Long-term safety of drug-eluting stents in patients on warfarin treatment

Figures & data

Table I. Base-line clinical and procedural characteristics of the DES and BMS study groups and their propensity score matched pairs.

	Overall population			Propensity score matched pairs
	DES group (191 patients)	BMS group (224 patients)	P value	DES group (101 patients)	BMS group (101 patients)	P value
Age, years	68.4 ± 7.8	70.0 ± 9.3	0.02	69.1 ± 7.5	71.3 ± 9.1	0.03
Female, n (%)	51 (26.7)	53 (23.7)	0.48	24 (23.8)	24 (23.8)	1.00
Risk factors, n (%)
Family history of CAD	67 (35.1)	60 (26.8)	0.07	27 (26.7)	29 (28.7)	0.75
Diabetes	63 (33.0)	56 (25.0)	0.07	31 (30.7)	33 (32.7)	0.76
Hypertension	123 (64.4)	143 (63.8)	0.91	57 (56.4)	61 (60.4)	0.57
Hypercholesterolaemia	140 (73.3)	151 (67.4)	0.19	70 (69.3)	70 (69.3)	1.00
History of smoking	50 (26.2)	60 (26.8)	0.89	20 (19.8)	25 (24.8)	0.40
Medical history, n (%)
Heart failure	39 (20.4)	47 (21.0)	0.89	22 (21.8)	16 (15.8)	0.28
Myocardial infarction	58 (30.4)	91 (40.6)	0.03	38 (37.6)	34 (33.7)	0.56
PCI	29 (15.2)	29 (12.9)	0.51	17 (16.8)	15 (14.9)	0.70
CABG	43 (22.5)	39 (17.4)	0.19	26 (25.7)	18 (17.8)	0.17
Stroke	46 (24.1)	46 (20.5)	0.39	23 (22.8)	20 (19.8)	0.61
Peripheral vascular disease	20 (10.5)	24 (10.7)	0.94	11 (10.9)	9 (8.9)	0.64
Renal disease	11 (5.8)	11 (4.9)	0.70	4 (4.0)	6 (5.9)	0.52
Medication, n (%)
Thrombolysis	2 (1.0)	7 (3.1)	0.19	2 (2.0)	2 (2.0)	1.00
GP IIb/IIIa inhibitors	56 (29.3)	65 (29.0)	0.95	30 (29.7)	32 (31.7)	0.76
Indication for PCI, n (%)
Acute coronary syndrome	83 (43.5)	122 (54.5)	0.03	49 (48.5)	48 (47.5)	0.89
Non-ST-elevation myocardial infarction	41 (21.5)	63 (28.1)	0.12	21 (20.8)	28 (27.7)	0.25
ST-elevation myocardial infarction	14 (7.3)	25 (11.2)	0.18	9 (8.9)	8 (7.9)	0.80
Unstable angina	28 (14.7)	34 (15.2)	0.88	19 (18.8)	12 (11.9)	0.17
Left ventricular ejection fraction, %	51 ± 14	49 ± 13	0.13	52 ± 13	50 ± 12	0.32
Stent diameter, mm	3.1 ± 0.4	3.2 ± 0.5	0.047	3.1 ± 0.4	3.2 ± 0.5	0.46
Stent length, mm	27 ± 14	19 ± 10	<0.0001	22 ± 9	21 ± 10	0.11
No. of stents per patient	1.4 ± 0.6	1.3 ± 0.6	0.08	1.3 ± 0.6	1.2 ± 0.5	0.33
Out-patient bleeding risk index	1.3 ± 0.9	1.3 ± 0.8	0.42	1.2 ± 0.8	1.3 ± 0.7	0.16
CHADS2 score	1.6 ± 1.1	1.8 ± 1.2	0.26	1.6 ± 1.1	1.8 ± 1.1	0.22
Femoral access, n (%)	151 (79.1)	167 (74.6)	0.28	81 (80.2)	71 (70.3)	0.10

Continuous data are presented as mean ± standard deviation unless otherwise indicated.

CAD = coronary artery disease; PCI = percutaneous coronary intervention; CABG = coronary artery bypass grafting; GP = glycoprotein.

Table II. Antithrombotic medication at discharge and duration of major treatment options.

