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 4, August 2023, pages 291-301

A Randomized Controlled Trial Comparing BioMime Sirolimus-Eluting Stent With Everolimus-Eluting Stent: Two-Year Outcomes of the meriT-V Trial

Figure 1. Kaplan-Meier analysis of ID-TVR up to the 2-year follow-up. ID-TVR: ischemia-driven target vessel revascularization.

Figure 2. Kaplan-Meier curve of the cumulative incidence of all MI events in both study arms. MI: myocardial infarction.

**Table 1.** Design Characteristics of the DES Used in the meriT-V Trial [2]
Stent	Alloy	Strut thickness	Drug (dose density)	Polymer	Coating thickness	Bare metal platform	Biodegradability of polymer coating (yes/no)	Polymer degradation (months)
DES: drug-eluting stent; PLLA: poly-L-lactic acid; PLGA: poly-lactic co-glycolic acid; PVDF: polyvinylidine fluoride.
XIENCE V (Abbott Vascular)	L605 CoCr	81 µm	Everolimus (1.0 µg/mm²)	Permanent fluorinated PVDF polymer	7.8	Vision^®	-	Not applicable
BioMime (Meril Life Science)	L605 CoCr	65 µm	Sirolimus (1.25 µg/mm²)	PLLA-PLGA	2	Nextgen™ (Meril Life Sciences Pvt. Ltd., India)	✓	9

Table 1. Design Characteristics of the DES Used in the meriT-V Trial [2]

Stent

Alloy

Strut thickness

Drug (dose density)

Polymer

Coating thickness

Bare metal platform

Biodegradability of polymer coating (yes/no)

Polymer degradation (months)

DES: drug-eluting stent; PLLA: poly-L-lactic acid; PLGA: poly-lactic co-glycolic acid; PVDF: polyvinylidine fluoride.

XIENCE V (Abbott Vascular)

L605 CoCr

81 µm

Everolimus (1.0 µg/mm²)

Permanent fluorinated PVDF polymer

7.8

Vision^®

Not applicable

BioMime (Meril Life Science)

L605 CoCr

65 µm

Sirolimus (1.25 µg/mm²)

PLLA-PLGA

Nextgen™ (Meril Life Sciences Pvt. Ltd., India)

✓

**Table 2.** Clinical Outcomes of meriT Series Trials
meriT-1 [9]	meriT-2 [13]	meriT-3 [14]	meriT-V [15]
CAD: coronary artery disease; ID-TLR: Ischemia-driven target lesion revascularization; ID-TVR: Ischemia-driven target vessel revascularization; IHD: ischemic heart disease; LLL: late lumen loss; MACE: major adverse cardiac event; ST: stent thrombosis; TV-MI: target vessel-related myocardial infarction.
Single-center/first in man	Multicenter	Multicenter/post-marketing	Multicenter
India	India (11 sites)	India (15 sites)	Europe (15 sites), Brazil (three sites)
30 patients/30 de novo lesions	250 patients/355 de novo lesions	All-comers patients 1,161/1,312 lesions	Randomized; 256 patients (BioMime 170/182 lesions vs. 86/95 lesions XIENCE)
8-month angiographic follow-up	8-month angiographic follow-up	-	9-month angiographic follow-up
Key results (1 year)	Key results (1 year)	Key results (1 year)	Key results (9-month follow-up)
Procedural success: 100%	Procedural success: 99.2%	High procedural success rate	Procedural success: BioMime 99.41% vs. 98.84%
In-stent LLL: 0.15 mm; in segment: 0.17 mm; binary restenosis: 0%	In-stent LLL: 0.12 mm; in segment: 0.11 mm	-	-
MACE (cardiac death, MI and TLR); ST: 0%	MACE (cardiac death 0.8%, MI 0.4% or any TLR 5.2%): 6%; ST: 0.4%	MACE (cardiac death 1.4%, MI 0.35% and any TLR 0.52%): 2.35%; ST: 0.1%	MACE (cardiac death, any MI and ID-TVR): BioMime 2.98 vs. XIENCE 7.14%; BioMime vs. XIENCE; Death 0% for both; MI 0.6% vs. 4.76% (any MI); ID-TLR/ID-TVR: 2.38% in both groups; ST: 0% in both groups; TV-MI: BioMime 0.6% vs. XIENCE 1.19%
Indications: silent ischemia	CAD/IHD	CAD	IHD

