Table 4.

Clinical Events During the Entire Duration of Follow-Up (Median, 2.7 Years) of the Study Patients

	Stent-Only (N=185)	Balloon-Stent (N=390)	Balloon and Stent HR (95% CI)	Likelihood Ratio P Value*
Entire study
TVF	71 (38%)	127 (33%)	0.89(0.67–1.19)	0.43
Death from any cause	38 (21%)	62 (16%)	0.84 (0.56–1.26)	0.39
Cardiac or unknown cause of death (component of TVF)	31 (17%)	45 (12%)	0.74 (0.47–1.17)	0.20
Cardiac death	16 (9%)	27 (7%)	0.85 (0.46–1.57)	0.60
Noncardiac death	7 (4%)	17 (4%)	1.27 (0.53–3.06)	0.60
Unknown cause of death	15 (8%)	18 (5%)	0.63 (0.32–1.25)	0.18
Any MI during follow-up	31 (17%)	77 (20%)	1.30 (0.86–1.98)	0.21
Target vessel MI during follow-up (component of TVF)	15 (8%)	54 (14%)	1.92 (1.08–3.40)	0.0232
Non-Target vessel MI during follow-up	20 (11%)	34 (9%)	0.86 (0.50–1.50)	0.59
Any revascularization	73 (39%)	120 (31%)	0.78 (0.59–1.05)	0.10
Target vessel revascularization (component of TVF)	44 (24%)	72 (18%)	0.80 (0.55–1.17)	0.25
Target lesion revascularization	27 (15%)	54 (14%)	1.02 (0.64–1.61)	0.95
Patient-oriented composite end point	84 (45%)	155 (40%)	0.91 (0.70–1.19)	0.48
Target lesion failure	59 (32%)	115 (29%)	1.01 (0.74–1.38)	0.96
Definite stent thrombosis	1 (1%)	18 (5%)	9.20 (1.23–68.92)	0.0085
Definite or probable stent thrombosis	9 (5%)	43 (11%)	2.52 (1.23–5.18)	0.009
Stroke	4 (2%)	18 (5%)	2.37 (0.80–7.02)	0.11
TVF or SVG occlusion that did not receive intervention	73 (39%)	134 (34%)	0.91 (0.68–1.21)	0.51

TVF is a composite of cardiac death, target vessel MI, and target vessel revascularization. Patient-oriented composite end point includes all cause death, any MI, and target vessel revascularization. HR indicates hazard ratio; MI, myocardial infarction; SVG, saphenous vein graft; and TVF, target vessel failure.

^*P value is based on χ² goodness-of-fit test.