Cardiol Res

Cardiology Research, ISSN 1923-2829 print, 1923-2837 online, Open Access

Article copyright, the authors; Journal compilation copyright, Cardiol Res and Elmer Press Inc

Journal website https://cr.elmerpub.com

Original Article

Volume 15, Number 6, December 2024, pages 439-452

Safety and Efficacy of BioMime Sirolimus-Eluting Stent System in All-Comers Real-World Population With Coronary Artery Stenosis: MILES Global Registry

**Table 1.** Patient Demographics and Baseline Clinical Characteristics
Parameter	Total sample (N = 771)	Stent length > 30 mm (n = 253)	Stent diameter 4 and 4.5 mm (n = 49)	Subjects with bifurcation lesions (n = 82)	Subjects with CTO (n = 127)
CTO: chronic total occlusion; SD: standard deviation.
Age, years, mean ± SD	64.15 ± 10.95	63.05 ± 11.04	64.57 ± 12.42	64.87 ± 10.33	62.86 ± 10.68
Male, n (%)	576 (74.71)	189 (74.70)	39 (79.59)	64 (78.05)	98 (77.17)
Body mass index, kg/m², mean ± SD	26.84 ± 4.42	26.88 ± 4.55	27.92 ± 4.11	26.60 ± 4.00	26.11 ± 4.36
Systolic blood pressure, mm Hg, mean ± SD	132.54 ± 21.68	134.14 ± 22.20	134.14 ± 24.21	135.23 ± 23.27	129.18 ± 22.52
Diastolic blood pressure, mm Hg, mean ± SD	77.10 ± 12.82	76.82 ± 12.76	79.55 ± 11.44	79.12 ± 13.08	76.84 ± 14.91
Heart rate, bpm, mean ± SD	72.74 ± 12.73	70.92 ± 11.82	71.63 ± 9.86	74.88 ± 13.37	72.91 ± 13.65
Medical history, n (%)	n = 771	n = 253	n = 49	n = 82	n = 127
Family history of cardiovascular disease	209 (27.11)	69 (27.27)	17 (34.69)	24 (29.27)	36 (28.35)
Smokers	364 (47.21)	78 (30.83)	21 (42.86)	21 (25.61)	56 (44.09)
Alcoholic	132 (17.12)	39 (15.42)	13 (26.53)	17 (20.73)	23 (18.11)
Diabetes mellitus	207 (26.85)	81 (32.02)	5 (10.20)	22 (26.83)	33 (25.98)
Dyslipidemia	391 (50.71)	130 (51.38)	20 (40.82)	40 (48.78)	52 (40.94)
Anemia	10 (1.30)	5 (1.98)	-	2 (2.44)	2 (1.57)
Liver disease	14 (1.82)	3 (1.19)	-	1 (1.22)	2 (1.57)
Hypertension	490 (63.55)	171 (67.59)	28 (57.14)	49 (59.76)	75 (59.06)
Renal insufficiency	36 (4.67)	16 (6.32)	3 (6.12)	5 (6.10)	4 (3.15)
Chronic lung disease	43 (5.58)	16 (6.32)	4 (8.16)	7 (8.54)	9 (7.09)
Peripheral vascular disease	30 (3.89)	13 (5.14)	5 (10.20)	3 (3.66)	2 (1.57)
Other illness	137 (17.77)	39 (15.42)	11 (22.45)	22 (26.83)	26 (20.47)
Cardiovascular history, n (%)	n = 771	n = 253	n = 49	n = 82	n = 127
History of stroke	33 (4.28)	11 (4.35)	21 (42.86)	3 (3.66)	4 (3.15)
Cardiovascular disease	139 (18.03)	58 (22.92)	6 (12.24)	16 (19.51)	20 (15.75)
Transient ischemic attack	6 (0.78)	1 (0.40)	0 (0)	1 (1.22)	1 (0.79)
History of previous myocardial infarction	118 (15.3)	42 (16.60)	7 (14.29)	11 (13.41)	15 (11.81)
History of percutaneous coronary intervention	100 (12.97)	34 (13.44)	6 (12.24)	10 (12.20)	13 (10.24)
History of coronary artery bypass graft surgery	3 (0.39)	2 (0.79)	0 (0)	1 (1.22)	0 (0)
Others	48 (6.23)	13 (5.14)	3 (6.12)	3 (3.66)	5 (3.94)
Current angina, n (%)	n = 765	n = 251	n = 49	n = 81	n = 126
Stable	235 (30.71)	78 (31.08)	14 (28.57)	25 (30.86)	25 (19.84)
Unstable	363 (47.45)	116 (46.22)	27 (55.10)	40 (49.38)	60 (47.62)
Not applicable	167 (21.83)	57 (22.71)	8 (16.33)	16 (19.75)	41 (32.54)

Table 1. Patient Demographics and Baseline Clinical Characteristics

Parameter

Total sample (N = 771)

Stent length > 30 mm (n = 253)

Stent diameter 4 and 4.5 mm (n = 49)

Subjects with bifurcation lesions (n = 82)

Subjects with CTO (n = 127)

CTO: chronic total occlusion; SD: standard deviation.

Age, years, mean ± SD

64.15 ± 10.95

63.05 ± 11.04

64.57 ± 12.42

64.87 ± 10.33

62.86 ± 10.68

Male, n (%)

576 (74.71)

189 (74.70)

39 (79.59)

64 (78.05)

98 (77.17)

Body mass index, kg/m², mean ± SD

26.84 ± 4.42

26.88 ± 4.55

27.92 ± 4.11

26.60 ± 4.00

26.11 ± 4.36

Systolic blood pressure, mm Hg, mean ± SD

132.54 ± 21.68

134.14 ± 22.20

134.14 ± 24.21

135.23 ± 23.27

129.18 ± 22.52

Diastolic blood pressure, mm Hg, mean ± SD

77.10 ± 12.82

76.82 ± 12.76

79.55 ± 11.44

79.12 ± 13.08

76.84 ± 14.91

Heart rate, bpm, mean ± SD

72.74 ± 12.73

70.92 ± 11.82

71.63 ± 9.86

74.88 ± 13.37

72.91 ± 13.65

Medical history, n (%)

n = 771

n = 253

n = 49

n = 82

n = 127

Family history of cardiovascular disease

209 (27.11)

69 (27.27)

17 (34.69)

24 (29.27)

36 (28.35)

Smokers

364 (47.21)

78 (30.83)

21 (42.86)

21 (25.61)

56 (44.09)

Alcoholic

132 (17.12)

39 (15.42)

13 (26.53)

17 (20.73)

23 (18.11)

