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 17, Number 4, August 2026, pages 308-320

Pristine+™ Everolimus-Eluting Cobalt-Chromium Coronary Stent System: A Prospective, Multicenter Registry

↓ Figure 1. Device design of Pristine+™ everolimus-eluting coronary stent system (Relisys Medical Devices Limited).

↓ Figure 3. (a) Distribution of lesions in the main coronaries. (b) Pristine+™ EES stent diameters used. EES: everolimus-eluting stent.

↓ Figure 4. The 12-month Kaplan–Meier cumulative incidence curve for (a) MACE and (b) TLF. MACE: major adverse cardiac event; TLF: target lesion failure.

↓ Figure 5. CKD: present Kaplan–Meier analyses of subgroup cumulative incidence for (a) MACE and (b) TLF. CKD: chronic kidney disease; MACE: major adverse cardiac event; TLF: target lesion failure.

↓ Figure 6. Hypertension: present Kaplan–Meier analyses of subgroup cumulative incidence for (a) MACE and (b) TLF. MACE: major adverse cardiac event; TLF: target lesion failure.

↓ Figure 7. Diabetes: present Kaplan–Meier analyses of subgroup cumulative incidence for (a) MACE and (b) TLF. MACE: major adverse cardiac event; TLF: target lesion failure.

↓ **Table 1.** Baseline and at Discharge Characteristics (N = 1,088 Patients)
Category	Details
ACS: acute coronary syndrome; BMI: body mass index; BP: blood pressure; CABG: coronary artery bypass grafting; CCBs: calcium channel blockers; CCS: chronic coronary syndrome; CKD: chronic kidney disease; LVEF: left ventricular ejection fraction; MI: myocardial infarction; NSTEMI: non-ST-segment elevation myocardial infarction; N: number of patients; PTCA: percutaneous transluminal coronary angioplasty; P2Y12: purinergic receptor P2Y12; SD: standard deviation; STEMI: ST-segment elevation myocardial infarction.
Demographics
Male	859 (78.9%)
Female	229 (21.1%)
Age	58.6 ± 10.6 years
BMI	24.1 ± 3.5 kg/m²
Comorbidities
Diabetes	378 (34.7%)
> 10 years	124 (11.4%)
Hypertension	695 (63.9%)
CKD	143 (13.4%)
Smokers	280 (25.7%)
Cardiac function
LVEF overall	49.1 ± 10.0
< 40	149 (13.7%)
40–50	542 (49.8%)
> 50	397 (36.5%)
Vital signs
Systolic BP	130.1 ± 10.4 mm Hg
Diastolic BP	83.4 ± 8.7 mm Hg
Heart rate	80.0 ± 14.2 bpm
Prior cardiac history
PTCA	55 (5.1%)
MI	81 (7.4%)
CABG	21 (1.9%)
Clinical presentation
ACS	1,037 (95.3%)
STEMI	617 (56.7%)
NSTEMI	117 (10.8%)
Unstable angina	303 (27.9%)
CCS	51 (4.7%)
Pharmacotherapy at discharge
Antiplatelets: aspirin	1,078 (99.1%)
Ticagrelor	970 (89.2%)
Clopidogrel	80 (7.4%)
Prasugrel	22 (2.0%)
Statins	1,068 (98.2%)
Beta-blockers	628 (57.7%)
Calcium channel blockers (CCBs)	125 (11.5%)

↓ Table 1. Baseline and at Discharge Characteristics (N = 1,088 Patients)

Category

Details

ACS: acute coronary syndrome; BMI: body mass index; BP: blood pressure; CABG: coronary artery bypass grafting; CCBs: calcium channel blockers; CCS: chronic coronary syndrome; CKD: chronic kidney disease; LVEF: left ventricular ejection fraction; MI: myocardial infarction; NSTEMI: non-ST-segment elevation myocardial infarction; N: number of patients; PTCA: percutaneous transluminal coronary angioplasty; P2Y12: purinergic receptor P2Y12; SD: standard deviation; STEMI: ST-segment elevation myocardial infarction.

Demographics

Male

859 (78.9%)

Female

229 (21.1%)

Age

58.6 ± 10.6 years

BMI

24.1 ± 3.5 kg/m²

Comorbidities

Diabetes

378 (34.7%)

> 10 years

124 (11.4%)

Hypertension

695 (63.9%)

CKD

143 (13.4%)

Smokers

280 (25.7%)

Cardiac function

LVEF overall

49.1 ± 10.0

< 40

149 (13.7%)

40–50

542 (49.8%)

> 50

397 (36.5%)

Vital signs

Systolic BP

130.1 ± 10.4 mm Hg

Diastolic BP

83.4 ± 8.7 mm Hg

Heart rate

80.0 ± 14.2 bpm

Prior cardiac history

PTCA

55 (5.1%)

81 (7.4%)

CABG

21 (1.9%)

Clinical presentation

ACS

1,037 (95.3%)

STEMI

617 (56.7%)

NSTEMI

117 (10.8%)

Unstable angina

303 (27.9%)

CCS

51 (4.7%)

