Table 1.
Clinical End Points, Serious Adverse Events, and Hospitalizations.*
| End Point or Event | From Baseline to 1 Yr | From 1 Yr to 2 Yr† | From Baseline to 2 Yr | ||||||
|---|---|---|---|---|---|---|---|---|---|
| CABG (N = 151) | CABG plus Repair (N = 150) | P Value | CABG (N = 128) | CABG plus Repair (N = 137) | P Value | CABG (N = 151) | CABG plus Repair (N = 150) | P Value | |
| no. of patients (%) | no. of patients (%) | no. of patients (%) | |||||||
|
| |||||||||
| Clinical end point | |||||||||
|
| |||||||||
| Death | 11 (7.3) | 10 (6.7) | 0.83 | 5 (3.9) | 5 (3.6) | 1.0 | 16 (10.6) | 15 (10.0) | 0.86 |
|
| |||||||||
| Stroke | 2 (1.3) | 6 (4.0) | 0.17 | 0 | 0 | NA | 2 (1.3) | 6 (4.0) | 0.17 |
|
| |||||||||
| Increase of ≥1 NYHA class‡ | 9 (7.7) | 12 (9.4) | 0.63 | 14 (14.0) | 12 (10.4) | 0.42 | 14 (14.0) | 12 (10.4) | 0.42 |
|
| |||||||||
| Rehospitalization for heart failure | 20 (13.2) | 22 (14.7) | 0.72 | 6 (4.7) | 6 (4.4) | 0.90 | 22 (14.6) | 26 (17.3) | 0.51 |
|
| |||||||||
| Mitral-valve surgery after index procedure | 0 | 2 (1.3) | 0.25 | 2 (1.6) | 0 | 0.23 | 2 (1.3) | 2 (1.3) | 1.0 |
|
| |||||||||
| LVAD or heart transplantation | 1 (0.7) | 4 (2.7) | 0.21 | 0 | 1 (0.7) | 1.0 | 1 (0.7) | 4 (2.7) | 0.21 |
|
| |||||||||
| Composite MACCE end point | 38 (25.2) | 38 (25.3) | 0.97 | 24 (18.8) | 19 (13.9) | 0.28 | 48 (31.8) | 46 (30.7) | 0.83 |
|
| |||||||||
| no. of events (no./100 patient-yr) | no. of events (no./100 patient-yr) | no. of events (no./100 patient-yr) | |||||||
|
| |||||||||
| Serious adverse events | |||||||||
|
| |||||||||
| Any | 158 (118.9) | 192 (141.1) | 0.11 | 42 (40.0) | 43 (36.0) | 0.63 | 200 (84.0) | 235 (92.0) | 0.35 |
|
| |||||||||
| Heart failure | 30 (22.6) | 31 (22.8) | 0.97 | 9 (8.6) | 9 (7.5) | 0.79 | 39 (16.4) | 40 (15.7) | 0.84 |
|
| |||||||||
| Neurologic dysfunction | |||||||||
|
| |||||||||
| Any | 4 (3.0) | 14 (10.3) | 0.02 | 0 | 0 | NA | 4 (1.7) | 14 (5.5) | 0.02 |
|
| |||||||||
| Stroke | 2 (1.5) | 7 (5.1) | 0.10 | 0 | 0 | NA | 2 (0.8) | 7 (2.7) | 0.11 |
|
| |||||||||
| Myocardial infarction | |||||||||
|
| |||||||||
| Nonperioperative | 1 (0.8) | 1 (0.7) | 0.99 | 1 (1.0) | 0 | 0.32 | 2 (0.8) | 1 (0.4) | 0.53 |
|
| |||||||||
| Perioperative | 1 (0.8) | 0 | 0.32 | 0 | 0 | NA | 1 (0.4) | 0 | 0.32 |
|
| |||||||||
| Renal failure | 4 (3.0) | 4 (2.9) | 0.97 | 3 (2.9) | 2 (1.7) | 0.56 | 7 (2.9) | 6 (2.3) | 0.69 |
|
| |||||||||
| Bleeding | 4 (3.0) | 2 (1.5) | 0.40 | 2 (1.9) | 0 | 0.16 | 6 (2.5) | 2 (0.8) | 0.14 |
|
| |||||||||
| Arrhythmia | |||||||||
|
| |||||||||
| Supraventricular | 11 (8.3) | 24 (17.6) | 0.03 | 0 | 0 | NA | 11 (4.6) | 24 (9.4) | 0.04 |
|
| |||||||||
| Ventricular | 5 (3.8) | 2 (1.5) | 0.25 | 0 | 2 (1.7) | 0.16 | 5 (2.1) | 4 (1.6) | 0.66 |
|
| |||||||||
| Localized infection | 19 (14.3) | 18 (13.2) | 0.81 | 3 (2.9) | 7 (5.9) | 0.28 | 22 (9.2) | 25 (9.8) | 0.84 |
|
| |||||||||
| Endocarditis | 0 | 2 (1.5) | 0.16 | 1 (1.0) | 0 | 0.32 | 1 (0.4) | 2 (0.8) | 0.60 |
|
| |||||||||
| Sepsis | 7 (5.3) | 9 (6.6) | 0.65 | 0 | 0 | NA | 7 (2.9) | 9 (3.5) | 0.72 |
|
| |||||||||
| Respiratory failure | 8 (6.0) | 10 (7.3) | 0.67 | 1 (1.0) | 0 | 0.32 | 9 (3.8) | 10 (3.9) | 0.94 |
|
| |||||||||
| Hospitalization | |||||||||
|
| |||||||||
| Any readmission | 96 (75.2) | 89 (68.6) | 0.54 | 37 (35.4) | 40 (33.8) | 0.83 | 133 (57.3) | 129 (52.0) | 0.43 |
|
| |||||||||
| Readmission for cardiovascular causes | 51 (40.0) | 46 (35.5) | 0.56 | 20 (19.2) | 18 (15.2) | 0.48 | 71 (30.6) | 64 (25.8) | 0.32 |
CABG denotes coronary-artery bypass grafting, LVAD left ventricular assist device, MACCE major adverse cardiac or cerebrovascular event, NA not applicable, and NYHA New York Heart Association.
During the period from 1 year to 2 years, the number of patients includes all those with MACCE, which was defined as death, stroke, subsequent mitral-valve surgery, hospitalization for heart failure, or worsening New York Heart Association class. Excluded from the number of patients who were evaluated were patients who died, withdrew, or were lost to follow-up by 1 year. Several patients had events both before and after 1 year. In the CABG-alone group, 10 of 14 patients with worsening NYHA class had their first event after 1 year, 2 of 6 patients were readmitted to the hospital for heart failure for the first time after 1 year, and 13 of 24 with MACCE had their first event after 1 year. In the combined-procedure group, the numbers of patients were 6 of 12 for worsening NYHA class, 4 of 6 for hospital readmission, and 11 of 19 with MACCE. In the combined-procedure group, 1 patient received an LVAD during year 1 and underwent heart transplantation in year 2.
Changes in the NYHA class were evaluated in 117 patients in the CABG group and in 127 patients in the combined-procedure group at 1 year and in 100 patients and 115 patients, respectively, at 2 years.