Diabetes mellitus

207 (26.85)

81 (32.02)

5 (10.20)

22 (26.83)

33 (25.98)

Dyslipidemia

391 (50.71)

130 (51.38)

20 (40.82)

40 (48.78)

52 (40.94)

Anemia

10 (1.30)

5 (1.98)

2 (2.44)

2 (1.57)

Liver disease

14 (1.82)

3 (1.19)

1 (1.22)

2 (1.57)

Hypertension

490 (63.55)

171 (67.59)

28 (57.14)

49 (59.76)

75 (59.06)

Renal insufficiency

36 (4.67)

16 (6.32)

3 (6.12)

5 (6.10)

4 (3.15)

Chronic lung disease

43 (5.58)

16 (6.32)

4 (8.16)

7 (8.54)

9 (7.09)

Peripheral vascular disease

30 (3.89)

13 (5.14)

5 (10.20)

3 (3.66)

2 (1.57)

Other illness

137 (17.77)

39 (15.42)

11 (22.45)

22 (26.83)

26 (20.47)

Cardiovascular history, n (%)

n = 771

n = 253

n = 49

n = 82

n = 127

History of stroke

33 (4.28)

11 (4.35)

21 (42.86)

3 (3.66)

4 (3.15)

Cardiovascular disease

139 (18.03)

58 (22.92)

6 (12.24)

16 (19.51)

20 (15.75)

Transient ischemic attack

6 (0.78)

1 (0.40)

0 (0)

1 (1.22)

1 (0.79)

History of previous myocardial infarction

118 (15.3)

42 (16.60)

7 (14.29)

11 (13.41)

15 (11.81)

History of percutaneous coronary intervention

100 (12.97)

34 (13.44)

6 (12.24)

10 (12.20)

13 (10.24)

History of coronary artery bypass graft surgery

3 (0.39)

2 (0.79)

0 (0)

1 (1.22)

0 (0)

Others

48 (6.23)

13 (5.14)

3 (6.12)

3 (3.66)

5 (3.94)

Current angina, n (%)

n = 765

n = 251

n = 49

n = 81

n = 126

Stable

235 (30.71)

78 (31.08)

14 (28.57)

25 (30.86)

25 (19.84)

Unstable

363 (47.45)

116 (46.22)

27 (55.10)

40 (49.38)

60 (47.62)

Not applicable

167 (21.83)

57 (22.71)

8 (16.33)

16 (19.75)

41 (32.54)

**Table 2.** Lesion Characteristics
Characteristics	Total sample (N = 771)	Stent length > 30 mm (n = 253)	Stent diameter 4 and 4.5 mm (n = 49)	Subjects with bifurcation lesions (n = 82)	Subjects with CTO (n = 127)
ACC: American College of Cardiology; AHA: American Heart Association; CTO: chronic total occlusion; TIMI: thrombolysis in myocardial infarction.
Total number of treatable lesions, n	1,079	278	49	91	141
Diseased vessel, n (%)	n = 755	n = 250	n = 48	n = 80	n = 126
Single vessel	486 (64.37)	146 (58.40)	32 (66.67)	37 (46.25)	68 (53.97)
Double vessel	183 (24.24)	67 (26.80)	9 (18.75)	26 (32.5)	40 (31.75)
Triple vessel or more	86 (11.39)	37 (14.80)	7 (14.58)	17 (21.25)	18 (14.29)
Lesion location, n (%)	n = 1,079	n = 278	n = 49	n = 91	n = 141
Left main	6 (0.56)	0 (0)	0 (0)	2 (2.2)	0 (0)
Right coronary artery	309 (28.64)	109 (39.21)	31 (63.27)	12 (13.19)	56 (39.72)
Left anterior descending	458 (42.45)	117 (42.09)	17 (34.69)	51 (56.04)	47 (33.33)
Left circumflex	169 (15.66)	43 (15.47)	1 (2.04)	19 (20.88)	24 (17.02)
Diagonal	36 (3.34)	0 (0)	0 (0)	5 (5.49)	6 (4.26)
Obtuse marginal	54 (5)	9 (3.24)	0 (0)	0 (0)	4 (2.84)
Posterior descending	17 (1.58)	0 (0)	0 (0)	2 (2.2)	4 (2.84)
Intermediate/anterolateral	17 (1.58)	0 (0)	0 (0)	0 (0)	0 (0)
Others	13 (1.2)	0 (0)	0 (0)	0 (0)	0 (0)
Type of stenosis, n (%)	n = 1,067	n = 274	n = 49	n = 91	n = 141
De novo	1,049 (98.31)	264 (96.35)	48 (97.96)	80 (87.91)	139 (98.58)
In-stent	9 (0.84)	6 (2.19)	1 (2.04)	2 (2.2)	1 (0.71)
Bifurcation	9 (0.84)	4 (1.46)	0 (0)	9 (9.89)	1 (0.71)
Thrombus load, n (%)	n = 1,067	n = 269	n = 49	n = 91	n = 141
None	858 (80.41)	190 (70.63)	35 (71.43)	69 (75.82)	75 (53.19)
Mild	74 (6.94)	25 (9.29)	6 (12.24)	7 (7.69)	13 (9.22)
Moderate	95 (8.9)	40 (14.87)	5 (10.2)	10 (10.99)	26 (18.44)
Severe	40 (3.75)	14 (5.2)	3 (6.12)	5 (5.49)	27 (19.15)
ACC/AHA type, n (%)	n = 1,067	n = 272	n = 49	n = 91	n = 141
A	164 (15.37)	31 (11.4)	5 (10.2)	11 (12.09)	6 (4.26)
B1	403 (37.77)	92 (33.82)	18 (36.73)	28 (30.77)	27 (19.15)
B2	265 (24.84)	63 (23.16)	15 (30.61)	21 (23.08)	34 (24.11)
C	235 (22.02)	86 (31.62)	11 (22.45)	31 (34.07)	74 (52.48)
Morphology, n (%)	n = 1,064	n = 273	n = 49	n = 91	n = 141
Concentric	556 (52.26)	151 (55.31)	31 (63.27)	54 (59.34)	75 (53.57)
Eccentric	508 (47.74)	122 (44.69)	18 (36.73)	37 (40.66)	65 (46.43)
TIMI flow prior to treatment, n (%)	n = 1,078	n = 274	n = 49	n = 91	n = 141
TIMI 0	157 (14.56)	62 (22.63)	5 (10.2)	14 (15.38)	118 (83.69)
TIMI 1	72 (6.68)	30 (10.95)	1 (2.04)	4 (4.4)	6 (4.26)
TIMI 2	191 (17.72)	50 (18.25)	12 (24.49)	14 (15.38)	7 (4.96)
TIMI 3	658 (61.04)	132 (48.18)	31 (63.27)	59 (64.84)	10 (7.09)
TIMI flow post-procedure, n (%)	n = 1,040	n = 278	n = 49	n = 84	n = 132
TIMI 0	6 (0.58)	2 (0.72)	0 (0)	2 (2.38)	4 (3.03)
TIMI 1	5 (0.48)	1 (0.36)	0 (0)	0 (0)	4 (3.03)
TIMI 2	25 (2.4)	5 (1.8)	2 (4.08)	0 (0)	4 (3.03)
TIMI 3	1,004 (96.54)	270 (97.12)	47 (95.92)	82 (97.62)	120 (90.91)
Total occlusion, n (%)	141/1,067 (13.21)	45/101 (44.55)	48/49 (97.96)	13/91 (14.29)	141/141 (100)
Tortuosity of lesion, n (%)	n = 1,067	n = 273	n = 49	n = 91	n = 141
Mild	784 (73.48)	197 (72.16)	43 (87.76)	66 (72.53)	104 (73.76)
Moderate	217 (20.34)	59 (21.61)	6 (12.24)	20 (21.98)	12 (8.51)
Severe	66 (6.19)	17 (6.23)	0 (0)	5 (5.49)	25 (17.73)
Lesion calcification, n (%)	n = 1,067	n = 273	n = 49	n = 91	n = 141
Mild	634 (59.42)	149 (54.58)	30 (61.22)	57 (62.64)	81 (57.45)
Moderate	217 (20.34)	70 (25.64)	8 (16.33)	16 (17.58)	20 (14.18)
Severe	47 (4.4)	24 (8.79)	4 (8.16)	8 (8.79)	6 (4.26)
Not applicable	169 (15.84)	205 (73.74)	7 (14.29)	10 (10.99)	34 (24.11)

