Table 3.
| a: Risk factors stratified by primary endpoints for first (I1) and second (I2) investigation. | |||||
|---|---|---|---|---|---|
| N | Alive n=64 |
Arrhythmic death/ resusciated cardiac arrest n=13 |
Death other n=13 |
P-value | |
| Autonomic tone | |||||
| BRS_I1, ms/mmHG, Med | 55 | 10·3 (6·3–18·9) | 6·3 (4·7–12·0) | 4·1 (1·6–8·1) | 0·012 |
| BRS_I2, ms/mmHG, Med | 65 | 10·2 (7·5–19·0) | 6·2 (5·0–10·9) | 14·2 (9·0–24·0) | 0·4 |
| LF/HF_I1, LF to HF ratio, Med | 49 | 2·4 (1·2–4·9) | 2·5 (1·8–3·7) | 1·3 (0·4–2·2) | 0·25 |
| LF/HF_I2, LF to HF ratio, Med | 67 | 3·4 (1·7–5·2) | 2·6 (1·9–3·7) | 5·5 (3·4–5·8) | 0·52 |
| HRV_I1, SDNN, ms, Med | 50 | 130 (100–158) | 102 (80–106) | 65 (56–91) | <0·001 |
| HRV_I2, SDNN, ms, Med | 53 | 121 (97–143) | 104 (94–123) | 99 (78–113) | 0·36 |
| Electrical substrate | |||||
| SAECG_I1 | 55 | 0·68 | |||
| Negative | 25 (69) | 6 (60) | 5 (56) | ||
| Non-negative | 11 (31) | 4 (40) | 4 (44) | ||
| SAECG_I2 | 57 | 0·58 | |||
| Negative | 30 (62) | 4 (67) | 1 (33) | ||
| Non-negative | 18 (38) | 2 (33) | 2 (67) | ||
| MTWA_I1 | 90 | <0·001 | |||
| Negative | 53 (83) | 2 (15) | 10 (77) | ||
| Non-negative | 11 (17) | 11 (85) | 3 (23) | ||
| MTWA_I2 | 73 | ||||
| Negative | 45 (71) | 0 | 3 (75) | 0·002 | |
| Non-negative | 18 (29) | 6 (100) | 1 (25) | ||
| Clinical variables | |||||
| History of syncope_I1 | 90 | 4 (6) | 4 (31) | 1 (8) | 0·026 |
| Non-sustained VT_I1 | 55 | 7 (20) | 5 (45) | 1 (11) | 0·14 |
| NYHA_I1 classification | 90 | <0·001 | |||
| NYHA I | 32 (50) | 6 (46) | 2 (15) | ||
| NYHA II | 30 (47) | 5 (38) | 4 (31) | ||
| NYHA III | 2 (3) | 2 (15) | 7 (54) | ||
| LVEF_I1, %, Med | 90 | 46 (32–67) | 33 (29–39) | 26 (22–35) | <0·001 |
| LVEF_I2, %, Med | 73 | 47 (36–67) | 31 (26–38) | 31 (24–41) | 0·006 |
| QTC_I1, ms, Med | 48 | 453 (426–466) | 464 (425–486) | 478 (466–494) | 0·18 |
| QTC_I2, ms, Med | 41 | 435 (403–465) | 459 (446–460) | 462 (452–471) | 0·41 |
| Crea_I1, mg/dl, Med | 38 | 1·0 (0·9–1·2) | 1·1 (1·1–1·3) | 1·2 (1·2–1·3) | 0·51 |
| Crea_I2, mg/dl, Med | 33 | 1·0 (0·9–1·2) | 1·1 (1·1–1·3) | 1·2 (1·2–1·3) | 0·44 |
| b: Risk factors stratified by secondary endpoints for first (I1) and second (I2) investigation | |||||
|---|---|---|---|---|---|
| N | Alive, n=66 |
Cardiac death, n=21 |
Non-cardiac death, n=3 |
P- value |
|
| Autonomic tone | |||||
| BRS_I1, ms/mmHG, Med | 55 | 10·3 (6·6–19·8) | 4·7 (1·7–8·3) | 8·2 (8·1–8·4) | 0·006 |
| BRS_I2, ms/mmHG, Med | 66 | 12·1 (7·0–18·8) | 13·8 (9·4–20·9) | 9·0 (6·4–11·6) | 0·7 |
| LF/HF_I1, LF to HF ratio, Med | 49 | 2·5 (1·3–5·1) | 2·0 (0·9–2·6) | 3·7 (2·0–5·4) | 0·3 |
| LF/HF_I2, LF to HF ratio, Med | 67 | 3·4 (1·7–5·1) | 2·3 (1·3–2·9) | 5·8 (5·6–5·9) | 0·14 |
| HRV_I1, SDNN, ms, Med | 50 | 130 (100–158) | 84 (63–102) | 96 (76–115) | 0·001 |
| HRV_I2, SDNN, ms, Med | 53 | 120 (96–142) | 125 (110–138) | 78 (68–89) | 0·25 |
| Electrical substrate | |||||
| MTWA_I1 | 90 | <0·001 | |||
| Negative | 54 (82) | 8 (38) | 3 (100) | ||
| Non-negative | 12 (18) | 13 (62) | 0 | ||
| MTWA_I2 | 73 | ||||
| Negative | 45 (69) | 1 (17) | 2 (100) | 0·02 | |
| Non-negative | 20 (31) | 5 (83) | 0 | ||
| Clinical variables | |||||
| NYHA_I1 classification | 90 | <0·001 | |||
| NYHA I | 33 (50) | 6 (29) | 1 (33) | ||
| NYHA II | 31 (47) | 6 (29) | 2 (67) | ||
| NYHA III | 2 (3) | 9 (43) | 0 | ||
| LVEF_I1, %, Med | 90 | 46 (32–67) | 29 (25–35) | 36 (36–49) | <0·001 |
| LVEF_I2, %, Med | 73 | 47 (35–67) | 26 (21–28) | 47 (41–53) | 0·003 |
Data are n (%), unless otherwise indicated; Med=median (Q1–Q3); I1, I2 Investigation 1 and 2, N is the number of non-missing values; tests used: Pearson Chi-square test, Kruskal-Wallis test.