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 15, Number 3, June 2024, pages 169-178

Long-Term Safety and Performance of BioMime™ Morph Sirolimus-Eluting Coronary Stent System for Very Long Coronary Lesions

Figure 3. Kaplan-Meier curve for MACE free survival at 36 months. MACE: major adverse cardiovascular event.

**Table 1.** Baseline and Demographic Characteristics
Characteristics	n = 88
BMI: body mass index; CAD: coronary artery disease; COPD: chronic obstructive pulmonary disease; LVEF: left ventricular ejection fraction; NSTEMI: non-ST-elevation myocardial infarction; PCI: percutaneous coronary intervention; SD: standard deviation; STEMI: ST-elevation myocardial infarction.
Age, years, mean ± SD	58.72 ± 10.10
Sex, n (%)
Male	73 (82.95)
Female	15 (17.05)
BMI, kg/m², mean ± SD	25.59 ± 3.35
Systolic blood pressure, mm Hg, mean ± SD	128.91 ± 23.78
Diastolic blood pressure, mm Hg, mean ± SD	80.94 ± 10.03
Heart rate, beats per minute, mean ± SD	77.32 ± 10.81
Medical history, n (%)
Diabetes mellitus	52 (59.09)
Hypertension	48 (54.55)
Dyslipidemia	1 (1.14)
Smoking	14 (15.91)
Alcohol consumption	6 (6.82)
COPD	2 (2.27)
Ischemic heart disease	69 (78.41)
Angina	72 (81.82)
PCI	2 (2.27)
Stroke	2 (2.27)
Other illness	1 (1.14)
Family history of CAD	4 (4.55)
LVEF, %, mean ± SD	50.23 ± 9.22
Cardiac status, n (%)
Stable angina	2 (2.27)
Unstable angina	11 (12.50)
STEMI	44 (50.00)
NSTEMI	5 (5.68)
Asymptomatic/silent ischemia	2 (2.27)

Table 1. Baseline and Demographic Characteristics

Characteristics

n = 88

BMI: body mass index; CAD: coronary artery disease; COPD: chronic obstructive pulmonary disease; LVEF: left ventricular ejection fraction; NSTEMI: non-ST-elevation myocardial infarction; PCI: percutaneous coronary intervention; SD: standard deviation; STEMI: ST-elevation myocardial infarction.

Age, years, mean ± SD

58.72 ± 10.10

Sex, n (%)

Male

73 (82.95)

Female

15 (17.05)

BMI, kg/m², mean ± SD

25.59 ± 3.35

Systolic blood pressure, mm Hg, mean ± SD

128.91 ± 23.78

Diastolic blood pressure, mm Hg, mean ± SD

80.94 ± 10.03

Heart rate, beats per minute, mean ± SD

77.32 ± 10.81

Medical history, n (%)

Diabetes mellitus

52 (59.09)

Hypertension

48 (54.55)

Dyslipidemia

1 (1.14)

Smoking

14 (15.91)

Alcohol consumption

6 (6.82)

COPD

2 (2.27)

Ischemic heart disease

69 (78.41)

Angina

72 (81.82)

PCI

2 (2.27)

Stroke

2 (2.27)

Other illness

1 (1.14)

Family history of CAD

4 (4.55)

LVEF, %, mean ± SD

50.23 ± 9.22

Cardiac status, n (%)

Stable angina

2 (2.27)

Unstable angina

11 (12.50)

STEMI

44 (50.00)

NSTEMI

5 (5.68)

Asymptomatic/silent ischemia

2 (2.27)

**Table 2.** Lesion Characteristics
Variables	Treated lesions (n = 92)/patients (n = 88)
CASS: coronary artery surgery study; CTO: chronic total occlusion; LAD: left anterior descending artery; LCx: left circumflex artery; RCA: right coronary artery.
Diseased vessel, n (%)
Single vessel	29 (32.95)
Double vessel	41 (46.6)
Triple vessel or more	18 (20.45)
Lesion type, n (%)
Calcified	4 (4.35)
Diffused	1 (1.09)
CTO	5 (5.43)
Thrombus	17 (18.48)
Discrete	11 (11.96)
Tandem	1 (1.09)
Lesion location (CASS code), n (%)
RCA	24 (26.09)
LAD	63 (68.48)
LCx	5 (5.43)
Lesion class, n (%)
A	11 (11.96)
B1	41 (44.57)
B2	17 (18.48)
C	23 (25.00)
Stenosis type, n (%)
de novo	92 (100)
In-stent	0
Bifurcation	0

Table 2. Lesion Characteristics

Variables

Treated lesions (n = 92)/patients (n = 88)

CASS: coronary artery surgery study; CTO: chronic total occlusion; LAD: left anterior descending artery; LCx: left circumflex artery; RCA: right coronary artery.