Table 2. Lesion Characteristics

Characteristics

Total sample (N = 771)

Stent length > 30 mm (n = 253)

Stent diameter 4 and 4.5 mm (n = 49)

Subjects with bifurcation lesions (n = 82)

Subjects with CTO (n = 127)

ACC: American College of Cardiology; AHA: American Heart Association; CTO: chronic total occlusion; TIMI: thrombolysis in myocardial infarction.

Total number of treatable lesions, n

1,079

278

141

Diseased vessel, n (%)

n = 755

n = 250

n = 48

n = 80

n = 126

Single vessel

486 (64.37)

146 (58.40)

32 (66.67)

37 (46.25)

68 (53.97)

Double vessel

183 (24.24)

67 (26.80)

9 (18.75)

26 (32.5)

40 (31.75)

Triple vessel or more

86 (11.39)

37 (14.80)

7 (14.58)

17 (21.25)

18 (14.29)

Lesion location, n (%)

n = 1,079

n = 278

n = 49

n = 91

n = 141

Left main

6 (0.56)

0 (0)

2 (2.2)

0 (0)

Right coronary artery

309 (28.64)

109 (39.21)

31 (63.27)

12 (13.19)

56 (39.72)

Left anterior descending

458 (42.45)

117 (42.09)

17 (34.69)

51 (56.04)

47 (33.33)

Left circumflex

169 (15.66)

43 (15.47)

1 (2.04)

19 (20.88)

24 (17.02)

Diagonal

36 (3.34)

0 (0)

5 (5.49)

6 (4.26)

Obtuse marginal

54 (5)

9 (3.24)

0 (0)

4 (2.84)

Posterior descending

17 (1.58)

0 (0)

2 (2.2)

4 (2.84)

Intermediate/anterolateral

17 (1.58)

0 (0)

Others

13 (1.2)

0 (0)

Type of stenosis, n (%)

n = 1,067

n = 274

n = 49

n = 91

n = 141

De novo

1,049 (98.31)

264 (96.35)

48 (97.96)

80 (87.91)

139 (98.58)

In-stent

9 (0.84)

6 (2.19)

1 (2.04)

2 (2.2)

1 (0.71)

Bifurcation

9 (0.84)

4 (1.46)

0 (0)

9 (9.89)

1 (0.71)

Thrombus load, n (%)

n = 1,067

n = 269

n = 49

n = 91

n = 141

None

858 (80.41)

190 (70.63)

35 (71.43)

69 (75.82)

75 (53.19)

Mild

74 (6.94)

25 (9.29)

6 (12.24)

7 (7.69)

13 (9.22)

Moderate

95 (8.9)

40 (14.87)

5 (10.2)

10 (10.99)

26 (18.44)

Severe

40 (3.75)

14 (5.2)

3 (6.12)

5 (5.49)

27 (19.15)

ACC/AHA type, n (%)

n = 1,067

n = 272

n = 49

n = 91

n = 141

164 (15.37)

31 (11.4)

5 (10.2)

11 (12.09)

6 (4.26)

403 (37.77)

92 (33.82)

18 (36.73)

28 (30.77)

27 (19.15)

265 (24.84)

63 (23.16)

15 (30.61)

21 (23.08)

34 (24.11)

235 (22.02)

86 (31.62)

11 (22.45)

31 (34.07)

74 (52.48)

Morphology, n (%)

n = 1,064

n = 273

n = 49

n = 91

n = 141

Concentric

556 (52.26)

151 (55.31)

31 (63.27)

54 (59.34)

75 (53.57)

Eccentric

508 (47.74)

122 (44.69)

18 (36.73)

37 (40.66)

65 (46.43)

TIMI flow prior to treatment, n (%)

n = 1,078

n = 274

n = 49

n = 91

n = 141

TIMI 0

157 (14.56)

62 (22.63)

5 (10.2)

14 (15.38)

118 (83.69)

TIMI 1

72 (6.68)

30 (10.95)

1 (2.04)

4 (4.4)

6 (4.26)

TIMI 2

191 (17.72)

50 (18.25)

12 (24.49)

14 (15.38)

7 (4.96)

TIMI 3

658 (61.04)

132 (48.18)

31 (63.27)

59 (64.84)

10 (7.09)

TIMI flow post-procedure, n (%)

n = 1,040

n = 278

n = 49

n = 84

n = 132

TIMI 0

6 (0.58)

2 (0.72)

0 (0)

2 (2.38)

4 (3.03)

TIMI 1

5 (0.48)

1 (0.36)

0 (0)

4 (3.03)

TIMI 2

25 (2.4)

5 (1.8)

2 (4.08)

0 (0)

4 (3.03)

TIMI 3

1,004 (96.54)

270 (97.12)

