Introduction
Methods
Study design and participants
Etiological identification of Cardiac embolism
Treatments
Variables and imaging assessment
Outcomes
Statistical analysis
Results
Patient characteristics
Total (N = 406) | Placebo (n = 194) | Tirofiban (n = 212) | P value | |
---|---|---|---|---|
Age, y | 69 (59–75) | 68(57–76) | 69(59–78) | 0.442 |
Male, n (%) | 179(44.1) | 86(44.3) | 93(43.9) | 0.079 |
Smoking, n (%) | 47(11.6) | 19(9.8) | 28(13.2) | 0.07 |
Medical history, n (%) | ||||
Coronary heart disease | 74(18.2) | 40(20.6) | 34(16) | 0.05 |
Atrial fibrillation | 261(64.3) | 124(63.9) | 137(64.6) | 0.082 |
Hypertension | 197(48.5) | 92(47.4) | 105(49.5) | 0.072 |
Hyperlipidemia | 39(9.6) | 15(7.7) | 24(11.3) | 0.064 |
Diabetes | 68(16.7) | 29(14.9) | 39(18.4) | 0.069 |
Ischemic stroke | 85(20.9) | 44(22.7) | 41(19.3) | 0.069 |
Prestroke antithrombolic history, n (%) | ||||
History antiplatelet | 41(10.1) | 19(9.8) | 22(10.4) | 0.128 |
History anticoagulation | 63(15.5) | 31(16.0) | 32(15.1) | 0.106 |
Baseline SBP, mmHg | 148 (132–166) | 147 (131–164) | 150 (133–169) | 0.433 |
Serum glucose | 7.0 (5.6–9.2) | 7.0 (5.5–9.1) | 7.0 (5.6–9.3) | 0.9 |
Occlusion site, n (%) | 0.061 | |||
ICA intracranial | 101(24.9) | 49(25.3) | 52(24.5) | |
MCA-M1 | 239(58.9) | 114(58.8) | 125(59) | |
MCA-M2 | 66(16.3) | 31(16) | 35(16.5) | |
Substantial reperfusion, n (%) | 386(95.1) | 183(94.3) | 203(95.8) | 0.146 |
Anesthesia, n (%) | 0.087 | |||
General | 105(25.9) | 49(25.3) | 56(26.4) | |
Local | 301(74.1) | 145(74.7) | 156(73.6) | |
Baseline NIHSS | 16 (12–19) | 15 (11–18) | 16 (12–20) | 0.076 |
Baseline ASPECTS | 8 (7–9) | 8 (7–9) | 8 (7–9) | 0.456 |
Onset to randomization, min | 334(223–505) | 313(203–483) | 350(236–527) | 0.045 |
Onset to recanalization, min | 389(280–577) | 359(268–546) | 405(289–587) | 0.054 |
Total passes | 2 (2–3) | 2 (1–3) | 2 (2–3) | 0.051 |
ASITN-SIR | 2 (2–3) | 2 (2–3) | 2 (2–3) | 0.508 |
Efficacy outcomes
Total (N = 406) | Placebo (n = 194) | Tirofiban (n = 212) | P-value | |
---|---|---|---|---|
Efficacy outcomes | ||||
3-month mRS score | 3(1–4) | 3(1–4) | 3(1–4) | 0.941 |
3-month mRS score 0–1, n (%) | 149(36.7) | 69(35.6) | 80(37.7) | 0.681 |
3-month mRS score 0–2, n (%) | 202(49.8) | 96(49.5) | 106(50) | 0.921 |
3-month mRS score 0–3, n (%) | 251(61.8) | 121(62.4) | 130(61.3) | 0.839 |
NIHSS 24 h minus baseline | − 2(− 6 to 2) | − 2(− 6 to 2) | − 2(− 6 to 2) | 0.825 |
NIHSS 7d minus baseline | − 5(− 10 to 1) | − 5(− 10 to 1) | − 5(− 10 to 2) | 0.358 |
Reperfusion at 48 h, n (%) | 295(96.4) | 144(97.3) | 151(95.6) | 0.417 |
3-month EQ5D5L | 0.7(0.2–1.0) | 0.7(0.2–0.9) | 0.7(0.2–1.0) | 0.863 |
Safety outcomes | ||||
sICH, n (%) | 33(8.1) | 7(3.6) | 26(12.3) | 0.002 |
Any ICH, n (%) | 148(36.5) | 62(32.1) | 86(40.6) | 0.078 |
3-month death, n (%) | 76(18.7) | 31(16) | 45(21.2) | 0.176 |
Safety outcomes
Unadjusted model | Adjusted model | |||
---|---|---|---|---|
Coefficients (95% CI) | P value | Coefficients (95% CI) | P value | |
3-month mRS score | 0.99(0.7,1.39) | 0.941 | 0.91(0.64,1.3) | 0.617 |
3-month mRS score 0–1 | 1.1(0.73,1.65) | 0.651 | 1(0.63,1.57) | 0.994 |
3-month mRS score 0–2 | 1.02(0.69,1.51) | 0.917 | 0.97(0.63,1.51) | 0.907 |
3-month mRS score 0–3 | 0.96(0.64,1.43) | 0.828 | 0.93(0.59,1.47) | 0.763 |
NIHSS 24 h minus baseline | 0.3(− 1.49,2.08) | 0.745 | 1.38(0.54,3.49) | 0.5 |
NIHSS 7d minus baseline | 1.29(− 1,3.57) | 0.27 | 1.77(0.15,20.34) | 0.647 |
Reperfusion at 48 h | 1.36(0.55,3.35) | 0.509 | 1.04(− 1.18,3.25) | 0.837 |
3-month EQ5D5L | − 0.01(− 0.08,0.07) | 0.879 | 0.89(− 1.56,1.91) | 0.847 |
sICH | 3.71(1.57,8.77) | 0.003 | 3.85(1.59,9.09) | 0.003 |
Any ICH | 1.44(0.96,2.17) | 0.079 | 1.44(0.94,2.19) | 0.094 |
3-month death | 1.42(0.85,2.35) | 0.177 | 1.48(0.88,2.52) | 0.143 |