Table 4.
End Point Analyses of Global and Regional LV Function Between Baseline and 6 Months
| BMC | Placebo | Analysis Between- Group Difference in 6- Month Change (95% CI) |
||||||
|---|---|---|---|---|---|---|---|---|
| No. | Mean (SD) |
95% CI | No. | Mean (SD) |
95% CI |
P Value |
||
| Overall Effect of Therapy | ||||||||
| Global LV Function | ||||||||
| LVEF, % | ||||||||
| Baseline | 75 | 45.2(10.6) | 37 | 44.5(10.8) | ||||
| Follow-up | 75 | 48.3(13.3) | 37 | 47.8(13.6) | ||||
| Within-group change | 75 | 3.2(10.3) | (0.9 to 5.5) | 37 | 3.3(9.7) | (0.2 to 6.4) | −0.1 (−4.1 to 3.9) | 0.959 |
|
| ||||||||
| Regional LV Function | ||||||||
| Infarct zone wall motion, mm | ||||||||
| Baseline | 75 | 4.0(4.7) | 37 | 4.1(3.7) | ||||
| Follow-up | 75 | 5.7(6.3) | 37 | 6.7(6.3) | ||||
| Within-group change | 75 | 1.7(5.5) | (0.5 to 2.9) | 37 | 2.6(4.9) | (1.0 to 4.2) | −0.9 (−3.0 to 1.2) | 0.409 |
| Border zone wall motion, mm | ||||||||
| Border zone wall motion, mm | ||||||||
| Baseline | 75 | 15.2(9.9) | 37 | 13.1(10.4) | ||||
| Follow-up | 75 | 19.1(11.8) | 37 | 17.4(13.0) | ||||
| Within-group change | 75 | 3.8(8.8) | (1.8 to 5.8) | 37 | 4.3(8.0) | (1.7 to 6.9) | −0.5 (−3.9 to 2.9) | 0.777 |
|
| ||||||||
| Day 3 | ||||||||
| Global LV Function | ||||||||
| LVEF, % | ||||||||
| Baseline | 41 | 46.1 (11.1) |
22 | 41.6 (10.0) |
||||
| Follow-up | 41 | 49.6 (14.2) |
22 | 45.9 (13.8) |
||||
| Within-group change | 41 | 3.5 (11.0) | (0.1 to 6.9) |
22 | 4.4 (10.6) | (0.0 to 8.8) | −0.9 (−6.6 to 4.9) | 0.763 |
|
| ||||||||
| Regional LV Function | ||||||||
| Infarct zone wall motion, mm | ||||||||
| Baseline | 41 | 4.2 (5.2) | 22 | 3.7 (4.3) | ||||
| Follow-up | 41 | 6.3 (6.9) | 22 | 6.1 (6.7) | ||||
| Within-group change | 41 | 2.1 (5.9) | (0.3 to 3.9) |
22 | 2.4 (5.3) | (0.2 to 4.6) | −0.3 (−3.3 to 2.7) | 0.824 |
| Border zone wall motion, mm | ||||||||
| Baseline | 41 | 16.7 (11.2) | 22 | 12.6 (11.0) | ||||
| Follow-up | 41 | 20.2 (12.9) |
22 | 16.9 (12.9) |
||||
| Within-group change | 41 | 3.5 (9.3) | (0.7 to 6.3) |
22 | 4.3 (8.7) | (0.7 to 7.9) | −0.8 (−5.6 to 4.0) | 0.745 |
|
| ||||||||
| Day 7 | ||||||||
| Global LV Function | ||||||||
| LVEF, % | ||||||||
| Baseline | 34 | 44.0 (9.9) | 15 | 48.8 (10.9) |
||||
| Follow-up | 34 | 46.8 (12.3) |
15 | 50.4 (13.3) |
||||
| Within-group change | 34 | 2.8 (9.7) | (−0.5 to 6.1) |
15 | 1.7 (8.2) | (−2.4 to 5.8) | 1.1 (−4.7 to 6.9) | 0.702 |
|
| ||||||||
| Regional LV Function | ||||||||
| Infarct zone wall motion, mm | ||||||||
| Baseline | 34 | 3.8 (3.9) | 15 | 4.7 (2.7) | ||||
| Follow-up | 34 | 5.0 (5.5) | 15 | 7.4 (5.9) | ||||
| Within-group change | 34 | 1.2 (4.9) | (−0.4 to 2.8) | 15 | 2.8 (4.4) | (0.6 to 5.0) | −1.6 (−4.5 to 1.4) | 0.297 |
| Border zone wall motion, mm | ||||||||
| Baseline | 34 | 13.5 (7.7) | 15 | 13.8 (9.7) | ||||
| Follow-up | 34 | 17.7 (10.3) |
15 | 18.2 (13.6) |
||||
| Within-group change | 34 | 4.2 (8.3) | (1.4 to 7.0) |
15 | 4.4 (7.2) | (0.8 to 8.0) | −0.1 (−5.1 to 4.8) | 0.955 |