47 (95.92)

82 (97.62)

120 (90.91)

Total occlusion, n (%)

141/1,067 (13.21)

45/101 (44.55)

48/49 (97.96)

13/91 (14.29)

141/141 (100)

Tortuosity of lesion, n (%)

n = 1,067

n = 273

n = 49

n = 91

n = 141

Mild

784 (73.48)

197 (72.16)

43 (87.76)

66 (72.53)

104 (73.76)

Moderate

217 (20.34)

59 (21.61)

6 (12.24)

20 (21.98)

12 (8.51)

Severe

66 (6.19)

17 (6.23)

0 (0)

5 (5.49)

25 (17.73)

Lesion calcification, n (%)

n = 1,067

n = 273

n = 49

n = 91

n = 141

Mild

634 (59.42)

149 (54.58)

30 (61.22)

57 (62.64)

81 (57.45)

Moderate

217 (20.34)

70 (25.64)

8 (16.33)

16 (17.58)

20 (14.18)

Severe

47 (4.4)

24 (8.79)

4 (8.16)

8 (8.79)

6 (4.26)

Not applicable

169 (15.84)

205 (73.74)

7 (14.29)

10 (10.99)

34 (24.11)

**Table 3.** Procedural Characteristics
Procedural characteristics	Total sample (N = 771)	Stent length > 30 mm (n = 253)	Stent diameter 4 and 4.5 mm (n = 49)	Subjects with bifurcation lesions (n = 82)	Subjects with CTO (n = 127)
CTO: chronic total occlusion; SD: standard deviation.
Lesion pre-dilatation done, n (%)	599 (55.51)	205 (73.74)	39 (79.59)	73 (80.22)	94 (66.67)
Lesion length, mm, mean ± SD, (n = 1,075)	22.75 ± 12.22	34.61 ± 12.72	16.04 ± 6.95	21.32 ± 10.22	25.16 ± 9.49
Stent length, mm, n (%)	n = 1,039	n = 278	n = 52	n = 84	n = 132
8	10 (0.96)	0 (0)	0 (0)	1 (1.19)	0 (0)
13	82 (7.89)	0 (0)	6 (11.54)	8 (9.52)	4 (3.03)
16	119 (11.45)	0 (0)	6 (11.54)	8 (9.52)	12 (9.09)
19	206 (19.83)	0 (0)	26 (50)	13 (15.48)	13 (9.85)
24	205 (19.73)	0 (0)	7 (13.46)	18 (21.43)	28 (21.21)
29	138 (13.28)	0 (0)	4 (7.69)	10 (11.9)	19 (14.39)
32	84 (8.08)	84 (30.22)	2 (3.85)	9 (10.71)	18 (13.64)
37	64 (6.16)	63 (22.66)	1 (1.92)	1 (1.19)	13 (9.85)
40	63 (6.06)	63 (22.66)	0 (0)	8 (9.52)	12 (9.09)
44	39 (3.75)	39 (14.03)	0 (0)	4 (4.76)	8 (6.06)
48	29 (2.79)	29 (10.43)	0 (0)	4 (4.76)	5 (3.79)
Stent length, mm, mean ± SD	25.57 ± 9.35	38.30 ± 5.24	20.25 ± 5.29	26.45 ± 10.12	29.11 ± 9.21
Stent diameter, mm, n (%)	n = 1,039	n = 278	n = 52	n = 84	n = 132
2.5	247 (23.77)	74 (26.62)	0 (0)	22 (26.19)	37 (28.03)
2.75	162 (15.59)	50 (17.99)	0 (0)	13 (15.48)	18 (13.64)
3	363 (34.94)	104 (37.41)	0 (0)	26 (30.95)	48 (36.36)
3.5	214 (20.6)	47 (16.91)	0 (0)	19 (22.62)	28 (21.21)
4	38 (3.66)	2 (0.72)	37 (71.15)	4 (4.76)	0 (0)
4.5	15 (1.44)	1 (0.36)	15 (28.85)	0 (0)	1 (0.76)
Stent diameter, mm, mean ± SD (n = 1,039)	3.00 ± 0.44	2.92 ± 0.36	4.14 ± 0.23	2.99 ± 0.43	2.94 ± 0.38
% Diameter stenosis, pre-procedure, mean ± SD	83.93 ± 12.84	83.48 ± 12.37	83.12 ± 17.30	85.04 ± 12.68	99.21 ± 3.74
% Diameter stenosis post-procedure, mean ± SD	4.22 ± 11.50	4.91 ± 8.73	4.12 ± 6.90	4.64 ± 13.28	3.25 ± 10.69
Reference vessel diameter, mm, mean ± SD	2.96 ± 0.47	2.92 ± 0.45	3.89 ± 0.70	2.93 ± 0.46	2.90 ± 0.53
Minimum lumen diameter, pre-procedure, mm, mean ± SD	1 ± 1.69	1.12 ± 2.88	1.33 ± 1.00	1.08 ± 0.97	0.79 ± 1.91
Minimum lumen diameter post-procedure, mm, mean ± SD	2.96 ± 1.35	2.76 ± 0.65	3.84 ± 0.49	3.09 ±2.75	2.88 ± 0.65

Table 3. Procedural Characteristics

Procedural characteristics

Total sample (N = 771)

Stent length > 30 mm (n = 253)

Stent diameter 4 and 4.5 mm (n = 49)

Subjects with bifurcation lesions (n = 82)

Subjects with CTO (n = 127)

CTO: chronic total occlusion; SD: standard deviation.

Lesion pre-dilatation done, n (%)

599 (55.51)

205 (73.74)

39 (79.59)

73 (80.22)

94 (66.67)

Lesion length, mm, mean ± SD, (n = 1,075)

22.75 ± 12.22

34.61 ± 12.72

16.04 ± 6.95

21.32 ± 10.22

25.16 ± 9.49

Stent length, mm, n (%)

n = 1,039

n = 278

n = 52

n = 84

n = 132

10 (0.96)

0 (0)

1 (1.19)

0 (0)

82 (7.89)

0 (0)

6 (11.54)

8 (9.52)

4 (3.03)

119 (11.45)

0 (0)

6 (11.54)

8 (9.52)

12 (9.09)

206 (19.83)

0 (0)

26 (50)

13 (15.48)

13 (9.85)

205 (19.73)

0 (0)

7 (13.46)

18 (21.43)

28 (21.21)

138 (13.28)

0 (0)

4 (7.69)

10 (11.9)

19 (14.39)

84 (8.08)

84 (30.22)

2 (3.85)

9 (10.71)

18 (13.64)

64 (6.16)

