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://www.cardiologyres.org

Original Article

Volume 14, Number 5, October 2023, pages 360-369

Long-Term Assessment of Thin-Strut BioMime Coronary Stent System in Real-World Population at Single-Center: A Retrospective Observational Study

Figure 1. The STROBE flow diagram of patients (non-cumulative) who were enrolled and followed-up for 4 years. STROBE: Strengthening the Reporting of Observational Studies in Epidemiology; FU: follow-up.

**Table 1.** Baseline Demographics and Clinical Characteristics
Characteristics	Patients (n = 1,188)
Values are expressed as n (%) or mean ± SD. ACS: acute coronary syndrome; bpm: beats per minute; CABG: coronary artery bypass grafting; CAD: coronary artery disease; COPD: chronic obstructive pulmonary disease; LVEF: left ventricular ejection fraction; MI: myocardial infarction; NSTEMI: non-ST-elevation MI; PCI: percutaneous coronary intervention; PTCA: percutaneous transluminal coronary angioplasty; SD: standard deviation; STEMI: ST-elevation MI.
Patient demographics
Age (years)	53.26 ± 10.31
Male	1,024 (86.20)
Female	164 (13.80)
Heart rate, bpm	80.60 ± 7.19
Systolic blood pressure, mm Hg	120.34 ± 15.48
Diastolic blood pressure, mm Hg	76.54 ± 7.87
Serum creatinine, mg/dL	1.03 ± 1.28
Medical history
Hypertension	273 (22.98)
Diabetes mellitus	202 (17.00)
Hypercholesterolemia	3 (0.25)
Ischemic heart disease	2 (0.17)
Thrombolysis	19 (1.60)
Current smokers	650 (54.71)
Alcohol consumption	123 (10.35)
Stroke	4 (0.34)
COPD	4 (0.34)
Previous CAD	19 (1.60)
Stable angina	1,007 (84.76)
ACS	181 (15.15)
Unstable angina	37 (3.11)
STEMI	134 (11.28)
NSTEMI	10 (0.84)
Other illnesses	13 (1.09)
History of previous interventions
Previous CABG	1 (0.08)
Previous PCI	28 (2.36)
Primary PTCA	75 (6.31)
LVEF, %	47.38 ± 10.08

Table 1. Baseline Demographics and Clinical Characteristics

Characteristics

Patients (n = 1,188)

N (%) or mean ± SD

Values are expressed as n (%) or mean ± SD. ACS: acute coronary syndrome; bpm: beats per minute; CABG: coronary artery bypass grafting; CAD: coronary artery disease; COPD: chronic obstructive pulmonary disease; LVEF: left ventricular ejection fraction; MI: myocardial infarction; NSTEMI: non-ST-elevation MI; PCI: percutaneous coronary intervention; PTCA: percutaneous transluminal coronary angioplasty; SD: standard deviation; STEMI: ST-elevation MI.

Patient demographics

Age (years)

53.26 ± 10.31

Male

1,024 (86.20)

Female

164 (13.80)

Heart rate, bpm

80.60 ± 7.19

Systolic blood pressure, mm Hg

120.34 ± 15.48

Diastolic blood pressure, mm Hg

76.54 ± 7.87

Serum creatinine, mg/dL

1.03 ± 1.28

Medical history

Hypertension

273 (22.98)

Diabetes mellitus

202 (17.00)

Hypercholesterolemia

3 (0.25)

Ischemic heart disease

2 (0.17)

Thrombolysis

19 (1.60)

Current smokers

650 (54.71)

Alcohol consumption

123 (10.35)

Stroke

4 (0.34)

COPD

4 (0.34)

Previous CAD

19 (1.60)

Stable angina

1,007 (84.76)

ACS

181 (15.15)

Unstable angina

37 (3.11)

STEMI

134 (11.28)

NSTEMI

10 (0.84)

Other illnesses

13 (1.09)

History of previous interventions

Previous CABG

1 (0.08)

