Two-year follow-up after percutaneous coronary intervention with titanium-nitride-oxide-coated stents versus paclitaxel-eluting stents in acute myocardial infarction

Figures & data

Table

ARC	Academic Research Consortium
BMS	bare-metal stent
CI	confidence interval
DES	drug-eluting stent
HR	hazard ratio
MACE	major adverse cardiac events
MI	myocardial infarction
NSTEMI	non-ST-elevation myocardial infarction
PCI	percutaneous coronary intervention
PES	paclitaxel-eluting stent
ST	stent thrombosis
STEMI	ST-elevation myocardial infarction
TIMI	thrombolysis in myocardial infarction
TITANOX	titanium-nitride-oxide
TLR	target lesion revascularization

Table I.  Baseline clinical characteristics in TITANOX group versus PES group.

	TITANOX (n=214)	PES (n=211)	P
Age, y (SD)	64±11	64±11	0.72
Male sex, n (%)	162 (76)	157 (74)	0.82
Risk Factors, n (%)
Family history of CAD	103 (48)	95 (45)	0.56
Diabetes	48 (22)	33 (16)	0.08
Hypertension	122 (57)	106 (50)	0.17
Hypercholesterolaemia	141 (66)	151 (72)	0.21
History of smoking	113 (53)	97 (46)	0.18
Medical History, n (%)
Myocardial infarction	33 (15)	20 (9)	0.08
PCI	22 (10)	10 (5)	0.04
CABG	16 (7)	13 (6)	0.70
Medication, n (%)
Clopidogrel before PCI	44 (21)	39 (18)	0.63
Thrombolysis	26 (12)	40 (19)	0.06
GP IIb/IIIa inhibitors	116 (54)	96 (45)	0.08
Indication for PCI, n (%)
NSTEMI	131 (61)	114 (54)	0.14
STEMI	83 (39)	97 (46)	0.14

CAD = coronary artery disease; CABG = coronary artery by-pass grafting; GP = glycoprotein. Other abbreviations are explained in the List of Abbreviations.

Table II.  Baseline angiographic variables and procedural characteristics.

	TITANOX (n=214)	PES (n=211)	P
Lesion characteristics
Left anterior descending artery, n (%)	98 (46)	91 (43)	0.63
Bifurcated lesion, n (%)	53 (25)	50 (24)	0.82
Reference diameter, (mm, SD)	3.16±0.45	3.11±0.50	0.35
Lesion length, (mm, SD)	13.6±5.6	13.2±6.4	0.47
TIMI flow grade, n (%)
0	46 (21)	45 (21)	1.0
1	10 (5)	14 (7)	0.41
2	61 (29)	38 (18)	0.01
3	97 (45)	114 (54)	0.08
Procedural characteristics
Direct stenting, n (%)	26 (12)	32 (15)	0.48
Post-dilatation, n (%)	89 (42)	73 (35)	0.16
Nominal stent size (mm, SD)	3.16±0.42	3.11±0.45	0.19
Stent length (mm, SD)	17.4±4.5	17.7±5.3	0.48
Total stent length (mm, SD)	18.5±6.4	19.2±7.2	0.26
No. of stents implanted per culprit lesion (SD)	1.1±0.3	1.1±0.4	0.24
Final TIMI flow grade 3, n (%)	211 (98.6)	204 (96.7)	0.22
Multivessel PCI, n (%)	30 (14)	19 (9)	0.13
Maximum creatine kinase MB (µg/litre)^a	63.8±100.8	70.9±117.0	0.53
Maximum troponin I (µg/litre)^b	34.7±76.6	26.5±59.2	0.31
Maximum troponin T (µg/litre)^c	5.1±22.4	2.6±3.8	0.39

^aAvailable in 145 patients in TITANOX group and in 141 patients in PES group.

^bAvailable in 140 patients in TITANOX group and in 145 patients in PES group.

^cAvailable in 72 patients in TITANOX group and in 61 patients in PES group.

Abbreviations are explained in the List of Abbreviations.

Figure 1.  Antiplatelet utilization at the time of the outcome event of definite stent thrombosis (ST). A: Antiplatelet therapy in 14 patients suffering definite ST. B: Time of the event and the utilization of clopidogrel during the definite ST. ^aDual antiplatelet therapy with aspirin and clopidogrel. Dark colour indicates the duration of clopidogrel withdrawal.