Table 2. Clinical Outcomes of meriT Series Trials

meriT-1 [9]

meriT-2 [13]

meriT-3 [14]

meriT-V [15]

CAD: coronary artery disease; ID-TLR: Ischemia-driven target lesion revascularization; ID-TVR: Ischemia-driven target vessel revascularization; IHD: ischemic heart disease; LLL: late lumen loss; MACE: major adverse cardiac event; ST: stent thrombosis; TV-MI: target vessel-related myocardial infarction.

Single-center/first in man

Multicenter

Multicenter/post-marketing

Multicenter

India

India (11 sites)

India (15 sites)

Europe (15 sites), Brazil (three sites)

30 patients/30 de novo lesions

250 patients/355 de novo lesions

All-comers patients 1,161/1,312 lesions

Randomized; 256 patients (BioMime 170/182 lesions vs. 86/95 lesions XIENCE)

8-month angiographic follow-up

9-month angiographic follow-up

Key results (1 year)

Key results (9-month follow-up)

Procedural success: 100%

Procedural success: 99.2%

High procedural success rate

Procedural success: BioMime 99.41% vs. 98.84%

In-stent LLL: 0.15 mm; in segment: 0.17 mm; binary restenosis: 0%

In-stent LLL: 0.12 mm; in segment: 0.11 mm

MACE (cardiac death, MI and TLR); ST: 0%

MACE (cardiac death 0.8%, MI 0.4% or any TLR 5.2%): 6%; ST: 0.4%

MACE (cardiac death 1.4%, MI 0.35% and any TLR 0.52%): 2.35%; ST: 0.1%

MACE (cardiac death, any MI and ID-TVR): BioMime 2.98 vs. XIENCE 7.14%; BioMime vs. XIENCE; Death 0% for both; MI 0.6% vs. 4.76% (any MI); ID-TLR/ID-TVR: 2.38% in both groups; ST: 0% in both groups; TV-MI: BioMime 0.6% vs. XIENCE 1.19%

Indications: silent ischemia

CAD/IHD

CAD

IHD

**Table 3.** Baseline Characteristics and Medical History of the Patients in BioMime™ and XIENCE Arm [15]
Variables	BioMime™ SES (N = 170)	XIENCE EES (N = 86)	P-value (BioMime™ SES vs. XIENCE EES)
CAD: coronary artery disease; LVEF: left ventricular ejection fraction; MI: myocardial infarction; N: number of patients; PCI: percutaneous coronary intervention; SD: standard deviation; ST: stent thrombosis; STEMI: ST elevation myocardial infarction.
Age (years), mean ± SD	64.33 ± 9.57	64.70 ± 8.99	0.75
Male, n (%)	111 (65.29)	53 (61.63)	0.56
Body mass index (kg/m²)	28.64 ± 4.45	29.40 ± 4.39	0.20
Cardiac risk factors, n (%)
Diabetes mellitus	41 (24.12)	18 (20.93)	0.57
Hypertension	125 (73.53)	68 (79.07)	0.11
Dyslipidemia	118 (69.41)	59 (68.60)	0.89
Chronic lung disease	9 (5.29)	10 (11.63)	0.07
Smokers	71 (41.76)	41 (47.67)	0.37
History of CAD	67 (39.41)	29 (33.72)	0.37
Renal insufficiency	4 (2.35)	2 (2.33)	0.99
Previous MI	37 (21.76)	13 (15.12)	0.25
Previous PCI	31 (18.24)	14 (16.28)	0.69
Cardiac status, n (%)
Stable angina	116 (68.24)	61 (70.9)	0.66
Unstable angina	25 (14.71)	12 (13.95)	0.87
Asymptomatic	16 (9.41)	5 (5.81)	0.32
STEMI	3 (1.76)	0 (0.0)	0.25
NSTEMI	10 (5.88)	8 (9.3)	0.31
LVEF, %	55.86 ± 7.22	56.82 ± 10.13	0.40