63 (22.66)

1 (1.92)

1 (1.19)

13 (9.85)

63 (6.06)

63 (22.66)

0 (0)

8 (9.52)

12 (9.09)

39 (3.75)

39 (14.03)

0 (0)

4 (4.76)

8 (6.06)

29 (2.79)

29 (10.43)

0 (0)

4 (4.76)

5 (3.79)

Stent length, mm, mean ± SD

25.57 ± 9.35

38.30 ± 5.24

20.25 ± 5.29

26.45 ± 10.12

29.11 ± 9.21

Stent diameter, mm, n (%)

n = 1,039

n = 278

n = 52

n = 84

n = 132

2.5

247 (23.77)

74 (26.62)

0 (0)

22 (26.19)

37 (28.03)

2.75

162 (15.59)

50 (17.99)

0 (0)

13 (15.48)

18 (13.64)

363 (34.94)

104 (37.41)

0 (0)

26 (30.95)

48 (36.36)

3.5

214 (20.6)

47 (16.91)

0 (0)

19 (22.62)

28 (21.21)

38 (3.66)

2 (0.72)

37 (71.15)

4 (4.76)

0 (0)

4.5

15 (1.44)

1 (0.36)

15 (28.85)

0 (0)

1 (0.76)

Stent diameter, mm, mean ± SD (n = 1,039)

3.00 ± 0.44

2.92 ± 0.36

4.14 ± 0.23

2.99 ± 0.43

2.94 ± 0.38

% Diameter stenosis, pre-procedure, mean ± SD

83.93 ± 12.84

83.48 ± 12.37

83.12 ± 17.30

85.04 ± 12.68

99.21 ± 3.74

% Diameter stenosis post-procedure, mean ± SD

4.22 ± 11.50

4.91 ± 8.73

4.12 ± 6.90

4.64 ± 13.28

3.25 ± 10.69

Reference vessel diameter, mm, mean ± SD

2.96 ± 0.47

2.92 ± 0.45

3.89 ± 0.70

2.93 ± 0.46

2.90 ± 0.53

Minimum lumen diameter, pre-procedure, mm, mean ± SD

1 ± 1.69

1.12 ± 2.88

1.33 ± 1.00

1.08 ± 0.97

0.79 ± 1.91

Minimum lumen diameter post-procedure, mm, mean ± SD

2.96 ± 1.35

2.76 ± 0.65

3.84 ± 0.49

3.09 ±2.75

2.88 ± 0.65

**Table 4.** Cumulative Outcomes After 24 Months Follow-Up
Events	In-hospital (n = 771)	1 month (n = 760)	9 months (n = 733)	12 months (n = 717)	24 months (n = 691)
Values are n (%). ^aOne patient suffered from MI, TVR, TVR including TLR. ^bFour patients suffered from MI, TVR, TVR including TLR. ^cEight patients suffered from MI, TVR, TVR including TLR. ^dTen patients suffered from MI, TVR, TVR including TLR. ^eTwelve patients suffered from MI, TVR, TVR including TLR. ^{f, g}Among 21 patients, ^fone patient had MI at 1 and 24 months, ^gone patient had MI at 9 and 24 months. MI: myocardial infarction; TVR: target vessel revascularization; TLR: target lesion revascularization; TVF: target vessel failure (composite of cardiac deaths, MI, and TVR including TLR); MACE: major adverse cardiovascular events (composite endpoint of cardiac death, MI, and TVR).
Death	0 (0)	1 (0.13)	6 (0.81)	8 (1.11)	14 (2.02)
Cardiac death	0 (0)	1 (0.13)	2 (0.27)	2 (0.28)	6 (0.87)
Non-cardiac death	0 (0)	0 (0)	3 (0.40)	4 (0.55)	5 (0.72)
Undetermined death	0 (0.00)	0 (0.00)	1 (0.13)	2 (0.28)	3 (0.43)
MI	1 (0.13)^a	6 (0.78)^{b, f}	14 (1.90)^{c, g}	18 (2.51)^d	21 (3.03)^{e, f, g}
TVR	1 (0.13)^a	5 (0.65)^b	14 (1.90)^c	17 (2.37)^d	23 (3.32)^e
TVR including TLR	1 (0.13)^a	5 (0.65)^b	14 (1.90)^c	17 (2.37)^d	23 (3.32)^e
TLR	0 (0)	3 (0.39)	12 (1.63)	15 (2.09)	21 (3.03)
Stent thrombosis	0 (0)	0 (0)	1 (0.13)	2 (0.28)	2 (0.28)
TVF	1 (0.13)	8 (1.05)	23 (3.13)	29 (4.04)	39 (5.64)
MACE	1 (0.13)	8 (1.05)	23 (3.13)	29 (4.04)	39 (5.64)

Table 4. Cumulative Outcomes After 24 Months Follow-Up

Events

In-hospital (n = 771)

1 month (n = 760)

9 months (n = 733)

12 months (n = 717)

24 months (n = 691)

Values are n (%). ^aOne patient suffered from MI, TVR, TVR including TLR. ^bFour patients suffered from MI, TVR, TVR including TLR. ^cEight patients suffered from MI, TVR, TVR including TLR. ^dTen patients suffered from MI, TVR, TVR including TLR. ^eTwelve patients suffered from MI, TVR, TVR including TLR. ^{f, g}Among 21 patients, ^fone patient had MI at 1 and 24 months, ^gone patient had MI at 9 and 24 months. MI: myocardial infarction; TVR: target vessel revascularization; TLR: target lesion revascularization; TVF: target vessel failure (composite of cardiac deaths, MI, and TVR including TLR); MACE: major adverse cardiovascular events (composite endpoint of cardiac death, MI, and TVR).