Diseased vessel, n (%)

Single vessel

29 (32.95)

Double vessel

41 (46.6)

Triple vessel or more

18 (20.45)

Lesion type, n (%)

Calcified

4 (4.35)

Diffused

1 (1.09)

CTO

5 (5.43)

Thrombus

17 (18.48)

Discrete

11 (11.96)

Tandem

1 (1.09)

Lesion location (CASS code), n (%)

RCA

24 (26.09)

LAD

63 (68.48)

LCx

5 (5.43)

Lesion class, n (%)

11 (11.96)

41 (44.57)

17 (18.48)

23 (25.00)

Stenosis type, n (%)

de novo

92 (100)

In-stent

Bifurcation

**Table 3.** Procedural Outcomes
Characteristics	Treated lesions (n = 92)/patients (n = 88)
SD: standard deviation; TIMI: thrombolysis in myocardial infarction.
Total number of lesions treated with study device	92
Total number of study device deployed	92
Study stents per patient	1.05
Totally occluded	23 (25.00)
Diameter stenosis (%), mean ± SD	90.17 ± 9.93
Average lesion length, mm, mean ± SD	43.32 ± 9.46
Procedure access site location, n (%)
Femoral right	86 (97.73)
Radial right	2 (2.27)
Contrast media used, n (%)
Ionic	60 (68.18)
Non-ionic	28 (31.82)
TIMI flow pre-procedure, n (%)
0	21 (22.83)
1	28 (30.43)
2	43 (46.74)
3	0
TIMI flow post-procedure, n (%)
0	0
1	0
2	0
3	92 (100)
Pre-dilatation, n (%)	83 (90.22)
Post-dilatation, n (%)	72 (78.26)
Average stent length, mm, mean ± SD	45.54 ± 10.20
Average stent diameter, mm, mean ± SD	2.99 ± 0.29
Stent length (mm), n (%)
30	17 (18.48)
40	26 (28.26)
50	30 (32.61)
60	19 (20.65)
Stent diameter (mm), n (%)
3.00 - 2.50	34 (36.96)
3.50 - 3.00	49 (53.26)
2.75 - 2.25	9 (9.78)
3.50 - 2.75	0
Procedure success, n (%)	88 (100)
Device success, n (%)	88 (100)

Table 3. Procedural Outcomes

Characteristics

Treated lesions (n = 92)/patients (n = 88)

SD: standard deviation; TIMI: thrombolysis in myocardial infarction.

Total number of lesions treated with study device

Total number of study device deployed

Study stents per patient

1.05

Totally occluded

23 (25.00)

Diameter stenosis (%), mean ± SD

90.17 ± 9.93

Average lesion length, mm, mean ± SD

43.32 ± 9.46

Procedure access site location, n (%)

Femoral right

86 (97.73)

Radial right

2 (2.27)

Contrast media used, n (%)

Ionic

60 (68.18)

Non-ionic

28 (31.82)

TIMI flow pre-procedure, n (%)

21 (22.83)

28 (30.43)

43 (46.74)

TIMI flow post-procedure, n (%)

92 (100)

Pre-dilatation, n (%)

83 (90.22)

Post-dilatation, n (%)

72 (78.26)

Average stent length, mm, mean ± SD

45.54 ± 10.20

Average stent diameter, mm, mean ± SD

2.99 ± 0.29

Stent length (mm), n (%)

17 (18.48)

26 (28.26)

30 (32.61)

19 (20.65)

Stent diameter (mm), n (%)

3.00 - 2.50

34 (36.96)

3.50 - 3.00

49 (53.26)

2.75 - 2.25

9 (9.78)

3.50 - 2.75

Procedure success, n (%)

88 (100)

Device success, n (%)

88 (100)

**Table 4.** Cumulative Clinical Events up to 36 Months Follow-Up
Events, n (%)	In-hospital (n = 88)	Follow-up
^aSeven patients suffered from MI and cardiac death. ID-TLR: ischemia-driven target lesion revascularization; ID-TVR: ischemia-driven target vessel revascularization; MACE: major adverse cardiovascular event; MI: myocardial infarction; ST: stent thrombosis; TLF: target lesion failure; TVF: target vessel failure.
All-cause death	0	1 (1.14)	4 (4.55)	8 (9.09)	10 (11.36)	11 (12.50)
Cardiac death^a	0	1 (1.14)	3 (3.41)	6 (6.82)	7 (7.95)	7 (7.95)
Non-cardiac death	0	0	1 (1.14)	2 (2.27)	3 (3.41)	4 (4.55)
MI^a	0	1 (1.14)	3 (3.41)	6 (6.82)	7 (7.95)	7 (7.95)
ID-TLR	0	0	0	0	0	0
ID-TVR	0	0	0	0	0	0
ST	0	0	0	0	0	0
TVF	0	1 (1.14)	3 (3.41)	6 (6.82)	7 (7.95)	7 (7.95)
TLF	0	1 (1.14)	3 (3.41)	6 (6.82)	7 (7.95)	7 (7.95)
MACE	0	1 (1.14)	3 (3.41)	6 (6.82)	7 (7.95)	7 (7.95)
Freedom from TLF	88 (100.0)	87 (98.86)	85 (96.59)	82 (93.18)	81 (92.05)	81 (92.05)