Previous PCI

28 (2.36)

Primary PTCA

75 (6.31)

LVEF, %

47.38 ± 10.08

**Table 2.** Lesion and Procedural Characteristics
Variable	N (%) or mean ± SD
Values are expressed as n (%) or mean ± SD. SD: standard deviation.
Target coronary vessel
Left anterior descending	514 (40.89)
Right coronary artery	500 (39.78)
Left circumflex	232 (18.46)
Others	11 (0.87)
Lesion location
Ostial	8 (0.60)
Proximal	488 (36.61)
Mid	594 (44.56)
Distal	243 (18.23)
Lesion characteristics
Bifurcation	106 (7.9)
Chronic total occlusion	327 (25.31)
Vessel disease
Single vessel disease	675 (56.82)
Double vessel disease	130 (10.94)
Multiple vessel disease	383 (32.24)
Lesion details
Total number of lesions	1,565
Total number of lesions treated	1,333
Lesion per patient	1.12
Mean lesion diameter (mm)	3.01 ± 0.29
Mean lesion length (mm)	29.62 ± 9.62
Stent details
Total number of study stents deployed	1,344
Stents per patient	1.13
Mean diameter of study device (mm)	3.17 ± 0.25
Mean length of study device (mm)	30.89 ± 6.31
Total number of other stents deployed	240
Total number of lesions treated with other stents	232
Mean stent length (mm)	26.83 ± 9.23
Mean stent diameter (mm)	2.89 ± 0.61
P2Y12 inhibitor therapy
Clopidogrel	725 (61.03)
Prasugrel	154 (12.96)
Ticagrelor	309 (26.01)

Table 2. Lesion and Procedural Characteristics

Variable

N (%) or mean ± SD

Values are expressed as n (%) or mean ± SD. SD: standard deviation.

Target coronary vessel

Left anterior descending

514 (40.89)

Right coronary artery

500 (39.78)

Left circumflex

232 (18.46)

Others

11 (0.87)

Lesion location

Ostial

8 (0.60)

Proximal

488 (36.61)

Mid

594 (44.56)

Distal

243 (18.23)

Lesion characteristics

Bifurcation

106 (7.9)

Chronic total occlusion

327 (25.31)

Vessel disease

Single vessel disease

675 (56.82)

Double vessel disease

130 (10.94)

Multiple vessel disease

383 (32.24)

Lesion details

Total number of lesions

1,565

Total number of lesions treated

1,333

Lesion per patient

1.12

Mean lesion diameter (mm)

3.01 ± 0.29

Mean lesion length (mm)

29.62 ± 9.62

Stent details

Total number of study stents deployed

1,344

Stents per patient

1.13

Mean diameter of study device (mm)

3.17 ± 0.25

Mean length of study device (mm)

30.89 ± 6.31

Total number of other stents deployed

240

Total number of lesions treated with other stents

232

Mean stent length (mm)

26.83 ± 9.23

Mean stent diameter (mm)

2.89 ± 0.61

P2Y12 inhibitor therapy

Clopidogrel

725 (61.03)

Prasugrel

154 (12.96)

Ticagrelor

309 (26.01)

**Table 3.** Cumulative Major Adverse Cardiac Events at 1-Year to 4-Year Follow-Up
Event	1-year	2-year	3-year	4-year
^aLost to follow-up. Values are expressed as n (%). MACE is defined as a composite of cardiac death, myocardial infarction (MI) attributed to target vessel and target lesion revascularization. ST: stent thrombosis; TLR: target lesion revascularization; TVR: target vessel revascularization; MI: myocardial infarction; TVMI: target vessel myocardial infarction.
All-death	25 (2.17)	47 (4.07)	53 (4.60)	69 (6.01)
Cardiac	7 (0.61)	13 (1.13)	14 (1.22)	21 (1.83)
Non-cardiac	18 (1.56)	34 (2.95)	39 (3.38)	48 (4.18)
MI
TVMI	0	0	0	0
Non-TVMI	1 (0.09)	1 (0.09)	1 (0.09)	1 (0.09)
TLR	0	4 (0.35)	10 (0.87)	18 (1.57)
TVR	0	7 (0.61)	17 (1.47)	27 (2.35)
ST	3 (0.3)	3 (0.3)	3 (0.3)	3 (0.3)
MACE	7 (0.61)	17 (1.47)	24 (2.08)	39 (3.40)

