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://cr.elmerpub.com

Original Article

Volume 16, Number 2, April 2025, pages 130-139

Safety and Performance of the MOZEC Sirolimus-Eluting Coronary Balloon in the Treatment of Stenotic Coronary Artery Lesions: A Real-World, Multicenter, Post-Marketing Surveillance Study

Figure 1. The MOZEC SEB showing its salient features and drug release mechanism. PTFE: polytetrafluoroethylene SEB: sirolimus-eluting balloon.

**Table 1.** Baseline Patient Characteristics
	Patients (n = 141)
^aBronchial asthma, hyperplasia, hypothyroidism and fistula, epigastric hernia and asymptomatic cholelithiasis, non-obstructive hypertrophic cardiomyopathy, interstitial lung disease, obstructive sleep apnea, renal calculi, dyspnea, MI and HBsAg positive. MI: myocardial infraction; CABG: coronary artery bypass graft; CAD: coronary artery disease; HBsAg: hepatitis B surface antigen; PCI: percutaneous coronary intervention; SD: standard deviation.
Characteristics
Age (years), mean ± SD	59.00 ± 9.84
Male, n (%)	109 (77.30)
Body mass index, kg/m², mean ± SD	26.19 ± 3.73
Heart rate, beats/min, mean ± SD	77.93 ± 11.65
Systolic blood pressure, mm Hg, mean ± SD	127.43 ± 18.08
Diastolic blood pressure, mm Hg, mean ± SD	76.19 ± 10.25
Medical history, n (%)
Diabetes mellitus	85 (60.28)
Dyslipidemia	6 (4.26)
Hypertension	94 (66.67)
Chronic renal insufficiency	1 (0.71)
Smokers	12 (8.51)
Alcoholics	6 (4.26)
Other illness^a	17 (12.06)
Cardiac history, n (%)
Previous MI	27 (19.15)
Previous PCI	40 (28.37)
Previous CABG	6 (4.26)
Family history of CAD	8 (5.67)
Diseased coronary arteries, n (%)
Single vessel	56 (39.72)
Double vessels	41 (29.08)
Triple vessels	42 (29.79)
Four vessels	2 (1.42)

Table 1. Baseline Patient Characteristics

Patients (n = 141)

^aBronchial asthma, hyperplasia, hypothyroidism and fistula, epigastric hernia and asymptomatic cholelithiasis, non-obstructive hypertrophic cardiomyopathy, interstitial lung disease, obstructive sleep apnea, renal calculi, dyspnea, MI and HBsAg positive. MI: myocardial infraction; CABG: coronary artery bypass graft; CAD: coronary artery disease; HBsAg: hepatitis B surface antigen; PCI: percutaneous coronary intervention; SD: standard deviation.

Characteristics

Age (years), mean ± SD

59.00 ± 9.84

Male, n (%)

109 (77.30)

Body mass index, kg/m², mean ± SD

26.19 ± 3.73

Heart rate, beats/min, mean ± SD

77.93 ± 11.65

Systolic blood pressure, mm Hg, mean ± SD

127.43 ± 18.08

Diastolic blood pressure, mm Hg, mean ± SD

76.19 ± 10.25

Medical history, n (%)

Diabetes mellitus

85 (60.28)

Dyslipidemia

6 (4.26)

Hypertension

94 (66.67)

Chronic renal insufficiency

1 (0.71)

Smokers

12 (8.51)

Alcoholics

6 (4.26)

Other illness^a

17 (12.06)

Cardiac history, n (%)

Previous MI

27 (19.15)

Previous PCI

40 (28.37)

Previous CABG

6 (4.26)

Family history of CAD

8 (5.67)

Diseased coronary arteries, n (%)

Single vessel

56 (39.72)

Double vessels

41 (29.08)

Triple vessels

42 (29.79)

Four vessels

2 (1.42)

