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 11, Number 4, August 2020, pages 219-225

Real-World Experience With a Tapered Biodegradable Polymer-Coated Sirolimus-Eluting Stent in Patients With Long Coronary Artery Stenoses

**Table 1.** Demographic And Clinical Characteristics of the Study Population
	All lengths (272 patients)	30 mm (36 patients)	40 mm (99 patients)	50 mm (77 patients)	60 mm (60 patients)	P value (ANOVA)	Post-hoc comparisons
ANOVA: analysis of variance; SD: standard deviation; eGFR: estimated glomerular filtration rate; CAD: coronary artery disease; ACS: acute coronary syndrome; NSTEMI: non-ST-elevation myocardial infarction; STEMI: ST-elevation myocardial infarction; CTO: chronic total occlusion; LVEF: left ventricular ejection fraction.
Age (years), mean (SD)	69.3 (11.4)	69.1 (11.0)	69.8 (9.9)	70.8 (9.1)	69.2 (14.1)	NS	0.74	0.74	0.91
Male sex, n (%)	206 (75.7%)	29 (80.6%)	73 (73.7%)	58 (77.8%)	46 (76.7%)	NS	0.68	0.68	0.86
Hypertension, n (%)	204 (75.0%)	24 (66.7%)	72 (72.7%)	58 (75.3%)	50 (83.3%)	NS	0.23	0.23	0.46
Type 2 diabetes, n (%)	70 (25.7%)	7 (19.4%)	21 (21.2%)	21 (27.2%)	21 (35.0%)	NS	0.10	0.10	0.48
Dyslipidemia, n (%)	116 (42.6%)	18 (50.0%)	44 (44.4%)	34 (44.2%)	20 (33.3%)	NS	0.21	0.21	0.27
Tobacco use, n (%)	181 (66.5%)	36 (100.0%)	49 (63.9%)	60 (77.9%)	36 (60.0%)	NS	0.77	0.77	0.34
eGRF (< 30 mL/min) , n (%)	38 (14.0%)	7 (19.4%)	17 (17.2%)	9 (11.9%)	5 (8.3%)	NS	0.16	0.16	0.50
Chronic CAD, n (%)	153 (56.3%)	18 (50.0%)	48 (48.4%)	49 (63.6%)	38 (63.3%)	NS	0.08	0.08	0.47
ACS, n (%)	119 (43.8%)	18 (50.0%)	51 (51.5%)	28 (36.4%)	22 (36.7%)	NS	0.10	0.10	0.47
NSTEMI	94 (34.6%)	14 (38.9%)	40 (40.4%)	23 (29.9%)	17 (28.3%)	NS	0.16	0.16	0.34
STEMI	25 (9.2%)	4 (11.1%)	11 (11.1%)	5 (6.5%)	5 (8.3%)	NS	0.50	0.50	0.79
CTO	23 (8.5%)	4 (11.2%)	6 (6.1%)	5 (6.5%)	8 (13.3%)	NS	0.28	0.28	0.72
LVEF (%), mean (SD)	61.1 (10.2)	61.3 (10.6)	62.2 (11.4)	61.0 (9.9)	60.5 (11.9)	NS	0.55	0.67	0.21

Table 1. Demographic And Clinical Characteristics of the Study Population

All lengths (272 patients)

30 mm (36 patients)

40 mm (99 patients)

50 mm (77 patients)

60 mm (60 patients)

P value (ANOVA)

Post-hoc comparisons

60 vs. 30 mm

60 vs. 40 mm

60 vs. 50 mm

ANOVA: analysis of variance; SD: standard deviation; eGFR: estimated glomerular filtration rate; CAD: coronary artery disease; ACS: acute coronary syndrome; NSTEMI: non-ST-elevation myocardial infarction; STEMI: ST-elevation myocardial infarction; CTO: chronic total occlusion; LVEF: left ventricular ejection fraction.