Table 3. Baseline Characteristics and Medical History of the Patients in BioMime™ and XIENCE Arm [15]

Variables

BioMime™ SES (N = 170)

XIENCE EES (N = 86)

P-value (BioMime™ SES vs. XIENCE EES)

CAD: coronary artery disease; LVEF: left ventricular ejection fraction; MI: myocardial infarction; N: number of patients; PCI: percutaneous coronary intervention; SD: standard deviation; ST: stent thrombosis; STEMI: ST elevation myocardial infarction.

Age (years), mean ± SD

64.33 ± 9.57

64.70 ± 8.99

0.75

Male, n (%)

111 (65.29)

53 (61.63)

0.56

Body mass index (kg/m²)

28.64 ± 4.45

29.40 ± 4.39

0.20

Cardiac risk factors, n (%)

Diabetes mellitus

41 (24.12)

18 (20.93)

0.57

Hypertension

125 (73.53)

68 (79.07)

0.11

Dyslipidemia

118 (69.41)

59 (68.60)

0.89

Chronic lung disease

9 (5.29)

10 (11.63)

0.07

Smokers

71 (41.76)

41 (47.67)

0.37

History of CAD

67 (39.41)

29 (33.72)

0.37

Renal insufficiency

4 (2.35)

2 (2.33)

0.99

Previous MI

37 (21.76)

13 (15.12)

0.25

Previous PCI

31 (18.24)

14 (16.28)

0.69

Cardiac status, n (%)

Stable angina

116 (68.24)

61 (70.9)

0.66

Unstable angina

25 (14.71)

12 (13.95)

0.87

Asymptomatic

16 (9.41)

5 (5.81)

0.32

STEMI

3 (1.76)

0 (0.0)

0.25

NSTEMI

10 (5.88)

8 (9.3)

0.31

LVEF, %

55.86 ± 7.22

56.82 ± 10.13

0.40

**Table 4.** Cumulative Clinical Outcomes of Both Study Arms Through the 2-Year Follow-Up
Clinical events	Follow-up
Values are presented as n (%). ID-TLR: ischemia-driven target lesion revascularization; ID-TVR: ischemia-driven target vessel revascularization; MACE: major adverse cardiac event; N: number of patients.
Death, n (%)
Cardiac death	0	0	0	0	0	0	NA
Non-cardiac death	0	0	1 (0.6%)	0	2 (1.19%)	0	0.32
Myocardial infarction	1 (0.59%)	1 (1.16%)	2 (1.19 %)	4 (4.76%)	3 (1.79%)	5 (5.95%)	0.17
ID-TLR	0	0	10 (5.95%)	3 (3.57%)	10 (5.95%)	3 (3.57%)	0.45
ID-TVR (including TLR)	0	0	10 (5.95%)	3 (3.57%)	10 (5.95%)	3 (3.57%)	0.45
ID-TVR (non-TLR)	0	0	4 (2.38%)	2 (2.38%)	4 (2.38%)	2 (2.38%)	0.99
Stent thrombosis, n (%)
Definite or probable/probable	0	0	0	1 (1.19%)	0	1 (1.19%)	0.16
Total of three-point MACE	1 (0.59%)	1 (1.16%)	11 (6.55%)	7 (8.33%)	13 (7.74%)	8 (9.52%)	0.6170

Table 4. Cumulative Clinical Outcomes of Both Study Arms Through the 2-Year Follow-Up

Clinical events

Follow-up

In-hospital (N = 256)

1 year (N = 252)

2 years (N = 252)

P-value (at 2 years)

BioMime (N = 170)

XIENCE (N = 86)

BioMime (N = 168)

XIENCE (N = 84)

BioMime (N = 168)

XIENCE (N = 84)

BioMime vs. XIENCE

Values are presented as n (%). ID-TLR: ischemia-driven target lesion revascularization; ID-TVR: ischemia-driven target vessel revascularization; MACE: major adverse cardiac event; N: number of patients.

