APPENDIX D.

CONTINUOUS TRIAL OUTCOMES FOR PATIENTS WITH PROXIMAL DVT: PCDT (INITIAL ANGIOJET ONLY) VERSUS CONTROL

Outcome	Control* (n = 191)		PCDT (Initial AngioJet only) (n = 75)		PCDT: control difference
	n	Mean (SE)	n	Mean (SE)	Mean difference (SE)	P value
Villalta scale score
At 6 mo	150	4.02 (0.32)	72	3.54 (0.50)	−0.49 (0.56)	.38
At 12 mo	135	4.07 (0.30)	63	3.44 (0.48)	−0.63 (0.53)	.24
At 18 mo	117	4.11 (0.34)	56	3.35 (0.54)	−0.76 (0.60)	.20
At 24 mo	123	4.16 (0.41)	48	3.25 (0.65)	−0.9 (0.75)	.23
VCSS score
At 6 mo	146	2.58 (0.25)	62	2.12 (0.38)	0.46 (0.44)	.29
At 12 mo	132	2.44 (0.26)	52	2.25 (0.41)	0.19 (0.47)	.69
At 18 mo	115	2.76 (0.28)	45	2.19 (0.44)	0.58 (0.50)	.25
At 24 mo	112	2.58 (0.28)	43	2.70 (0.45)	−0.12 (0.51)	.82
VEINES-QOL
At 1 mo	168	10.44 (1.87)	73	17.70 (2.71)	7.26 (3.14)	.02
At 6 mo	150	23.02 (1.96)	63	25.23 (2.82)	2.21 (3.23)	.50
At 12 mo	133	27.29 (1.99)	55	27.70 (2.85)	0.41 (3.23)	.90
At 18 mo	117	26.73 (1.98)	48	29.12 (2.79)	2.39 (3.12)	.44
At 24 mo	121	26.17 (2.17)	47	30.53 (3.11)	4.36 (3.47)	.21
VEINES symptoms
At 1 mo	168	10.85 (1.92)	73	18.50 (2.73)	7.65 (3.11)	.01
At 6 mo	150	19.66 (1.89)	63	21.50 (2.69)	1.84 (3.04)	.55
At 12 mo	133	20.19 (1.85)	55	22.34 (2.60)	2.15 (2.91)	.46
At 18 mo	117	20.72 (1.96)	48	23.18 (2.79)	2.46 (3.12)	.43
At 24 mo	121	21.24 (2.21)	47	24.02 (3.20)	2.78 (3.61)	.44

DVT = deep vein thrombosis; PCDT= pharmacomechanical catheter-directed venous thrombolysis; QOL = quality of life; SE = standard error; VCSS = venous clinical severity scale; VEINES = Venous Insufficiency Epidemiologic and Economic Study; VEINES-QOL = Venous Insufficiency Epidemiologic and Economic Study-Quality of Life.

^*Treatment groups are per-protocol patients.