Age (years), mean (SD)

69.3 (11.4)

69.1 (11.0)

69.8 (9.9)

70.8 (9.1)

69.2 (14.1)

0.74

0.91

Male sex, n (%)

206 (75.7%)

29 (80.6%)

73 (73.7%)

58 (77.8%)

46 (76.7%)

0.68

0.86

Hypertension, n (%)

204 (75.0%)

24 (66.7%)

72 (72.7%)

58 (75.3%)

50 (83.3%)

0.23

0.46

Type 2 diabetes, n (%)

70 (25.7%)

7 (19.4%)

21 (21.2%)

21 (27.2%)

21 (35.0%)

0.10

0.48

Dyslipidemia, n (%)

116 (42.6%)

18 (50.0%)

44 (44.4%)

34 (44.2%)

20 (33.3%)

0.21

0.27

Tobacco use, n (%)

181 (66.5%)

36 (100.0%)

49 (63.9%)

60 (77.9%)

36 (60.0%)

0.77

0.34

eGRF (< 30 mL/min) , n (%)

38 (14.0%)

7 (19.4%)

17 (17.2%)

9 (11.9%)

5 (8.3%)

0.16

0.50

Chronic CAD, n (%)

153 (56.3%)

18 (50.0%)

48 (48.4%)

49 (63.6%)

38 (63.3%)

0.08

0.47

ACS, n (%)

119 (43.8%)

18 (50.0%)

51 (51.5%)

28 (36.4%)

22 (36.7%)

0.10

0.47

NSTEMI

94 (34.6%)

14 (38.9%)

40 (40.4%)

23 (29.9%)

17 (28.3%)

0.16

0.34

STEMI

25 (9.2%)

4 (11.1%)

11 (11.1%)

5 (6.5%)

5 (8.3%)

0.50

0.79

CTO

23 (8.5%)

4 (11.2%)

6 (6.1%)

5 (6.5%)

8 (13.3%)

0.28

0.72

LVEF (%), mean (SD)

61.1 (10.2)

61.3 (10.6)

62.2 (11.4)

61.0 (9.9)

60.5 (11.9)

0.55

0.67

0.21

**Table 2.** Angiographic and Interventional Characteristics
	All lengths (272 patients)	30 mm (36 patients)	40 mm (99 patients)	50 mm (77 patients)	60 mm (60 patients)	P value (ANOVA)	Post-hoc comparison
ANOVA: analysis of variance; SD: standard deviation; ACC: American College of Cardiology; AHA: American Heart Association; TIMI: thrombolysis in myocardial infarction; IC: intracoronary; IVUS: intravascular ultrasound; OCT: coherent optical radiation tomography.
Radial access, n (%)	239 (87.9%)	33 (91.7%)	87 (87.9%)	66 (85.7%)	53 (88.3%)	NS	0.93	0.93	0.66
Diseased vessels/patient, mean (SD)	1.9 (0.8)	1.8 (0.8)	1.7 (0.7)	1.8 (0.7)	2.2 (0.7)	< 0.05	0.001	0.001	0.16
ACC/AHA type B2/C, n (%)	266 (97.8%)	35 (97.2%)	94 (94.9%)	77 (100.0%)	60 (100.0%)	NS	0.08	0.08	1.00
Severe tortuosity, n (%)	65 (23.9%)	6 (16.7%)	23 (23.3%)	21 (27.3%)	15 (25.0%)	NS	0.80	0.80	0.77
Severe calcium, n (%)	140 (51.5%)	10 (27.8%)	45 (45.5%)	49 (63.6%)	36 (60.0%)	NS	0.22	0.22	0.79
Stenosis length (mm), mean (SD)	48.8 (9.5)	29.9 (10.4)	38.2 (14.6)	51.6 (11.5)	61.5 (15.1)	< 0.001	0.001	0.001	0.001
Device success, n (%)	262 (96.3%)	35 (97.2%)	94 (94.9%)	74 (96.1%)	59 (98.3%)	NS	0.28	0.28	0.45
Final TIMI blood flow, mean (SD)	3.0 (0.1)	3.0 (0.0)	3.0 (0.0)	3.0 (0.0)	3.0 (0.1)	NS	0.20	0.20	0.26
Contrast medium (mL), mean (SD)	197.2 (71.7)	203.7 (82.4)	192.7 (64.6)	211.8 (87.8)	197.9 (62.8)	NS	0.73	0.73	0.23
IC imaging (IVUS/OCT) , n (%)	36 (13.2%)	6 (16.7%)	8 (13.8%)	10 (13.0%)	12 (24.9%)	NS	0.82	0.82	0.24
Buddy wire(s) , n (%)	49 (18.0%)	4 (11.1%)	18 (18.2%)	9 (25.0%)	18 (30.0%)	NS	0.09	0.09	0.99
Child-in-mother system, n (%)	14 (5.2%)	0 (0.0%)	3 (3.0%)	4 (11.1%)	7 (11.7%)	< 0.05	0.03	0.03	0.81
Anchoring balloon, n (%)	12 (4.4%)	1 (2.8%)	8 (8.1%)	2 (5.6%)	1 (1.7%)	NS	0.09	0.09	0.17
High support guidewire, n (%)	37 (13.6%)	6 (16.7%)	13 (13.1%)	4 (11.1%)	14 (23.3%)	NS	0.10	0.10	0.60
Rotational atherectomy, n (%)	21 (7.7%)	4 (11.2%)	8 (8.0%)	4 (11.2%)	5 (8.3%)	NS	0.82	0.82	0.80
Cutting balloon, n (%)	10 (3.6%)	2 (5.6%)	2 (2.0%)	2 (5.6%)	4 (6.6%)	NS	0.61	0.61	0.42