Table 4. Cumulative Clinical Events up to 36 Months Follow-Up

Events, n (%)

In-hospital (n = 88)

Follow-up

1 month (n = 88)

6 months (n = 88)

12 months (n = 88)

24 months (n = 88)

36 months (n = 88)

^aSeven patients suffered from MI and cardiac death. ID-TLR: ischemia-driven target lesion revascularization; ID-TVR: ischemia-driven target vessel revascularization; MACE: major adverse cardiovascular event; MI: myocardial infarction; ST: stent thrombosis; TLF: target lesion failure; TVF: target vessel failure.

All-cause death

1 (1.14)

4 (4.55)

8 (9.09)

10 (11.36)

11 (12.50)

Cardiac death^a

1 (1.14)

3 (3.41)

6 (6.82)

7 (7.95)

Non-cardiac death

1 (1.14)

2 (2.27)

3 (3.41)

4 (4.55)

MI^a

1 (1.14)

3 (3.41)

6 (6.82)

7 (7.95)

ID-TLR

ID-TVR

TVF

1 (1.14)

3 (3.41)

6 (6.82)

7 (7.95)

TLF

1 (1.14)

3 (3.41)

6 (6.82)

7 (7.95)

MACE

1 (1.14)

3 (3.41)

6 (6.82)

7 (7.95)

Freedom from TLF

88 (100.0)

87 (98.86)

85 (96.59)

82 (93.18)

81 (92.05)

**Table 5.** Comparison of Clinical Outcomes Involving Contemporary DES in Long Lesion Trials
Variables/stents	BioMime™ Morph (current study)	Kang et al, 2022 [23]	Gautier et al, 2022 [26]	Hsiao et al, 2022 [27]	Karmpaliotis et al, 2022 [28]	Sim et al, 2020 [29]	Paszek et al, 2019 [30]	Diaz Fernnndez et al, 2018 [31]	Rajesh et al, 2018 [32]
^aDefinite ST. ^bDefinite and probable ST. ^cIschemia driven. ^dTotal probable stent thrombosis. ^eMean stent length per lesion. ^fProbable ST. ^gDevice-oriented composite endpoint (DOCE) composed of cardiac death, target vessel-related MI and TLR. ^hMedian follow-up. ⁱValues are given as percentages. BP-BES: biodegradable polymer biolimus-eluting stents; CoCr-EES: cobalt chromium everolimus-eluting stent; DES: drug-eluting stent; MACE: major adverse cardiovascular event; MI: myocardial infarction; PtCr-EES: platinum-chromium everolimus-eluting stent; Re-ZES: Resolute (®) zotarolimus eluting stent; SES: sirolimus-eluting stent; ST: stent thrombosis; TLR: target lesion revascularization; TVR: target vessel revascularization.
Number of patients	88	224	255	250	245	476	268	213	100	117	290	610	343
Average length of stent, mm	45.54 ± 10.20	46.5 ± 16.9	44.5 ± 16.8	45.9 ± 17.1	40.2 ± 13.4	45.6 ± 17.1	66 ± 22	60.1 ± 20.6^e	50.96 ± 7.25	48.00	55.5 ± 16.8	39.83 ± 14.0	41.63 ± 2.77
Polymer type	Biodegradable	Biodegradable/permanent	Biodegradable/permanent	Biodegradable	Biodegradable	Permanent	Permanent	Permanent	Biodegradable	Permanent	Permanent	Permanent	NA
Drug	Sirolimus	Everolimus	Everolimus	Zotarolimus	Biolimus	Sirolimus	Everolimus	Everolimus	Everolimus	Everolimus	Everolimus and zotarolimus	Everolimus	Everolimus and sirolimus
Clinical follow-up	12-month	36-month	12-month	12-month	12-month	12-month	12-month	12-month	12-month	12-month	12-month	831 days^h (range: 390 - 1,373; interquartile range: 459)	12-month	12-month (n = 314)
Clinical outcomes, n (%)
Cardiac death	6 (6.82)	7 (7.95)	0	1 (0.4)	1 (0.4)	2 (0.8)	2 (0.4)	2 (0.7)	3 (1.4)	1 (1.0)	1 (0.9)	21 (6.9)	1 (0.2)	5 (1.6)
MI	6 (6.82)	7 (7.95)	22 (9.8)	40 (15.7)	29 (11.6)	34 (13.9)	51 (10.7)	1.2ⁱ	3 (1.4)	2 (2.0)	4 (3.4)	19 (6.6)	8 (1.3)	2 (0.6)
ST	0	0	1 (0.4)	0	0	3 (1.2)	2 (0.4)	2 (0.7)^a	2 (0.9)	0	1 (0.9)^f	21 (7.2)^b	4 (0.7)	7 (2.2)^d
MACE	6 (6.82)	7 (7.95)	32 (14.3)	42 (16.5)	35 (14.0)	41 (16.7)	62 (13.0)	NA	NA	NA	7 (6.0)	39 (13.4)^g	13 (2.1)	19 (6)
TLR	0^c	0^c	7 (3.1)	5 (2.0)	4 (1.6)	8 (3.3)	9 (1.9)	4.1ⁱ	NA	1 (1.0)	1 (0.9)	NA	4 (0.7)	3 (1)
TVR	0^c	0^c	9 (4.0)	5 (2.0)	5 (2.0)	9 (3.7)	10 (2.1)	NA	7 (3.3)	1 (1.0)	1 (0.9)	18 (6.2)	NA	NA