Pharmacotherapy at discharge

Antiplatelets: aspirin

1,078 (99.1%)

Ticagrelor

970 (89.2%)

Clopidogrel

80 (7.4%)

Prasugrel

22 (2.0%)

Statins

1,068 (98.2%)

Beta-blockers

628 (57.7%)

Calcium channel blockers (CCBs)

125 (11.5%)

↓ **Table 2.** Procedural Characteristics (N = 1,088 Patients; 1,386 Lesions)
Category	Details
Lesion location, stent length, and stent diameter are reported at the lesion level (1,386 lesions treated). Lesion classification, TIMI flow, procedural success, and device success are reported at the patient level based on the index target lesion (N = 1,088). ACC/AHA: American College of Cardiology/American Heart Association; LAD: left anterior descending artery; LMCA: left main coronary artery; LCx: left circumflex artery; mm: millimeter; PCI: percutaneous coronary intervention; RCA: right coronary artery; TIMI: thrombolysis in myocardial infarction.
Lesion classification (ACC/AHA)
Type A	239 (17.2%)
Type B1	446 (32.2%)
Type B2	229 (16.5%)
Type C	174 (12.6%)
Lesion locations (1,386 lesions)
LAD	660 (47.6%)
RCA	445 (32.1%)
LCx	178 (12.8%)
LMCA	14 (1.0%)
Distal branches	64 (4.6%)
Other	25 (1.8%)
Stent lengths (mm)
15	26 (1.9%)
18	182 (13.1%)
20	217 (15.7%)
24	255 (18.4%)
28	316 (22.8%)
32	390 (28.1%)
Stent diameters (mm)
2.5	76 (5.5%)
2.75	267 (19.3%)
3.0	649 (46.8%)
3.5	380 (27.4%)
4.0	14 (1.0%)
TIMI flow pre-PCI
TIMI 0	108 (9.9%)
TIMI 1	234 (21.5%)
TIMI 2	746 (68.6%)
TIMI flow post-PCI
TIMI 2	27 (2.5%)
TIMI 3	1,061 (97.5%)
Procedural success	1,083 (99.5%)
Device success	1,074 (98.7%)
Complications
Severe dissection	2
Abrupt closure	1
In-hospital deaths	2

↓ Table 2. Procedural Characteristics (N = 1,088 Patients; 1,386 Lesions)

↓ **Table 3.** Cumulative 12-Month Outcomes
Category	Details
*Post hoc sex-stratified all-cause mortality. CCBs: calcium channel blockers; CI-TLR: clinically indicated target-lesion revascularization; MACE: major adverse cardiac event; MI: myocardial infarction; N: number of patients; ST: stent thrombosis; TLF: target-lesion failure; TV-MI: target vessel-attributed myocardial infarction.
Mortality
Cardiac deaths	18 (1.65%)
All-cause deaths	25 (2.3%)
Male deaths	16 (64%)
Female deaths	9 (36%)
Ischemic events
MI	13 (1.19%)
TV-MI	1 (0.09%)
CI-TLR	0
Stent thrombosis
Total	9 (0.83%)
Probable	6 (0.55%)
Definite	3 (0.28%)
Late	0
Composite endpoints
MACE	40 (2.89%)
TLF	19 (1.77%)
Safety
Major bleeding	1 (0.09%)
Pharmacotherapy at 12 months
Aspirin	1,023 (94.0%)
Ticagrelor	726 (66.7%)
Clopidogrel	141 (13.0%)
Prasugrel	19 (1.7%)
Statins	1,027 (94.4%)
Beta-blockers	704 (64.7%)
CCBs	122 (11.2%)

Category

Details

*Post hoc sex-stratified all-cause mortality. CCBs: calcium channel blockers; CI-TLR: clinically indicated target-lesion revascularization; MACE: major adverse cardiac event; MI: myocardial infarction; N: number of patients; ST: stent thrombosis; TLF: target-lesion failure; TV-MI: target vessel-attributed myocardial infarction.

Mortality

Cardiac deaths

18 (1.65%)

All-cause deaths

25 (2.3%)

Male deaths

16 (64%)

Female deaths

9 (36%)

Ischemic events

13 (1.19%)

TV-MI

1 (0.09%)

CI-TLR

Stent thrombosis

Total

9 (0.83%)

Probable

6 (0.55%)

Definite

3 (0.28%)

Late

Composite endpoints

MACE

40 (2.89%)

TLF

19 (1.77%)

Safety

Major bleeding

1 (0.09%)

Pharmacotherapy at 12 months

Aspirin

1,023 (94.0%)

Ticagrelor

726 (66.7%)

Clopidogrel

141 (13.0%)

Prasugrel

19 (1.7%)

Statins

1,027 (94.4%)

Beta-blockers

704 (64.7%)

CCBs

122 (11.2%)