Death, n (%)

Cardiac death

Non-cardiac death

1 (0.6%)

2 (1.19%)

0.32

Myocardial infarction

1 (0.59%)

1 (1.16%)

2 (1.19 %)

4 (4.76%)

3 (1.79%)

5 (5.95%)

0.17

ID-TLR

10 (5.95%)

3 (3.57%)

10 (5.95%)

3 (3.57%)

0.45

ID-TVR (including TLR)

10 (5.95%)

3 (3.57%)

10 (5.95%)

3 (3.57%)

0.45

ID-TVR (non-TLR)

4 (2.38%)

2 (2.38%)

4 (2.38%)

2 (2.38%)

0.99

Stent thrombosis, n (%)

Definite or probable/probable

1 (1.19%)

0.16

Total of three-point MACE

1 (0.59%)

1 (1.16%)

11 (6.55%)

7 (8.33%)

13 (7.74%)

8 (9.52%)

0.6170

**Table 5.** Clinical Outcomes of Contemporary Trials on BP-DES and DP-DES Designs
Trials	Study details	Cardiac death	TLR	TVR	MI	TV-MI	Late ST	ST	Other events
Values are n (%). ACS: acute coronary syndrome; BP: biodegradable polymer; CI-TLR: clinically-indicated target lesion revascularization; CI-TVR: clinically-indicated target vessel revascularization; DP: durable polymer; ID-TLR: ischemia-driven target lesion revascularization; ID-TVR: ischemia-driven target vessel revascularization; MACE: major adverse cardiac event; N: number of patients; n-DES: new-generation drug-eluting stent; PCI: percutaneous coronary intervention; ST: stent thrombosis; STEMI: ST elevation myocardial infarction; TLF: target lesion failure; TVF: target vessel failure; TV-MI: target vessel-related myocardial infarction.
BIOSCIENCE (2-year follow-up) [24]	Orsiro arm: 1,063 patients (1,594 lesions); XIENCE arm: 1,056 patients (1,545 lesions); patients with presence or absence of STEMI	3.2% vs. 3.2%	6.4% vs. 5.8 %	8.1% vs. 7.5%	6.1% vs. 7.2%	4.1% vs. 4.5%	-	Definite/probable 3.9% vs. 4.9%; definite 1.1% vs. 0.8%	CI-TVR 7.7% vs. 6.8%; CI-TLR: 6.0% vs. 5.1%; TLF 10.5% vs. 10.4%; TVF 12.2% vs. 12.3%
DESSOLVE III (2-year follow-up) [25]	MiSTENT (703/1,398 patients) vs. XIENCE (695/1,398 patients); 20 centers in Europe; all comers	3.0% vs. 2.0%	5.1% vs. 6%	6.9% vs. 8.5%	3.0% vs. 2.8%	2.7% vs. 2.3%	Late 0.4% vs. 0.6%; very late ST 0.3% vs. 0.3%	Definite/probable 0.9% vs. 1.3%; definite 0.6% vs. 1%	CI-TVR 5.9% vs. 7.7%; CI-TLR: 4.6% vs. 5.4%; DOCE/TLF: 8.7% vs. 8.6%
BIOSTEMI trial (2-year follow-up) [22]	Orsiro (649/1,300 patients/651 lesions) vs. XIENCE (651/1,300 patients/806 lesions); 10 centers in Switzerland; first STEMI	2.9% vs. 3.2%	2.8% vs. 5.2%	3.4% vs. 6.3%	3.7% vs. 3.1%	1.5% vs. 2.0%	-	Definite/probable 2.0% vs. 2.3%; definite 1.4% vs. 1.8%	TLF: 5.1% vs. 8.1%; CI-TVR 3.1% vs. 6.1%; CI-TLR: 2.5% vs. 5.1%; TVF 6% vs. 9.4%
BIOFLOW-V trial (3-year follow-up) [23]	Orsiro (884/1,334 patients/1,051 lesions) vs. XIENCE (450/1,334 patients/561 lesions); 92 international randomized study centers; non-STEMI/ACS	1.1% vs. 1.2%	-	-	-	5% vs. 9.2%	Late and very late ST 0.1% vs. 1.2%	-	ID-TLR: 3.2% vs. 6.7%; MACE: 11.5% vs. 17.5%; TVF: 9.7% vs. 16.2; TLF: 8.2% vs. 13.6%
BIOFLOW-II trial (5-year follow-up) [26]	Orsiro (298 patients/332 lesions) vs. XIENCE (154 patients/173 lesions); 24 centers in eight European countries; de novo lesions	1.7% vs. 2.8%	-	-	4.5% vs. 6.2%	3.4% vs. 3.3%	-	Overall ST 0.7% vs. 2.8%; definite 0% vs. 0.7%; probable 0%	CI-TVR 12.6% vs. 10.1%; CI-TLR: 6.3% vs. 6.7%; TLF 10.4% vs. 12.7%; TVF 15.6% vs. 12.7%
BIOFLOW-V trial (5-year follow-up) [23]	Orsiro (884 patients) vs. XIENCE (450 patients); 92 randomized study centers; non-STEMI/ACS	2.6% vs. 1.9%	-	-		6.6% vs. 10.3%	Late and very late ST 0.3% vs. 1.6%	-	ID-TLR: 5.9% vs. 7.7%; ID-TVR: 9.6% vs. 12.4%; TLF 12.3% vs. 15.3%; TVF 15.2% vs .19%; MACE: 18.3% vs. 21.4%
BIORESORT trial (3-year follow-up) [27]	1,506/3,514 patients; Orsiro (525) vs. synergy (496) vs. resolute integrity (485); four clinical sites; all-comer trial	1.3% vs. 1.8% vs. 2.1%	1.7% vs. 2.5% vs. 4.4%	-	-	2.7% vs. 2.7% vs. 4.0%	-	Definite or probable ST 0.6% vs. 1.2% vs. 1.5%; definite ST 0.4% vs. 0.6% vs. 1.1%	TLF: 5.2% vs. 6.5% vs. 8.7%
SCAAR registry [28]	4,561 patients implanted with Orsiro and 69,570 n-DES group (XIENCE PRIME, XIENCE Xpedition and XIENCE ProX, PROMUS Element, Plus and Promus PRIMER, Resolute Integrity and Resolute, Onyx, SYNERGY; undergoing PCI	-	1.6% vs. 2.3%		6.0% vs. 5.2%		Late ST: 0.5% vs. 0.6%; very late ST: 0.7% vs. 0.8%	Definite ST: 0.7% vs. 0.8%

