Table 3.

Clinical Events at 12-Month Follow-Up for the Study Patients

	Stent-Only (N=185)	Balloon-Stent (N=390)	Balloon and Stent HR (95% CI)	Likelihood Ratio P Value*
12 mo
TVF	27 (15%)	74 (19%)	1.34 (0.86–2.08)	0.19
Death from any cause	14 (8%)	29 (7%)	1.00 (0.53–1.89)	1.00
Cardiac or unknown cause of death (component of TVF)	10 (5%)	22 (6%)	1.06 (0.50–2.23)	0.88
Cardiac death	9 (5%)	17 (4%)	0.91 (0.41–2.04)	0.82
Noncardiac death	4 (2%)	7 (2%)	0.85 (0.25–2.91)	0.80
Unknown cause of death	1 (1%)	5 (1%)	2.40 (0.28–20.52)	0.41
Any MI during follow-up	15 (8%)	42 (11%)	1.36 (0.75–2.45)	0.31
Target vessel MI during follow-up (component of TVF)	5 (3%)	29 (7%)	2.86 (1.11–7.38)	0.0232
Non-target vessel MI during follow-up	11 (6%)	15 (4%)	0.65 (0.30–1.41)	0.27
Any revascularization	31 (17%)	71 (18%)	1.10 (0.72–1.68)	0.65
Target vessel revascularization (component of TVF)	17 (9%)	44 (11%)	1.26 (0.72–2.21)	0.41
Target lesion revascularization	12 (6%)	35 (9%)	1.44 (0.75–2.77)	0.28
Patient-oriented composite end point	37 (20%)	85 (22%)	1.11 (0.75–1.63)	0.61
Target lesion failure	22 (12%)	68 (17%)	1.53 (0.94–2.47)	0.08
Definite stent thrombosis	1 (1%)	12 (3%)	5.92 (0.77–45.50)	0.05
Definite or probable stent thrombosis	3 (2%)	26 (7%)	4.30 (1.30–14.20)	0.0091
Stroke	0 (0%)	5 (1%)	N/A	0.18*
Postprocedural bleed	0 (0%)	2 (1%)	N/A	1.00*
TVF or SVG occlusion that did not receive intervention	27 (15%)	75 (19%)	1.36 (0.88–2.11)	0.17

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. Target lesion failure is a composite of cardiac or unknown death, target vessel MI, and TLR. HR indicates hazard ratio; MI, myocardial infarcation; N/A, not any; SVG, saphenous vein graft; and TVF, target vessel failure.

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