Death

0 (0)

1 (0.13)

6 (0.81)

8 (1.11)

14 (2.02)

Cardiac death

0 (0)

1 (0.13)

2 (0.27)

2 (0.28)

6 (0.87)

Non-cardiac death

0 (0)

3 (0.40)

4 (0.55)

5 (0.72)

Undetermined death

0 (0.00)

1 (0.13)

2 (0.28)

3 (0.43)

1 (0.13)^a

6 (0.78)^{b, f}

14 (1.90)^{c, g}

18 (2.51)^d

21 (3.03)^{e, f, g}

TVR

1 (0.13)^a

5 (0.65)^b

14 (1.90)^c

17 (2.37)^d

23 (3.32)^e

TVR including TLR

1 (0.13)^a

5 (0.65)^b

14 (1.90)^c

17 (2.37)^d

23 (3.32)^e

TLR

0 (0)

3 (0.39)

12 (1.63)

15 (2.09)

21 (3.03)

Stent thrombosis

0 (0)

1 (0.13)

2 (0.28)

TVF

1 (0.13)

8 (1.05)

23 (3.13)

29 (4.04)

39 (5.64)

MACE

1 (0.13)

8 (1.05)

23 (3.13)

29 (4.04)

39 (5.64)

**Table 5.** Cumulative Outcomes up to 24 Months Follow-Up for Population Treated With Stent > 30 mm in Length
Events	In-hospital (n = 253)	1 month (n = 248)	9 months (n = 239)	12 months (n = 234)	24 months (n = 228)
Values are presented in n (%). ^aOne patient suffered from MI, TVR and TVR including TLR. ^bFour patients suffered from MI, TVR and TVR including TLR. ^cFive patients suffered from MI, TVR and TVR including TLR. ^dSix patients suffered from MI, TVR and TVR including TLR. ^{e, f}Among nine patients, ^eone patient had MI at 1 and 24 months, ^fone patient had MI at 9 and 24 months follow-up. MI: myocardial infarction; TVR: target vessel revascularization; TLR: target lesion revascularization; TVF: target vessel failure (composite of cardiac deaths, MI and TVR including TLR); MACE: major adverse cardiovascular events (composite endpoint of cardiac death, MI and TVR).
Death	0 (0)	0 (0)	2 (0.84)	3 (1.38)	5 (2.19)
Cardiac death	0 (0)	0 (0)	1 (0.42)	1 (0.43)	3 (1.32)
Non-cardiac death	0 (0)	0 (0)	1 (0.42)	2 (0.85)	2 (0.88)
Undetermined death	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
MI	0 (0)	1 (0.40)^{a, e}	6 (2.51)^{b, f}	7 (2.99)^c	9 (3.95)^{d, e, f}
TVR	0 (0)	1 (0.40)^a	8 (3.35)^b	9 (3.85)^c	12 (5.26)^d
TVR including TLR	0 (0)	1 (0.40)^a	8 (3.35)^b	9 (3.85)^c	12 (5.26)^d
TLR	0 (0)	1 (0.40)	8 (3.35)	9 (3.85)	12 (5.26)
Stent thrombosis	0 (0)	0 (0)	1 (0.42)	1 (0.43)	1 (0.44)
TVF	0 (0)	1 (0.40)	11 (4.60)	12 (5.12)	16 (7.01)
MACE	0 (0)	1 (0.40)	11 (4.60)	12 (5.12)	16 (7.01)

Table 5. Cumulative Outcomes up to 24 Months Follow-Up for Population Treated With Stent > 30 mm in Length

Events

In-hospital (n = 253)

1 month (n = 248)

9 months (n = 239)

12 months (n = 234)

24 months (n = 228)

Values are presented in n (%). ^aOne patient suffered from MI, TVR and TVR including TLR. ^bFour patients suffered from MI, TVR and TVR including TLR. ^cFive patients suffered from MI, TVR and TVR including TLR. ^dSix patients suffered from MI, TVR and TVR including TLR. ^{e, f}Among nine patients, ^eone patient had MI at 1 and 24 months, ^fone patient had MI at 9 and 24 months follow-up. MI: myocardial infarction; TVR: target vessel revascularization; TLR: target lesion revascularization; TVF: target vessel failure (composite of cardiac deaths, MI and TVR including TLR); MACE: major adverse cardiovascular events (composite endpoint of cardiac death, MI and TVR).

Death

0 (0)

2 (0.84)

3 (1.38)

5 (2.19)

Cardiac death

0 (0)

1 (0.42)

1 (0.43)

3 (1.32)

Non-cardiac death

0 (0)

1 (0.42)

2 (0.85)

2 (0.88)

Undetermined death

0 (0)

1 (0.40)^{a, e}

6 (2.51)^{b, f}

7 (2.99)^c

9 (3.95)^{d, e, f}

TVR

0 (0)

1 (0.40)^a

8 (3.35)^b

9 (3.85)^c

12 (5.26)^d

TVR including TLR

0 (0)

1 (0.40)^a

8 (3.35)^b

9 (3.85)^c

12 (5.26)^d

TLR

0 (0)

1 (0.40)

8 (3.35)

9 (3.85)

12 (5.26)

Stent thrombosis

0 (0)

1 (0.42)

1 (0.43)

1 (0.44)

TVF

0 (0)

1 (0.40)

11 (4.60)

12 (5.12)

16 (7.01)

MACE

0 (0)

1 (0.40)

11 (4.60)

12 (5.12)

16 (7.01)

**Table 6.** Cumulative Clinical Events up to 24 Months for Population Treated With 4.00- and 4.50-mm Diameter Stent
Events	In-hospital (n = 49)	1 month (n = 49)	9 months (n = 48)	12 months (n = 48)	24 months (n = 48)
Values are presented in n (%). ^aOne patient suffered from MI, TVR and TVR including TLR. ^bOne patient suffered from MI, TVR and TVR including TLR. ^cTwo patients suffered from MI, TVR and TVR including TLR. ^dOne same patient had MI at 9 and 24 months follow-up. MI: myocardial infarction; TVR: target vessel revascularization; TLR: target lesion revascularization; TVF: target vessel failure (composite of cardiac deaths, MI and TVR including TLR); MACE: major adverse cardiovascular events (composite endpoint of cardiac death, MI and TVR).
Death	0 (0)	0 (0)	1 (2.08)	1 (2.08)	4 (8.33)
Cardiac death	0 (0)	0 (0)	0 (0)	0 (0)	1 (2.08)
Non-cardiac death	0 (0)	0 (0)	0 (0)	0 (0)	1 (2.08)
Undetermined death	0 (0)	0 (0)	1 (2.08)	1 (2.08)	2 (4.17)
MI	0 (0)	0 (0)	2 (4.17)^{a, d}	2 (4.17)^b	3 (6.25)^{c, d}
TVR	0 (0)	0 (0)	1 (2.08)^a	1 (2.08)^b	2 (4.17)^c
TVR including TLR	0 (0)	0 (0)	1 (2.08)^a	1 (2.08)^b	2 (4.17)^c
TLR	0 (0)	0 (0)	1 (2.08)	1 (2.08)	2 (4.17)
Stent thrombosis	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
TVF	0 (0)	0 (0)	3 (6.25)	3 (6.25)	5 (10.41)
MACE	0 (0)	0 (0)	3 (6.25)	3 (6.25)	5 (10.41)

Table 6. Cumulative Clinical Events up to 24 Months for Population Treated With 4.00- and 4.50-mm Diameter Stent

Events

In-hospital (n = 49)

1 month (n = 49)

9 months (n = 48)

12 months (n = 48)

24 months (n = 48)

Values are presented in n (%). ^aOne patient suffered from MI, TVR and TVR including TLR. ^bOne patient suffered from MI, TVR and TVR including TLR. ^cTwo patients suffered from MI, TVR and TVR including TLR. ^dOne same patient had MI at 9 and 24 months follow-up. MI: myocardial infarction; TVR: target vessel revascularization; TLR: target lesion revascularization; TVF: target vessel failure (composite of cardiac deaths, MI and TVR including TLR); MACE: major adverse cardiovascular events (composite endpoint of cardiac death, MI and TVR).