Table 5. Clinical Outcomes of Contemporary Trials on BP-DES and DP-DES Designs

Trials

Study details

Cardiac death

TLR

TVR

TV-MI

Late ST

Other events

Values are n (%). ACS: acute coronary syndrome; BP: biodegradable polymer; CI-TLR: clinically-indicated target lesion revascularization; CI-TVR: clinically-indicated target vessel revascularization; DP: durable polymer; ID-TLR: ischemia-driven target lesion revascularization; ID-TVR: ischemia-driven target vessel revascularization; MACE: major adverse cardiac event; N: number of patients; n-DES: new-generation drug-eluting stent; PCI: percutaneous coronary intervention; ST: stent thrombosis; STEMI: ST elevation myocardial infarction; TLF: target lesion failure; TVF: target vessel failure; TV-MI: target vessel-related myocardial infarction.

BIOSCIENCE (2-year follow-up) [24]

Orsiro arm: 1,063 patients (1,594 lesions); XIENCE arm: 1,056 patients (1,545 lesions); patients with presence or absence of STEMI

3.2% vs. 3.2%

6.4% vs. 5.8 %

8.1% vs. 7.5%

6.1% vs. 7.2%

4.1% vs. 4.5%

Definite/probable 3.9% vs. 4.9%; definite 1.1% vs. 0.8%

CI-TVR 7.7% vs. 6.8%; CI-TLR: 6.0% vs. 5.1%; TLF 10.5% vs. 10.4%; TVF 12.2% vs. 12.3%