**Table 2.** Location and Clinical Features of the Lesions
Total number of lesions treated	N = 181
LAD: left anterior descending artery; RCA: right coronary artery; LCX: left circumflex coronary artery; LMCA: left main coronary artery; R-PDA: right posterior descending artery; SD: standard deviation.
Lesion’s location, n (%)	N = 181
LAD	47 (25.96)
RCA	27 (14.91)
LCX	11 (6.07)
First diagonal	21 (11.60)
Second diagonal	1 (0.55)
First septal	1 (0.55)
Third obtuse marginal	2 (1.10)
R-PDA	7 (3.87)
Ramus	5 (2.76)
LMCA	1 (0.55)
Others	58 (32.04)
Total number of study devices used to treat the lesion, n	158
Clinical features of the lesions
Reference vessel diameter (mm), pre-procedure, mean ± SD	2.53 ± 0.46
Minimum lumen diameter (mm), pre-procedure, mean ± SD	1.49 ± 0.94
Percentage diameter stenosis, mean ± SD	86.08 ± 11.02
Lesion length (mm), mean ± SD	18.40 ± 8.96
Reference vessel diameter (mm), post-procedure, mean ± SD	2.61 ± 0.46
Minimum lumen diameter (mm), post-procedure, mean ± SD	2.44 ± 0.51

Table 2. Location and Clinical Features of the Lesions

Total number of lesions treated

N = 181

LAD: left anterior descending artery; RCA: right coronary artery; LCX: left circumflex coronary artery; LMCA: left main coronary artery; R-PDA: right posterior descending artery; SD: standard deviation.

Lesion’s location, n (%)

N = 181

LAD

47 (25.96)

RCA

27 (14.91)

LCX

11 (6.07)

First diagonal

21 (11.60)

Second diagonal

1 (0.55)

First septal

1 (0.55)

Third obtuse marginal

2 (1.10)

R-PDA

7 (3.87)

Ramus

5 (2.76)

LMCA

1 (0.55)

Others

58 (32.04)

Total number of study devices used to treat the lesion, n

158

Clinical features of the lesions

Reference vessel diameter (mm), pre-procedure, mean ± SD

2.53 ± 0.46

Minimum lumen diameter (mm), pre-procedure, mean ± SD

1.49 ± 0.94

Percentage diameter stenosis, mean ± SD

86.08 ± 11.02

Lesion length (mm), mean ± SD

18.40 ± 8.96

Reference vessel diameter (mm), post-procedure, mean ± SD

2.61 ± 0.46

Minimum lumen diameter (mm), post-procedure, mean ± SD

2.44 ± 0.51

**Table 3.** Safety Outcomes
Events, n (%)	In-hospital (n = 141)	1-month (n = 141)	6-month (n = 139)	12-month (n = 137)	24-month (n = 134)
^aTwo patients suffered from MI and TLR. ^bOne patient suffered from MI and cardiac death, ^cTwo patients suffered from MI and TLR. MACEs: major adverse cardiac events; MI: myocardial infarction; TLR: target lesion revascularization.
All-cause death	0	2 (1.42)	2 (1.44)	3 (2.19)	4 (2.99)
Cardiac death	0	1 (0.71)	1 (0.72)	2 (1.46)^b	2 (1.49)
Non-cardiac death	0	1 (0.71)	1 (0.72)	1 (0.73)	2 (1.49)
MI	0	1 (0.71)	3 (2.16)^a	5 (3.65)^{b, c}	5 (3.73)
TLR	0	0	2 (1.44)^a	4 (2.92)^c	4 (2.99)
Cumulative MACEs	0	2 (1.42)	4 (2.88)	6 (4.38)	6 (4.47)

Table 3. Safety Outcomes

Events, n (%)

In-hospital (n = 141)

1-month (n = 141)

6-month (n = 139)

12-month (n = 137)

24-month (n = 134)

^aTwo patients suffered from MI and TLR. ^bOne patient suffered from MI and cardiac death, ^cTwo patients suffered from MI and TLR. MACEs: major adverse cardiac events; MI: myocardial infarction; TLR: target lesion revascularization.

