Duration of dual antiplatelet treatment in the era of next generation drug-eluting stents

Table 1 Clinical outcomes at 12 mo and 24 mo¹

Clinical outcomes	At 12 mo		At 24 mo		HR (95%CI)2	P
	Clopidogrel + aspirin	Aspirin alone	Clopidogrel + aspirin	Aspirin alone	Clopidogrel + aspirin	Aspirin alone
Primary end point: MI or death from cardiac causes	0.7	0.5	1.8	1.2	1.65 (0.80-3.36)	0.17
Secondary end points
Death from any cause	0.5	0.5	1.6	1.4	1.52 (0.75-3.50)	0.24
MI	0.4	0.3	0.8	0.7	1.41 (0.54-3.71)	0.49
Stroke	0.3	0.3	1.0	0.3	2.22 (0.68-7.20)	0.19
Stent thrombosis, definite	0.2	0.1	0.4	0.4	1.23 (0.33-4.58)	0.76
Repeat revascularization	1.7	1.1	3.1	2.4	1.37 (0.83-2.27)	0.22
MI or death from any cause	0.8	0.8	2.3	1.7	1.57 (0.85-2.88)	0.15
MI, stroke, or death from any cause	1.1	1.1	3.2	1.8	1.73 (0.99-3.00)	0.05
MI, stroke, or death from cardiac causes	1.0	0.8	2.7	1.3	1.84 (0.99-3.45)	0.06
Major bleeding, according to TIMI criteria	0.2	0.1	0.2	0.1	2.96 (0.31-28.46)	0.35

¹For the total number of events for each type of end point, only the first event is counted. Cumulative rates of events are based on Kaplan-Meier estimates. All deaths were considered to be from cardiac causes unless an unequivocal noncardiac cause could be established;

²Hazard ratios are for the dual-therapy group as compared with the aspirin-alone group. MI: Myocardial infarction; TIMI: Thrombolysis in myocardial infarction. (Modified from Ref. [7]).

Table 2 Clinical outcomes of EXCELLENT trial n (%)

Clinical outcomes	6-mo DAPT	12-mo DAPT	HR1	P
	(n = 722)	(n = 721)	(95%CI)
Target vessel failure2	34 (4.8)	30 (4.3)	1.14 (0.70-1.86)	0.60
Total death	4 (0.6)	7 (1.0)	0.57 (0.17-1.95)	0.37
Cardiac death	2 (0.3)	3 (0.4)	0.67 (0.11-3.99)	0.66
Myocardial infarction	13 (1.8)	7 (1.0)	1.86 (0.74-4.67)	0.19
Death/myocardial infarction	17 (2.4)	14 (1.9)	1.21 (0.60-2.47)	0.58
Target vessel myocardial infarction	12 (1.7)	6 (0.8)	2.00 (0.75-5.34)	0.16
Cerebrovascular accident	3 (0.4)	5 (0.7)	0.60 (0.14-2.51)	0.48
Target lesion revascularization	17 (2.4)	18 (2.6)	0.94 (0.49-1.83)	0.86
Target vessel revascularization	22 (3.1)	22 (3.2)	1.00 (0.56-1.81)	0.99
Any revascularization	43 (6.2)	43 (6.2)	1.00 (0.66-1.53)	0.99
Stent thrombosis	6 (0.9)	1 (0.1)	6.02 (0.72-49.96)	0.10
Any bleeding	4 (0.6)	10 (1.4)	0.40 (0.13-1.27)	0.12
TIMI major bleeding	2 (0.3)	4 (0.6)	0.50 (0.09-2.73)	0.42
MACCE3	56 (8.0)	60 (8.5)	0.94 (0.65-1.35)	0.72
Safety end point4	24 (3.3)	21 (3.0)	1.15 (0.64-2.06)	0.64

The percentages shown are Kaplan-Meier estimates from the intention-to-treat analysis.

¹HRs are for the 6 mo vs 12 mo DAPT group;

²Target vessel failure was a composite of cardiac death, myocardial infarction or target vessel revascularization;

³MACCE was a composite of death, myocardial infarction, stroke or any revascularization;

⁴Safety end point was a composite of death, myocardial infarction, stroke, stent thrombosis or TIMI major bleeding. (Modified from Ref. [12]). DAPT: Dual antiplatelet therapy; TIMI: Thrombolysis in myocardial infarction; MACCE: Major cardiocerebral event.

Table 3 Two year clinical outcomes of TWENTE trial n (%)

	Resolute ZES	Xience V EES	Difference	P
	(n = 695)	(n = 692)	(95%CI)
Target vessel failure	75 (10.8)	80 (11.6)	-0.8 (-4.1 to 2.6)	0.65
Death
Any cause	29 (4.2)	33 (4.8)	-0.6 (-2.8 to 1.6)	0.59
Cardiac cause	11 (1.6)	19 (2.7)	-1.2 (-2.7 to 0.4)	0.14
Target vessel–related myocardial infarction
Any	37 (5.3)	39 (5.6)	-0.3 (-2.7 to 2.1)	0.80
Q-wave	8 (1.2)	9 (1.3)	-0.2 (-1.3 to 1.0)	0.80
Non–Q-wave	29 (4.2)	30 (4.3)	-0.2 (-2.3 to 2.0)	0.88
Clinically indicated target vessel revascularization
Any	39 (5.6)	35 (5.1)	0.6 (−1.8 to 2.9)	0.65
Target lesion failure	73 (10.5)	68 (9.8)	0.7 (−2.5 to 3.9)	0.68
Clinically indicated target lesion revascularization
Any	34 (4.9)	18 (2.6)	2.3 (0.3 to 4.3)	0.03
Death from cardiac causes or target vessel myocardial infarction	46 (6.6)	53 (7.7)	-1.0 (-3.8 to 1.7)	0.45
Major adverse cardiac events1	90 (12.9)	82 (11.8)	1.1 (-2.4 to 4.6)	0.53
Patient-oriented composite endpoint2	114 (16.4)	118 (17.1)	-0.7 (-4.6 to 3.3)	0.75
Stent thrombosis
Definite (0-720 d)	6 (0.9)	1 (0.1)	0.7 (-0.0 to 1.5)	0.12
Definite or probable (0-720 d)	8 (1.2)	10 (1.4)	-0.3 (-1.5 to 0.9)	0.63
Definite, probable, or possible (0-720 d)	14 (2.0)	20 (2.9)	-0.9 (-2.5 to 0.8)	0.29
Very late definite or probable (361-720 d)	2 (0.3)	2 (0.3)	0 (-0.6 to 0.6)	1.00

Values are n (%).

¹Major adverse cardiac events is a composite of all-cause death, any myocardial infarction, emergent coronary artery bypass surgery and clinically indicated target lesion revascularization;

²Patient-oriented composite endpoint is a composite endpoint of all-cause death, any myocardial infarction and any revascularization. (Modified from Ref. [17]). ZES: Zotarolimus-eluting stent; EES: Everolimus-eluting stent.