Table 3. Cumulative Major Adverse Cardiac Events at 1-Year to 4-Year Follow-Up

Event

1-year

2-year

3-year

4-year

N = 1,154

N = 1,153^a

N = 1,148^a

^aLost to follow-up. Values are expressed as n (%). MACE is defined as a composite of cardiac death, myocardial infarction (MI) attributed to target vessel and target lesion revascularization. ST: stent thrombosis; TLR: target lesion revascularization; TVR: target vessel revascularization; MI: myocardial infarction; TVMI: target vessel myocardial infarction.

All-death

25 (2.17)

47 (4.07)

53 (4.60)

69 (6.01)

Cardiac

7 (0.61)

13 (1.13)

14 (1.22)

21 (1.83)

Non-cardiac

18 (1.56)

34 (2.95)

39 (3.38)

48 (4.18)

TVMI

Non-TVMI

1 (0.09)

TLR

4 (0.35)

10 (0.87)

18 (1.57)

TVR

7 (0.61)

17 (1.47)

27 (2.35)

3 (0.3)

MACE

7 (0.61)

17 (1.47)

24 (2.08)

39 (3.40)

**Table 4.** Comparison of Cumulative Major Adverse Cardiac Events Between Long Stent (≥ 35 mm) and Short Stent (< 35 mm) Groups
BioMime stent length	1-year	2-year	3-year	4-year
^aLost to follow-up. Values are expressed as n (%). MACE is defined as a composite of cardiac death, myocardial infarction (MI) attributed to target vessel and target lesion revascularization. ST: stent thrombosis; TLR: target lesion revascularization; TVR: target vessel revascularization; MI: myocardial infarction; TVMI: target vessel myocardial infarction.
All-death	12 (3.0)	13 (1.7)	21 (5.3)	26 (3.4)	20 (5.1)	33 (4.3)	26 (6.6)	43 (5.7)
Cardiac	3 (7.6)	4 (0.5)	5 (1.3)	8 (1.0)	5 (1.3)	9 (1.2)	7 (1.8)	14 (1.9)
Non-cardiac	9 (2.3)	9 (1.2)	16 (4.1)	18 (2.4)	15 (3.8)	24 (3.1)	19 (4.8)	29 (3.8)
MI
TVMI	0	0	0	0	0	0	0	0
Non-TVMI	0	1 (0.1)	0	1 (0.1)	0	1 (0.1)	0	1 (0.1)
TLR	0	0	2 (0.5)	2 (0.3)	2 (0.5)	8 (1.0)	2 (0.5)	16 (2.1)
TVR	0	0	4 (1.0)	3 (0.4)	4 (1.0)	13 (1.7)	4 (1.0)	23 (3.0)
ST	1 (0.3)	2 (0.3)	1 (0.3)	2 (0.3)	1 (0.3)	2 (0.3)	1 (0.3)	2 (0.3)
MACE	3 (0.8)	4 (0.5)	8 (2.0)	9 (1.2)	8 (2.0)	17 (2.2)	10 (2.5)	23 (3.0)

Table 4. Comparison of Cumulative Major Adverse Cardiac Events Between Long Stent (≥ 35 mm) and Short Stent (< 35 mm) Groups

BioMime stent length

1-year

2-year

3-year

4-year

≥ 35 mm (n = 393)

< 35 mm (n = 761)

≥ 35 mm (n = 393)

< 35 mm (n = 761)

≥ 35 mm (n = 393)

< 35 mm^a (n = 760)

≥ 35 mm (n = 393)

< 35 mm^a (n = 755)

