1.00
48 (94.1)
53 (93.0)
0.81
NA
NA
NA
NA
1 (2.0)
7 (12.3)
0.04
0 (0.0)
2 (4.3)
tissue
protrusion, n (%)
Abnormal intra-stent tissue, n
(%)
Evagination, n (%)
PLIA score
0.32
0.43
NA
NA
NA
NA
10 (27.8)
19 (40.4)
NA
NA
NA
NA
21 (58.3)
24 (51.1)
29
NA
NA
NA
NA
5 (13.9)
4 (8.5)
NA
NA
NA
NA
0 (0)
0 (0)
n = 1689
n = 1795
n = 1628
n = 1801
Mean stent area*, mm2
7.95 (7.20–8.70)
7.55 (6.84–8.27)
0.46
7.79 (7.11–8.47)
7.5 (6.8–8.1)
0.50
8.44 (7.58–9.30)
7.58 (6.83–8.34)
0.14
Mean lumen area*, mm2
7.84 (7.08–8.61)
7.62 (6.89–8.36)
0.68
7.74 (7.09–8.40)
7.50 (6.88–8.12)
0.59
7.19 (6.37–8.01)
6.87 (6.15–7.88)
0.56
0.54 (0.47–0.61)
0.43 (0.36–0.50)
0.03
0.41 (0.35–0.46)
0.36 (0.31–0.42)
0.26
1.44 (1.29–1.59)
0.86 (0.72–1.00)
< 0.001
% intra-stent tissue area*, %
5.95 (3.94–7.79)
4.1 (2.56–7.52)
0.04
3.77 (2.29–5.17)
2.75 (1.69–4.74)
0.31
18.0 (15.7–20.4)
12.6 (10.5–14.7)
< 0.001
IUS*
4.89 (4.45–5.33)
5.97 (5.54–6.40)
0.001
4.89 (4.39–5.40)
4.94 (4.46–5.42)
0.90
2.19 (1.96–2.42)
2.81 (2.60–3.01)
< 0.001
Mean malapposed area*#, mm2
0.09 (0.07–0.10)
0.12 (0.10–0.15)
0.006
0.11 (0.08–0.13)
0.14 (0.11–0.17)
0.01
0.11 (0.05–0.17)
0.17 (0.11–0.22)
0.15
n = 14485
n = 16703
n = 13929
n = 17228
Cross-sectional level
Mean intra-stent tissue area*,
mm
Strut level
30
Number of struts per lesion, n
249 (198–332)
262 (204–360)
0.72
259 (206–334)
281 (208.5–341)
0.42
215 (182–261)
245 (184–295)
0.23
109 (72–159)
147 (90–209)
0.03
65 (34–97)
70 (36–99)
0.70
2 (0–6)
6 (2–17)
0.002
5 (1–12)
9 (3–17)
0.05
2 (0–9)
6 (0–12)
0.25
0 (0–0)
0 (0–2)
Number of uncovered struts per
lesion, n
Number of malapposed struts per
lesion, n
%covered
struts (%Embedded
0.74
51.6 (46.7–56.4)
40.3 (35.6–45.0)
0.001
71.4 (67.3–75.4)
72.3 (68.5–76.2)
%uncovered strut*, %
44.0 (39.1–48.9)
54.1 (49.4–58.8)
0.004
25.6 (22.0–29.1)
24.5 (21.2–27.9)
%malapposed strut*#, %
0.87 (0.73–1.03)
1.04 (0.89–1.23)
0.13
0.82 (0.69–0.97)
0.84 (0.71–0.99)
0.007
97.8 (96.0–99.5)
94.5 (93.0–96.1)
0.68
1.73 (0.28–3.17)
4.81 (3.52–6.09)
0.002
0.81
0.49 (0.00–1.06)
0.63 (0.12–1.14)
0.73
struts for post-PCI) *, %
Values are expressed as medians (interquartile range) for crude analysis or average (95% confidence interval) for multilevel analysis.
*: assessed by multilevel analysis.
Log transformed for analysis; all point estimators and confidence intervals were back-transformed to the original scale. IUS: intra-stent tissue unevenness score,
31
OCT: optical coherence tomography, PCI: percutaneous coronary intervention, PLIA: peri-strut low-intensity area, BP-EES: biodegradable polymer-coated
everolimus-eluting stents, CI: confidence interval, DP-EES: durable polymer-coated everolimus-eluting stent.
32
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