Table 2. Angiographic and Interventional Characteristics

All lengths (272 patients)

30 mm (36 patients)

40 mm (99 patients)

50 mm (77 patients)

60 mm (60 patients)

P value (ANOVA)

Post-hoc comparison

60 vs. 30 mm

60 vs. 40 mm

60 vs. 50 mm

ANOVA: analysis of variance; SD: standard deviation; ACC: American College of Cardiology; AHA: American Heart Association; TIMI: thrombolysis in myocardial infarction; IC: intracoronary; IVUS: intravascular ultrasound; OCT: coherent optical radiation tomography.

Radial access, n (%)

239 (87.9%)

33 (91.7%)

87 (87.9%)

66 (85.7%)

53 (88.3%)

0.93

0.66

Diseased vessels/patient, mean (SD)

1.9 (0.8)

1.8 (0.8)

1.7 (0.7)

1.8 (0.7)

2.2 (0.7)

< 0.05

0.001

0.16

ACC/AHA type B2/C, n (%)

266 (97.8%)

35 (97.2%)

94 (94.9%)

77 (100.0%)

60 (100.0%)

0.08

1.00

Severe tortuosity, n (%)

65 (23.9%)

6 (16.7%)

23 (23.3%)

21 (27.3%)

15 (25.0%)

0.80

0.77

Severe calcium, n (%)

140 (51.5%)

10 (27.8%)

45 (45.5%)

49 (63.6%)

36 (60.0%)

0.22

0.79

Stenosis length (mm), mean (SD)

48.8 (9.5)

29.9 (10.4)

38.2 (14.6)

51.6 (11.5)

61.5 (15.1)

< 0.001

0.001

Device success, n (%)

262 (96.3%)

35 (97.2%)

94 (94.9%)

74 (96.1%)

59 (98.3%)

0.28

0.45

Final TIMI blood flow, mean (SD)

3.0 (0.1)

3.0 (0.0)

3.0 (0.1)

0.20

0.26

Contrast medium (mL), mean (SD)

197.2 (71.7)

203.7 (82.4)

192.7 (64.6)

211.8 (87.8)

197.9 (62.8)

0.73

0.23

IC imaging (IVUS/OCT) , n (%)

36 (13.2%)

6 (16.7%)

8 (13.8%)

10 (13.0%)

12 (24.9%)

0.82

0.24

Buddy wire(s) , n (%)

49 (18.0%)

4 (11.1%)

18 (18.2%)

9 (25.0%)

18 (30.0%)

0.09

0.99

Child-in-mother system, n (%)

14 (5.2%)

0 (0.0%)

3 (3.0%)

4 (11.1%)

7 (11.7%)

< 0.05

0.03

0.81

Anchoring balloon, n (%)

12 (4.4%)

1 (2.8%)

8 (8.1%)

2 (5.6%)

1 (1.7%)

0.09

0.17

High support guidewire, n (%)

37 (13.6%)

6 (16.7%)

13 (13.1%)

4 (11.1%)

14 (23.3%)

0.10

0.60

Rotational atherectomy, n (%)

21 (7.7%)

4 (11.2%)

8 (8.0%)

4 (11.2%)

5 (8.3%)

0.82

0.80

Cutting balloon, n (%)

10 (3.6%)

2 (5.6%)

2 (2.0%)

2 (5.6%)

4 (6.6%)

