Stent-oriented versus patient-oriented outcome in patients undergoing early percutaneous coronary intervention for acute coronary syndrome: 2-year report from the BASE-ACS trial

Figures & data

Table I. Baseline clinical, angiographic, and procedural characteristics of the two individual study groups.

Variable	BAS group, n = 417	EES group, n = 410	P value
Age (years)	63 ± 12	63 ± 12	0.93
Male gender	317 (76)	312 (76.1)	0.94
Diabetes mellitus	65 (15.6)	75 (18.3)	0.31
Insulin-treated	19 (4.6)	17 (4.1)	0.87
Current smoking	144 (34.5)	134 (32.7)	0.61
Hyperlipidemia	191 (45.8)	197 (48)	0.53
Hypertension	201 (48.2)	212 (51.7)	0.33
Prior MI	56 (13.4)	40 (9.8)	0.10
Prior PCI	40 (9.6)	43 (10.5)	0.73
Prior CABG	20 (4.8)	17 (4.1)	0.74
Lesion type
A	44 (10.6)	52 (12.7)	0.39
B	297 (71.2)	303 (73.9)	0.39
C	76 (18.2)	55 (13.4)	0.07
Thrombus	193 (46.3)	171 (41.7)	0.21
Calcified lesions	183 (43.9)	169 (41.2)	0.44
Bifurcation lesions	81 (19.4)	96 (23.4)	0.18
Reference vessel diameter (mm)	3.13 ± 0.43	3.14 ± 0.43	0.65
Lesion length (mm)	14.4 ± 5.4	14.3 ± 6.5	0.73
Stent diameter (mm)	3.15 ± 0.44	3.15 ± 0.45	0.97
Stent length (mm)	18.0 ± 5.2	18.5 ± 5.6	0.18
Stents per culprit lesion	1.15 ± 0.38	1.14 ± 0.36	0.64
Total stent length per lesion (mm)	20.8 ± 9.4	20.6 ± 8.2	0.70
Direct stenting	134 (32.1)	126 (30.7)	0.71
Thrombus aspiration	82 (19.7)	72 (17.6)	0.48
Post-dilatation	176 (42.2)	180 (43.9)	0.67
Stent failure	0 (0.0)	4 (1.0)	0.03
Procedural success	416 (99.8)	409 (99.8)	0.99
Unfractionated heparin	105 (25.2)	110 (26.8)	0.63
Low-molecular-weight heparin	248 (59.5)	235 (57.3)	0.57
GP IIb/IIIa inhibitor	123 (29.5)	119 (29.0)	0.94
Bivalirudin	59 (14.1)	62 (15.1)	0.70

Continuous variables are presented as mean ± SD, while categorical variables are presented as frequency (percentage).

BAS = bioactive stent; CABG = coronary artery bypass grafting; EES = everolimus-eluting stent; GP = glycoprotein; MI = myocardial infarction; PCI = percutaneous coronary revascularization.

Figure 1. Kaplan–Meier estimates for the primary end-point, stent-oriented and patient-oriented outcomes, in the two study groups, over 24 months of follow-up. Kaplan–Meier curves show the cumulative incidence of major adverse cardiac events (the primary end-point), a composite of cardiac death, non-fatal MI, or ischemia-driven TLR (A); stent-oriented outcome, a composite of cardiac death, target vessel-related non-fatal MI, or ischemia-driven TLR (B); patient-oriented outcome, all-cause death, any non-fatal MI, or any revascularization (C). BAS = bioactive stents; EES = everolimus-eluting stents; MI = myocardial infarction; TLR = target lesion revascularization.

Table II. Clinical events in the two individual study groups at 24-month follow-up.

	BAS group, n = 417	EES group, n = 410	HR (95% CI)	P value
MACE	47 (11.3)	52 (12.7)	0.94 (0.77–1.15)	0.53
Stent-oriented outcome	42 (10.1)	46 (11.2)	0.94 (0.76–1.17)	0.53
Patient-oriented outcome	68 (16.3)	81 (19.8)	0.89 (0.76–1.05)	0.20
Cardiac death	9 (2.2)	7 (1.7)	1.14 (0.65–1.99)	0.64
Device-related cardiac death	8 (1.9)	3 (0.7)	1.83 (0.70–4.81)	0.22
All-cause death	23 (5.5)	13 (3.2)	1.39 (0.90–2.16)	0.13
Non-fatal MI	12 (2.9)	29 (7.1)	0.69 (0.56–0.85)	0.005
Device-related MI	5 (1.2)	21 (5.1)	0.60 (0.49–0.74)	0.001
Cardiac death or non-fatal MI	20 (4.8)	33 (8.0)	0.78 (0.63–0.98)	0.056
Ischemia-driven TLR	31 (7.4)	29 (7.1)	1.03 (0.78–1.35)	0.84
Non-TL TVR	2 (0.5)	8 (2.0)	0.62 (0.45–0.85)	0.062
Non-TVR	8 (1.9)	15 (3.7)	0.75 (0.55–1.02)	0.13

Variables are presented as frequency (percentage).

Stent-oriented outcome was defined as a composite of cardiac death, target vessel-related non-fatal MI, or ischemia-driven TLR. Patient-oriented outcome was defined as a composite of all-cause death, any non-fatal MI, or any revascularization.

BAS = bioactive stent; CI = confidence interval; EES = everolimus-eluting stent; HR = hazard ratio; MACE = major adverse cardiac events; MI = myocardial infarction; TLR = target lesion revascularization; TVR = target vessel revascularization.

Table III. Stent thrombosis in the two individual study groups according to ARC definition at 24-month follow-up.

	BAS group, n = 417	EES group, n = 410	P value
Definite stent thrombosis
Early (< 30 days)	3 (0.7)	7 (1.7)	0.19
Late (30–360 days)	0 (0)	2 (0.5)	0.15
Very late (> 360 days)	1 (0.2)	2 (0.5)	0.55
All definite stent thrombosis	4 (1.0)	11 (2.7)	0.05
Definite/probable stent thrombosis
Early (< 30 days)	5 (1.2)	8 (2.0)	0.39
Late (30–360 days)	0 (0)	3 (0.7)	0.08
Very late (> 360 days)	2 (0.4)	4 (1.0)	0.40
All definite/probable stent thrombosis	7 (1.6)	15 (3.7)	0.07

Variables are presented as frequency (percentage).

ARC = Academic Research Consortium; BAS = bioactive stent; EES = everolimus-eluting stent.