All-cause death

2 (1.42)

2 (1.44)

3 (2.19)

4 (2.99)

Cardiac death

1 (0.71)

1 (0.72)

2 (1.46)^b

2 (1.49)

Non-cardiac death

1 (0.71)

1 (0.72)

1 (0.73)

2 (1.49)

1 (0.71)

3 (2.16)^a

5 (3.65)^{b, c}

5 (3.73)

TLR

2 (1.44)^a

4 (2.92)^c

4 (2.99)

Cumulative MACEs

2 (1.42)

4 (2.88)

6 (4.38)

6 (4.47)

**Table 4.** Quantitative Coronary Angiographic Analysis
Parameters	Pre-procedure (n = 17)	Post-procedure (n = 17)	6-month follow-up (n = 17)	P value
Values are given in mean ± SD. MLD: minimal lumen diameter; SD: standard deviation.
In-device
Binary stenosis	0.93 ± 0.27	0.29 ± 0.47	0.31 ± 0.48	0.0078
MLD (mm)	0.49 ± 0.37	1.33 ± 0.28	1.15 ± 0.47	0.0005
In-segment
Binary stenosis	0.93 ± 0.27	0.29 ± 0.47	0.31 ± 0.48	0.0078
MLD (mm)	0.49 ± 0.37	1.28 ± 0.25	1.15 ± 0.47	0.0005
Proximal edge
MLD (mm)	2.04 ± 0.30	2.20 ± 0.53	2.22 ± 0.50	0.2368
Distal edge
MLD (mm)	1.73 ± 0.31	1.70 ± 0.34	1.82 ± 0.47	0.6989

Table 4. Quantitative Coronary Angiographic Analysis

Parameters

Pre-procedure (n = 17)

Post-procedure (n = 17)

6-month follow-up (n = 17)

P value

Values are given in mean ± SD. MLD: minimal lumen diameter; SD: standard deviation.

In-device

Binary stenosis

0.93 ± 0.27

0.29 ± 0.47

0.31 ± 0.48

0.0078

MLD (mm)

0.49 ± 0.37

1.33 ± 0.28

1.15 ± 0.47

0.0005

In-segment

Binary stenosis

0.93 ± 0.27

0.29 ± 0.47

0.31 ± 0.48

0.0078

MLD (mm)

0.49 ± 0.37

1.28 ± 0.25

1.15 ± 0.47

0.0005

Proximal edge

MLD (mm)

2.04 ± 0.30

2.20 ± 0.53

2.22 ± 0.50

0.2368

Distal edge

MLD (mm)

1.73 ± 0.31

1.70 ± 0.34

1.82 ± 0.47

0.6989

**Table 5.** Comparison of 2-Year Outcomes of MOZEC SEB With Contemporary DCB and DES
Study name	Study design	Device name	Sample size	Follow-up duration	Cardiac death	MI	TLR	MACE
^aMACEs (composite of cardiac death, MI, and TLR). ^bMACEs (death, MI, TVR). ^cMACEs (composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization). MACE: major adverse cardiac event; MI: myocardial infarction; SEB: sirolimus-eluting balloon; TLR: target lesion revascularization; SCB: sirolimus-coated balloon; SES: sirolimus-eluting coronary stent system, EES: everolimus-eluting coronary stent system; ZES: zotarolimus-eluting coronary stent system; RCT: randomized controlled trial.
MOZEC SEB	Real-world, multicenter, post-marketing surveillance study	MOZEC SEB	141	2 years	1.49%	3.73%	2.99%	4.47%
BASKET-SMALL 2 [14]	Multicenter, open-label, randomized noninferiority trial	Paclitaxel-coated balloon SeQuent Please^®	382	1 year	3.1%	1.6%	-	7.5%
		Everolimus-eluting Xience® stent and paclitaxel-eluting TAXUS Element® stent	376	1 year	1.3%	3.5%	-	7.3%
EASTBOURNE prospective registry [17]	Prospective, multicenter, real-world study	Magic Touch sirolimus DCB	2,123	1 year	1.5%	2.4%	5.9%	9.9%
Nanolute registry final results [19]	Prospective registry	Magic Touch SCB	408	2 years	0.7%	0.2%	3.2%	4.2%
SELFIE registry [21]	Prospective, single-center registry	Magic Touch SCB	62	11 ± 7 months	1.6%	3.2%	3.2%	4.8%
BIONYX trial [25]	Prospective, patient- and assessor-blinded, randomized noninferiority trial	Orsiro SES	1,245	2 years	1.6%	3.2%	3.4%	8.6%
		Resolute Onyx SES	1,243	2 years	1.0%	3.3%	3.9%	8.3%
THRIVE study [26]	Prospective, multicenter, real-world, single-arm registry	XIENCE EES	365	2 years	0.8%	3.0%	2.1%	6.0%^a
RESOLUTE clinical trial [27]	Prospective, multicenter, non-randomized, single-arm trial	Resolute ZES	139	2 years	0.7%	5.8%	1.4%	10.1%
DESSOLVE I and II trials [28]	DESSOLVE I: first-in-human, single-arm trial; and DESSOLVE II: randomized trial	MiStent SES	123	2 years	1.7%	2.5%	1.7%	6.7%^b
		Endeavor Sprint ZES	61	2 years	1.7%	5.0%	1.7%	13.3%^b
COMFORTABLE AMI RCT [29]	Prospective, randomized, single-blinded, controlled trial	Biolimus	575	1 year	2.9%	2.0%	1.6%	4.3%^c