DESSOLVE III (2-year follow-up) [25]

MiSTENT (703/1,398 patients) vs. XIENCE (695/1,398 patients); 20 centers in Europe; all comers

3.0% vs. 2.0%

5.1% vs. 6%

6.9% vs. 8.5%

3.0% vs. 2.8%

2.7% vs. 2.3%

Late 0.4% vs. 0.6%; very late ST 0.3% vs. 0.3%

Definite/probable 0.9% vs. 1.3%; definite 0.6% vs. 1%

CI-TVR 5.9% vs. 7.7%; CI-TLR: 4.6% vs. 5.4%; DOCE/TLF: 8.7% vs. 8.6%

BIOSTEMI trial (2-year follow-up) [22]

Orsiro (649/1,300 patients/651 lesions) vs. XIENCE (651/1,300 patients/806 lesions); 10 centers in Switzerland; first STEMI

2.9% vs. 3.2%

2.8% vs. 5.2%

3.4% vs. 6.3%

3.7% vs. 3.1%

1.5% vs. 2.0%

Definite/probable 2.0% vs. 2.3%; definite 1.4% vs. 1.8%

TLF: 5.1% vs. 8.1%; CI-TVR 3.1% vs. 6.1%; CI-TLR: 2.5% vs. 5.1%; TVF 6% vs. 9.4%

BIOFLOW-V trial (3-year follow-up) [23]

Orsiro (884/1,334 patients/1,051 lesions) vs. XIENCE (450/1,334 patients/561 lesions); 92 international randomized study centers; non-STEMI/ACS

1.1% vs. 1.2%

5% vs. 9.2%

Late and very late ST 0.1% vs. 1.2%

ID-TLR: 3.2% vs. 6.7%; MACE: 11.5% vs. 17.5%; TVF: 9.7% vs. 16.2; TLF: 8.2% vs. 13.6%

BIOFLOW-II trial (5-year follow-up) [26]

Orsiro (298 patients/332 lesions) vs. XIENCE (154 patients/173 lesions); 24 centers in eight European countries; de novo lesions

1.7% vs. 2.8%

4.5% vs. 6.2%

3.4% vs. 3.3%

Overall ST 0.7% vs. 2.8%; definite 0% vs. 0.7%; probable 0%

CI-TVR 12.6% vs. 10.1%; CI-TLR: 6.3% vs. 6.7%; TLF 10.4% vs. 12.7%; TVF 15.6% vs. 12.7%

BIOFLOW-V trial (5-year follow-up) [23]

Orsiro (884 patients) vs. XIENCE (450 patients); 92 randomized study centers; non-STEMI/ACS

2.6% vs. 1.9%

6.6% vs. 10.3%

Late and very late ST 0.3% vs. 1.6%

ID-TLR: 5.9% vs. 7.7%; ID-TVR: 9.6% vs. 12.4%; TLF 12.3% vs. 15.3%; TVF 15.2% vs .19%; MACE: 18.3% vs. 21.4%

BIORESORT trial (3-year follow-up) [27]

1,506/3,514 patients; Orsiro (525) vs. synergy (496) vs. resolute integrity (485); four clinical sites; all-comer trial

1.3% vs. 1.8% vs. 2.1%

1.7% vs. 2.5% vs. 4.4%

2.7% vs. 2.7% vs. 4.0%

Definite or probable ST 0.6% vs. 1.2% vs. 1.5%; definite ST 0.4% vs. 0.6% vs. 1.1%

TLF: 5.2% vs. 6.5% vs. 8.7%

SCAAR registry [28]

4,561 patients implanted with Orsiro and 69,570 n-DES group (XIENCE PRIME, XIENCE Xpedition and XIENCE ProX, PROMUS Element, Plus and Promus PRIMER, Resolute Integrity and Resolute, Onyx, SYNERGY; undergoing PCI

1.6% vs. 2.3%

6.0% vs. 5.2%

Late ST: 0.5% vs. 0.6%; very late ST: 0.7% vs. 0.8%

Definite ST: 0.7% vs. 0.8%