	DES (n = 191)	BMS (n = 224)	P value
Aspirin + clopidogrel	36 (18.8%)	30 (13.4%)	0.14
Triple therapy^a	119 (62.3%)	129 (57.6%)	0.37
Warfarin + aspirin	12 (6.3%)	28 (12.5%)	0.04
Warfarin + clopidogrel	23 (12.0%)	37 (16.5%)	0.21
Warfarin monotherapy	1 (0.5%)	0	NS
Duration on triple therapy, months	4.2 ± 3.1	2.1 ± 1.8	< 0.0001
Duration of clopidogrel therapy, months	6.6 ± 6.8	4.6 ± 7.6	0.01
Duration of warfarin + aspirin combination, months	17.3 ± 19.4	11.6 ± 16.7	0.37

^aTriple therapy with warfarin, aspirin, and clopidogrel.

DES = drug-eluting stent; BMS = bare-metal stent.

Data are presented as mean ± SD unless otherwise indicated.

Table III. Outcome events in the overall series and in propensity-matched pairs according to the stent type.

	Overall population			Propensity score matched pairs
	DES group (191 patients)	BMS group (224 patients)	P value	DES group (101 patients)	BMS group (101 patients)	P value
MACCE, n (%)	76 (39.8)	95 (42.4)	0.59	40 (39.6)	43 (42.6)	0.67
Myocardial infarction	34 (17.8)	33 (14.7)	0.40	17 (16.8)	9 (8.9)	0.93
All-cause death	35 (18.3)	53 (23.7)	0.19	16 (15.8)	24 (23.8)	0.16
TVR	20 (10.5)	21 (9.4)	0.71	11 (10.9)	10 (9.9)	0.82
Redo PCI	40 (20.9)	37 (16.5)	0.25	26 (25.7)	15 (14.9)	0.05
CABG	6 (3.1)	11 (4.9)	0.37	4 (4.0)	6 (5.9)	0.52
Stroke/TIA	17 (8.9)	19 (8.5)	0.88	6 (5.9)	10 (9.9)	0.30
Stent thrombosis, n (%)	6 (3.1)	7 (3.1)	0.99	5 (5.0)	2 (2.0)	0.45
Cardiac death, n (%)	15 (7.9)	29 (12.9)	0.09	9 (8.9)	15 (14.9)	0.19
Major bleeding, n (%)	28 (14.7)	29 (12.9)	0.61	18 (17.8)	13 (12.9)	0.33

MACCE = major adverse cardiac and cerebrovascular events; TIA = transient ischaemic attack; TVR = target vessel revascularization; PCI = percutaneous coronary intervention; CABG = coronary artery bypass grafting.

Table IV. Antithrombotic therapy during stent thrombosis.

Timing	Days after stenting	Stent	Antithrombotic therapy	INR	Level of evidence (20)	Days after clopidogrel discontinuation
Acute
1.	0	BMS	Triple therapy^a	1.8	definite
2.	0	DES	Warfarin	2.8	probable
Subacute
3.	2	BMS	Warfarin+aspirin	1.9	definite
4.	3	DES	Warfarin+aspirin	1.6	probable
5.	4	BMS	Warfarin+aspirin	2.2	definite
6.	5	BMS	Triple therapy	NA	definite
7.	5	BMS	Warfarin+aspirin	NA	definite
8.	5	BMS	Warfarin+aspirin	2.0	definite
9.	10	BMS	Triple therapy	4.9	definite
10.	17	DES	Triple therapy	1.7	definite
Late
11.	105	DES	Warfarin+clopidogrel	1.9	definite
Very late
12.	451	DES	Warfarin	1.6	definite	271
13.	1325	DES	Warfarin+aspirin	2.7	definite	1325

^a Triple therapy with warfarin, aspirin, and clopidogrel.

DES = drug-eluting stent; BMS = bare-metal stent; NA = not available.

Figure 1. Kaplan–Meier estimates of freedom from MACCE according to the stent type in patients on OAC.

Figure 2. Kaplan–Meier estimates of freedom from major bleeding according to the stent type in patients on OAC.

Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, . Clinical end points in coronary stent trials. A case for standardized definitions. Circulation. 2007;115: 2344–51.

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