Table 5. Comparison of 2-Year Outcomes of MOZEC SEB With Contemporary DCB and DES

Study name

Study design

Device name

Sample size

Follow-up duration

Cardiac death

TLR

MACE

^aMACEs (composite of cardiac death, MI, and TLR). ^bMACEs (death, MI, TVR). ^cMACEs (composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization). MACE: major adverse cardiac event; MI: myocardial infarction; SEB: sirolimus-eluting balloon; TLR: target lesion revascularization; SCB: sirolimus-coated balloon; SES: sirolimus-eluting coronary stent system, EES: everolimus-eluting coronary stent system; ZES: zotarolimus-eluting coronary stent system; RCT: randomized controlled trial.

MOZEC SEB

Real-world, multicenter, post-marketing surveillance study

MOZEC SEB

141

2 years

1.49%

3.73%

2.99%

4.47%

BASKET-SMALL 2 [14]

Multicenter, open-label, randomized noninferiority trial

Paclitaxel-coated balloon SeQuent Please^®

382

1 year

3.1%

1.6%

7.5%

Everolimus-eluting Xience® stent and paclitaxel-eluting TAXUS Element® stent

376

1 year

1.3%

3.5%

7.3%

EASTBOURNE prospective registry [17]

Prospective, multicenter, real-world study

Magic Touch sirolimus DCB

2,123

1 year

1.5%

2.4%

5.9%

9.9%

Nanolute registry final results [19]

Prospective registry

Magic Touch SCB

408

2 years

0.7%

0.2%

3.2%

4.2%

SELFIE registry [21]

Prospective, single-center registry

Magic Touch SCB

11 ± 7 months

1.6%

3.2%

4.8%

BIONYX trial [25]

Prospective, patient- and assessor-blinded, randomized noninferiority trial

Orsiro SES

1,245

2 years

1.6%

3.2%

3.4%

8.6%

Resolute Onyx SES

1,243

2 years

1.0%

3.3%

3.9%

8.3%

THRIVE study [26]

Prospective, multicenter, real-world, single-arm registry

XIENCE EES

365

2 years

0.8%

3.0%

2.1%

6.0%^a

RESOLUTE clinical trial [27]

Prospective, multicenter, non-randomized, single-arm trial

Resolute ZES

139

2 years

0.7%

5.8%

1.4%

10.1%

DESSOLVE I and II trials [28]

DESSOLVE I: first-in-human, single-arm trial; and DESSOLVE II: randomized trial

MiStent SES

123

2 years

1.7%

2.5%

1.7%

6.7%^b

Endeavor Sprint ZES

2 years

1.7%

5.0%

1.7%

13.3%^b

COMFORTABLE AMI RCT [29]

Prospective, randomized, single-blinded, controlled trial

Biolimus

575

1 year

2.9%

2.0%

1.6%

4.3%^c