Table 2. Open in new tab Primary...

Outcome	Number of Event (%)	Adjusted Hazard Ratio and 95% CI
3-month follow-up
IS	15 (4.5)	16 (2.8)	43 (2.8)	1.35 (0.73–2.49)	.332	0.84 (0.46–1.55)	.576	1.61 (0.77–3.36)	.204
Death from any cause	9 (2.7)	7 (1.2)	14 (0.9)	3.14 (1.28–7.74)	.013	1.99 (0.76–5.22)	.162	1.58 (0.56–4.49)	.391
MI	0 (0.0)	3 (0.5)	0 (0.0)	NA	NA	NA	NA	NA	NA
Composite endpoint^a	25 (7.4)	25 (4.4)	60 (4.0)	1.62 (1.01–2.63)	.051	1.05 (0.65–1.72)	.836	1.54 (0.87–2.74)	.139
1-year follow-up
IS	42 (12.5)	42 (7.4)	92 (6.1)	1.91 (1.31–2.79)	.001	1.16 (0.80–1.70)	.439	1.64 (1.06–2.56)	.028
Death from any cause	26 (7.7)	20 (3.5)	75 (5.0)	1.56 (0.98–2.48)	.060	0.88 (0.53–1.46)	.616	1.78 (0.98–3.24)	.060
MI	3 (0.9)	6 (1.1)	8 (0.5)	1.47 (0.36–5.93)	.593	2.10 (0.66–6.71)	.211	0.70 (0.16–3.02)	.630
Composite endpoint^a	67 (19.9)	64 (11.3)	173 (11.5)	1.64 (1.23–2.20)	.001	1.04 (0.77–1.40)	.808	1.59 (1.11–2.26)	.011
Overall follow-up
IS	57 (16.9)	52 (9.2)	114 (7.5)	2.03 (1.46–2.82)	<.001	1.20 (0.85–1.69)	.296	1.69 (1.14–2.50)	.008
Death from any cause	41 (12.2)	35 (6.2)	124 (8.2)	1.26 (0.87–1.81)	.225	0.81 (0.55–1.20)	.297	1.54 (0.97–2.46)	.067
MI	7 (2.1)	6 (1.1)	16 (1.1)	1.71 (0.68–4.31)	.259	0.96 (0.36–2.58)	.942	1.77 (0.58–5.44)	.320
Composite endpoint^a	95 (28.2)	87 (15.4)	243 (16.1)	1.55 (1.22–1.99)	<.001	1.00 (0.77–1.28)	.978	1.56 (1.16–2.11)	.004

Outcome

Number of Event (%)

Adjusted Hazard Ratio and 95% CI

SIM vs ATOR

EZ-SIM vs ATOR

SIM vs EZ-SIM

SIM (n = 337)

EZ-SIM (n = 564)

ATOR (n = 1510)

HR (95% CI)

3-month follow-up

15 (4.5)

16 (2.8)

43 (2.8)

1.35 (0.73–2.49)

.332

0.84 (0.46–1.55)

.576

1.61 (0.77–3.36)

.204

Death from any cause

9 (2.7)

7 (1.2)

14 (0.9)

3.14 (1.28–7.74)

.013

1.99 (0.76–5.22)

.162

1.58 (0.56–4.49)

.391

0 (0.0)

3 (0.5)

0 (0.0)

Composite endpoint^a

25 (7.4)

25 (4.4)

60 (4.0)

1.62 (1.01–2.63)

.051

1.05 (0.65–1.72)

.836

1.54 (0.87–2.74)

.139

1-year follow-up

42 (12.5)

42 (7.4)

92 (6.1)

1.91 (1.31–2.79)

.001

1.16 (0.80–1.70)

.439

1.64 (1.06–2.56)

.028

Death from any cause

26 (7.7)

20 (3.5)

75 (5.0)

1.56 (0.98–2.48)

.060

0.88 (0.53–1.46)

.616

1.78 (0.98–3.24)

.060

3 (0.9)

6 (1.1)

8 (0.5)

1.47 (0.36–5.93)

.593

2.10 (0.66–6.71)

.211

0.70 (0.16–3.02)

.630

Composite endpoint^a

67 (19.9)

64 (11.3)

173 (11.5)

1.64 (1.23–2.20)

.001

1.04 (0.77–1.40)

.808

1.59 (1.11–2.26)

.011

Overall follow-up

57 (16.9)

52 (9.2)

114 (7.5)

2.03 (1.46–2.82)

<.001

1.20 (0.85–1.69)