0.61

0.42

**Table 3.** Antithrombotic Treatment Before, During and Following PCI
Antithrombotic treatments	Antithrombotic treatment start	Overall, n (%)
PCI: percutaneous cardiovascular intervention.
Clopidogrel	31 (11.4%)	156 (57.4%)	192 (70.6%)	187 (68.8%)
Ticagrelor	70 (25.7%)	5 (1.8%)	68 (25.0%)	75 (27.6%)
Prasugrel	10 (3.7%)	0 (0.0%)	12 (4.4%)	10 (3.7%)
Aspirin	195 (71.7%)	61 (22.4%)	256 (94.1%)	256 (94.1%)
Dual antiplatelet therapy	111 (40.8%)	145 (53.3%)	256 (94.1%)	256 (94.1%)
Unfractionated heparin	0 (0.0%)	153 (56.3%)	0 (0.0%)	153 (56.3%)
Bivalirudin	0 (0.0%)	4 (1.5%)	0 (0.0%)	4 (1.5%)
Enoxaparin	115 (42.3%)	0 (0.0%)	0 (0.0%)	115 (42.3%)
Warfarin	6 (2.2%)	2 (0.7%)	2 (0.7%)	8 (2.9%)
Dabigatran	2 (0.7%)	16 (5.9%)	14 (5.1%)	10 (3.7%)
Oral AntiXa	8 (2.9%)	2 (0.7%)	6 (2.2%)	8 (2.9%)

Table 3. Antithrombotic Treatment Before, During and Following PCI

Antithrombotic treatments

Antithrombotic treatment start

Overall, n (%)

Pre-PCI, n (%)

Peri-PCI and post-PCI, n (%)

Discharge, n (%)

PCI: percutaneous cardiovascular intervention.

Clopidogrel

31 (11.4%)

156 (57.4%)

192 (70.6%)

187 (68.8%)

Ticagrelor

70 (25.7%)

5 (1.8%)

68 (25.0%)

75 (27.6%)

Prasugrel

10 (3.7%)

0 (0.0%)

12 (4.4%)

10 (3.7%)

Aspirin

195 (71.7%)

61 (22.4%)

256 (94.1%)

Dual antiplatelet therapy

111 (40.8%)

145 (53.3%)

256 (94.1%)

Unfractionated heparin

0 (0.0%)

153 (56.3%)

0 (0.0%)

153 (56.3%)

Bivalirudin

0 (0.0%)

4 (1.5%)

0 (0.0%)

4 (1.5%)

Enoxaparin

115 (42.3%)

0 (0.0%)

115 (42.3%)

Warfarin

6 (2.2%)

2 (0.7%)

8 (2.9%)

Dabigatran

2 (0.7%)

16 (5.9%)

14 (5.1%)

10 (3.7%)

Oral AntiXa

8 (2.9%)

2 (0.7%)

6 (2.2%)

8 (2.9%)

**Table 4.** Predictors of Successful BioMime Morph Stent Deployment According to Logistic Regression Analysis
	Univariate analysis	Multivariate analysis
SE: standard error; DF: degrees of freedom; ACC: American College of Cardiology; AHA: American Heart Association.
Age (years)	-0.096	0.041	0.019	-0.129	0.054	0.017
Male sex	-1.088	1.064	0.306
Severe calcium	-1.218	0.701	0.083	-0.964	1.021	0.345
Type 2 diabetes	-0.398	0.728	0.584
Stenosis length (mm)	-0.054	0.025	0.031	-0.102	0.037	0.006
Severe tortuosity	-2.105	0.706	0.003	-2.744	0.970	0.005
ACC/AHA type B2/C stenosis	1.742	1.147	0.129
	Chi-square	DF	P value
Overall model fit	29.522	4	< 0.0001
Hosmer and Lemeshow test	9.912	8	0.27

Table 4. Predictors of Successful BioMime Morph Stent Deployment According to Logistic Regression Analysis

Univariate analysis

Multivariate analysis

Coefficient

P value

Coefficient

P value

SE: standard error; DF: degrees of freedom; ACC: American College of Cardiology; AHA: American Heart Association.

Age (years)

-0.096

0.041

0.019

-0.129

0.054

0.017

Male sex

-1.088

1.064

0.306

Severe calcium

-1.218

0.701

0.083

-0.964

1.021

0.345

Type 2 diabetes

-0.398

0.728

0.584

Stenosis length (mm)

-0.054

0.025

0.031

-0.102

0.037

0.006

Severe tortuosity

-2.105

0.706

0.003

-2.744

0.970

0.005

ACC/AHA type B2/C stenosis

1.742

1.147

0.129

Chi-square

P value

Overall model fit

29.522

< 0.0001

Hosmer and Lemeshow test

9.912

0.27