All-death

12 (3.0)

13 (1.7)

21 (5.3)

26 (3.4)

20 (5.1)

33 (4.3)

26 (6.6)

43 (5.7)

Cardiac

3 (7.6)

4 (0.5)

5 (1.3)

8 (1.0)

5 (1.3)

9 (1.2)

7 (1.8)

14 (1.9)

Non-cardiac

9 (2.3)

9 (1.2)

16 (4.1)

18 (2.4)

15 (3.8)

24 (3.1)

19 (4.8)

29 (3.8)

TVMI

Non-TVMI

1 (0.1)

TLR

2 (0.5)

2 (0.3)

2 (0.5)

8 (1.0)

2 (0.5)

16 (2.1)

TVR

4 (1.0)

3 (0.4)

4 (1.0)

13 (1.7)

4 (1.0)

23 (3.0)

1 (0.3)

2 (0.3)

1 (0.3)

2 (0.3)

1 (0.3)

2 (0.3)

1 (0.3)

2 (0.3)

MACE

3 (0.8)

4 (0.5)

8 (2.0)

9 (1.2)

8 (2.0)

17 (2.2)

10 (2.5)

23 (3.0)

**Table 5.** Comparison of Clinical Outcomes With Contemporary Devices
Study name	Study design	Device name	Strut thickness	Sample size (FU number/enrolled number)	Follow-up duration	Cardiac death	MI	TLR/CD-TLR/CI-TLR	TVR	ST	MACE
CD-TLR: clinically-driven target lesion revascularisation; CI-TLR: clinically-indicated target lesion revascularisation; DES: drug-eluting stent; FU: follow-up; MI: myocardial infarction; MACE: major adverse cardiac event; POCO: patient-oriented composite outcomes; RES: rapamycin-eluting stent; SES: sirolimus-eluting stent; ST: stent thrombosis; TLF: target lesion failure; TLR: target lesion revascularisation; TVR: target vessel revascularization; TVMI: target vessel myocardial infarction.
BioMime GBPR (current study)	Retrospective, real-world registry	BioMime SES	65 µm	1,148/1,188	4 years	1.83%	TVMI: 0%, non-TVMI: 0.09%	1.57%	2.35%	0.3%	3.4%
				1,154/1,188	1 year	0.61%	TVMI: 0%, non-TVMI: 0.09%	0%	0%	0.3%	0.61%
FLEX registry [20]	Retrospective, observational registry	Suprafelx SES	60 µm	980/1,995	1 year	1.8%	1.6%	0.7%	Non-TL TVR: 0.2%	1.1%	3.7%
Tetriflex SES [21]	Retrospective, observational registry	Tetriflex SES	60 µm	1,218/1,269	1 year	0.82%	TVMI: 3.20%	1.72%	-	0.65%	TLF: 5.75%
T-FLEX registry [22]	Retrospective, observational registry	Biodegradable polymer coated SES	60 µm	1,143/1,203	1 year	0.6%	2.1%	1.9%	-	0.8%	TLF: 3.8%
Thailand Orsiro registry [23]	Prospective, observational registry	Orsiro SES	60 µm	139/150	1 year	5.3%	1.3%	0%	0.7%	1.3%	TLF: 5.3%
FlexyRap^® DES study [24]	Retrospective, observational, post-marketing study	FlexyRap RES	60 µm	500	5 years	0%	TVMI: 0.4%	0%	0%	Late ST: 0.4%, very late ST: 0.4%	0.4%
Genoss DES™ prospective registry [25]	Prospective, single-arm observational, multicenter registry	Genoss DES™ SES	70 µm	622	1 year	0.2%	Any MI: 0.6%	0.5%	0.8%	0.6%	POCO: 3.9% (including any death, any MI, and any revascularization)
BIOFLOW-VII [26]	Prospective, multicenter single-arm US post-marketing study	Orsiro SES	60 µm	556	1 year	0%	Any MI: 1.7%	0.9%	2.3%	0.4%	3.2%
The e-Cobra study [27]	Prospective, multicenter, observational study	Cobra PzF Polyzene F nano coating stent	70 µm	915/940	1 year	3.7%	4.8%	4.3%	5.0%	Definite: 0.7%, probable: 0.7%, possible: 2.3%	8.6% (cardiac death 3.7%, or MI 4.8%, or TLR: 4.3%)
LEADERS FREE III study [28]	Prospective, multicenter, single-arm study	BioFreedom™ Biolimus-A9-eluting Co-Cr stent	84 - 88 µm	401	1 year	3.7%	4.4%	4.2%	5.0%	1.0%	-