↓ **Table 4.** Clinical Outcome Comparison (CKD, Diabetes, Hypertension, Smokers Subsets)
Outcome	CKD (N = 143)	Diabetes (N = 378)	Hypertension (N = 695)	Smokers (N = 280)
CI-TLR: clinically indicated target-lesion revascularization; CKD: chronic kidney disease; MI: myocardial infarction; MACE: major adverse cardiac events; N: number of patients; ST: stent thrombosis; TLF: target-lesion failure; TV-MI: target vessel myocardial infarction.
Cardiac death	6 (4.2%)	9 (2.4%)	12 (1.7%)	5 (1.8%)
MI	3 (2.1%)	4 (1.1%)	13 (1.9%)	2 (0.7%)
Stent thrombosis	2 (1.4%)	7 (1.9%)	6 (0.9%)	2 (0.7%)
MACE	9 (6.36%)	13 (3.48%)	25 (3.67%)	7 (2.5%)
CI-TLR	0	0	0	0
TV-MI	0	0	1 (0.1%)	0
TLF	6 (4.24%)	9 (2.4%)	13 (1.91%)	5 (1.8%)

↓ Table 4. Clinical Outcome Comparison (CKD, Diabetes, Hypertension, Smokers Subsets)

Outcome

CKD (N = 143)

Diabetes (N = 378)

Hypertension (N = 695)

Smokers (N = 280)

CI-TLR: clinically indicated target-lesion revascularization; CKD: chronic kidney disease; MI: myocardial infarction; MACE: major adverse cardiac events; N: number of patients; ST: stent thrombosis; TLF: target-lesion failure; TV-MI: target vessel myocardial infarction.

Cardiac death

6 (4.2%)

9 (2.4%)

12 (1.7%)

5 (1.8%)

3 (2.1%)

4 (1.1%)

13 (1.9%)

2 (0.7%)

Stent thrombosis

2 (1.4%)

7 (1.9%)

6 (0.9%)

2 (0.7%)

MACE

9 (6.36%)

13 (3.48%)

25 (3.67%)

7 (2.5%)

CI-TLR

TV-MI

1 (0.1%)

TLF

6 (4.24%)

9 (2.4%)

13 (1.91%)

5 (1.8%)

↓ **Table 5.** Comparison of Outcomes From Contemporary Sirolimus-Eluting and Everolimus-Eluting Stents
Trial	Device	Population	ACS status	Cardiac death (%)	MI/TV-MI (%)	TLF (%)	TLR (%)	ST (%)
Cross-trial comparisons should be interpreted cautiously because of differences in study design, patient characteristics, ACS prevalence, endpoint definitions, and follow-up methodology. ACS: acute coronary syndrome; CAD: coronary artery disease; EES: everolimus-eluting stent; STEMI: ST-segment elevation myocardial infarction; BP-SES: biodegradable polymer sirolimus-eluting stent; TVF: target vessel failure; TLF: target-lesion failure; TLR: target lesion revascularization; MI: myocardial infarction; ISR: in-stent restenosis.
meriT-V (Abizaid, 2023) [15]	Xience (EES)	86 de novo CAD	Stable CAD	0	6	NR	2.4	1.2
BIOSTEMI (Pilgrim, 2021) [12]	Orsiro (BP-SES)	649 STEMI	ACS (100% STEMI)	2.9	1.5 (TV-MI)	5.1	2.5	1.4
BIOSTEMI (Pilgrim, 2021) [12]	Xience (EES)	651 STEMI	ACS (100% STEMI)	3.2	2.0 (TV-MI)	8.1	5.1	1.8
TARGET All-Comers (Xu, 2019) [13]	Firehawk (BP-SES)	823 CAD (ACS + ISR)	Mixed	1.7	5.7 (TV-MI)	8.7	2.6	1.7

↓ Table 5. Comparison of Outcomes From Contemporary Sirolimus-Eluting and Everolimus-Eluting Stents

Trial

Device

Population

ACS status

Cardiac death (%)

MI/TV-MI (%)

TLF (%)

TLR (%)

ST (%)

Cross-trial comparisons should be interpreted cautiously because of differences in study design, patient characteristics, ACS prevalence, endpoint definitions, and follow-up methodology. ACS: acute coronary syndrome; CAD: coronary artery disease; EES: everolimus-eluting stent; STEMI: ST-segment elevation myocardial infarction; BP-SES: biodegradable polymer sirolimus-eluting stent; TVF: target vessel failure; TLF: target-lesion failure; TLR: target lesion revascularization; MI: myocardial infarction; ISR: in-stent restenosis.

meriT-V (Abizaid, 2023) [15]

Xience (EES)

86 de novo CAD

Stable CAD

2.4

1.2

BIOSTEMI (Pilgrim, 2021) [12]

Orsiro (BP-SES)

649 STEMI

ACS (100% STEMI)

2.9

1.5 (TV-MI)

5.1

2.5

1.4

BIOSTEMI (Pilgrim, 2021) [12]

Xience (EES)

651 STEMI

ACS (100% STEMI)

3.2

2.0 (TV-MI)

8.1

5.1

1.8

TARGET All-Comers (Xu, 2019) [13]

Firehawk (BP-SES)

823 CAD (ACS + ISR)

Mixed

1.7

5.7 (TV-MI)

8.7

2.6

1.7