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Online Appendix for the following JACC: Cardiovascular Intervention article
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TITLE: Relation between bioresorbable scaffold sizing using QCA-Dmax and
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clinical outcomes at 1 year in 1232 patients from three study cohorts (ABSORB
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Cohort B, ABSORB EXTEND and ABSORB II).
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AUTHORS: Yuki Ishibashi1, M.D., Ph.D. ; Shimpei Nakatani1M.D.; Yohei Sotomi2, M.D.;
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Pannipa Suwannasom1, M.D.; Maik J. Grundeken2, M.D.; Hector M. Garcia-Garcia1, M.D.,
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Ph.D.; Antonio L. Bartorelli3, M.D.; Robert Whitbourn4, M.D.; Bernard Chevalier5, M.D.;
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Alexandre Abizaid6 M.D, Ph.D.; John A Ormiston7, MBChB, PhD, Richard J. Rapoza8,Ph.D.;
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Susan Veldhof 9 R.N.; Yoshinobu Onuma1, M.D., Ph.D, ; Patrick W Serruys10, M.D., Ph.D.
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Online Appendix Table legend
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Online Appendix Table 1 Incidence of clinical events at 1 year based on the
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appropriateness of the scaffold size selection within 0.5 mm
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Online Appendix Table 2 Incidence of clinical events at 1 year based on the
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appropriateness of the scaffold size selection within 0.4 mm
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Online Appendix Table 3 The incidence rate of stent thrombosis according to the
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distribution of Dmax measurements minus nominal scaffold size of patients who
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received a scaffold in a vessel with both proximal and distal Dmax smaller than
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device nominal size (scaffold oversize group) vs. the others (scaffold non-oversize
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group)
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Online Appendix Figure legend
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Online Appendix Figure 1.
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Distribution of proximal and distal Dmax measurements minus nominal scaffold
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size in patients with or without major adverse cardiac events is shown. When the
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appropriateness of scaffold size was defined by nominal scaffold diameter within
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0.4 mm of Dmax, blue box. The differences between the distal Dmax and nominal
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scaffold size are plotted on the Y-axis and X-axis, respectively. The red filled
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circles represent the patients who experienced ID-MACE at 1 year. The graphical
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presentation demonstrates that major adverse cardiac events were more frequently
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observed in patients who were categorized in inappropriate scaffold implantation
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group (outside blue box), the events were higher than appropriate group (inside
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blue box)
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MACE: major adverse cardiac events; Dmax: maximum lumen diameter.
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Online Appendix Figure 2.
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Time-to-event curves for MACE (A) and their components (B: death, C: target
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vessel MI; D: ID-TLR) in patients with inappropriate or appropriate scaffold size
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when use 0.4 mm as a cutoff value.
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Online Appendix Figure 3.
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Correlation between scaffold footprint and post-procedural reference vessel
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diameter in patients with “scaffold oversize group” group. Scaffold expansion
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below nominal diameters can lead to a denser polymer surface pattern and a higher
