Table 2.
Primary and secondary outcome results. All regression analyses adjusted for stratification variables. Abbreviations: CrI–credible interval, CI–confidence interval.
Control rt-PA-alone N=29 |
Low-Dose Argatroban + rt-PA N=30 |
High-Dose Argatroban + rt-PA N=31 |
Low + High-Dose Argatroban + rt-PA N=61 |
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---|---|---|---|---|
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PRIMARY OUTCOME | ||||
mRS 0–1 at 90-days N(%) | 6(21) | 9(30) | 10(32) | 19(31) |
RR (95% CrI), probability RR>1.0 | – | 1.17 (0.57, 2.37), 0.67 | 1.27 (0.63, 2.53), 0.74 | 1.34 (0.68, 2.76), 0.79 |
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SECONDARY OUTCOMES | ||||
Symptomatic Intracerebral Hemorrhage N(%) | 3(10) | 4(13) | 2(7) | 6(10) |
RR (95% CrI), probability RR>1.0 | – | 1.55 (1.07, 2.25), 0.99 | 1.73 (1.04, 2.89), 0.98 | – |
Recanalization at 2–3 hours | N=11 | N=20 | N=15 | N=35 |
Complete N (%) | 2(18) | 3(15) | 4(27) | 7(20) |
RR (95% CrI), probability RR>1.0 | – | 0.98 (0.61, 1.56), 0.46 | 1.05 (0.66, 1.68), 0.58 | 1.02 (0.64, 1.63), 0.53 |
Complete + Partial N (%) | 6(55) | 4(20) | 7(47) | 11(31) |
RR (95% CrI), probability RR>1.0 | – | 0.86 (0.55, 1.33), 0.25 | 1.06 (0.68, 1.65), 0.60 | 0.92 (0.59, 1.43), 0.35 |
Neurological Improvement, NIHSS, median (IQR) | ||||
RR (95% CrI), probability RR>1.0 | ||||
2-hours | 11 (6,19) N=29 | 14.5 (5,18) N=28 | 11 (4,16) N=31 | 13 (5,18) N=59 |
– | 1.11 (0.78, 1.58), 0.73 | 0.94 (0.66, 1.33), 0.36 | 1.02 (0.74, 1.39), 0.55 | |
24-hours | 10 (5,18) N=29 | 14 (3,20) N=29 | 9 (4,16) N=31 | 11.5 (3.5,18) N=60 |
– | 1.19 (0.79, 1.81), 0.79 | 0.94 (0.62, 1.42), 0.38 | 1.06 (0.72, 1.54), 0.62 | |
48-hours | 8 (3,18) N=27 | 10 (4,21) N=29 | 10 (2,17) N=31 | 10 (2.5,20) N=60 |
– | 1.19 (0.76, 1.88), 0.78 | 0.97 (0.61, 1.53), 0.44 | 1.09 (0.71, 1.63), 0.65 | |
Day 7 | 5 (3,14) N=27 | 10.5 (3,18) N=30 | 6 (2,14) N=29 | 9 (2,16) N=59 |
– | 1.17 (0.7, 1.98), 0.72 | 0.9 (0.53, 1.53), 0.34 | 1.03 (0.64, 1.66), 0.55 | |
Day 90 | 2.5 (1,8) N=24 | 5.5 (1.5,12.5) N=24 | 2 (1,7) N=25 | 3 (1,12) N=49 |
– | 1.33 (0.73, 2.42), 0.83 | 1.02 (0.55, 1.88), 0.52 | 1.21 (0.68, 2.1), 0.75 | |
Quality of Life at 90-days, median (IQR) | ||||
EuroQol EQ-5D utility | 0.62 (0,0.82) N=29 | 0.38 (0.05,0.79) N=28 | 0.64 (0.18,0.84) N=29 | 0.48 (0.12,0.83) N=57 |
Standard Gamble utility | 0.83 (0.45,0.98) N=27 | 0.68 (0.05,0.94) N=27 | 0.88 (0.50,0.95) N=28 | 0.78 (0.45,0.94) N=55 |
Visual Analogue Scale (converted to 0–1 scale) | 0.50 (0.28,0.75) N=28 | 0.42 (0.22,0.80) N=28 | 0.60 (0.50,0.85) N=29 | 0.50 (0.30,0.80) N=57 |