Death

0 (0)

1 (2.08)

4 (8.33)

Cardiac death

0 (0)

1 (2.08)

Non-cardiac death

0 (0)

1 (2.08)

Undetermined death

0 (0)

1 (2.08)

2 (4.17)

0 (0)

2 (4.17)^{a, d}

2 (4.17)^b

3 (6.25)^{c, d}

TVR

0 (0)

1 (2.08)^a

1 (2.08)^b

2 (4.17)^c

TVR including TLR

0 (0)

1 (2.08)^a

1 (2.08)^b

2 (4.17)^c

TLR

0 (0)

1 (2.08)

2 (4.17)

Stent thrombosis

0 (0)

TVF

0 (0)

3 (6.25)

5 (10.41)

MACE

0 (0)

3 (6.25)

5 (10.41)

**Table 7.** Cumulative Major Cardiac Clinical Events up to 24 Months in Patients With Bifurcation Lesions
Events	In-hospital (n = 82)	1-month (n = 81)	9-months (n = 79)	12-months (n = 78)	24-months (n = 74)
Values are presented in n (%). ^aOne patient suffered from MI, TVR and TVR including TLR. ^bTwo patients suffered from MI, TVR and TVR including TLR. ^cFour patients suffered from MI, TVR and TVR including TLR. ^dFour patients suffered from MI, TVR and TVR including TLR. ^eOne same patient had MI at 1- and 24-month follow-up. MI: myocardial infarction; TVR: target vessel revascularization; TLR: target lesion revascularization; TVF: target vessel failure (composite of cardiac deaths, MI and TVR including TLR); MACE: major adverse cardiovascular events (composite endpoint of cardiac death, MI and TVR).
Death	0 (0)	0 (0)	0 (0)	1 (1.28)	3 (4.05)
Cardiac death	0 (0)	0 (0)	0 (0)	0 (0)	1 (1.35)
Non-cardiac death	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Undetermined death	0 (0)	0 (0)	0 (0)	1 (1.28)	2 (2.70)
MI	0 (0)	1 (1.23)^{a, e}	3 (3.84)^b	6 (7.69)^c	7 (9.46)^{d, e}
TVR	0 (0)	2 (2.47)^a	4 (5.06)^b	6 (7.69)^c	7 (9.46)^d
TVR including TLR	0 (0)	2 (2.47)^a	4 (5.06)^b	6 (7.69)^c	7 (9.46)^d
TLR	0 (0)	2 (2.47)	4 (5.06)	6 (7.69)	7 (9.46)
Stent thrombosis	0 (0)	0 (0)	1 (1.27)	1 (1.28)	1 (1.35)
TVF	0 (0)	2 (2.46)	5 (6.32)	9 (11.53)	12 (16.21)
MACE	0 (0)	2 (2.46)	5 (6.32)	9 (11.53)	12 (16.21)

Table 7. Cumulative Major Cardiac Clinical Events up to 24 Months in Patients With Bifurcation Lesions

Events

In-hospital (n = 82)

1-month (n = 81)

9-months (n = 79)

12-months (n = 78)

24-months (n = 74)

Values are presented in n (%). ^aOne patient suffered from MI, TVR and TVR including TLR. ^bTwo patients suffered from MI, TVR and TVR including TLR. ^cFour patients suffered from MI, TVR and TVR including TLR. ^dFour patients suffered from MI, TVR and TVR including TLR. ^eOne same patient had MI at 1- and 24-month follow-up. MI: myocardial infarction; TVR: target vessel revascularization; TLR: target lesion revascularization; TVF: target vessel failure (composite of cardiac deaths, MI and TVR including TLR); MACE: major adverse cardiovascular events (composite endpoint of cardiac death, MI and TVR).

Death

0 (0)

1 (1.28)

3 (4.05)

Cardiac death

0 (0)

1 (1.35)

Non-cardiac death

0 (0)

Undetermined death

0 (0)

1 (1.28)

2 (2.70)

0 (0)

1 (1.23)^{a, e}

3 (3.84)^b

6 (7.69)^c

7 (9.46)^{d, e}

TVR

0 (0)

2 (2.47)^a

4 (5.06)^b

6 (7.69)^c

7 (9.46)^d

TVR including TLR

0 (0)

2 (2.47)^a

4 (5.06)^b

6 (7.69)^c

7 (9.46)^d

TLR

0 (0)

2 (2.47)

4 (5.06)

6 (7.69)

7 (9.46)

Stent thrombosis

0 (0)

1 (1.27)

1 (1.28)

1 (1.35)

TVF

0 (0)

2 (2.46)

5 (6.32)

9 (11.53)

12 (16.21)

MACE

0 (0)

2 (2.46)

5 (6.32)

9 (11.53)

12 (16.21)

**Table 8.** Cumulative Major Cardiac Events up to 24 Months Follow-Up for Population With CTO
Events	In-hospital (n = 127)	1 month (n = 126)	9 months (n = 119)	12 months (n = 117)	24 months (n = 113)
Values are presented in n (%). ^aTwo patients suffered from MI, TVR and TVR including TLR. ^bThree patients suffered from MI, TVR and TVR including TLR. ^cThree patients suffered from MI, TVR and TVR including TLR. MI: myocardial infarction; TVR: target vessel revascularization; TLR: target lesion revascularization; TVF: target vessel failure (composite of cardiac deaths, MI and TVR including TLR); MACE: major adverse cardiovascular events (composite endpoint of cardiac death, MI and TVR).
Death	0 (0)	0 (0)	2 (1.68)	2 (1.71)	2 (1.77)
Cardiac death	0 (0)	0 (0)	1 (0.84)	1 (0.85)	1 (0.88)
Non-cardiac death	0 (0)	0 (0)	1 (0.84)	1 (0.85)	1 (0.88)
Undetermined death	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
MI	0 (0)	1 (0.79)	4 (3.36)^a	5 (4.27)^b	5 (4.42)^c
TVR	0 (0)	0 (0)	3 (2.52)^a	5 (4.27)^b	5 (4.42)^c
TVR including TLR	0 (0)	0 (0)	3 (2.52)^a	5 (4.27)^b	5 (4.42)^c
TLR	0 (0)	0 (0)	3 (2.52)	5 (4.27)	5 (4.42)
Stent thrombosis	0 (0)	0 (0)	1 (0.84)	1 (0.85)	1 (0.88)
TVF	0 (0)	1 (0.79)	6 (5.04)	8 (6.83)	8 (7.07)
MACE	0	1 (0.79)	6 (5.04)	8 (6.83)	8 (7.07)