Table 5. Comparison of Clinical Outcomes With Contemporary Devices

Study name

Study design

Device name

Strut thickness

Sample size (FU number/enrolled number)

Follow-up duration

Cardiac death

TLR/CD-TLR/CI-TLR

TVR

MACE

CD-TLR: clinically-driven target lesion revascularisation; CI-TLR: clinically-indicated target lesion revascularisation; DES: drug-eluting stent; FU: follow-up; MI: myocardial infarction; MACE: major adverse cardiac event; POCO: patient-oriented composite outcomes; RES: rapamycin-eluting stent; SES: sirolimus-eluting stent; ST: stent thrombosis; TLF: target lesion failure; TLR: target lesion revascularisation; TVR: target vessel revascularization; TVMI: target vessel myocardial infarction.

BioMime GBPR (current study)

Retrospective, real-world registry

BioMime SES

65 µm

1,148/1,188

4 years

1.83%

TVMI: 0%, non-TVMI: 0.09%

1.57%

2.35%

0.3%

3.4%

1,154/1,188

1 year

0.61%

TVMI: 0%, non-TVMI: 0.09%

0.3%

0.61%

FLEX registry [20]

Retrospective, observational registry

Suprafelx SES

60 µm

980/1,995

1 year

1.8%

1.6%

0.7%

Non-TL TVR: 0.2%

1.1%

3.7%

Tetriflex SES [21]

Retrospective, observational registry

Tetriflex SES

60 µm

1,218/1,269

1 year

0.82%

TVMI: 3.20%

1.72%

0.65%

TLF: 5.75%

T-FLEX registry [22]

Retrospective, observational registry

Biodegradable polymer coated SES

60 µm

1,143/1,203

1 year

0.6%

2.1%

1.9%

0.8%

TLF: 3.8%

Thailand Orsiro registry [23]

Prospective, observational registry

Orsiro SES

60 µm

139/150

1 year

5.3%

1.3%

0.7%

1.3%

TLF: 5.3%

FlexyRap^® DES study [24]

Retrospective, observational, post-marketing study

FlexyRap RES

60 µm

500

5 years

TVMI: 0.4%

Late ST: 0.4%, very late ST: 0.4%

0.4%

Genoss DES™ prospective registry [25]

Prospective, single-arm observational, multicenter registry

Genoss DES™ SES

70 µm

622

1 year

0.2%

Any MI: 0.6%

0.5%

0.8%

0.6%

POCO: 3.9% (including any death, any MI, and any revascularization)

BIOFLOW-VII [26]

Prospective, multicenter single-arm US post-marketing study

Orsiro SES

60 µm

556

1 year

Any MI: 1.7%

0.9%

2.3%

0.4%

3.2%

The e-Cobra study [27]

Prospective, multicenter, observational study

Cobra PzF Polyzene F nano coating stent

70 µm

915/940

1 year

3.7%

4.8%

4.3%

5.0%

Definite: 0.7%, probable: 0.7%, possible: 2.3%

8.6% (cardiac death 3.7%, or MI 4.8%, or TLR: 4.3%)

LEADERS FREE III study [28]

Prospective, multicenter, single-arm study

BioFreedom™ Biolimus-A9-eluting Co-Cr stent

84 - 88 µm

401

1 year

3.7%

4.4%

4.2%

5.0%

1.0%