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polymer-to-artery ratio.
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MACE: major adverse cardiac events
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Online Appendix. Table 1. Incidence of clinical events at 1 year based on the appropriateness of the scaffold size selection within 0.5 mm
Clinical outcomes
appropriately-sized
(cutoff 0.5mm)
(n=867 pts)
inappropriately-sized
(cutoff 0.5 mm)
(n=365 pts)
% (n)
95% CI
% (n)
95% CI
OR [95%CI]
p value
Cardiac Death, % (n)
0.35 (3)
0.07-1.01
0.55 (2)
0.07-1.96
1.58 [0.26-9.54]
0.64
Myocardial infarction, % (n)
3.23 (28)
2.16-4.63
4.38 (16)
2.53-7.02
1.37 [0.73-2.57]
0.32
QMI, % (n)
0.69 (6)
0.25-1.50
1.10 (4)
0.30-2.78
1.59 [0.45-5.67]
0.49
NQMI, % (n)
2.54 (22)
1.60-3.82
3.29 (12)
1.71-5.67
1.31 [0.64-2.68]
0.45
TVMI, % (n)
3.00 (26)
1.97-4.36
4.11 (15)
2.32-6.69
1.39 [0.72-2.65]
0.38
Ischemia Driven TLR, % (n)
1.61 (14)
0.89-2.69
3.29 (12)
1.71-5.67
2.07 [0.95-4.52]
0.08
Composite of cardiac death, all MI
and clinically indicated target lesion
revascularization (MACE)
4.50 (39)
3.22-6.10
6.30 (23)
4.04-9.31
1.26 [0.73-2.20]
0.20
Composite of cardiac death, target
vessel MI and clinically indicated
target lesion revascularization
(DoCE)
4.38 (38)
3.12-5.97
5.48 (20)
3.38-8.34
1.43 [0.84-2.43]
0.46
Composite of all death, all MI and all
revascularization (PoCE)
5.77 (50)
4.31-7.53
7.67 (28)
5.16-10.90
1.36 [0.84-2.19]
0.25
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Clinical outcomes
appropriately-sized
(cutoff 0.5mm)
(n=867 pts)
inappropriately-sized
(cutoff 0.5 mm)
(n=365 pts)
% (n)
95% CI
% (n)
95% CI
OR [95%CI]
p value
1.04 (9)
0.48-1.96
1.10 (4)
0.30-2.78
1.06[0.32-3.45]
1.0
-Definite ST, n (%)
0.58 (5)
0.19-1.34
1.10 (4)
0.30-2.78
1.91[0.51-7.15]
0.46
-Probable ST, n (%)
0.23 (2)
0.03-0.83
0 (0)
0.00-1.01
NA
1.0
-Possible ST, n (%)
0.23 (2)
0.03-0.83
0 (0)
0.00-1.01
NA
1.0
Scaffold thrombosis, n (%)
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QMI: Q-wave myocardial infarction; NQMI: non-Q-wave myocardial infarction; TVMI: target vessel myocardial infarction; TlR: target lesion revascularization;
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MACE: major adverse cardiac events; MI: myocardial infarction;; DoCE: device oriented composite end point; PoCE: patient oriented composite end point; ST:
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scaffold thrombosis.
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Online Appendix. Table 2. Incidence of clinical events at 1 year based on the appropriateness of the scaffold size selection within 0.4 mm
Clinical outcomes
appropriately-sized
(cutoff 0.4 mm)
(n=645 pts)
inappropriately-sized
(cutoff 0.4 mm)
(n=587pts)
% (n)
95% CI
% (n)
95% CI
OR [95%CI]
p value
Cardiac Death, % (n)
0.31 (2)
0.04-1.12
0.51 (3)
0.11-1.49
1.65 [0.28-9.92]
0.67
Myocardial infarction, % (n)
2.79 (18)
1.66-4.37
4.43 (26)
2.91-6.42
1.61 [0.88-2.98]
0.13
QMI, % (n)
0.78 (5)
0.25-1.80
0.85 (5)
0.28-1.98
1.10 [0.32-3.82]
1.00
NQMI, % (n)
2.02 (13)
1.08-3.42
3.58 (21)
2.23-5.42
1.80 [0.90-3.64]
0.12
TVMI, % (n)
2.64 (17)
1.54-4.19
4.09 (24)
2.64-6.02
1.58 [0.84-2.96]
0.20
Ischemia Driven TLR, % (n)
1.09 (7)
0.44-2.22
3.24 (19)
1.96-5.01
3.05 [1.27-7.31]
0.01
Composite of cardiac death, all MI
and clinically indicated target lesion
revascularization (MACE)
3.57 (23)
2.27-5.30
6.64 (39)
4.77-8.97
1.93 [1.14-3.26]
0.02
Composite of cardiac death, target
vessel MI and clinically indicated
target lesion revascularization
(DoCE)
3.26 (21)
2.03-4.93
6.30 (37)
4.48-8.58
2.00 [1.16-3.46]
0.02
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Clinical outcomes
appropriately-sized
(cutoff 0.4 mm)
(n=645 pts)
inappropriately-sized
(cutoff 0.4 mm)
(n=587pts)
% (n)
95% CI
% (n)
95% CI
OR [95%CI]
p value
Composite of all death, all MI and
all revascularization (PoCE)
4.65 (30)
3.16-6.57
8.18 (48)
6.09-10.70
1.83 [1.14-2.92]
0.01
Scaffold thrombosis, n (%)
1.09 (7)
0.44-2.22
1.02 (6)
0.38-2.21
0.94 [0.32-2.82]
1.00
-Definite ST, n (%)
0.78 (5)
0.25-1.80
0.58 (4)
0.19-1.74
0.88 [0.24-3.29]
1.00
-Probable ST, n (%)
0.16 (1)
0.00-0.86
0.17 (1)
0.00-0.95
1.10 [0.07-17.6]
1.00
-Possible ST, n (%)
0.16 (1)
0.00-0.86
0.17 (1)
0.00-0.95
1.10 [0.07-17.6]
1.00
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QMI: Q-wave myocardial infarction; NQMI: non-Q-wave myocardial infarction; TVMI: target vessel myocardial infarction; TlR: target lesion revascularization;
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MACE: major adverse cardiac events; MI: myocardial infarction;; DoCE: device oriented composite end point; PoCE: patient oriented composite end point; ST:
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scaffold thrombosis.