Table 8. Cumulative Major Cardiac Events up to 24 Months Follow-Up for Population With CTO

Events

In-hospital (n = 127)

1 month (n = 126)

9 months (n = 119)

12 months (n = 117)

24 months (n = 113)

Values are presented in n (%). ^aTwo patients suffered from MI, TVR and TVR including TLR. ^bThree patients suffered from MI, TVR and TVR including TLR. ^cThree patients suffered from MI, TVR and TVR including TLR. MI: myocardial infarction; TVR: target vessel revascularization; TLR: target lesion revascularization; TVF: target vessel failure (composite of cardiac deaths, MI and TVR including TLR); MACE: major adverse cardiovascular events (composite endpoint of cardiac death, MI and TVR).

Death

0 (0)

2 (1.68)

2 (1.71)

2 (1.77)

Cardiac death

0 (0)

1 (0.84)

1 (0.85)

1 (0.88)

Non-cardiac death

0 (0)

1 (0.84)

1 (0.85)

1 (0.88)

Undetermined death

0 (0)

1 (0.79)

4 (3.36)^a

5 (4.27)^b

5 (4.42)^c

TVR

0 (0)

3 (2.52)^a

5 (4.27)^b

5 (4.42)^c

TVR including TLR

0 (0)

3 (2.52)^a

5 (4.27)^b

5 (4.42)^c

TLR

0 (0)

3 (2.52)

5 (4.27)

5 (4.42)

Stent thrombosis

0 (0)

1 (0.84)

1 (0.85)

1 (0.88)

TVF

0 (0)

1 (0.79)

6 (5.04)

8 (6.83)

8 (7.07)

MACE

1 (0.79)

6 (5.04)

8 (6.83)

8 (7.07)

**Table 9.** Clinical Outcomes Comparison of BioMime Stent With Other Drug-Coated/Bare Metal Stents
Stents	No. of patients (n)	Clinical follow-up	Cardiac death	Non-cardiac death	MI	TVR	ST	TVF	MACE
^aMACE (composite endpoint of cardiac death, MI, and TVR). ^bMACE (composite of cardiac death, MI, and TLR). ^cARC defined - probable/definite. ^dMACE (death, MI, TVR). ^eMACE (composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization). BMS: bare metal stent; EES: everolimus-eluting stent; MACE: major adverse cardiovascular events; MI: myocardial infarction; SES: sirolimus-eluting stent; ST: stent thrombosis; TVF: target vessel failure, TVR: target vessel revascularization; ZES: zotarolimus-eluting stent.
BioMime SES	691	2 years	6 (0.87)	5.5 (0.72)	21 (3.03)	23 (3.32)	2 (0.28)	39 (5.64)	39 (5.64)^a
XIENCE EES [40]	365	2 years	3 (0.8)	-	11(3.0)	7 (1.9)	6 (1.6)	-	22 (6.0)^b
Resolute ZES [41]	139	2 years	1 (0.7)	3 (2.2)	8 (5.8)	2 (1.4)	0 (0.0)	11 (7.9)	14 (10.1)
MiStent SES [42]	123	2 years	2 (1.7)	1 (0.8)	3 (2.5)	2 (1.7)	1 (0.0)^c	6 (5.0)	8 (6.7)^d
Endeavor Sprint ZES [42]	61	2 years	1 (1.7)	0 (0.0)	3 (5.0)	5 (8.3)	1 (1.7)^c	7 (11.7)	8 (13.3)^d
Biolimus [43]	575	1 year	16 (2.9)	-	-	11 (2.0)	5 (0.9)	-	24 (4.3)^e
Orsiro SES [26]	1,245	2 years	21 (1.6)	-	39 (3.2)	57 (4.7)	11 (0.9)	87 (7.1)	107 (8.6)
Gazelle BMS [43]	582	1 year	20 (3.5)	-	-	37 (6.5)	12 (2.1)	-	49 (8.7)^e

Table 9. Clinical Outcomes Comparison of BioMime Stent With Other Drug-Coated/Bare Metal Stents

Stents

No. of patients (n)

Clinical follow-up

Cardiac death

Non-cardiac death

TVR

TVF

MACE

^aMACE (composite endpoint of cardiac death, MI, and TVR). ^bMACE (composite of cardiac death, MI, and TLR). ^cARC defined - probable/definite. ^dMACE (death, MI, TVR). ^eMACE (composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization). BMS: bare metal stent; EES: everolimus-eluting stent; MACE: major adverse cardiovascular events; MI: myocardial infarction; SES: sirolimus-eluting stent; ST: stent thrombosis; TVF: target vessel failure, TVR: target vessel revascularization; ZES: zotarolimus-eluting stent.

BioMime SES

691

2 years

6 (0.87)

5.5 (0.72)

21 (3.03)

23 (3.32)

2 (0.28)

39 (5.64)

39 (5.64)^a

XIENCE EES [40]

365

2 years

3 (0.8)

11(3.0)

7 (1.9)

6 (1.6)

22 (6.0)^b

Resolute ZES [41]

139

2 years

1 (0.7)

3 (2.2)

8 (5.8)

2 (1.4)

0 (0.0)

11 (7.9)

14 (10.1)

MiStent SES [42]

123

2 years

2 (1.7)

1 (0.8)

3 (2.5)

2 (1.7)

1 (0.0)^c

6 (5.0)

8 (6.7)^d

Endeavor Sprint ZES [42]

2 years

1 (1.7)

0 (0.0)

3 (5.0)

5 (8.3)

1 (1.7)^c

7 (11.7)

8 (13.3)^d

Biolimus [43]

575

1 year

16 (2.9)

11 (2.0)

5 (0.9)

24 (4.3)^e

Orsiro SES [26]

1,245

2 years

21 (1.6)

39 (3.2)

57 (4.7)

11 (0.9)

87 (7.1)

107 (8.6)

Gazelle BMS [43]

582

1 year

20 (3.5)

37 (6.5)

12 (2.1)

49 (8.7)^e