Follow-up available, n (%) |
524 (100.0) |
220 (100.0) |
304 (100.0) |
|
|
TEE |
TEE |
TEE |
TEE |
TEE |
TEE |
No. of TEE, n (%) |
457 (87.2) |
190 (86.4) |
267 (87.8) |
0.69 |
0.69 |
Residual flow, n (%) |
33 (6.3) |
10 /190 (5.4) |
23 /267 (7.6) |
0.84 |
0.84 |
Significant flow, n (%) |
5 (1.0) |
2 /190 (1.1) |
3 /267 (1.1) |
>0.99 |
>0.99 |
DRT, n (%) |
18 (3.4) |
5 /190 (2.6) |
13/267 (4.9) |
0.63 |
0.63 |
Anti-thrombotic therapy at the time of follow-up |
Anti-thrombotic therapy at the time of follow-up |
Anti-thrombotic therapy at the time of follow-up |
Anti-thrombotic therapy at the time of follow-up |
Anti-thrombotic therapy at the time of follow-up |
Anti-thrombotic therapy at the time of follow-up |
Any anticoagulation, n (%) |
31 (5.9) |
14 (6.4) |
17 (5.6) |
0.71 |
0.71 |
Vitamin K antagonists, n (%) |
4 (0.7) |
2 (0.9) |
2 (0.7) |
>0.99 |
>0.99 |
Non-vitamin K antagonists, n (%) |
27 (5.2) |
12 (5.5) |
15 (4.9) |
0.84 |
0.84 |
Single anti-platelet, n (%) |
464 (88.5) |
188 (85.5) |
276 (90.8) |
0.07 |
0.07 |
Dual anti-platelet, n (%) |
19 (3.6) |
9 (4.1) |
10 (3.3) |
0.64 |
0.64 |
Anticoagulant plus anti-platelet, n (%) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
>0.99 |
>0.99 |
No anti-thrombus therapy, n (%) |
10 (1.9) |
9 (4.1) |
1 (0.3) |
<0.01 |
<0.01 |
Clinical events outcome |
Clinical events outcome |
Clinical events outcome |
Clinical events outcome |
Clinical events outcome |
Clinical events
outcome |
|
All |
DAPT |
ACT |
HR (95% CI)#
|
P-value* |
|
n =524 |
n =220 |
n =304 |
|
|
Primary efficacy outcome |
40 (7.6) |
21 (9.5) |
19 (6.3) |
1.58
(0.84–2.97) |
0.14 |
Primary safety outcome |
28 (5.3) |
10 (4.5) |
18 (5.9) |
0.80
(0.38–1.69) |
0.57 |
Net clinical benefit, n (%) |
66 (12.6) |
30 (13.6) |
36 (11.8) |
1.23
(0.75–2.02) |
0.39 |
Death |
Death |
Death |
Death |
Death |
Death |
All-cause death, n (%) |
45 (8.6) |
26 (11.8) |
19 (6.3) |
1.97
(1.09–3.58) |
0.02 |
Cardiovascular/Unexplained death, n (%) |
23 (4.4) |
14 (6.4) |
9 (3.0) |
2.24 (0.98–5.14) |
0.05 |
Non-cardiovascular death, n (%) |
22 (4.2) |
12 (5.4) |
10 (3.3) |
1.74
(0.74–4.05) |
0.19 |
Ischemic stroke/tia/se |
Ischemic stroke/tia/se |
Ischemic stroke/tia/se |
Ischemic stroke/tia/se |
Ischemic stroke/tia/se |
Ischemic
stroke/tia/se |
Ischemic stroke/TIA/SE, n (%) |
18 (3.4) |
7 (3.2) |
11 (3.6) |
0.94
(0.37–2.41) |
0.90 |
Ischemic stroke, n (%) |
13 (2.5) |
5 (2.3) |
8 (2.6) |
0.92
(0.30–2.78) |
0.88 |
Disabling stroke, n (%) |
7 (1.3) |
3 (1.4) |
4 (1.3) |
1.10
(0.24–4.96) |
0.90 |
Non-disabling stroke, n (%) |
6 (1.1) |
2 (0.9) |
4 (1.3) |
0.74
(0.14–3.76) |
0.72 |
TIA, n (%) |
5 (1.0) |
2 (0.9) |
3 (1.0) |
0.98 (0.16–5.86) |
0.98 |
SE, n (%) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
- |
>0.99 |
Bleedings |
Bleedings |
Bleedings |
Bleedings |
Bleedings |
Bleedings |
Any bleeding |
62 (11.8) |
17 (7.7) |
45 (14.8) |
0.53 (0.32–0.88) |
0.02 |
Major bleeding, n (%) |
28 (5.3) |
10 (4.5) |
18 (5.9) |
0.80
(0.38–1.69) |
0.57 |
Intracranial, n (%) |
3 (0.5) |
0 (0.0) |
3 (1.0) |
- |
0.15 |
Gastrointestinal, n (%) |
19 (3.6) |
7 (3.2) |
12 (4.0) |
0.84
(0.34–2.09) |
0.70 |
Other sites, n (%) |
6 (1.1) |
3 (1.4) |
3 (1.0) |
1.45 (0.28–7.39) |
0.65 |
CRNMB, n (%) |
34 (6.5) |
7 (3.2) |
27 (8.9) |
0.37 (0.19–0.73) |
0.01 |