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Online Appendix. Table 3. The incidence rate of stent thrombosis according to the distribution of Dmax measurements minus nominal scaffold size of
patients who received a scaffold in a vessel with both proximal and distal Dmax smaller than device nominal size (scaffold oversize group) vs. the
others (scaffold non-oversize group)
Variable
scaffold non-oversize group
(n=649 pts)
(N=583 pts)
% (n)
95% CI
% (n)
95% CI
p value
Definite ST
0.92 (6)
0.34-2.00
0.51 (3)
0.11-1.50
0.51
Probable ST
0.31 (2)
0.04-1.11
0 (0)
0.00-0.63
0.50
Possible ST
0.31 (2)
0.04-1.11
0 (0)
0.00-0.63
0.50
Acute, n (%)
0.15 (1)
0.00-0.86
0 (0)
0.00-0.63
1.00
-Definite, n (%)
0.15 (1)
0.00-0.86
0 (0)
0.00-0.63
1.00
-Probable, n (%)
0 (0)
0.00-0.57
0 (0)
0.00-0.63
NA
-Possible, n (%)
0 (0)
0.00-0.57
0 (0)
0.00-0.63
NA
0.62 (4)
0.17-1.57
0.34 (2)
0.04-1.23
0.69
-Definite, n (%)
0.46 (3)
0.10-1.35
0.34 (2)
0.04-1.23
1.00
-Probable, n (%)
0.15 (1)
0.00-0.86
0 (0)
0.00-0.63
1.00
-Possible, n (%)
0 (0)
0.00-0.57
0 (0)
0.00-0.63
NA
0.77 (5)
0.25-1.79
0.17 (1)
0.00-0.95
0.22
-Definite, n (%)
0.31 (2)
0.04-1.11
0.17 (1)
0.00-0.95
1.00
-Probable, n (%)
0.15 (1)
0.00-0.86
0 (0)
0.00-0.63
1.00
-Possible, n (%)
0.31 (2)
0.04-1.11
0 (0)
0.00-0.63
0.50
Subacute, n (%)
Late, n (%)
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scaffold oversize group
Scaffold thrombosis was categorized as acute (< 1 day), subacute (1-30 days) and late (31 to 365 days) and was defined according to the ARC guidelines as follows: definite: acute
coronary syndrome and angiographic or pathologic confirmation of scaffold thrombosis; probable: unexplained death ≤ 30 days or TV-MI without angiographic information
Comparisons were performed by fisher exact test.
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Online Appendix-Figure 1.
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Cumulative incidence of
cardiac death, MI and ID-TLR
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Appropriate (0.4 mm cutoff)
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Logrank test
p= 0.001
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10.0%
4.6%
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0
0
180
360
540
Time after index procedure
C
B
Inappropriate (0.4 mm cutoff)
(%)
720
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Logrank test
p=0.04
10
5.5%
5.5%
5
3.0%
4.7%
0
0
180
360
540
Time after index procedure
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Logrank test
p= 0.226
15
10
5
1.1%
0
0
720
(days)
10
180
360
540
Time after index procedure
D
Logrank test
p= 0.061
(%)
(days)
(%)
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Cumulative incidence of cardiac death
A
Cumulative incidence of ID-TLR
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Online Appendix-Figure 2
Cumulative incidence of
Target vessel MI
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0.3%
720
(days)
(%)
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Logrank test
p= 0.016
15
10
5.6%
5
2.7%
0
0
180
360
540
Time after index procedure
720
(days)
Online Appendix Figure 3
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