.296

1.69 (1.14–2.50)

.008

Death from any cause

41 (12.2)

35 (6.2)

124 (8.2)

1.26 (0.87–1.81)

.225

0.81 (0.55–1.20)

.297

1.54 (0.97–2.46)

.067

7 (2.1)

6 (1.1)

16 (1.1)

1.71 (0.68–4.31)

.259

0.96 (0.36–2.58)

.942

1.77 (0.58–5.44)

.320

Composite endpoint^a

95 (28.2)

87 (15.4)

243 (16.1)

1.55 (1.22–1.99)

<.001

1.00 (0.77–1.28)

.978

1.56 (1.16–2.11)

.004

Outcome	Number of Event (%)	Adjusted Hazard Ratio and 95% CI
3-month follow-up
IS	15 (4.5)	16 (2.8)	43 (2.8)	1.35 (0.73–2.49)	.332	0.84 (0.46–1.55)	.576	1.61 (0.77–3.36)	.204
Death from any cause	9 (2.7)	7 (1.2)	14 (0.9)	3.14 (1.28–7.74)	.013	1.99 (0.76–5.22)	.162	1.58 (0.56–4.49)	.391
MI	0 (0.0)	3 (0.5)	0 (0.0)	NA	NA	NA	NA	NA	NA
Composite endpoint^a	25 (7.4)	25 (4.4)	60 (4.0)	1.62 (1.01–2.63)	.051	1.05 (0.65–1.72)	.836	1.54 (0.87–2.74)	.139
1-year follow-up
IS	42 (12.5)	42 (7.4)	92 (6.1)	1.91 (1.31–2.79)	.001	1.16 (0.80–1.70)	.439	1.64 (1.06–2.56)	.028
Death from any cause	26 (7.7)	20 (3.5)	75 (5.0)	1.56 (0.98–2.48)	.060	0.88 (0.53–1.46)	.616	1.78 (0.98–3.24)	.060
MI	3 (0.9)	6 (1.1)	8 (0.5)	1.47 (0.36–5.93)	.593	2.10 (0.66–6.71)	.211	0.70 (0.16–3.02)	.630
Composite endpoint^a	67 (19.9)	64 (11.3)	173 (11.5)	1.64 (1.23–2.20)	.001	1.04 (0.77–1.40)	.808	1.59 (1.11–2.26)	.011
Overall follow-up
IS	57 (16.9)	52 (9.2)	114 (7.5)	2.03 (1.46–2.82)	<.001	1.20 (0.85–1.69)	.296	1.69 (1.14–2.50)	.008
Death from any cause	41 (12.2)	35 (6.2)	124 (8.2)	1.26 (0.87–1.81)	.225	0.81 (0.55–1.20)	.297	1.54 (0.97–2.46)	.067
MI	7 (2.1)	6 (1.1)	16 (1.1)	1.71 (0.68–4.31)	.259	0.96 (0.36–2.58)	.942	1.77 (0.58–5.44)	.320
Composite endpoint^a	95 (28.2)	87 (15.4)	243 (16.1)	1.55 (1.22–1.99)	<.001	1.00 (0.77–1.28)	.978	1.56 (1.16–2.11)	.004

Table 2.

