Table 2.
Primary and Secondary Study Endpoint Outcomes1 [N= 1653 patients]
| Parameter | S-CPR [N=813] | Intervention2 [N=840] | p-value |
|---|---|---|---|
| PRIMARY COMPOSITE STUDY ENDPOINTS | |||
| Hospital Discharge-mRS3: | |||
| 0 | 3 (0.4) | 11 (1.3) | |
| 1 | 8 (1.0) | 11 (1.3) | |
| 2 | 26 (3.2) | 30 (3.6) | |
| 3 | 10 (1.2) | 23 (2.7) | 0.0394 |
| 4 | 10 (1.2) | 9 (1.1) | |
| 5 | 16 (2.0) | 18 (2.1) | |
| 6 | 727 (89.4) | 734 (87.4) | |
| Survival to hospital discharge not available | 6 (0.7) | 2 (0.2) | |
| Survived, MRS data not available | 7 (0.9) | 2 (0.2) | |
| mRS ≤ 3 (Primary Study Endpoint) | 47 (5.8%) | 75 (8.9%) | 0.019 |
| SECONDARY SURVIVAL ENDPOINTS | |||
| Survived to 24 hours post-arrest | 176 (21.6) | 197 (23.5) | 0.41 |
| Data not available | 9 (1.1) | 6 (0.7) | |
| Survived to hospital discharge | 80 (9.8) | 104 (12.4) | 0.12 |
| Data not available | 6 (0.7) | 2 (0.4) | |
| Discharge location, % of discharged: | |||
| Home | 47 (58.8) | 67 (64.4) | 0.75 |
| Other | 28 (35.0) | 35 (33.7) | |
| Data not available | 5 (6.2) | 2 (1.9) | |
| Survived to 90 Days | 58 (7.1) | 87 (10.4) | 0.029 |
| Data not available | 15 (1.8) | 8 (1.0) | |
| Survived to 1 Year | 48 (5.9) | 74 (8.8) | 0.030 |
| Data not available | 19 (2.3) | 19 (2.3) | |
| Initial arrest rhythm mRS ≤3 | |||
| VF/Pulseless VT | 40 (16.7) | 66 (22.9) | 0.06455 |
| Asystole | 3 (0.8) | 6 (1.6) | |
| PEA | 3 (1.7) | 2 (1.2) | |
| Unknown | 1 (0.1) | 1 (0.1) | |
| NEUROLOGIC ASSESSMENT | |||
| CASI6 (subjects with complete score, validity = 1) | |||
| 90 day | 93.2 ± 7.4 | 90.4 ± 13.4 | 0.251 |
| Data N/A | 19 (33) | 35 (40) | |
| 365 days | 92.9 ± 12.0 | 94.5 ± 4.5 | 0.473 |
| Data N/A | 16 (33) | 32 (43) | |
| Beck Depression Score7 | |||
| 90 day | 4.8 ± 3.9 | 6.5 ± 6.8 | 0.098 |
| Data N/A | 14 (24) | 22 (25) | |
| 365 days | 5.2 ± 6.3 | 5.5 ± 5.9 | 0.862 |
| Data N/A | 13 (27) | 17 (23) | |
Values are expressed as number of patients (percentage) unless otherwise indicated, and includes all patients who met final study enrollment endpoint criteria. P-values are based on subjects with data on status available.
Received active compression decompression cardiopulmonary resuscitation plus and impedance threshold device
mRS= modified Rankin Scale as follows: 0= asymptomatic, 1= no significant disability, 2= slight disability, 3= moderate disability, 4= moderately severe disability, 5= severe disability, 6= dead.
P-value = 0.039 for difference in distribution of mRS values.
A Mantel-Haenszel test statistic across the 3 initial arrest rhythm groups was used.
CASI = Cognitive Abilities Screening Instrument: assessment of attention, short- and long-term memory, judgment, spatial ability, concentration; based on a scale of 0–100 where 100 is a perfect score.
Beck Depression Index: evaluation of depression using a scale of 0–63 where 0–13=minimal signs of depression, 14–19=mild, 20–28=moderate, and 29–63=severe.