Table 2.
Primary Endpoint by Randomization Group Overall and Stratified by Moderate or less TR at Baseline
| All Patients | MVS Alone (N=203) | MVS + TA (N=198) | Relative Risk (95% CI) | P-value |
|---|---|---|---|---|
| Primary Endpoint | ||||
| Imputed - % (95% CI) | 10.2 (6.0, 14.5) | 3.9 (1.1, 6.7) | 0.37 (0.16, 0.86) | 0.02 |
| Observed | 20/188 (10.6) | 7/185 (3.8) | 0.35 (0.15, 0.81) | - |
| Died within 2 Years | 9/199 (4.5) | 6/190 (3.2) | 0.69 (0.25, 1.88) | - |
| TV Operation within 2 Years | 0/190 (0.0) | 0/184 (0.0) | - | - |
| Progression of TR at 2 Years | 11/179 (6.1) | 1/179 (0.6) | 0.09 (0.01, 0.69) | - |
| <Moderate TR at Baselinea | MVS Alone (N=126) | MVS + TA (N=124) | Relative Risk (95% CI) | |
| Primary Endpoint | ||||
| Observed | 7/115 (6.1) | 4/117 (3.4) | 0.56 (0.17, 1.87) | - |
| Died within 2 Years | 6/123 (4.9) | 3/119 (2.5) | 0.52 (0.13, 2.02) | - |
| TV Operation within 2 Years | 0/117 (0.0) | 0/116 (0.0) | - | - |
| Progression of TR at 2 Years | 1/109 (0.9) | 1/114 (0.9) | 0.96 (0.06, 15.10) | - |
| Moderate TR at Baselinea | MVS Alone (N=76) | MVS + TA (N=73) | Relative Risk (95% CI) | |
| Primary Endpoint | ||||
| Observed | 13/72 (18.1) | 3/67 (4.5) | 0.25 (0.07, 0.83) | - |
| Died within 2 Years | 3/75 (4.0) | 3/70 (4.3) | 1.07 (0.22, 5.13) | - |
| TV Operation within 2 Years | 0/72 (0.0) | 0/67 (0.0) | - | - |
| Progression of TR at 2 Years | 10/69 (14.5) | 0/64 (0.0) | - | - |
a
- Two patients are excluded from stratified analyses because the echo core lab was unable to read/confirm the degree of TR at baseline