Open in new tab

Primary Outcomes in Various Follow-Up Periods

Outcome	Number of Event (%)			Adjusted Hazard Ratio and 95% CI
	Number of Event (%)			SIM vs ATOR		EZ-SIM vs ATOR		SIM vs EZ-SIM
	SIM (n = 337)	EZ-SIM (n = 564)	ATOR (n = 1510)	HR (95% CI)	P	HR (95% CI)	P	HR (95% CI)	P
3-month follow-up
IS	15 (4.5)	16 (2.8)	43 (2.8)	1.35 (0.73–2.49)	.332	0.84 (0.46–1.55)	.576	1.61 (0.77–3.36)	.204
Death from any cause	9 (2.7)	7 (1.2)	14 (0.9)	3.14 (1.28–7.74)	.013	1.99 (0.76–5.22)	.162	1.58 (0.56–4.49)	.391
MI	0 (0.0)	3 (0.5)	0 (0.0)	NA	NA	NA	NA	NA	NA
Composite endpoint^a	25 (7.4)	25 (4.4)	60 (4.0)	1.62 (1.01–2.63)	.051	1.05 (0.65–1.72)	.836	1.54 (0.87–2.74)	.139
1-year follow-up
IS	42 (12.5)	42 (7.4)	92 (6.1)	1.91 (1.31–2.79)	.001	1.16 (0.80–1.70)	.439	1.64 (1.06–2.56)	.028
Death from any cause	26 (7.7)	20 (3.5)	75 (5.0)	1.56 (0.98–2.48)	.060	0.88 (0.53–1.46)	.616	1.78 (0.98–3.24)	.060
MI	3 (0.9)	6 (1.1)	8 (0.5)	1.47 (0.36–5.93)	.593	2.10 (0.66–6.71)	.211	0.70 (0.16–3.02)	.630
Composite endpoint^a	67 (19.9)	64 (11.3)	173 (11.5)	1.64 (1.23–2.20)	.001	1.04 (0.77–1.40)	.808	1.59 (1.11–2.26)	.011
Overall follow-up
IS	57 (16.9)	52 (9.2)	114 (7.5)	2.03 (1.46–2.82)	<.001	1.20 (0.85–1.69)	.296	1.69 (1.14–2.50)	.008
Death from any cause	41 (12.2)	35 (6.2)	124 (8.2)	1.26 (0.87–1.81)	.225	0.81 (0.55–1.20)	.297	1.54 (0.97–2.46)	.067
MI	7 (2.1)	6 (1.1)	16 (1.1)	1.71 (0.68–4.31)	.259	0.96 (0.36–2.58)	.942	1.77 (0.58–5.44)	.320
Composite endpoint^a	95 (28.2)	87 (15.4)	243 (16.1)	1.55 (1.22–1.99)	<.001	1.00 (0.77–1.28)	.978	1.56 (1.16–2.11)	.004

Outcome	Number of Event (%)			Adjusted Hazard Ratio and 95% CI
	Number of Event (%)			SIM vs ATOR		EZ-SIM vs ATOR		SIM vs EZ-SIM
	SIM (n = 337)	EZ-SIM (n = 564)	ATOR (n = 1510)	HR (95% CI)	P	HR (95% CI)	P	HR (95% CI)	P
3-month follow-up
IS	15 (4.5)	16 (2.8)	43 (2.8)	1.35 (0.73–2.49)	.332	0.84 (0.46–1.55)	.576	1.61 (0.77–3.36)	.204
Death from any cause	9 (2.7)	7 (1.2)	14 (0.9)	3.14 (1.28–7.74)	.013	1.99 (0.76–5.22)	.162	1.58 (0.56–4.49)	.391
MI	0 (0.0)	3 (0.5)	0 (0.0)	NA	NA	NA	NA	NA	NA
Composite endpoint^a	25 (7.4)	25 (4.4)	60 (4.0)	1.62 (1.01–2.63)	.051	1.05 (0.65–1.72)	.836	1.54 (0.87–2.74)	.139
1-year follow-up
IS	42 (12.5)	42 (7.4)	92 (6.1)	1.91 (1.31–2.79)	.001	1.16 (0.80–1.70)	.439	1.64 (1.06–2.56)	.028
Death from any cause	26 (7.7)	20 (3.5)	75 (5.0)	1.56 (0.98–2.48)	.060	0.88 (0.53–1.46)	.616	1.78 (0.98–3.24)	.060
MI	3 (0.9)	6 (1.1)	8 (0.5)	1.47 (0.36–5.93)	.593	2.10 (0.66–6.71)	.211	0.70 (0.16–3.02)	.630
Composite endpoint^a	67 (19.9)	64 (11.3)	173 (11.5)	1.64 (1.23–2.20)	.001	1.04 (0.77–1.40)	.808	1.59 (1.11–2.26)	.011
Overall follow-up
IS	57 (16.9)	52 (9.2)	114 (7.5)	2.03 (1.46–2.82)	<.001	1.20 (0.85–1.69)	.296	1.69 (1.14–2.50)	.008
Death from any cause	41 (12.2)	35 (6.2)	124 (8.2)	1.26 (0.87–1.81)	.225	0.81 (0.55–1.20)	.297	1.54 (0.97–2.46)	.067
MI	7 (2.1)	6 (1.1)	16 (1.1)	1.71 (0.68–4.31)	.259	0.96 (0.36–2.58)	.942	1.77 (0.58–5.44)	.320
Composite endpoint^a	95 (28.2)	87 (15.4)	243 (16.1)	1.55 (1.22–1.99)	<.001	1.00 (0.77–1.28)	.978	1.56 (1.16–2.11)	.004

The HRs were adjusted for all covariates listed in Table 1 and Supplemental Table 2. NA, not applicable.

Any one of IS, HS, cardiovascular death, or MI.

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