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 http://www.cardiologyres.org

Original Article

Volume 9, Number 6, December 2018, pages 350-357

Clinical Outcomes of Novel Long-Tapered Sirolimus-Eluting Coronary Stent System in Real-World Patients With Long Diffused De Novo Coronary Lesions

**Table 1.** Baseline Demographics and Clinical Characteristics
Characteristics	Patients (n = 362)
CABG: coronary artery bypass grafting; CAD: coronary artery disease; LVEF: left ventricular ejection fraction; MI: myocardial infarction; NSTEMI: non ST-elevation myocardial infarction; PCI: percutaneous coronary intervention; STEMI: ST-elevation myocardial infarction. Values are presented as frequency (percentage).
Patient demographics
Age (mean ± SD), years	61.09 ± 9.04
Male	290 (80.1)
Baseline medical history
Diabetes mellitus	170 (47.0)
Hypertension	159 (43.9)
Smoker	15 (4.1)
Previous CABG	5 (1.4)
Previous PCI	22 (6.1)
History of angina	124 (34.3)
Family history of CAD	55 (15.2)
Previous stroke	8 (2.2)
Previous chronic obstructive pulmonary disease	6 (1.7)
Previous MI	43 (11.9)
Cardiac status before index procedure
Stable angina	110 (30.4)
Unstable angina	50 (13.8)
STEMI	69 (19.1)
NSTEMI	44 (12.2)
Asymptomatic	89 (24.6)
LVEF %, mean ± SD	46.96 ± 10.02

Table 1. Baseline Demographics and Clinical Characteristics

Characteristics

Patients (n = 362)

CABG: coronary artery bypass grafting; CAD: coronary artery disease; LVEF: left ventricular ejection fraction; MI: myocardial infarction; NSTEMI: non ST-elevation myocardial infarction; PCI: percutaneous coronary intervention; STEMI: ST-elevation myocardial infarction. Values are presented as frequency (percentage).

Patient demographics

Age (mean ± SD), years

61.09 ± 9.04

Male

290 (80.1)

Baseline medical history

Diabetes mellitus

170 (47.0)

Hypertension

159 (43.9)

Smoker

15 (4.1)

Previous CABG

5 (1.4)

Previous PCI

22 (6.1)

History of angina

124 (34.3)

Family history of CAD

55 (15.2)

Previous stroke

8 (2.2)

Previous chronic obstructive pulmonary disease

6 (1.7)

Previous MI

43 (11.9)

Cardiac status before index procedure

Stable angina

110 (30.4)

Unstable angina

50 (13.8)

STEMI

69 (19.1)

NSTEMI

44 (12.2)

Asymptomatic

89 (24.6)

LVEF %, mean ± SD

46.96 ± 10.02

**Table 2.** Lesion and Procedural Characteristics
Characteristics	Patients (n = 362)/lesions (n = 625)
Values are presented as frequency (percentage).
Total number of lesions treated with BioMime Morph SES system	402
Total number of lesions treated with other stents	144
Unknown/ no stent treated lesions	79
Target lesion location
Left anterior descending artery	236/402 (58.7)
Right coronary artery	128/402 (31.8)
Left circumflex artery	33/402 (8.2)
Left main	5/402 (1.2)
Lesion per patient	1.11 (402/362)
Disease vessel
Single vessel disease	156/362 (43.1)
Double vessel disease	125/362 (34.5)
Triple vessel disease	81/362 (22.4)
Average target lesion length (mm), Mean±SD	40.25 ± 5.54
% Occlusion, Mean±SD	86.10 ± 9.50

Table 2. Lesion and Procedural Characteristics

Characteristics

Patients (n = 362)/lesions (n = 625)

Values are presented as frequency (percentage).

Total number of lesions treated with BioMime Morph SES system

402

Total number of lesions treated with other stents

144

Unknown/ no stent treated lesions

Target lesion location

Left anterior descending artery

236/402 (58.7)

Right coronary artery

128/402 (31.8)

Left circumflex artery

33/402 (8.2)

Left main

5/402 (1.2)

Lesion per patient

1.11 (402/362)

Disease vessel

Single vessel disease

156/362 (43.1)

Double vessel disease

125/362 (34.5)

Triple vessel disease

81/362 (22.4)

Average target lesion length (mm), Mean±SD

40.25 ± 5.54

% Occlusion, Mean±SD

86.10 ± 9.50

**Table 3.** BioMime Morph SES system characteristics
Characteristics	Patients (n=362)
Values are presented as frequency (percentage).
Stent length (mm)
30	77/390 (19.74)
40	125/390 (32.05)
50	110/390 (28.21)
60	78/390 (20.00)
Average stent length (mm), mean ± SD	44.85 ± 10.23
Stent diameter (mm)
2.75 - 2.25	53/390 (13.59)
3.00 - 2.50	151/390 (38.72)
3.5 - 2.75	15/390 (3.85)
3.5 - 3.0	171/390 (43.85)
Average proximal stent diameter (mm), mean ± SD	3.2 ± 0.29
Average distal stent diameter (mm), mean ± SD	2.70 ± 0.29
BioMime Morph SES system per patient	1.08 (390/362)

Table 3. BioMime Morph SES system characteristics

Characteristics

Patients (n=362)

Values are presented as frequency (percentage).