Table III.  Clinical events during 2 years of follow-up.

	TITANOX (n=214)	PES (n=211)	HR	95% CI	P
MI, n (%)
Patient with any event	11 (5.1)	33 (15.6)	3.4	1.7–7.0	<0.001
0 to 12 months after index PCI	9 (4.2)	17 (8.1)	2.0	0.9–4.6	0.11
12 to 24 months after index PCI	2 (0.9)	16 (7.6)	8.7	2.0–38.3	0.001
Cardiac death, n (%)
Patient with any event	2 (0.9)	10 (4.7)	5.3	1.1–24.4	0.02
0 to 12 months after index PCI	1 (0.5)	4 (1.9)	4.1	0.5–37.1	0.21
12 to 24 months after index PCI	1 (0.5)	6 (2.8)	6.2	0.7–52.2	0.07
TLR, n (%)
Patient with any event	20 (9.3)	21 (10.0)	1.1	0.6–2.0	0.87
0 to 12 months after index PCI	20 (9.3)	15 (7.1)	0.7	0.4–1.5	0.48
12 to 24 months after index PCI	0 (0)	6 (2.8)			0.01
MACE, n (%)
Patient with any event	24 (11.2)	46 (21.8)	2.2	1.3–3.8	0.004
0 to 12 months after index PCI	22 (10.3)	27 (12.8)	1.3	0.7–2.3	0.45
12 to 24 months after index PCI	2 (0.9)	19 (9.0)	10.5	2.4–45.6	< 0.001
ST, n (%)^a
Patient with any event	1 (0.5)	13 (6.2)	14.0	1.8–107.9	0.001
0 to 12 months after index PCI	1 (0.5)	7 (3.3)	7.3	0.9–59.9	0.04
12 to 24 months after index PCI	0 (0)	6 (2.8)			0.01
ST according to ARC, n (%)^b
Patient with any event	2 (0.9)	18 (8.5)	9.9	2.3–43.2	< 0.001
0 to 12 months after index PCI	2 (0.9)	9 (4.3)	4.7	1.0–22.1	0.03
12 to 24 months after index PCI	0 (0)	9 (4.3)			0.002
MI or cardiac death, n (%)	11 (5.1)	40 (19.0)	4.3	2.1–8.7	< 0.001
All-cause death, n (%)
Patient with any event	10 (4.7)	15 (7.1)	1.6	0.7–3.6	0.31
0 to 12 months after index PCI	5 (2.3)	6 (2.8)	1.2	0.4–4.1	0.77
12 to 24 months after index PCI	5 (2.3)	9 (4.3)	1.9	0.6–5.7	0.29

^aPer protocol stent thrombosis.

^bStent thrombosis defined according to Academic Research Consortium (ARC) classification.

HR = hazard ratio; CI = confidence interval. Other abbreviations are explained in the List of Abbreviations.

Table IV.  Independent predictors of clinical outcomes.

Variable	HR	95% CI	P
Myocardial infarction^a
Previous CABG	9.18	3.12–27.00	<0.001
PES	3.96	1.87–8.40	<0.001
Culprit lesion in LAD	3.03	1.40–6.55	0.005
Cardiac death^b
PES	5.93	1.26–28.02	0.02
Previous CABG	5.06	1.23–20.86	0.03
MACE^c
PES	2.51	1.42–4.43	0.002
Hypercholesterolaemia	0.45	0.25–0.79	0.005
Reference vessel diameter	0.40	0.16–0.98	0.046
Lesion in bifurcation	1.81	1.00–3.28	0.049
Definite ST^d
Culprit lesion in LAD	6.30	1.66–23.96	0.007
PES	14.54	1.85–114.44	0.01
Nominal stent diameter	0.02	0.001–0.53	0.02

^aAdditional variables entered in the multivariable model but not found to be significant were: nominal stent diameter, lesion in bifurcation, and reference vessel diameter.

^bAdditional variable entered in the multivariable model but not found to be significant was: age.

^cAdditional variables entered in the multivariable model but not found to be significant were: nominal stent diameter, culprit lesion in LAD, and female gender.

^dAdditional variables entered in the multivariable model but not found to be significant was: reference vessel diameter.

HR = hazard ratio; CABG = coronary artery by-pass grafting; CI = confidence interval; LAD = left anterior descending artery. Other abbreviations are explained in the List of Abbreviations.