Table 3. Safety Data at 12 Months.
| No. (%) | Event rate per patient-year (95% CI) | ||
|---|---|---|---|
| Events | Patientsa | ||
| MACCE | |||
| Mortality | 5 (22.7) | 5 (2.2) | 0.023 (0.009-0.055) |
| Stroke | 7 (31.8) | 6 (2.7) | 0.032 (0.014-0.074) |
| Myocardial infarction | 7 (31.8) | 7 (3.1) | 0.032 (0.015-0.067) |
| Ischemic-driven target vessel revascularization of supported graft or associated target coronary artery | 3 (13.6) | 3 (1.3) | 0.014 (0.004-0.042) |
| Composite MACCE | 22 (100) | 16 (7.1) | 0.101 (0.061-0.168) |
| Non-MACCE | |||
| Non-MACCE revascularizationb | 10 (6.8) | 10 (4.5) | 0.046 (0.025-0.084) |
| Bleeding | 2 (1.4) | 2 (0.9) | 0.009 (0.002-0.036) |
| Cardiac arrest | 2 (1.4) | 2 (0.9) | 0.009 (0.002-0.037) |
| Sustained ventricular arrhythmia requiring defibrillation or cardioversion | 3 (2.1) | 3 (1.3) | 0.014 (0.004-0.042) |
| Sustained supraventricular arrhythmia requiring drug treatment or cardioversion | 14 (9.6) | 13 (5.8) | 0.064 (0.037-0.111) |
| Cardiac conduction abnormalities or sustained bradycardia requiring permanent pacemaker placement | 3 (2.1) | 3 (1.3) | 0.014 (0.004-0.042) |
| Pericardial fluid collection | 2 (1.4) | 2 (0.9) | 0.009 (0.002-0.037) |
| Pleural effusion | 7 (4.8) | 7 (3.1) | 0.032 (0.015-0.067) |
| Pneumothorax | 2 (1.4) | 2 (0.9) | 0.009 (0.002-0.036) |
| Hepatic dysfunction | 1 (0.7) | 1 (0.4) | 0.005 (0.001-0.033) |
| Localized infection | 23 (15.8) | 18 (8.0) | 0.105 (0.064-0.174) |
| Sepsis | 4 (2.7) | 4 (1.8) | 0.018 (0.007-0.049) |
| Kidney failure | 1 (0.7) | 1 (0.4) | 0.005 (0.001-0.033) |
| Respiratory failure | 4 (2.7) | 4 (1.8) | 0.018 (0.007-0.049) |
| Heart failure | 7 (4.8) | 6 (2.7) | 0.032 (0.014-0.074) |
| Arterial non-CNS thromboembolism | 1 (0.7) | 1 (0.4) | 0.005 (0.001-0.032) |
| Venous thromboembolic event | 8 (5.5) | 7 (3.1) | 0.037 (0.017-0.079) |
| Wound dehiscence | 1 (0.7) | 1 (0.4) | 0.005 (0.001-0.033) |
| Other adverse event | 51 (34.9) | 37 (16.5) | 0.234 (0.162-0.337) |
| All serious AEs and non-MACCE revascularizations | 146 (100) | 85 (37.9) | 0.670 (0.528-0.849) |
| Hospitalizations, all causes | 89 | 62 (27.7) | 0.421 (0.315-0.561) |
Abbreviations: AE, adverse event; CNS, central nervous system; MACCE, major adverse coronary and cerebrovascular events.
a
The denominator is 224 patients.
b
Non-MAACE revascularizations include non–ischemic-driven target vessel revascularization of supported graft or associated target coronary artery (n = 1), ischemic or nonischemic target vessel revascularization of unsupported graft or associated target coronary artery (n = 5), or revascularization of nonstudy vein grafts/vessels (n = 4).