Stent length (mm)

77/390 (19.74)

125/390 (32.05)

110/390 (28.21)

78/390 (20.00)

Average stent length (mm), mean ± SD

44.85 ± 10.23

Stent diameter (mm)

2.75 - 2.25

53/390 (13.59)

3.00 - 2.50

151/390 (38.72)

3.5 - 2.75

15/390 (3.85)

3.5 - 3.0

171/390 (43.85)

Average proximal stent diameter (mm), mean ± SD

3.2 ± 0.29

Average distal stent diameter (mm), mean ± SD

2.70 ± 0.29

BioMime Morph SES system per patient

1.08 (390/362)

**Table 4.** Other Implanted Stent Characteristics
Characteristics	Patients (n = 362)
Values are presented as frequency (percentage).
Total number of lesions treated with other stents	144
Total number other stents implanted	132
Average stent length (mm), mean ± SD	22.97 ± 9.03
Average stent diameter (mm), mean ± SD	2.95 ± 0.38
Other stent used
Metafor	1/132 (0.76)
Ultimaster	1/132 (0.76)
Resolute integrity	1/132 (0.76)
Promus PREMIER	1/132 (0.76)
GRAFTMASTER RX	2/132 (1.52)
Resolute onyx	2/132 (1.52)
Endeavour	3/132 (2.27)
Endeavour resolute	3/132 (2.27)
Xience family	8/132 (6.06)
BioMime Aura	13/132 (6.85)
PROMUS Element	12/132 (9.09)
Evermine 50	37/132 (28.03)
BioMime	48/132 (36.36)
No stent treated lesions	79

Table 4. Other Implanted Stent Characteristics

Characteristics

Patients (n = 362)

Values are presented as frequency (percentage).

Total number of lesions treated with other stents

144

Total number other stents implanted

132

Average stent length (mm), mean ± SD

22.97 ± 9.03

Average stent diameter (mm), mean ± SD

2.95 ± 0.38

Other stent used

Metafor

1/132 (0.76)

Ultimaster

1/132 (0.76)

Resolute integrity

1/132 (0.76)

Promus PREMIER

1/132 (0.76)

GRAFTMASTER RX

2/132 (1.52)

Resolute onyx

2/132 (1.52)

Endeavour

3/132 (2.27)

Endeavour resolute

3/132 (2.27)

Xience family

8/132 (6.06)

BioMime Aura

13/132 (6.85)

PROMUS Element

12/132 (9.09)

Evermine 50

37/132 (28.03)

BioMime

48/132 (36.36)

No stent treated lesions

**Table 5.** Cumulative Major Adverse Events at 1, 6 and 12-Month Follow-Up
Events	In-hospital, n (%)	1-month, n (%)	6-month, n (%)	12-month, n (%)
n: number of patients; MI: myocardial infarction; ID-TLR: ischemia-driven target lesion revascularization; ID-TVR: ischemia driven target vessel revascularization; MACE: major adverse cardiac events; ST: stent thrombosis. Values are presented as frequency (percentage).
All cause death	0 (0.0)	2 (0.6)	4 (1.1)	6 (1.7)
Cardiac death	0 (0.0)	1 (0.3)	2 (0.6)	4 (1.1)
Non-cardiac death	0 (0.0)	1 (0.3)	2 (0.6)	2 (0.6)
MI	0 (0.0)	1 (0.3)	1 (0.3)	1 (0.3)
ID-TLR	0 (0.0)	0 (0.0)	1 (0.3)	2 (0.6)
ST	1 (0.3)	1 (0.3)	1 (0.3)	1 (0.3)
Acute	1 (0.3)	1 (0.3)	1 (0.3)	1 (0.3)
Sub-acute	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Late	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
MACE	0 (0.0)	2 (0.6)	4 (1.1)	7 (2.0)

Table 5. Cumulative Major Adverse Events at 1, 6 and 12-Month Follow-Up

Events

In-hospital, n (%)

1-month, n (%)

6-month, n (%)

12-month, n (%)

n = 362 (100%)

n = 355 (98.1%)

n: number of patients; MI: myocardial infarction; ID-TLR: ischemia-driven target lesion revascularization; ID-TVR: ischemia driven target vessel revascularization; MACE: major adverse cardiac events; ST: stent thrombosis. Values are presented as frequency (percentage).

All cause death

0 (0.0)

2 (0.6)

4 (1.1)

6 (1.7)

Cardiac death

0 (0.0)

1 (0.3)

2 (0.6)

4 (1.1)

Non-cardiac death

0 (0.0)

1 (0.3)

2 (0.6)

0 (0.0)

1 (0.3)

ID-TLR

0 (0.0)

1 (0.3)

2 (0.6)

1 (0.3)

Acute

1 (0.3)

Sub-acute

0 (0.0)

Late

0 (0.0)

MACE

0 (0.0)

2 (0.6)

4 (1.1)

7 (2.0)