Table 5. Comparison of Clinical Outcomes Involving Contemporary DES in Long Lesion Trials

Variables/stents

BioMime™ Morph (current study)

Kang et al, 2022 [23]

Gautier et al, 2022 [26]

Hsiao et al, 2022 [27]

Karmpaliotis et al, 2022 [28]

Sim et al, 2020 [29]

Paszek et al, 2019 [30]

Diaz Fernnndez et al, 2018 [31]

Rajesh et al, 2018 [32]

CoCr-EES

PtCr-EES

Re-ZES

BP-BES

SES

EES

EES + ZES

EES

EES + SES

^aDefinite ST. ^bDefinite and probable ST. ^cIschemia driven. ^dTotal probable stent thrombosis. ^eMean stent length per lesion. ^fProbable ST. ^gDevice-oriented composite endpoint (DOCE) composed of cardiac death, target vessel-related MI and TLR. ^hMedian follow-up. ⁱValues are given as percentages. BP-BES: biodegradable polymer biolimus-eluting stents; CoCr-EES: cobalt chromium everolimus-eluting stent; DES: drug-eluting stent; MACE: major adverse cardiovascular event; MI: myocardial infarction; PtCr-EES: platinum-chromium everolimus-eluting stent; Re-ZES: Resolute (®) zotarolimus eluting stent; SES: sirolimus-eluting stent; ST: stent thrombosis; TLR: target lesion revascularization; TVR: target vessel revascularization.

Number of patients

224

255

250

245

476

268

213

100

117

290

610

343

Average length of stent, mm

45.54 ± 10.20

46.5 ± 16.9

44.5 ± 16.8

45.9 ± 17.1

40.2 ± 13.4

45.6 ± 17.1

66 ± 22

60.1 ± 20.6^e

50.96 ± 7.25

48.00

55.5 ± 16.8

39.83 ± 14.0

41.63 ± 2.77

Polymer type

Biodegradable

Biodegradable/permanent

Biodegradable

Permanent

Biodegradable

Permanent

Drug

Sirolimus

Everolimus

Zotarolimus

Biolimus

Sirolimus

Everolimus

Everolimus and zotarolimus

Everolimus

Everolimus and sirolimus

Clinical follow-up

12-month

36-month

12-month

831 days^h (range: 390 - 1,373; interquartile range: 459)

12-month

12-month (n = 314)

Clinical outcomes, n (%)

Cardiac death

6 (6.82)

7 (7.95)

1 (0.4)

2 (0.8)

2 (0.4)

2 (0.7)

3 (1.4)

1 (1.0)

1 (0.9)

21 (6.9)

1 (0.2)

5 (1.6)

6 (6.82)

7 (7.95)

22 (9.8)

40 (15.7)

29 (11.6)

34 (13.9)

51 (10.7)

1.2ⁱ

3 (1.4)

2 (2.0)

4 (3.4)

19 (6.6)

8 (1.3)

2 (0.6)

1 (0.4)

3 (1.2)

2 (0.4)

2 (0.7)^a

2 (0.9)

1 (0.9)^f

21 (7.2)^b

4 (0.7)

7 (2.2)^d

MACE

6 (6.82)

7 (7.95)

32 (14.3)

42 (16.5)

35 (14.0)

41 (16.7)

62 (13.0)

7 (6.0)

39 (13.4)^g

13 (2.1)

19 (6)

TLR

0^c

7 (3.1)

5 (2.0)

4 (1.6)

8 (3.3)

9 (1.9)

4.1ⁱ

1 (1.0)

1 (0.9)

4 (0.7)

3 (1)

TVR

0^c

9 (4.0)

5 (2.0)

9 (3.7)

10 (2.1)

7 (3.3)

1 (1.0)

1 (0.9)

18 (6.2)