Medium-to-long term outcomes of bioresorbable scaffold treatment in patients with acute coronary syndrome

Table 1 General data on the included patients, n (%)

Characteristic	Overall (n = 128)	Observation group (n = 55)	Control group (n = 73)	P value
Age (year), mean ± SD	63 ± 10	62 ± 11	64 ± 6	0.42
Male	95 (74)	40 (73)	67 (92)	0.09
Type of lesion				0.71
Non-STEMI	95 (74)	40 (73)	55 (76)
STEMI	33 (26)	15 (27)	18 (24)
Heart rate (bpm), mean ± SD	72 ± 16	71 ± 16	72 ± 17	0.01
Systolic pressure (mmHg), mean ± SD	114 ± 21	114 ± 20	119 ± 22	0.27
Diastolic pressure (mmHg), mean ± SD	73 ± 16	71 ± 9	76 ± 7	0.14
Left ventricular ejection fraction (%), mean ± SD	47 ± 10	47 ± 10	47 ± 11	0.47
Creatinine (mmol/L), mean ± SD	72 ± 22	72 ± 24	79 ± 10	0.21
Pulmonary arterial hypertension	15 (12)	6 (11)	9 (12)	0.62
Diabetes mellitus	22 (17)	9 (16)	13 (18)	0.76
Dyslipidemia	42 (33)	17 (31)	25 (34)	0.22
Smoking	42 (33)	24 (44)	18 (25)	0.62
Family history of coronary artery disease	44 (34)	19 (35)	25 (34)	0.42
Antithrombotics
Aspirin	92 (72)	34 (62)	58 (79)	-
Clopidogrel	46 (36)	20 (36)	26 (36)	1.00
Direct oral anticoagulant	6 (5)	2 (4)	4 (5)	0.42

STEMI: ST-segment elevation myocardial infarction.

Table 2 General information on the lesions, n (%)

Characteristic	Number of lesions (n = 201)	BRS treatment (n = 87)	DES treatment (n = 114)	P value
Treated blood vessels				0.80
Left anterior descending artery	103 (51)	43 (49)	49 (43)
Left circumflex artery	46 (23)	19 (22)	33 (29)
Right coronary artery	52 (26)	25 (19)	32 (28)
Type of lesion				0.96
A	52 (26)	20 (23)	32 (28)
B1	70 (35)	32 (37)	38 (33)
B2	79 (39)	35 (40)	44 (39)
Initial TIMI flow				0.28
0	53 (26)	27 (31)	26 (23)
1	14 (7)	6 (7)	8 (7)
2	15 (8)	7 (8)	8 (7)
3	119 (59)	47 (54)	72 (63)
Final TIMI flow
2	5 (2)	3 (3)	2 (2)	-
3	196 (98)	84 (97)	112 (98)	-
Number of stents per lesion (bpm), mean ± SD	1.2 ± 0.4	1.72 ± 0.38	1.21 ± 0.41	0.34
Predilation	201 (100)	87 (100)	114 (100)	-
Average stent diameter (mm), mean ± SD	3.25 ± 0.25	3.3 ± 0.25	3.3 ± 0.21	0.32
Average stent length (mm), mean ± SD	21.1 ± 2.3	22.6 ± 3.3	21.7 ± 2.5	0.13

BRS: Bioresorbable scaffolds; DES: Drug-eluting stents; TIMI: Thrombolysis in myocardial infarction.

Table 3 Clinical follow-up outcome, n (%)

Clinical outcome	6 months			1 year			2 years			3 years
	Observation group	Control group	P value	Observation group	Control group	P value	Observation group	Control group	P value	Observation group	Control group	P value
Follow-up patients	52 (95)	69 (95)	0.65	48 (87)	63 (86)	0.73	43 (78)	60 (82)	0.14	32 (37)	46 (40)	0.34
Main end point
DoCE	2 (4)	3 (4)	0.19	7 (15)	6 (10)	0.03a	9 (31)	11 (13)	0.08	5 (16)	7 (15)	0.22
CD	0 (0)	0 (0)	-	0 (0)	0 (0)	-	1 (2)	1 (2)	0.52	1 (3)	2 (4)	0.18
ScT	1 (2)	2 (3)	0.84	2 (4)	2 (3)	0.53	2 (7)	3 (5)	0.14	3 (9)	5 (11)	0.34
TV-MI	1 (2)	1 (1)	0.75	2 (4)	2 (3)	0.07	2 (5)	3 (5)	0.12	2 (6)	4 (8)	0.07
TLR	0 (0)	0 (0)	-	3 (6)	3 (5)	0.35	4 (9)	4 (7)	0.06	3 (9)	5 (11)	0.53
Secondary end point
TVR	0 (0)	0 (0)	-	0 (0)	0 (0)	-	1 (2)	2 (5)	0.01a	2 (6)	2 (4)	0.33
CBG	0 (0)	0 (0)	-	0 (0)	0 (0)	-	0 (0)	0 (0)	-	1 (3)	0 (0)	0.85
Non-cardiogenic death	0 (0)	2 (3)	0.65	0 (0)	1 (2)	0.11	2(5)	1 (2)	0.73	1 (3)	2 (4)	0.49

^aP < 0.05.

CD: Cardiac death; CBG: Coronary bypass grafting; DoCE: Device-oriented composite endpoint; ScT: Scaffold thrombosis; TV-MI: Target-vessel myocardial infarction; TLR: Target-lesion revascularization; TVR: Target-vessel revascularization.

Table 4 Comparison of serum inflammatory levels before and after treatment in the two groups of patients, mean ± SD

Group		IL-6 (μg/L)	CRP (pg/mL)	TNF-α (ng/L)	MMP-9 (ng/L)
Observation group	PCI postoperative	8.4 ± 1.7	78.9 ± 17.0	129.2 ± 20.1	16.9 ± 1.1
	Review after 1 month	6.0 ± 1.0	41.7 ± 6.4	112.9 ± 14.0	14.9 ± 1.1
t (P value)		11.2 (0.21)	19.2 (0.01a)	9.4 (0.07)	17.0 (0.08)
Control group	PCI postoperative	8.4 ± 1.4	76.1 ± 18.9	124.1 ± 14.7	16.3 ± 1.8
	Review after 1 month	4.7 ± 2.4	23.0 ± 7.9	83.7 ± 10.8	12.3 ± 0.7
t (P value)		22.0 (0.01a)	24.3 (< 0.01a)	24.0 (0.01a)	20.2 (0.12)

^aP ≤ 0.01.

IL-6: Interleukin-6; CRP: C-reactive protein; TNF-α: Tumor necrosis factor-alpha; MMP-9: Matrix Metalloproteinase-9; PCI: Percutaneous coronary intervention.